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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing the list of top health technology hazards identified by ECRI. ECRI is an independent, nonprofit organization that improves the safety, quality, and cost-effectiveness of care across all healthcare settings. Each year, they publish this Top 10 list to help bring awareness to problem technology concerns and encourage improvement. During this conversation, the following questions are addressed:

We discussed this in a podcast in March 2024. Why are we discussing this again?
What is ECRI, and what is the purpose of this list?
Why is this topic important to device manufactures and to patients?
What’s on the current 2026 hazards list?
How do the hazards in the 2026 list compare to previous years?
At the end of the day, what, if anything, have we learned? Are we going in the right direction or simply treading water?
What are today’s takeaways?

Listen to this discussion and see if you have issues you should address based on this list. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about how to best determine the efficacy of regulatory and quality team members. A variety of real-world examples are provided that demonstrate the need to “trust but verify” the actions of these team members. During this conversation, the following questions are addressed:

Why the need to measure the safety and efficacy of the regulatory and quality team?
What can happen if you put too much trust or reliance on your regulatory consultant?
Can you give a specific example where there was too much trust?
Can you give us another regulatory example, perhaps involving clinical trials?
Can you provide a quality or manufacturing example, perhaps involving AI?
What are today’s takeaways?

Listen to this discussion and see if you need a plan to verify your regulatory and quality team members’ actions. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s third-party review program. This option is available for certain 510k reviews. It is performed through an independent organization that is not part of the agency. As such, there are additional costs involved but the time savings could potential make up for that added expense. Other factors and considerations are also reviewed. During this conversation, the following questions are addressed:

If I need to get a 510k clearance on my new medical device, is going through the FDA my only option?
Under what circumstances should a sponsor consider using the third-party review program?
Under what circumstances should a sponsor not consider using the third-party review program?
How popular is the third-party review program, i.e., why are many people not familiar with it?
Can you provide some examples of devices that have gone through the third-party review program.
What advice would you provide in choosing which third-party review organization to work with?
What are the key steps when considering using the third-party review program?
When evaluating potential third-party review organizations, do you have recommendations on what questions to ask?
Is there anything like the third-party review program outside the US, i.e. is there any regulatory precedent?
What else is important, and what are today’s takeaways?

Listen to this discussion and see if you may have interest in the third-party review program. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers should be doing now and what can wait for a later time. During this conversation, the following questions are addressed:

As most are already familiar with QMS and now QMSR, we’ll dive deeper. Can you tell me if all sections of the QMSR listed in the QSR are required for all medical devices?
Is a full QMS required to be in place in order to secure FDA clearance or approval?
What about the sections of the QMSR? Are all of them equal in terms of importance? Are some sections more important than others?
When do I need to have a QMS in place?
What if I never intend to market my device? First, maybe provide an example of when that would be the case, and then address the first part.
Should all QMS systems look the same?
Are there differences with the QMSR with premarket vs. postmarket?
How do you know the QMS is working? How can you be sure?
What are the important takeaways from today’s session?

Listen to this discussion and see if you are compliant with the new QMSR. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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In this Medtech Matters podcast episode, sponsored by Nelson Labs, we’re discussing the importance of E&L (extractables and leachables) and biocompatibility testing for a variety of medical devices. The pair from Nelson Labs—Audrey Turley, B.S., Director of Lab Operations – Biosafety, and Kristin Treece, Ph.D., Principal Scientist - Analytical Chemistry—bring their expertise to the conversation, where a number of issues are resolved. During this episode, the following questions are addressed:

First, what is Nelson Labs? What do you do?
What is E&L testing?
Why is it important?
What is being tested?
Is this done on all medical devices?
Are there different tests for E&L depending on the device and/or application?
When is E&L testing performed?
What is biocomp testing?
Why is it important?
When is it performed?
How do you perform in vivo testing? (and what does in vivo mean?)
Anything else device manufacturers need to know about E&L and/or biocomp testing?

Listen to this discussion and see if you still have questions about E&L and/or biocompatibility testing. If you do, reach out to Nelson Labs to get answers. Feel free to use the links or contact mechanism here.

Click here to learn more about Nelson Labs >>>>>

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the following questions are addressed:

First, can you please explain what is out-of-bounds? (i.e., What will we NOT talk about?)
What can FDA do during the shutdown?
If a company currently has a submission under review, pending communications (e.g., emails, questions, pre-submission meetings), or other activities currently pending with the Agency, what would you advise the company to do? How should they proceed?
If a company plans to make a submission, request a pre-submission meeting, or engage with FDA about other activities in the near future (but has not done so yet), what would you advise the company to do? How should they proceed?
Can a company submit a pre-sub request during this shutdown?
From a public policy perspective, how could situations like these be mitigated or possibly prevented in the future?
What additional thoughts/questions/comments/concerns/recommendations/etc. do you think are important to share regarding the shutdown and its implications on medical device companies in particular and regulatory affairs in general?
What else is important?
What are today’s takeaways?

Listen to this discussion and see if you can take action during the shutdown. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about a recent Editor’s Letter I wrote for MPO that gave reasons why placing a warning label on wellness devices about their status as an FDA regulated medical device would be a good idea. Does Mike agree? Do you agree that patients should be provided with an explanation that a wellness product does not get reviewed or approved by the FDA? During this conversation, the following questions are addressed:

My editorial is about wellness products. Before discussing further, can you remind us what a wellness product is?
Why did you write this column and given wellness devices have been “formally recognized” by FDA since 2016, why did you write it now?
In your title, you use Wellness Products vs. Wellness Devices. Why?
You point out in your editorial that general wellness devices are low risk devices. In fact, that’s part of the title of the guidance. But is it correct to say, “General wellness devices are low-risk devices”?
Let’s discuss the example from my editorial (SaltAir by Halosense).
Should wellness devices be required to have a disclaimer regarding their lack of FDA review, or should it be the consumer's responsibility to research and find out more about the product on their own?
If a disclaimer is recommended (maybe not required), what should the disclaimer say?
What else is important?
What are today’s takeaways?

Listen to this discussion and see if you think wellness products should get a warning. If you’

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re highlighting comments made by FDA representatives at an event about the most common premarket review issues they see in submissions. First, there is some discussion regarding whether the issues are truly premarket or postmarket concerns. Then, we look at what these are, why they are likely so common, examples of them, and how to avoid running into these issues yourself. During this conversation, the following questions are addressed:

Recently, three medical device senior operations officers from FDA’s Office of Inspections and Investigations spoke at a conference about the most common “issues” FDA encounters during the premarketing review of medical devices. Can you give a recap of what they said?
In your 30+ years of experience working in the medical device industry, would you agree with FDA that these are the three most common issues?
Before discussing the three specific common problems individually, what do you think is the “root cause” of these problems?
Can you provide some examples?
How can design change and design creep get companies in trouble with FDA?
What does “marketing beyond authorized intended use” mean?
Do you have suggestions and/or best practices to avoid running into problems around these issues?
What else is important?
What are today’s takeaways?

Listen to this discussion and see if you've run into these issues yourself. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we’re digging in to find out why almost a third of the reports are delayed or incomplete. We’ll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed:

First, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is.
What are the MAUDE reporting requirements?
How well does the MAUDE reporting system work?
Are there consequences for a delayed or incomplete report?
Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone?
What should manufacturers do?
What should the FDA do?
What else is important?
What are today’s takeaways?

Listen to this discussion and see if your company might have an issue with submitting a correct MAUDE report. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation on off-label communication. In this part, we’re examining the downside or negative aspects of this practice. We cover potential concerns and scenarios to avoid. Specifically, the following questions are addressed:

Mike, maybe you can kick things off with a very quick overview of what we previously covered in the first part of the conversation.
Now getting into that downside I mentioned in my opening, what are the disadvantages of off-label communication? In other words, what’s potentially wrong with allowing manufacturers to advertise uncleared or unapproved product claims?
Why are some (including some within the industry) opposed to giving manufacturers permission to advertise off-label claims?
Do you have any examples you can share?
Is it possible to find an appropriate balance between what claims should be vetted through the FDA and those that don’t need to be?
What happens when a company makes unsupported, deceptive, or completely false claims about a product?
In your professional opinion, should we allow a company to advertise unapproved claims that haven’t gone through a formal review process? Is it a good thing or a bad thing?
What else is important?
What are the most important takeaways?

Listen to this discussion after you’ve heard Part 1 and see what you think of off-label communication and the guidance. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about off-label communication. More specifically, we’re reviewing a recent guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed:

Can you first please provide an explanation of what “off-label” is in terms of the FDA?
Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication?
What’s new in this “final” guidance?
What is meant by firm-initiated communication containing scientific information on unapproved uses?
If you communicate with an organization about unapproved (or off-label) uses, what will happen?
If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion?
Does FDA need to know about the communication?
What else is important?
What are the most important takeaways?

Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this discussion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing over-the-counter (OTC) devices and aspects developers need to keep in mind for these devices. A variety of topics are covered, from regulatory questions to human factors design to cleaning protocols. Real-world examples are used to help illustrate several discussion topics. Specifically, the following questions are addressed:

What is an OTC device and how do OTC devices compare to prescriptive devices?
Can you provide some examples of OTC devices?
What types of devices are potential candidates for OTC status, including a switch from prescription (Rx) to OTC?
Does a switch from Rx to OTC for a 510(k)-cleared device require a new premarket submission?
Can real-world evidence (RWE) be used to support a premarket submission for an OTC device, including a switch from Rx to OTC use?

After you listen to this discussion, move on to part 2 to gain more specific insights as we narrow down on particular factors. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation about over-the-counter (OTC) medical devices. If you haven’t already enjoyed part 1 of the discussion, please be sure to listen to that one first. In this segment, we look at more specific regulatory- and design-related questions that could create some misunderstanding or confusion. Specifically, the following questions are addressed:
What is the process for bringing a novel OTC device to market?
Under what circumstances would a switch from Rx to OTC require a De Novo or premarket approval application (PMA) in lieu of a 510(k) submission?
What considerations may be relevant when designing an OTC device?
What is the mechanism for obtaining feedback from the FDA on the necessary data to support a premarket submission for an OTC device??
What are the requirements for clinical trials of OTC devices?
What is the role of human factors testing for OTC devices?
What are the labeling considerations for OTC devices?
What are the cleaning or disinfection considerations for OTC devices?
What are the Unique Device Identifier (UDI) requirements for OTC devices?
What else is important?
Are OTC devices searchable in the FDA’s medical device databases?
When are OTC digital health solutions or software regulated as devices?
What considerations apply to OTC software devices or connected devices?
What are todays take-aways?

After listening to both parts of the discussion, do you have a better understanding of OTC devices and are you evaluating your own products to see if any should be considered for this expansion? If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing a common part of a regulatory submission—the device description. While this element may seem to be straightforward, an extraordinary number of challenges originate with this portion of a submission. This discussion reviews the role this section plays in a regulatory submission and common mistakes that occur are covered. Specifically, the following questions are addressed:

Of all the potential topics we could be covering, why has device descriptions come up as one we should discuss?
What support do you have to say device descriptions are one of the most poorly written sections of a pre-sub or final regulatory submission?
What is the point of the device description in a regulatory submission? Why would it be so important to get it right?
How can you verify your device description does its job? How do you know?
How do you balance technical detail with simplicity in a device description, especially when you’re describing a complex device?
Is it worthwhile to reiterate the device description in a pre-sub meeting? Shouldn’t the reviewers already be familiar with it if it was included in the pre-sub submission.
Can you share specific recommendations on how to best write or design a device description?
Do you have an example you can share?
What else is important and/or what should listeners take away from this episode?

Listen to this discussion and see if you think you may have submitted device descriptions incorrectly in the past. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the potential implications for the medical device regulatory sector as a result of the U.S. presidential election. This recording took place two weeks following the election results. In addition, we speak about some recurring themes that are not exclusive to the election, such as the impact of regulatory on innovation. Specifically, the following questions are addressed:

Based on the fact things can continue to change, why discuss this now?
Would it be possible to eliminate the FDA? What might replace it?
Is there too much regulation of medical devices? Or is it just the opposite—too little? What’s the sweet spot?
There are some who believe the more regulation we have, the less innovation that’s possible. Do you agree? Are these directly impacted by each other?
Is it possible to separate regulation and politics?
Other than AdvaMed, which said it was looking forward to working with the new administration for what that’s worth, why isn’t the FDA or industry speaking about the possible eliminations at FDA?
Do you agree that safety and efficacy should NOT be a function of politics?
Without naming specific people, who is the type of person you’d want heading HHS or the FDA?
Does this discussion have implications related to reimbursement or CMS?
If you were serving as a regulatory consultant for a company looking at what’s potentially coming down the road, how would you advise them today?
Any final thoughts on what’s important for this discussion/topic?

Listen to this discussion and see if you agree with our assessments. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re drawing inspiration from an item I wrote about recently in one of my MPO editor’s letters. Specifically, I’m referring to the news of an assisted suicide machine that was being considered for introduction in Switzerland, where assisted suicide is legal under certain conditions. However, following the first instance of someone successfully using the device within the country, several people involved were arrested and the situation is being investigated further. Specifically, the following questions are addressed:

Should this be a device that goes through a regulatory review? Given its purpose, should it be treated as a regulated device?
If it were a regulated medical device, what would its classification be?
What would be its pathway to market?
Does risk have the same definition for a device like this?
Similarly, what about safety and efficacy? Is testing or a clinical trial required or even appropriate?
Is there a precedent for this type of product? Not talking about a predicate here but a precedent.
Any final thoughts on what’s important for this discussion/topic?

Listen to this discussion and see if you have a better understanding of CAPAs. If you’d like to share thoughts, ask questions, or have a suggestion

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1, click here to do so. Specifically, the following questions are addressed in part 2:

You have submitted a PCCP with a previous regulatory submission, but you have not yet made the actual, real-world change to the device. Can that PCCP submission, assuming it was approved, be used as a predicate for a 510k submission?
For what types of devices should I consider a PCCP?
Can you provide a few examples of PCCPs?
Can PCCPs be used for manufacturing?
Since the use of a PCCP is relatively new, can you think of what questions could potentially arise? What questions might we not have just yet?
Anything else you’d like to say about the use of a PCCP we haven’t covered?
What are the important takeaways?

After both parts, do you have a better understanding of PCCPs? If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier podcast on this topic). The more recent guidance expands the scope to any medical device, whether it has AI/ML or not. Specifically, the following questions are addressed:

What is a predetermined change control plan and why is it important?
FDA published two guidances on PCCPs (one last year in April and one just this past August). These two guidances sound similar (maybe substantially equivalent), so what’s the difference?
What’s the difference between a PCCP for a SaMD with ML or AI different from a PCCP for a non-SaMD device, like a catheter or stent?
Are there any limits on changes in a PCCP?
How and when do I submit a PCCP?
What are the advantages of submitting a PCCP?
Are there any disadvantages of submitting a PCCP?

Listen to part 2 of this discussion and then see if you have a better understanding of PCCPs. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpose, and how to best implement it. Specifically, the following questions are addressed:

Could you please briefly highlight the reasons FDA issues 483 observations and warning letters?
What is a CAPA and when should it be used?
What are the most common reasons for 483s and warning letters involving a CAPA?
How do you know if your CAPA is doing what it’s supposed to do?
Is industry taking the wrong approach with a CAPA? Is there a better way we could be looking at this issue?
How are CAPAs related to other aspects of the QMS, such as risk, post-market surveillance, or complaint handling?
Do you have examples that might help illustrate what we’ve discussed?
What else is important and/or what are the most important takeaways?

Listen to this discussion and see if you have a better understanding of CAPAs. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, the following questions are addressed:

Could you please explain what a 483 is and what a warning letter is? Are they the same thing?
What are some common reasons or examples of why a company would get a 483 or warning letter?
What are the first steps for a company that has just received a warning letter or 483?
Who is responsible for the response to a 483 or warning letter? Does this fall to regulatory? Quality? Who really should be responsible for addressing it?
Is it common for a company to get a warning letter or 483 for the same issue? If that happens, what then should the company do?
What’s worse than a 483 or warning letter? Is there a higher level that really causes a concern for the company involved?
What should be considered in terms of the PR hit as a result of a 483 or warning letter?
Do you have suggestions with regard to preventing a 483 or warning letter?
Anything more a company should consider and after that, please share what you consider to be the most important takeaways?

Listen to this discussion and see if you have a better handle on what to do if you get a 483 or warning letter. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some attention. So today, we’re going to look at what’s driving that attention and discuss the reasons behind it. We’ll also talk about how the FDA is seeking to use real-world evidence. Specifically, the following questions are addressed:

We’ve discussed real-world evidence previously, in podcasts from 2017 and 2020, but what’s the cause for us to do so today?
Without requiring people to go back and relisten to those previous podcasts—not that I’d object—can you please briefly explain what real-world evidence is? Could you also mention how it compares and contrasts with real-world data?
How does real-world evidence compare to what’s deemed the gold standard—randomized clinical trials?
Do you have any examples of how real-world evidence has been used in regulatory submissions?
FDA has a new draft guidance around real-world evidence. What’s actually new in this?
In your estimation, what are the limitations of the new guidance? Is it falling short of what its goal should be or is supposed to be?
Does the real-world data or evidence need to come from use within the U.S.?
In discussing the possibility of doing this topic, you mentioned manufacturers may be missing a real opportunity with real-world evidence. What do you mean by that?
What are the takeaways?

Listen to this discussion and see what you think of the use of real-world evidence. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices that unfortunately ended up being quite dangerous even though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documentary, The Bleeding Edge, was discussed but others are new. Specifically, the following questions are addressed:

First Mike, can you provide a definition of what a dangerous device is?
As I mentioned in the introduction, we previously discussed the 2018 documentary The Bleeding Edge, which featured some dangerous devices. How far back do dangerous devices go though? Are these a relatively newer problem?
Another publisher’s website featured a slideshow of four dangerous devices. But do you have any sort of idea of how many others there may have been?
With all the regulations in place, regulatory professionals that work in this industry, and FDA oversight, how do any “dangerous devices” make it to the market?
Should we be adding regulations to address these devices so they don’t happen again?
What are the takeaways?

Listen to this discussion and see what you think of the system we have to attempt to prevent these types of devices from getting to market. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the news that tie into the safety of medical devices. First, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-party testing lab data may be unreliable and, in some cases, falsified. Specifically, the following questions are addressed:

Can you give some additional insights into each of these news items and explain how they are connected?
Given the medtech universe and all the different types of devices it encompasses, a syringe seems somewhat low on the list of advanced devices. What can we learn from this device?
If a basic device like a syringe cracks or doesn’t function properly, how realistic is it that the issue is reported to the manufacturer or FDA?
If my device includes a syringe but it’s not manufactured by one of the companies that received a warning letter (or maybe it’s not even made in China), do I have anything to worry about?
Do you have an example to help illustrate this?
Looking beyond syringes, obviously virtually all device manufacturers rely on testing data. If the FDA is warning makers about third-party labs providing fabricated, duplicated, or otherwise unreliable data, what should companies do who use third-party testing labs?
What are the takeaways?

Listen to this discussion and see what you think of these concerns regarding device safety. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the latest annual list put out by ECRI, an independent authority on healthcare technology and safety, on their top 10 health technology hazards for 2024. The full list is available at the organization’s website, which is at www.ecri.org. Specifically, the following questions are addressed:

What is ECRI and what is the purpose of this list?
Number one on the list is medical devices for the home. Specifically, they indicate medical devices may pose usability challenges for home users, risking misuse and patient harm. Can you please explain why this would be number one on the list? What’s the issue with usability?
The second item on the list involves inadequate or onerous device cleaning instructions. So this isn’t really about cleaning protocols, but rather the instructions that indicate how the device should be cleaned. What’s the concern here?
The fourth item is regarding the sustainability trend. Specifically, ECRI states this one as overlooked environmental impacts of patient care endanger public health. This is more of a product design issue, correct?
Another hot topic item, number five calls out insufficient governance of AI used in medical technologies risks inappropriate care decisions. Is this indicating we should avoid relying too heavily on decisions indicated by AI and ensure clinician overview of findings?
Still another hot button, cybersecurity issues ranks at number six on the list. Specifically, it is listed as ransomware targeting the healthcare sector remains a critical threat. This ties in directly to the significant efforts being put forth to ensure connected devices have a cybersecurity plan in place, correct?
What are the takeaways?

Listen to this discussion and see what you think of these items on the list or what was missed and should have been on the list. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:

Could you please explain what an IRB or institutional review board is?
If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?
Are there situations in which I would not need an IRB approval prior to a clinical trial?
Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?
What information do I need to provide to the IRB for its review?
What kind of timeline should I expect with the IRB review process?
Do I have any recourse if the IRB review comes back not in my favor?
What are the takeaways?

Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s Breakthrough Designation Program (BDP). It’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive solution. Specifically, the following questions are addressed:

Can you please explain what the Breakthrough Device Designation program is?
When did the reimbursement component come into play with regard to the BDP?
Why is it important for a BDP device to have reimbursement tied to it upon regulatory approval/clearance?
What concerns did CMS have regarding the reimbursement portion of the BDP?
This year, we’ve seen proposed legislation from Congress to force CMS to pay for devices that gain the BDP designation. What’s going on with these?
Does the ridiculously low number of devices associated with the TCET demonstrate an underlying problem with all of this?
What about the proposed “reasonable and necessary” caveat that’s also associated with the TCET? Do we need to clarify what this means or just replace it entirely?
What are the takeaways?

Listen to this discussion and see how you feel about the latest proposed reimbursement plan. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed:

Can you please provide a brief explanation of the 510k pathway?
Why is the agency attempting to strengthen the program? What is their ultimate goal?
With the predicate device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?
What other best practices are tied to the predicate device selection?
How do you gather clinical data on a device that’s not cleared or approved and just being submitted to the FDA?
For what situations is the agency considering clinical data in a submission and why?
For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?
What do these mean to you? What will they mean to medical device manufacturers?
What are the takeaways?

Listen to this discussion and let us know what you think of any or all of these guidances. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for recalls. Specifically, the following questions are addressed:

Before we get into the reasons around why, can give a very brief overview of what exactly a device recall is?
Medical device recalls aren’t new, so why are we taking a closer look at them today?
Should we have been able to see this coming? Was this foreseeable?
Are all of these recalls, or really any recalls, equal in terms of how serious they are?
Can you explain what is meant by faulty manufacturing? Are machines making bad parts and it’s not being recognized?
Who’s job is it to set the specs?
Why the sudden increase? In 2022, recalls hit their lowest level in a decade. So what changed that now in 2023, they are at such a high level?
Moving forward, what could we do/should we do to mitigate these risks and minimize residual risk for devices in the future?
What are the takeaways?

Listen to this discussion and see if you feel more comfortable about avoiding a recall. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Specifically, the following questions are addressed:

Can you please give a brief overview of what an AI or ML product is?
Can you explain how this product can, quote evolve, as the FDA puts it?
Now can you cover what a predetermined change control plan is and how it relates to the AI/ML product in this discussion?
So why is this important? Why is it important to enable an AI or ML device to evolve?
Can you offer real world examples of how this all works?
What are the takeaways? Or in this instance, perhaps you could reiterate the most important tasks a company needs to keep in mind for their AI/ML products.

Listen to this discussion and see if you think this guidance addresses the issues associated with AI/ML. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed:

First, would you please explain the various levels of a recall as it relates to a medical device and what each level means?
Can you quickly remind us of how a predicate device is used in a 510k submission?
Given we’ve laid the groundwork, can you now please explain how a recalled device can be used as a predicate device?
Is there any argument that can be made for having it be valid to use a Class 1 recall device as a predicate?
Do you think a recall should invalidate a device from being used as a predicate? Or, would you ever suggest a recalled device to a client to be used as a predicate?
I know some have argued for a “cap” to a device being used as a predicate, for example, nothing older than 10 years. Should there be a minimum amount of time a device should be on the market in clinical use to be able to be used as a predicate?
What are the most important takeaways?

Listen to this discussion and see if you think using a recalled device as a predicate is a good regulatory strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that’s the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes that get other companies into trouble with the agency. Specifically, the following questions are addressed:

Can run through the top reasons for 483s and warning letters?
Can you provide some examples of CAPA problems and offer suggestions for avoiding them?
Like CAPAs, design controls accounted for more than 12% of the list. Can you provide examples of these violations and suggestions on how to avoid them?
Third among the top was complaint handling, almost 11% of all violations. Do you have examples of these and tips for avoiding them?
Are these top three problems really identical to what we’ve seen in previous years? Are these the same mistakes again?
What are the most important takeaways with regard to today’s discussion?

Listen to this discussion and see if you might be vulnerable to a 483 upon your next inspection. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed between the two parts of this podcast presentation:

Can you start today’s conversation by explaining why we’ve selected this topic for today’s discussion? Has there been an update to this debate?
What is an LDT?
Why do labs develop their own LDTs?
Can you provide a couple of examples of LDTs?
Currently, are LDTs regulated? Why and who is involved?
You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?
Is there precedent we can examine for using enforcement discretion to not regulate LDTs?
What is the relationship between LDTs and Theranos?
What is your recommendation for companies developing LDTs and/or IVDs?
Do you have suggestions for improving the status quo with regard to LDTs?
What are the important takeaways from this discussion manufacturers should keep in mind?

Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company’s products. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of this podcast presentation:

Can you start today’s conversation by explaining why we’ve selected this topic for today’s discussion? Has there been an update to this debate?
What is an LDT?
Why do labs develop their own LDTs?
Can you provide a couple of examples of LDTs?
Currently, are LDTs regulated? Why and who is involved?
You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?
Is there precedent we can examine for using enforcement discretion to not regulate LDTs?
What is the relationship between LDTs and Theranos?
What is your recommendation for companies developing LDTs and/or IVDs?
Do you have suggestions for improving the status quo with regard to LDTs?
What are the important takeaways from this discussion manufacturers should keep in mind?

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA’s emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the following questions are addressed:

Could you please explain what an EUA is within the regulatory context of the pandemic?
Under whose authority is the pandemic deemed over such that the status of devices on the market under EUAs become a concern?
How will the FDA handle these EUA products?
What should companies be doing now if they want to keep their products on the market after the EUAs expire?
Are there any considerations companies should keep in mind with an EUA product?
Are there any reasons a company may not want an EUA product to go through a full regulatory review?
What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see if the end of EUAs impacts your company. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:

Could you please explain what 510k exempt actually means?
Are all Class I medical devices exempt and all Class II devices not exempt?
What’s the difference between Class I exempt and Class II exempt?
What is the difference between general controls and special controls? How are these relevant to exempt status?
Could you give some examples of products that are Class I exempt and explain why they are afforded that status?
Now could you do the same for Class II products that are exempt and give reasons why?
What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see how 510k exempt may affect your company’s products and future regulatory submissions. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:

Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?
Can you speak to the relationship between intended use and off-label use?
When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?
To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?
Can you share a couple real-world examples of acceptable off-label promotion?
Where is the cut-off? In other words, what should companies be sure they AREN’T doing with regard to off-label promotion?
What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see if you’re able to promote an off-label use of one of your devices. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:

Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?
How can labeling, both high level and low level, be used as a strategic advantage?
Could you please explain the difference between intended use and indications for use?
What is this intended use rule and why is it important to medical device manufacturers?
What is meant by manufacturer's objective intent?
Do you have examples you can provide?
What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see how Intended Use affects your device labeling. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA’s regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:

Would you please explain what we mean by Special Controls? What are they, and how and when are they used?
What makes these “special”?
Would you mind providing some real-world examples of Special Controls?
How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?
With regard to Special Controls, what are the most important takeaways to keep in mind?

Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:

Please start with an explanation of the FDA’s review process. What happens after the agency receives a submission?
This is the third Refuse to Accept guidance from FDA. Can you provide an overview of all three and explain how they should be used?
What was the agency’s goal in releasing these guidance documents?
Do you have examples you can share of submissions rejected on RTA review?
The agency has tried to modernize with the offering of some etools. Can you explain what these are and what advantages and disadvantages there are to using them?
How should a medical device manufacturer view these documents and how should they use them?
What are the options for a device maker upon the rejection of a submission?
What are today’s takeaways with regard to Refuse to Accept guidance from the FDA?

Listen to this episode and see if you better understand how to avoid a Refuse to Accept rejection. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why companies need to be ready to conduct a recall. The FDA’s involvement with a recall is also presented as well as what “recall ready” means. Specifically, the following questions are addressed:

Can you start by explaining what a voluntary recall is and why or when it’s used?
Is there any differences in the process for a voluntary recall across any of FDA’s categories, such as pharma, medical device, food, etc.?
Is there a non-voluntary recall (or one that is ordered)? If so, how is that different?
The FDA states a company within a product distribution chain needs to be “recall ready.” What does this mean?
What are the steps in a voluntary recall?
Is the FDA involved in a voluntary recall beyond being notified? If so, how?
How do you ensure everyone who needs to be contacted about a recall is reached?
What are the most important takeaways companies need to keep in mind about voluntary recalls?

Listen to this episode and see if you better understand voluntary recalls. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:

While we’ve mentioned letter to file a number of times in other podcasts, can you please take a minute to explain exactly what a letter to file is and when it should be used?
Why is a letter to file important?
When does a medical device company submit a letter to file to the FDA?
Does the FDA provide any guidance on a letter to file or offer a template to use for it?
What goes into a Letter to file?
Can you provide some real-world examples of when to consider using a letter to file versus not using one? Does the type of change matter?
Are there situations where using a letter to file could result in an adverse effect to what was intended?
When it comes to a letter to file, what are the most important takeaways for listeners to keep in mind?

Listen to this episode and see if you better understand the point of the letter to file and when to use it. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dave Anderson, president of Neuromodulation at Medtronic. He offers insights on the ways in which neuromodulation is being used to address a variety of conditions and diseases. He also covers trends within the space such as what is driving the growth. Anderson also discusses the incorporation of smart technologies into these systems and the benefits that offers. Specifically, the following questions are addressed.

What exactly are we talking about when we say neuromodulation? What are some of the technologies and application areas?
How fast is the neuromodulation space growing? What is driving that growth?
Has the opioid crisis put a spotlight on device-delivered technologies for pain management?
One of the most exciting aspects of medical technologies is the smart functionality they can offer. How is Medtronic using AI, patient data, and connectivity within the neuromodulation space?
What’s ahead in neuromodulation? What can we expect to see from Medtronic in the coming year?

Listen to this episode and see what you think of Medtronic’s neuromodulation strategy. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Juliana Blum, Co-founder and Executive Vice President of Corporate Development at Humacyte. She speaks to the technology behind their regenerative solution and how it can be leveraged as a technology platform to fulfill a variety of bioengineered tissue needs. Specifically, the following questions are addressed.

What is Humacyte and tell us a bit about your technology?
What are the applications for bioengineered tissue?
Obviously without giving away trade secrets, can you tell us a bit about how it is fabricated?
What were the major challenges that needed to be overcome to develop this?
What’s ahead for Humacyte?

Listen to this episode and see what you think of the company’s bioengineered tissue technology platform. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andy Doraiswamy, founder and CEO of Koya Medical. He highlights the benefits of his company’s compression therapy solution, which can be accomplished while the patient remains mobile and active. Specifically, the following questions are addressed.

What is Koya Medical and what is your clinical focus area?
You recently gained clearance for the Dayspring Lite. What is this and how does it differ from the Dayspring?
Is this device only used to address lymphedema in cancer patients or can it be used to treat other conditions that could benefit from compression therapy?
What is the feedback from patients? Have you had patients who went through more traditional treatments to address lymphedema and then used the Dayspring and can compare the two?
What’s next for Koya Medical?

Listen to this episode and see what you think of compression therapy technology that enables mobility to be restored. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Favet, CEO of NeuroPace. He offers insights into how his technology helps those suffering with epilepsy. In addition, he provides an explanation of the firm’s nSight Platform. Finally, he talks about the partnership with another organization focused on epilepsy and how it integrates with his firm’s technologies. Specifically, the following questions are addressed.

Can you please explain what the focus of your company NeuroPace is?
What is the nSight Platform and how does it lead to a better treatment protocol for patients with epilepsy?
Why have you partnered with Seizure Tracker?
With the three of these systems combined and working together, what is the impact to those with epilepsy?
What’s next for NeuroPace? What are the next steps?

Listen to this episode and see what you think of these epilepsy solutions. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Elad Walach, Co-Founder and CEO of Aidoc. He explains how artificial intelligence is being leveraged to assist radiologists in diagnosing conditions that weren’t originally even being sought. The Aidoc software constantly runs in the background of the imaging system to examine all patient scans without any further direction or commands. Specifically, the following questions are addressed.

Can you please tell us what Aidoc is and what your focus is?
How much time is saved for a radiologist in leveraging Aidoc versus the more traditional review method?
What is the accuracy level with detection and how does it compare to the average for human error?
Can this system function as a training or educational tool just as well as being a clinical tool?
What’s next for Aidoc?

Listen to this episode and see what you think of Aidoc's ability to scan beyond the original condition. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which the agency’s regulatory oversight could be considered lacking. If the agency incorporated the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhance communication with the FDA? Could they be welcome additions? Specifically, the following questions are addressed:

Can you please take a minute to explain why we are dedicating an episode to what’s missing from regulatory and quality systems?
First topic on the list is communicating with the FDA. Do we need a Wellness Device registration, wellness pre-sub, or wellness device database?
What about a catch-up 510k and letter to file pre-sub?
How about a pre-sub for manufacturing issues or to resolve 483s and/or warning letters?
Let’s jump to regulatory pathway. Is a pathway needed that provides a de novo like version of the PMA?
Staying in this realm, what about the idea of having substantial equivalence in the Class III and PMA realm?
What are today’s takeaways in what we may be missing in regulatory and quality systems?

Listen to this episode and see what you think of these regulatory ideas. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Fischel, CEO of Stereotaxis. He explains how his robotic surgical system works and what makes it unique from other systems on the market. He also speaks about the additional benefits that could be realized for interventional technology as a result of his system’s ability to “pull” the catether through the patient’s vasculature. Specifically, the following questions are addressed.

What type of technology does Stereotaxis offer and what is the target clinical area?
How does your system improve upon the traditional methods of performing interventional procedures?
Many of my listeners are familiar with robotic systems as it relates to automation or minimally invasive surgical systems. How does your system compare to the more traditional thought of a robotic system?
What is the learning curve for doctors seeking to learn how to use your system who are accustomed to more traditional procedures?
What’s ahead for Stereotaxis? What’s on the horizon?

Listen to this episode and see what you think of the unique robotic surgical system from Stereotaxis. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Deepak Khuntia, chief medical officer and senior VP of Medical Affairs at Varian. He offers insights on the company’s FLASH technology* and the significant differences between it and other radiation treatment systems. Dr. Khuntia also provides information about a clinical trial taking place to better understand the effect the FLASH system has on surrounding tissue. Specifically, the following questions are addressed.

You’re currently conducting a clinical trial on your FLASH therapy. Can you explain what the technology is and what it’s used for?
How does this treatment compare with more traditional methods for addressing this condition?
Are there future potential applications where the FLASH technology could be used?
Is this the first clinical trial incorporating the technology? I’m curious as to the response/feedback from physicians.
In terms of the Flash technology, or Varian on the whole, what’s ahead? What are the next steps?

Listen to this episode and see what you think of Varian’s FLASH technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

*Note: FLASH therapy is under development and is not available for commercial sale.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Moshe Safran, CEO of RSIP Vision U.S. He shares technology advancements and his thoughts about them as related to the imaging field. Of note is his comments on 3D reconstruction as well as the impact artificial intelligence is having on the space. Specifically, the following questions are addressed.

What is RSIP Vision and what is your area of focus?
Medical imaging technology is rapidly advancing in several ways. Let’s start with 3D reconstruction. How is this being used today and how is it transforming medical imaging?
Imaging advancements are also impacting joint replacement procedures. What are the real innovations here and how are they enhancing treatment?
How about the use of AI in image capture? What’s happening here to improve processes?
What are the key takeaways in terms of using AI in medical technology? Why is it important?
What’s ahead for RSIP? What can we expect or where is your focus?

Listen to this episode and see what you think of emerging imaging technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent offering put out by the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a playbook for device makers to involve threat modeling of medical devices in its approach to cybersecurity. Best practices for addressing cybersecurity of medical devices is also covered. Specifically, the following questions are addressed:

Can you start things off by explaining what Threat Modeling is?
Regarding this playbook the FDA released, is this purely a type of best practices item or is this something that may have regulatory implications tied to it somewhere down the road?
Why is the FDA putting such attention on cybersecurity in medical devices? Is this about patient safety?
Are there currently regulatory requirements with regard to cybersecurity?
What do you foresee happening with FDA and cybersecurity? Will there continue to be guidance and/or will it become a bigger part of a regulatory review?
What are your suggestions or takeaways for device manufacturers when it comes to cybersecurity and the FDA?

You can download the playbook for Threat Modeling Medical Devices discussed in this podcast by clicking HERE.

Listen to this episode and see what you think of the FDA’s interest in cybersecurity. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a video record of a surgery is beneficial to physicians. He speaks to the educational advantages that can be realized and also talks about the legal implications of using his technology in a malpractice suit. Specifically, the following questions are addressed.

Can you please provide a brief overview of Theator?
Is this technology used for surgical training, surgical planning, or both?
Does this technology function in real time or is it only outside of the OR?
What if a surgeon was sued for a mistake during a surgical procedure. Could this technology be used as evidence?
What’s next for Theator? Where is the company headed?

Listen to this episode and see what you think of capturing surgeries on video with Theator. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Amit Phadnis, chief digital officer at GE Healthcare. He makes several predictions for the new year about how technology will impact the delivery of healthcare. Topics of discussion include the reduction of burnout among healthcare workers, continued integration and understanding of AI, reduction of healthcare inequalities, acceleration of telehealth, and other related areas. Specifically, the following questions are addressed.

You have a number of predictions for 2022 that I’d like to explore. Let’s start with a continued emergence of innovations to reduce burnout. Why are these important and do you have examples of some more recent ones?
Talk to me about physicians become more particular about AI. Are they overwhelmed or beginning to recognize what’s valuable and what’s not?
Another prediction you have is that technology will help the workforce reduce healthcare inequalities. What does that mean?
The pandemic resulted in an incredible acceleration of telehealth. How will we grow from that and find the real value play for it?
You say that precision health will revolutionize healthcare delivery. What does that mean specifically?
In what other ways do you see AI and other advanced medical technologies making an impact in 2022?

Listen to this episode and see what you think of Phadnis’ predictions of healthcare and technology in 2022. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andrew Ekdahl, worldwide president of joint reconstruction at DePuy Synthes. He offers insight on the company’s approach to knee replacement, blending a number of technologies to achieve a restoration. Ekdahl also speaks to the impact newer innovations, such as robotic-assisted surgical technologies and data driven solutions, have on knee implants. Specifically, the following questions are addressed.

I understand DePuy is taking a different approach to total knee replacement. Instead, it’s being looked at as knee restoration. Can you explain what that is and why the differentiation in language?
How is data driven technologies being used to help with this mission?
What’s happening in terms of implant development? Are the implants changing to meet with this effort?
To further enhance this mission to restore the knee, how is personalized medicine (a term we hear often) playing a role here?
How does this effort meet with the needs (and wants) of surgeons? Is this speeding up surgical procedures?
What about the instrumentation? Any changes and/or advancements in that space?
What is this leading to? Where is DePuy headed in terms of the knee, joints, or the larger orthopedic space?

Listen to this episode and see what you think of DePuy's knee restoration strategy. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Kathy Lee-Sepsick, founder and CEO of Femasys. She provides an overview of how the company’s technology is helping women who are dealing with infertility. She also speaks about a device that enables a non-surgical means of permanent birth control. Specifically, the following questions are addressed.

Can you please start off by giving us a little insight on what Femasys is?
So your technologies are at both end of the spectrum, addressing infertility and also helping to prevent pregnancy. Can you talk a bit about the FemaSeed and how it different from other available infertility technologies?
What is FemBlock and how does it work?
What is FemVue and how did it change the current standard for this type of medicine?
What’s next for Femasys? Where is the firm headed?

Listen to this episode and see what you think of the women’s health technologies from Femasys. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Asha Parekh, a biomedical engineer and CEO of Front Line Medical. She explains how the COBRA-OS can stop internal bleeding to prevent patients from dying due to loss of blood. She also explains how the technology differs from current treatment methods. Specifically, the following questions are addressed.

Can you please start by telling us a little about Front Line Medical Technologies and your COBRA-OS technology?
How does the COBRA-OS technology differ from other available solutions?
When is the COBRA-OS used? Is this used in a hospital or in an emergency situation at the scene (of say an accident)?
Can you share some of the stats associated with this technology? In other words, how does it measure up to other technologies in survival rate, success rate, etc.?
What’s next for Front Line Medical Technologies?

Listen to this episode and see what you think of Front Line’s COBRA-OS technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bryan Lord, CEO and co-Founder of Pristine Surgical. He provides a number of reasons why disposable endoscopes should be indicated for medical procedures. Lord also highlights some of the challenges with reusable scopes and how single-use solutions help to eliminate them. Specifically, the following questions are addressed.

Let’s start with a quick overview of what Pristine Surgical is about. Can you tell us about the company and technology?
Why have there been such problems with the cleaning and sterilization of endoscopes?
I understand safety in terms of instrument cleaning shortcomings, but has COVID had an impact as well?
Do you encounter questions regarding durability and/or functionality of single-use scopes? If so, how do you address them?
When compared to reusable scopes, are there any tasks that can’t be performed with a single-use scope?
Are the images and videos able to be shared in a similar manner to most companies’ scope offerings?
When people hear about a single-use product, they think of the trash created. Have you looked at the environmental impact of single-use versus reusable scopes?
What’s next for Pristine Surgical?

Listen to this episode and see what you think of Pristine’s single-use scope technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Carlton Weatherby, vice president and general manager of Spine and Biologics at Medtronic. He provides insight on why the organization acquired Mazor and Titan Spine, the strategy for the division to address more of the care continuum, and how trends are being addressed such as AI, data, and MIS. Specifically, the following questions are addressed.

Medtronic has made two interesting acquisitions in the Spine space. Can you tell us what made Mazor and Titan Spine attractive targets?
Medtronic has demonstrated an interest in providing a solution for the entire care chain in other therapy areas, such as in diabetes. Is Spine headed in a similar direction?
As you know, minimally invasive in spine is the trend. How is Medtronic addressing this?
Another significant trend in medtech is the incorporation of data and artificial intelligence. What is Medtronic doing in these areas with regard to spine?
What’s ahead? What can you share with regard to Medtronic’s spine future?

Listen to this episode and see what you think of Medtronic’s approach to spine. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device manufacturers can benefit from a commercial strategy standpoint through the leveraging of its regulatory strategy. Knowing how to make the regulatory process more challenging to help prevent “me too” products to reach the market can be a commercial advantage for medtech firms. Specifically, the following questions are addressed:

First, why don’t we begin with you describing exactly what you mean when you say a company’s regulatory strategy? And is that strategy company-wide or does a regulatory strategy change with each product?
Who should be involved with the creation of a regulatory strategy if anyone beyond the regulatory representative?
So how does the regulatory strategy and commercial strategy intertwine?
What benefits can be realized from this approach?
Would you please provide some real world example to further help illustrate the relationship between the two when it’s successful?
What should be the most important considerations for medical device firms to keep in mind regarding their commercial strategy when identifying their regulatory strategy?

In addition, several previous podcasts were mentioned. To listen to those, click on the podcast title below.

Breakthrough Designation Program Update—Mike on Medtech
Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech
Breakthrough Designation Program—Mike on Medtech
Reimbursement Debate Over FDA Breakthrough Device Designation

De Novo Final Rule—Mike on Medtech
Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

Listen to this episode and see what you think of the intermingling of regulatory and commercial strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jackie Butler, director of BIO El Paso – Juarez, and Philip Morton, product development lab manager at MCA. They offer insights on how strong the region has been in supporting medical device manufacturers and how their organizations is only building upon that foundation. They explain the benefits of the organizations and the services they provide—free of charge—to U.S.-based companies. Specifically, the following questions are addressed.

What is Bio El Paso?
Can you tell me what MCA is?
What is the connection between BIO El Paso and MCA?
What’s the impact you are making on the medical device industry?
The Devise Product Realization Hub offers a variety of services free of charge to companies. Can you discuss these?
Do you have any success stories you could share?
What are the next steps for this program and your organizations as they remain relevant to the medical device industry?

Listen to this episode and see what you think of the El Paso/Juarez region. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Tom O’Brien, worldwide president of Endomechanical at Ethicon. He shares insights on the company’s approach to the development of surgical instrumentation and reducing surgical complications. O’Brien also offers data from a recent study on the new Echelon Circular Powered Stapler and the improvements it offers for clinicians. Specifically, the following questions are addressed.

Can you start by explaining what is encompassed within the Endomechanical unit at Ethicon?
When it comes to the design and development of a surgical device, what are the key priorities for Ethicon and why?
When companies talk about reducing surgical complications, what do they really mean and how is Ethicon trying to do this?
Speaking of complications, Ethicon recently had data on a new stapler, the Echelon Circular Powered Stapler. Can you speak to the study about this device and what benefits it provides?
Are there clinical areas on the horizon you are looking to address (that you can speak about, that is)?

Listen to this episode and see what you think of Ethicon and its approach to surgical instrumentation. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announced for the FDA’s de novo regulatory pathway. As part of the discussion, the de novo is explained, when it should be used, why it exists, and what points of interest were included in the final rule. Specifically, the following questions are addressed:

Can you please briefly explain what the de novo regulatory pathway is?
How does this option differ from the 510(k) and PMA?
When is the de novo used?
Were there any surprises or changes made in the final rule as issued?
Apparently there was some dissatisfaction with the agency not removing inspection requirements in the final rule. Can you explain why this was an issue?
What should device makers keep in mind if they are exploring the de novo regulatory pathway for a product?

Listen to this episode and see what you think of the de novo regulatory pathway. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medical device firm who thinks the FDA is requiring them to take unfair measures or is being overly burdensome. We discuss the formal and informal options as well as the potential consequences. Specifically, the following questions are addressed:

If after a 510k submission or pre-sub meeting, is there something you can do if you feel the FDA is being overly burdensome? Can you do something if you think the agency is asking more of you than of your competitors?
What informal actions can you take?
If you’ve had no success with the informal options, are there formal actions you can take?
What about least burdensome? Can you cite that with any success?
Are there consequences to embarking on any of these actions? Might a company face pushback for questioning the agency?
What are the most important items medical device manufacturers need to keep in mind if they choose to question the FDA?

Listen to this episode and see what you think of the options available to you in dealing with the FDA if it’s being overly burdensome. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Fazila Seker, president and CEO of MOLLI Surgical. She explains the benefits of the MOLLI Surgical system as compared to the way breast tumors are traditionally located and marked for surgical removal. Further, the magnetic innovation behind the system is discussed. Specifically, the following questions are addressed.

What is MOLLI Surgical? What is your primary clinical focus areas?
How does your technology differ from the typical treatment device used for breast surgery?
Is this the first time a magnetic solution has been used for this type of application in breast surgery?
What has been the response from surgeons and medical professionals who have used your system?
What are the next steps for MOLLI Surgical? What can we expect down the road?

Listen to this episode and see what you think of the MOLLI Surgical system. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as they relate to the U.S. regulatory system. While many are familiar with the device classification system, they may not be as familiar with the other two systems or their purpose. Whether or not all three systems are actually needed is also explored. Specifically, the following questions are addressed:

First, can you explain how we handle risk in medtech manufacturing in the U.S.?
What is the medical device classification system and why do we have it?
What is the Significant Risks vs. Non-Significant Risk system?
What about software? What is the Software classification system?
How are the three systems of risk related?
Do we need three separate systems to handle risk?
What are the most important items medical device manufacturers need to keep in mind with regard to risk?

Listen to this episode and see what you think of the three systems of risk. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Russ Johannesson, CEO of Glooko. He speaks about the advantages remote monitoring offers to both physicians of diabetics as well as the patients themselves. He also offers insights into how his solution is used in conjunction with other device makers’ technologies. Specifically, the following questions are addressed.

What is Glooko and what do you do?
Does your solution work across all vendor technologies or are you partnered with select companies?
Given you were offering this technology prior to the pandemic, what did you learn about the use of the technology during the pandemic when people needed remote capabilities?
What are the next stages for advancement? Do you have functionality you’re working on incorporating?
What’s ahead? Where will Glooko be in five to ten years?

Listen to this episode and see what you think of remote monitoring of diabetes. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Steven LeBoeuf, founder of Valencell. He provides insights on his company’s biomedical sensors, which can be incorporated into many different types of technologies, from fitness clothing to bracelets to footware. Specifically, the following questions are addressed.

What is Valencell? What does the company do?
Why is wearable biomedical sensing important?
Can this technology be used to sense other biometrics?
What types of applications are you incorporating these sensors into? Can you share any of your partners and share what they are doing specifically?
What’s next for you and Valencell? What’s ahead five to ten years from now?

Listen to this episode and see what you think of wearable biomedical sensing technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at recently proposed legislation regarding in vitro diagnostics and lab developed tests. The previous version of the Verifying Accurate, Leading-edge IVCT Development Act or VALID, which was proposed just before the pandemic, split the industry with the AACC and ACLA not supportive of it, while AdvaMed and CAP were in favor of the proposed legislation. Specifically, the following questions are addressed:

First, can you clarify what an IVD and LDT is and what the differences are?
How are these currently regulated or how were they regulated?
Why is there a call for changes to the regulatory process for these tests.
Why is this proposal so divisive to the industry and these organizations?
The last time this was proposed, it never even went to a vote. Will this version see the same fate or might this one have a little more support behind it given how important testing was during the pandemic?

Listen to this episode and see what you think of the proposed testing regulations. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Julie Kemink, COO at LifeSource. She speaks to the technologies being used within organ donation, primarily for transport and preservation. She also offers insights on upcoming technologies such as the use of drones, bioprinting of organs, and tracking solutions. Specifically, the following questions are addressed.

What is LifeSource?
As more of an end user of medical devices for transplant and organ donation, can you speak to the transition you’ve seen of those technologies?
I understand you’re exploring the use of drones for the transport of organs. Can you tell me a bit of what’s happening there?
What about bioprinting of organs? What are you seeing with that?
I understand you’re also looking at tracking technologies for organs. What is the objective there?
What about technologies used to monitor a transplant following the surgical procedure? Why is that needed?
What more is needed from medical device manufacturers for this healthcare segment?

Listen to this episode and see what you think of trade secrets. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the letter, the agency stated it was working with a number of manufacturers and other partners to determine the scope of medical devices affected and contact any potentially impacted firms. Specifically, the following questions are addressed:

How does this happen?
Is there anything a device manufacturer can do to verify whether information from their sterilization provider has been falsified?
If this happened to a device manufacturer whose products were used within healthcare facilities and a problem occurred, does this open them up to a liability lawsuit.
This seems like a situation where the agency would be just as interested in working with the device manufacturer to resolve the problem. What’s it like working with the FDA in this type of situation?
What recommendations would you make to a manufacturer who had used this sterilization provider?

Listen to this episode and see what you think of this sterilization situation. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Adam Powell, a partner at Knobbe Martens. He provides clarification on what qualifies as a trade secret. He also shares best practices for companies who hire an employee from a direct competitor to avoid any potential legal issues or concerns. Specifically, the following questions are addressed.

What is a trade secret?
What are some of the methods companies should be using to protect confidential information?
What should a company do if an employee took confidential information?
What should a company do if they hire an employee from a competitor?
Where is the line drawn between trade secret and acquired experience? What about implementing best practices?

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Bill Hunter, the CEO of Canary Medical. He offers additional information about the company’s ‘smart’ implant technology. He provides insight on the benefits of orthopedic implants that can communicate with physicians on the implant’s status as well as how the patient is doing with recovery postoperative. Specifically, the following questions are addressed.

Can you start by telling me what Canary Medical does?
Are you planning to market smart implants and devices from your company or will your device work with other manufacturers’ offerings?
Why has it taken so long for device manufacturers to offer smart implant technologies even though they’ve been discussed for years?
What’s next after orthopedic implants?
How long before we start seeing connectivity within any type of device that is implanted into the body, regardless of size, location, or purpose?

Listen to this episode and see what you think of the remote monitoring of cardiac devices. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Arnaud Rosier, the CEO and founder of Implicity. He offers insights on his company’s technology, which enables the remote monitoring of implanted cardiac devices. Dr. Rosier speaks about working with the device makers as well as the physicians using his software. He also speaks to the value of remote monitoring during the pandemic. Specifically, the following questions are addressed.

Why did you create Implicity and what does the company do?
Do you partner with device makers or are you able to collect the data without their buy-in?
What are the challenges with remote monitoring and did we see more emerge during the pandemic?
What needs to happen within the reimbursement space before remote monitoring and data management solutions are likely to change?
How do you respond to concerns over data privacy with a solution like yours?

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Hanan Ben-Asher, the COO of PixCell Medical. He shares his ideas on the healthcare value of gaining access to rapid blood test diagnostics. Without requiring a full laboratory to obtain results, his testing protocol would enable point-of-care blood testing to take place anywhere. Specifically, the following questions are addressed.

What is PixCell and what does the company do?
During the pandemic, we got a perfect example of why diagnostics are so important. Did we learn why rapid diagnostics are even more important?
What are the technologies that are enabling more rapid diagnostics?
How are AI and machine vision being incorporated into diagnostics?
Why do we need to expand the use of blood testing and make it more accessible?

Listen to this episode and see what you think of the benefits of rapid blood testing. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Anthony Fernando, the president and CEO of Asensus Surgical. He talks about his company’s Senhance robotic surgical system and how it stands apart from competitors. In addition, he discusses the integration of artificial intelligence and machine learning within robotic surgical technologies. Specifically, the following questions are addressed.

Your company offers the Senhance Surgical System. Can you tell me what that is?
We’re seeing an emergence of robotic surgical systems in healthcare. What differentiates the Senhance System?
What role is AI and machine learning playing in robotic surgical systems?
I mentioned the emergence of robotic surgical solutions we are seeing. Why is that? What’s driving this segment?
What’s ahead for robotic surgical systems? Where is this sector headed in five years?

Listen to this episode and see what you think of the Senhance system. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the 483s medical device manufacturing facilities received in 2020. The list comes from the FDA and points to trends among device manufacturers that the quality systems companies have in place may not be used adequately. Actions to take to avoid such concerns in the future are addressed as well as best practices device makers should consider. Specifically, the following questions are addressed:

If every company is required to have a quality management system in place, how does this happen?
Is there something to be said about the FDA’s numbers given how many companies are registered with the FDA for the manufacture of medical devices?
So if CAPA, complaint handling, and design controls represent approximately a third of the 483s issued in 2020, what are the other two thirds.
What are your tips and suggestions for companies to avoid these types of citations?
Do you think the pandemic had any impact on these numbers? Were some companies ill-prepared for a virtual inspection with the FDA?

Listen to this episode and see what you think of the top 483s in 2020. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Roxie Mooney, the CEO and Healthcare Commercialization Strategist of Legacy DNA. She shares a number of best practices for companies determining their pathway to market for a new medical device. She also shares ideas and strategies for how medical device manufacturers can better leverage marketing channels to target a specific audience. Specifically, the following questions are addressed.

What is Legacy DNA and how are you helping medical device manufacturers?
What’s the biggest or most common mistake you see with regard to a company’s market strategy?
What are some of your best suggestions for getting to market and gaining market share?
How did the pandemic disrupt device manufacturers’ pathway to market?
Do you anticipate any lasting changes with regard to a firm getting to market or do you expect an eventual return to business as usual?

Listen to this episode and see what you think of the suggestions provided and how they could affect your market startegy. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Greg Nicola, the chief medical officer at NeuTigers. He shares information about the firm’s involvement with Princeton University and the neural networks they are leveraging for use in the medical space. Further, he discusses why the use of this technology on edge devices is a differentiator for AI. Specifically, the following questions are addressed.

What is NeuTigers?
What is meant by shrinking AI?
How is this being used within the healthcare space?
Do you have real world examples of it being used?
What are the next steps for this technology within healthcare? Do you have other clinical areas on your radar that you’d like to address?

Listen to this episode and see what you think of the NeuTigers, neural networks, and the use of AI on edge devices. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Giovanni Di Napoli, president of Gastrointestinal at Medtronic. He shares insights on several of Medtronic’s gastrointestinal diagnostic devices, including the Pillcam—a pill-sized camera a patient swallows to gain views of the digestive tract. The device provides an alternative to a colonoscopy as a first-step procedure. Additionally, Di Napoli gives information about the capabilities of the AI-driven GI Genius technology. Specifically, the following questions are addressed.

What types of medical technology does Medtronic offer through its Gastrointestinal unit?
Let’s focus specifically on the Pillcam. What is this technology and is it an alternative to a colonoscopy?
Given the movement to expand telehealth we are seeing as one result of the pandemic, how does this align with the functionality and benefits of the Pillcam?
Why is Medtronic teaming up with Amazon around the Pillcam at home program and what are the goals of this collaboration?
What is GI Genius and how does it tie to the Pillcam?
Any chance you can give us any type of scoop on the next steps for the GI Genius technology?

Listen to this episode and see what you think of the industry’s response to the need for COVID diagnostics. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Chris Hagen, vice president of the global COVID-19 task force and marketing for Beckman Coulter. He addresses a number of issues around the COVID-19 pandemic, from challenges with the ramp-up of production to securing needed supplies from a supply chain under stress. Hagen also speaks to the federal government’s response and how it affected diagnostic manufacturers. Specifically, the following questions are addressed.

For those who don’t know what Beckman Coulter is, can you give a brief introduction?
How has Beckman Coulter contributed to the fight against COVID-19?
What was it like for a firm like Beckman Coulter to scale up manufacturing to meet the incredible demand for COVID-19 diagnostics?
What was the impact of all those tests on the diagnostic infrastructure, such as the processing labs, and were the manufacturers able to aid with this portion in any way?
How is the federal government trying to increase testing capability and what’s the impact on manufacturers?
For Beckman Coulter, what are the lessons learned from the pandemic that you can carry forward?

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the guidelines issued by the European Commission on the reprocessing of devices indicated by the manufacturer as beings single-use. Liability is brought up, as well as concerns such as material compatibility with reprocessing protocols with devices not intended to be used more than once. We also discuss measures device manufacturers should take if there’s a chance of their single-use devices being reprocessed to avoid patient injury. Specifically, the following questions are addressed:

If a company states a device is single-use, how is it OK for a regulatory agency to override that indication and say it is OK to reprocess the device for at least one more use?
Don’t we encounter specific material or device concerns that could arise with such a blanket guidance? What reprocessing system is safe to use and won’t have material incompatibility issues?
How would the quality/design control requirements (design inputs) differ? I mean, if the design engineer is developing a single-use device, one would think he or she wouldn’t have to follow the same protocols as they would for a reprocessed device.
Does this guidance mean developers of single-use devices have to test their device for multi-use and reprocessing?
Are there limitations on this guidance? Are there certain types of single-use devices that the guidance does not permit to be reprocessed?
If a patient is harmed by a reprocessed device, who is liable? The device maker, the regulatory agency, or the reprocessor?
Does this guidance reflect a need for a new definition of single-use?

Listen to this episode and see what you think of the European Commission issuing these guidelines. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Shaka Bahadu, the COO and co-founder of Cipher Skin. He explains how his mesh measures movement and how it could be of value to physical therapists treating patients following surgery or injury. In addition, the mesh enables the attachment of additional sensors that could be used to measure pulse, oxygen level, and other important data points. Specifically, the following questions are addressed.

Could you please provide an explanation of your company Cipher Skin, and really, more specifically, the Cipher Mesh technology?
What are the application areas for this technology within the healthcare space?
I understand the Department of Defense is even interested in the technology. Anything you can talk about there?
Do you foresee future applications where this could be implanted? Perhaps in an application that measures motion of the lungs or heart?
What are the next steps for you and Cipher Skin?

Listen to this episode and see what you think of Cipher Skin and Cipher Mesh. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Clive Smith, founder and CEO of Thinklabs. He gives an explanation of what his digital stethoscope is, how it works, and why it’s proved beneficial during the pandemic. Further, there’s a detour into a larger discussion on digital health, its evolving role in healthcare, and how we can expect it to develop going forward. Smith also tells us how digital health is like self-driving cars! Specifically, the following questions are addressed.

Would you mind starting us off with a brief introduction of what Thinklabs is and tell us a little about your digital stethoscope product?
How has the Thinklabs One digital stethoscope been used to help during the COVID-19 pandemic?
With the rapid growth of telehealth, how might your digital stethoscope be used in this type of healthcare environment?
Does the price point of your system enable it to be used in a number of homes or is there a different type of use case you envision?
Would this technology have a value to medical device manufacturers conducting clinical trials?

Listen to this episode and see what you think of the Thinklabs One digital stethoscope. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Guy Harchen, VP Client Strategy at FreeMind Group. He provides an explanation of what non-dilutive funding is and why its so attractive to medical device firms. We also get into his vision of the future of digital health and how it will dramatically change how healthcare functions. His views on the pace of that change, however, are particularly interesting. Specifically, the following questions are addressed.

What is the FreeMind Group and what do you do?
What is non-dilutive funding?
From your perspective, why does digital health matter?
Is the U.S. government interested in the growth of digital health? Why?
What do you expect to happen with digital health post-pandemic?

Listen to this episode and see what you think of non-dilutive funding and/or digital health. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recent issues impacting the proposed reimbursement for products that have been granted breakthrough device status from the FDA. With talk of too many devices being given BDP status along with the fact that a newly cleared device can still be viewed as experimental, the reimbursement policy is going through some additional review. Specifically, the following questions are addressed:

Can you please explain the details of the BDP reimbursement policy that was being proposed?
Can you provide some specifics on what’s driving this reevaluation of the policy?
As I mentioned in the introduction, are there too many devices gaining BDP status? I mean, as we’ve discussed in the past, the fact that 510k devices are even eligible for a breakthrough designation seems ridiculous. What’s your opinion on this?
What’s meant by the comments regarding a newly approved or cleared device being unproven?
How is this policy reevaluation impacting medical device companies and their regulatory strategies?

Listen to this episode and see what you think of the BDP reimbursement delay and if changes could impact your regulatory strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Chen Levin, CEO of XACT Robotics. She offers insights on the capabilities of the XACT ACE Robotic System that enables a doctor to identify a target in the body and the robot to reach the target. The robot can make adjustments should the target move due to the movement of tissue during the procedure. The robot can be used for ablation, biopsy, or drug delivery. Specifically, the following questions are addressed.

Can you please briefly explain the current problem with trying to diagnose a suspicious tumor that’s too small or hard to reach?
How does the XACT ACE robot help with this challenge?
What type of vision system is being used by the robot to visualize the tissue?
How does the robot track the tissue even if it moves during the procedure?
How many of these are being implemented? How many of these are out on the market?
Are there other applications for this type of technology that are either in development or could see market soon?

Listen to this episode and see what you think of this robotic navigation technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Christophe Bancel, CEO of TISSIUM. He provides information about the incredible material technology his company offers, enabling a replacement for human tissue. Based on the mix of three polymers, the firm can vary the characteristics such that it can be used for muscle or a section of colon or some other soft tissue application. Specifically, the following questions are addressed.

Your company specializes in tissue reconstruction using something called biomorphic programmable polymers. Can you explain what that is?
What are the potential applications for this type of technology?
So is this a raw material, a medical device, or a bit of both?
Does the material completely breakdown as healing occurs or does some of it remain to aid with strength?
What has occurred already with regard to market launch/regulatory reviews and what are the next stages for the company?

Listen to this episode and see what you think of these programmable polymers. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Ken Miller, CEO of BioVentrix. He shares insights on how his technology helps to treat patients who have suffered from a heart attack and aren’t responding well to the traditional stent protocol. His solution helps bring the heart back to its normal size after the attack to prevent heart failure from the enlarged heart getting tired. Specifically, the following questions are addressed.

Let’s start with an introduction to your company and its LIVE Therapy system. Can you tell us what that is and the treatment it offers?
The FDA granted your technology a breakthrough device designation. What was that application process like?
Have you seen a difference in how your submission is handled by the agency with the BDP designation compared to prior experience?
Your system is currently involved in a clinical trial. What have been the results of that thus far?
What is your anticipated timeline for the system to gain regulatory approval and see a market launch?

Listen to this episode and see what you think of the BioVentrix Live Therapy system. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Daley, CEO of OrthogenRx. He speaks on the benefits of hyaluronic acid (HA) to address osteoarthritis as an alternative to pain medications and surgical replacement. The FDA, however, has recently changed its oversight of HA and is now treating it as if it were a drug instead of a device. Specifically, the following questions are addressed.

Your company offers a hyaluronic acid treatment for osteoarthritis. Can you provide a brief explanation of that technology?
For 20 years, hyaluronic acid was treated as a device by the FDA. Then in 2018, the agency questioned that classification and indicated it might be a drug? What impact does that have on a company like yours?
Did the FDA give a reason for their change in thinking?
Has there been any new decisions on this since the agency questioned the classification in 2018?
More and more combination products are emerging and those that interact with the body or breakdown and deliver a pharmaceutical agent. What could the FDA’s actions with regard to hyaluronic acid mean for companies of those types of products?

Listen to this episode and see what you think of the FDA’s revised stance on this technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a still relatively newer option for medical device manufacturers in gaining a priority status with their regulatory review. STeP (Safer Technologies Program) emphasizes devices that enhance safety (as opposed to efficacy as is the case with the Breakthrough Device Program). Specifically, the following questions are addressed:

Can you please give us a brief overview of the program?
How does this program compare and contrast to the breakthrough devices program?
What’s been the latest updates to STeP?
What should companies consider or be aware of if they are looking at participating in this program?
Any additional comments or final thoughts on STeP?

You can view the STeP guidance from the FDA by clicking here.

Listen to this episode and see what you think of the STeP designation and if it is appropriate for a device you’re going to submit to the agency. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Peter Vranes, co-founder and co-CEO of the Australian company Nutromics. He offers insight on a platform technology that enables continuous molecular monitoring. Using continuous glucose monitoring as an example for the potential for the technology, Vranes explains how his technology is capable of tracking any target, not just glucose. Specifically, the following questions are addressed.

Your company has developed a continuous molecular monitoring platform. What does that mean exactly?
Most people are aware of why you need to monitor glucose especially for diabetics but why seek to measure anything other than glucose continuously?
How is your technology different from continuous glucose monitors already on the market?
What is your first intended market for the technology and why did you choose it?
Does the platform lend itself to be expanded to monitor other items such as white blood cell count or perhaps a disease?
You’re developing a smart patch to serve as a carrier for the platform. When are you looking to launch that and what will the functions of the patch be?
Is this technology only suitable for in hospital use?

Listen to this episode and see what you think of this platform for continuous molecular monitoring. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jennifer Meade, president of the breast and skeletal health division at Hologic. She offers insight on the company’s recent acquisition activity as well as its partnership involving artificial intelligence. Meade also speaks to the importance of AI within Hologic technology and its efforts to encourage greater patient compliance. Specifically, the following questions are addressed.

You were promoted to the position of president of the breast and skeletal health division in August of last year. What are your top priorities for your segment of Hologic in 2021 and beyond?
Hologic didn’t waste time this year with an acquisition just a few days after the ball dropped on the new year. Can you speak to the reason behind the Somatex acquisition and where you see this fitting into your larger plan?
It was announced last year that Hologic was working with RadNet on an artificial intelligence-based initiative. Can you tell me more about that?
How is Hologic leveraging AI in other areas and technologies?
Does Hologic see opportunities at the technology or device level to help increase compliance with regular breast cancer screenings?

Listen to this episode and see what you think of Hologic’s approach to addressing women’s breast health. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Maninder Bedi, founder and chief medical officer of Optimize EP, and Ravi Kartan, president and CEO of the same firm. They speak about the importance of their solution for physicians to save time reviewing EP monitoring reports. They also speak to the machine learning algorthms that are employed within the software to enable a more effective offering. Specifically, the following questions are addressed.

Let’s start with a little bit of an introduction to the EP process. How is data associated with an EP captured, reviewed and analyzed currently?
How is Optimize EP and your See-Arm software attempting to change this?
Since this is collecting remote monitoring data, I’m guessing this isn’t a solution intended for a hospital or healthcare environment exclusively? This is used for patients with monitoring technology on their person at home?
Is the software compatible with any technology that’s being used to capture the data or does it only work with certain partners?
Does the software have any impact on the patient in terms of what they need to do?
Can you speak to the algorithms that are incorporated into the software and what they enable? Do they help with diagnosis or detection of a problem?
What is the availability status of this technology? Regulatory approvals? On the market?

Listen to this episode and see what you think of Opitmize EP’s software solution for remote patient monitoring data. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Linnea Burman, Vice President & General Manager, Enabling Technologies: Cranial & Spinal Technologies at Medtronic. She speaks about the company’s interest in Mazor Robotics and why they made the acquisition. Burman also speaks about the evolving robotic surgical landscape as well as what’s ahead for Medtronic within the space. Specifically, the following questions are addressed.

Let’s start with the significant news Medtronic made a couple years ago when they purchased Mazor. What’s the latest with that robotic surgical technology?
What was it about Mazor that made it such an attractive target to Medtronic?
While the Mazor is indicated for orthopedic surgery, there’s been talk of Medtronic’s initiatives for a soft tissue robotic surgical solution. Can you speak to that at all?
The da Vinci aside, the soft tissue space for robotic surgery seems to be a longer development cycle compared to orthopedics. Do you have any insight why this seems to be the case?
While current robotic surgical systems are very exciting, we’re only at the early stages of development. Without giving away all the secrets, where do you see this technology headed?

Listen to this episode and see what you think of Medtronic’s current and future robotic surgical solution initiatives. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss one of the most talked about regulatory elements of the last ten months—emergency use authorizations (or EUAs). The conversation is about what they are, when they are used, and, perhaps most importantly, what happens when the emergency is deemed over. Specifically, the following questions are addressed:

Can you provide a full explanation of the EUA and when it is used?
What happens to products that have received an EUA to get to market during the pandemic once the emergency is deemed over?
How does an EUA fit within a company’s regulatory strategy?
Can a company use real-world evidence from a product’s time on the market as a result of an EUA in its regulatory submission for that product?
For companies that have been granted an EUA, what are the most important things to keep in mind as we hopefully get closer to the end of the pandemic?

Listen to this episode and see what you think of EUAs and whether your firm needs to take action as a result of one of your products having one. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Nadine Hachach-Haram, the founder and CEO of Proximie. Her firm enables clinicians to collaborate from anywhere in the world. The solutions is hardware agnostic and enables connections in remote regions with low internet functionality. Specifically, the following questions are addressed.

Can you please tell us about your company and what it’s doing to the traditional surgical environment?
Does your company provide all the hardware and software components to enable the connection?
Is the hardware and software required on both ends?
One unique thing I noticed about your technology is that it operates on weaker internet connections. Why was that an important factor and important to you?
What’s the reaction from surgeons to the system?

Listen to this episode and see what you think of Proximie and the capabilities it enables for surgical consults and collaboration. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Liane Teplitsky, vice president and worldwide general manager of robotics at Zimmer Biomet. She provides some background on how we arrived at where we are today, what’s driving the robotic surgery movement, what the latest with the company’s Rosa system is, and what’s ahead. Specifically, we pose the following questions to him.

What’s the latest with Zimmer Biomet and the Rosa system?
Why have robotic surgical technologies exploded in the orthopedic space?
What’s been the overall reception by surgeons to these systems?
How is data informatics playing a role in robotic surgical systems?
With the incorporation of AI and machine learning, are we at the early stages of physician-assisted surgeries, where the robot is doing more of the procedure and the surgeon is supervising?

Listen to this episode and see what you think of Zimmer Biomet’s strategy for robotic surgery. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a number of the priorities Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), has mentioned in recent presentations. The agency had also laid out several priorities in a document a few years ago to be acted upon from 2018 through 2020, which has now been extended to 2021. Specifically, we address a number of questions, including:

What are the important priorities for CDRH in 2021?
- Tracking of submissions and electronic templates
- Decentralized clinical trials with CDER and CBER
- Feedback from patients through new Collaborative Communities forum
- Digital Health Center of Excellence
How will the COVID-19 pandemic impact these priorities and CDRH operations moving forward?
What’s been the impact on non-COVID devices? Are new devices still being developed or being reviewed by the agency?
What about the impact of politics and the new incoming administration?

Listen to this episode and see what you think of communication with the FDA and if there are methods you could use which you aren’t. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Jesse Wheeler, head of MedTech and Analytics at Draper, a not-for-profit engineering innovation company. He explains what organization does and how its projects can help to improve medical devices. His latest project involves the development of an ECG sensing technology that does not require contact with the patient. Specifically, we pose the following questions to him.

First can you tell us a little about Draper and what you do?
I understand you’re developing a noncontact sensor to replace traditional ECG technology. How does it work and why could it be a better alternative?
Beyond the hospital, where could technology such as this enable ECG monitoring?
Are there additional applications possible leveraging this technology?
What are the obstacles remaining to getting this technology to market?

Listen to this episode and see what you think of Draper and its non-contact ECG sensor. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a variety of ways in which medical device manufacturers communicate with the FDA. Mike provides best practices he’s used and also shares stories from his own experience interacting with the agency for real-world projects. Specifically, we address a number of questions, including:

Let’s review the more common or well-understood methods of communicating with the FDA.
- Regulatory submission
- Response to inspection or 483
- Pre-sub meeting
- Social media
- Letter to file
What other methods are there outside of those?
How has communication been handled during the pandemic?
Can you share best practices when communicating with the FDA? Dos and don’ts?
What ways would you like to see established for communication with the FDA?

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Joe Mullings, chairman and CEO of The Mullings Group—a talent acquisition firm focused on medtech—and host of the web series TrueFuture. As someone who works with leading medtech manufacturers and travels the world to explore regions where new medtech is being developed, Mullings was able to provide an interesting viewpoint on what’s got him excited and how lessons learned from the pandemic could help the industry. Specifically, we pose the following questions to him.

Through your various ventures, you’re exposed to quite a bit of emerging medtech. What has you most excited and why?
How are these new technologies impacting the types of people the medtech industry is hiring?
Are you getting interest for medtech talent from non-traditional industry players? With the pandemic, we saw companies like GM and Tesla partnering with medical device firms to produce critical products. Are these same types of companies seeking to incorporate medtech into their products?
In your fourth season of True Future, you visit Israel, which has been an emerging hub for medtech R&D for some time now. What interesting things did you find there?
You’re also moderating a panel at ICI’s Global Digital Summit on the Virtualization of Care. What does that mean and how will it impact today’s healthcare space?

Listen to this episode and see what you think of Joe Mullings and his various roles. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bruce Lichorowic, President and CEO of Galen Robotics. The company is developing a robotic surgical system, like other medical device manufacturers, but has interesting plans on how it will roll it out to the market. The system will not require a capital investment from hospitals. Specifically, we pose the following questions to him.

There are a number of medtech companies developing or marketing robotic surgical solutions. What makes the Galen Robotics system unique?
Is neurosurgery an emerging area for robotic surgery?
What is digital surgery as a service?
What has been the feedback from hospitals and surgeons regarding digital surgery as a service?
What’s the timeframe for you launch of this service?

Listen to this episode and see what you think of Galen Robotics and their “subscription” plan. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Kevin Goodwin, CEO of EchoNous. The company offers a portable, point-of-care ultrasound solution that provides real-time views of the heart, lungs, and abdomen. With significant computing power driving it, but only weighing eight ounces, the technology provides a stark contrast to traditional cart-based systems. Specifically, we pose the following questions to him.

Please tell me about EchoNous and what makes your ultrasound technologies unique?
Why is point-of-care ultrasound so important for healthcare, especially right now during the pandemic?
What have been the challenges in developing this type of ultrasound system?
What impact does AI have on the system and the level of care it enables?
What’s next for EchoNous?

Listen to this episode and see what you think of EchoNous. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mark Toland, who was previously the CEO of Corindus, and Rick Anderson, who was formerly the WorldWide Franchise Chairman at J&J. They are now both on the board at Cardiologs. They talk about what interested them in the company, the important role cardiovascular diagnostics play in the battle against heart disease, and the impact of artificial intelligence on the device performance. Specifically, we pose the following questions to them.

What is Cardiologs and what attracted you to the organization?
What does this influx of AI-powered technologies mean for healthcare?
Are the challenges associated with reimbursement when it comes to AI-based technologies being addressed?
What challenges are still inhibiting the growth of this technology segment?
What is the response from caregivers and physicians? Are they ready to adopt AI-based technologies?

Listen to this episode and see what you think of Cardiologs. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Sham Dholakia, senior VP of medical affairs and clinical operations at CareDx. Dr. Dholakia talks about the technologies his company provides to best match donated organs with the patients who so desperately need them. Since current methods detect problems with an organ match after the transplant, CareDX is trying to proactively prevent this from occurring. Specifically, we pose the following questions to him.

What is CareDx and what is the technology you offer?
What are the challenges with transplants and how does your technology address them?
What have been the challenges in the development of your technology?
What are the “smart” aspects of your technology?

Listen to this episode and see what you think of CareDX and its technologies. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Justin Barad, orthopedic surgeon and founder of Osso VR. Barad shares insights on the advantages of leveraging virtual reality technologies for the simulation of surgical procedures for training, introducing new products, and other applications. He also offers his thoughts on the influx of new, “smart” technologies that are encompassing the traditional implants in orthopedics. Specifically, we pose the following questions to him.

Please tell us about Osso VR and specifically, your virtual reality based surgical training platform?
I’ve definitely seen a shift in orthopedics even within the last five years where sensors, virtual and augmented reality, robotics, and other non-traditional orthopedic advancements are impacting this sector. As both a surgeon and a medical device professional, what’s your impression of this influx of new innovations?
How do these technologies impact the way we care for patients?
From your point of view, what has the pandemic revealed about the orthopedic industry? Beyond the negative impact on surgical procedures, are there lessons to learn that we can use going forward?
Is the rapid adoption of telehealth going to have a significant impact on orthopedics?

Listen to this episode and see what you think of Osso VR and its technologies. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidances on biocompatibility submissions and nitinol-containing devices. Although the two are separate guidance documents, we combine them into a single discussion. Specifically, we address a number of questions, including:

What is the biocompatibility guidance in regard to?
Does this help simplify the pathway to market for commonly used materials that have a proven record?
The fact that we’re talking about “intact skin surface,” this wouldn’t apply to any type of wound care products, correct?
With the nintinol-containing devices guidance, what’s the purpose behind that?
Is this guidance primarily being put out due to the potential for an allergic reaction to nickel or is it more about the unique physical characteristics of Nitinol?
What are the primary takeaways from these guidances device makers should keep in mind?

There are also a number of references made. Following are links for more information on those items.

Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin (Draft, Oct, 2020)
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" [Finalized Sept, 2020]
Final Guidance: Technical Considerations for NonClinical Assessment of Medical Devices Containing Nitinol (Oct 15, 2020; draft issued April 2019)
Mike on Medtech: FDA's Material Evaluation (April 2, 2019)
Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable (July 25, 2017)

Listen to this episode and see what you think of these two guidance documents and whether they could affect an upcoming product you are producing. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Itai Nemovicher, CEO and founder of The Orthopaedic Implant Company. Nemovicher offers insights into what makes his company and its orthopedic technologies unique within the sector and how the company uses that to compete with larger players. There is also discussion of the company’s 10th anniversary and the achievements its had in that time. Specifically, we pose the following questions to him.

What is The Orthopaedic Implant Company and what is its niche within the medical device space?
Last September, your firm partnered with Intermountain health systems. How did this come about and what was the goal of the arrangement?
What have been the results of the partnership?
How is OIC able to achieve such savings for a customer like Intermountain compared to other device manufacturers?
OIC is celebrating 10 years within the orthopedic industry. What are some of the achievements the company has accomplished during that time?
What’s next for OIC? What’s on the horizon?

Listen to this episode and see what you think of OIC and its technologies. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Maman, CEO and co-founder of Binah. Maman shares information about his telehealth technology, which enables medical providers to get vital signs readings of patients before speaking with them through a video portal. The technology is platform agnostic as it only requires a camera on the patient’s side to capture the information. Specifically, we pose the following questions to him.

What is Binah.ai and what is your technology solution?
As AI is still relatively new in being incorporated into medical technology, can you share your experience working with it?
What has the pandemic done to the interest level in your technology?
I’ve heard telemedicine has advanced in six months during the pandemic what was expected to take six years. How does such rapid adoption impact the industry?
What aspects of telemedicine do you expect to remain post-pandemic?

Listen to this episode and see what you think of the technology and the capabilities it offers to telehealth solutions. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidance on Multiple Function Device Products. While the terminology can be somewhat confusing, the guidance, and more importantly, how manufacturers comply with it is relatively straightforward. Specifically, we address a number of questions, including:

What is a multiple function device as it relates to the FDA’s guidance?
What’s the difference between a regulated medical device and a consumer product?
How does something like a multiple function device differ from a combination product?
What regulatory strategy suggestions do you have for dealing with this type of device?
What concerns exist from a regulatory viewpoint if a sensor, such as a camera, is updated for non-regulated purposes? Will that impact the clearance of a regulated product that leverages that camera for sensing, such as a visual detection app that can detect skin cancer?
What other significant takeaways from this guidance must manufacturers keep in mind?

Listen to this episode and see what you think of the Multiple Function Device Products guidance and whether it could affect an upcoming product you are producing. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss how the breakthrough designation program has changed since its inception. While the language of the program has not changes, FDA’s interpretation of it has shifted somewhat. Find out what’s “new” in this episode. Specifically, we address a number of questions, including:

Can you remind us what the BDP is? Why was it created? Who should consider it?
How is the 510k pathway able to be used in conjunction with this program?
How does the BDP differ from the STeP (or Safer Technologies Program)?
So what’s “new” in the BDP? Why are we talking about it again?
In what ways could the program be improved still?

Listen to this episode and see what you think of the BDP and whether it could be for an upcoming product you are producing. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look back at a variety of the topics that have been covered in the past 49 episodes. We check out what were the top five most popular topics, while also inquiring about the omissions from the list. Did the episodes you find most interesting or valuable make the list? Find out in this episode.

Listen to this episode and see what you think of the top five list or any of the other topics mentioned. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of a new compliance program with regard to inspections for combination products. The impact to the device manufacturers of this type of product is examined following an introduction to what combination products are. Specifically, we address a number of questions, including:

What are combination products? What are the different types?
The FDA recently issued a new compliance program which included its approach to inspections for combination products. What exactly does that mean? What is the compliance program being referred to here?
What are the most important details to manufacturers of combination products, whether drug/device or biologic/device?
Does any of this represent a drastic change in how things were performed previously?
What are the most important takeaways with regard to regulatory changes for manufacturers of combination products?

Listen to this episode and see what you think of this guidance and determine if it impacts your company and your products. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the term “nonbinding feedback” and what it means for medical device manufacturers. While the feedback comes from the FDA, it’s not mandatory that the feedback (or advice or recommendation) needs to be followed. Specifically, we address a number of questions, including:

What does nonbinding mean with regard to input or advice from the FDA?
The nonbinding feedback we spoke about back in May 2019 had to do with 483s from site inspections. Where else does nonbinding feedback come into play with the FDA?
Although the FDA’s feedback or recommendation may be nonbinding, is it always a good idea to follow the advice?
What happens if you don’t follow nonbinding advice? Are you setting yourself up for a problem or a tougher “fight” with the FDA?
What are the most important takeaways with regard to how a company should handle nonbinding feedback?

Listen to this episode and see what you think of nonbinding feedback as well as how your company has reacted to it in the past. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use (or lack of use) of real world evidence. This discussion is a sort of update on the first Mike on Medtech podcast, which offered an introduction to real world evidence. Specifically, we address a number of questions, including:

Can you please provide a quick refresher on what real world evidence (RWE) is within the context of the FDA’s world?
How was the agency viewing the use of real world evidence for a medical device’s regulatory pathway at the time?
What does the actual use of real world evidence look like today?
Why hasn’t real world evidence seen the implementation the agency was expecting or hoping to see? What are the challenges?
Should medical device manufacturers be using RWE?
What are the most important takeaways device manufacturers need to keep in mind with regard to the use of RWE?

You can click here to listen to the aforementioned first podcast about real world evidence from 2017.

Listen to this episode and see what you think of the use of real world evidence and whether it’s something your company should be looking to use for your next label expansion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pre-sub program and best practices for companies to consider prior to their scheduled appointment with the agency. Specifically, we address a number of questions, including:

Can you please give a brief overview of what the FDA’s pre-sub program is?
Is the pre-sub only for certain types of devices or when using certain regulatory pathways or is it available to all device makers?
Are there questions you shouldn’t ask during the pre-sub?
What’s the most common mistakes you’ve heard companies made during their pre-sub?
Will the FDA help a company determine what regulatory pathway to take during a pre-sub?
Will the FDA give recommendations on things such as testing protocols a certain type of device should go through during a pre-sub?
Is there any information you shouldn’t share with the FDA during a pre-sub? In other words, can being too transparent hurt you?
What’s the most important thing for a company to keep in mind with regard to a pre-sub?

There is also mention of the first podcast from 2017 where the pre-sub program was introduced and discussed. Click here to listen to that presentation.

Listen to this episode and see what you think of the eSTAR pilot program. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Scott Whitaker, CEO and president of AdvaMed, the world’s largest medical technology association. He’s participating in the podcast to provide insight into the COVID-19 pandemic and the challenges the medical device industry has been facing as a result. Specifically, we ask him about the following questions.

We are hearing about the medical device industry mobilizing to support the healthcare professionals treating those with COVID-19. Overall, is the medical device industry keeping up and where are the greatest challenges being encountered?
What are medtech firms telling you the real pain points are they are facing?
Can you share your thoughts on the companies who are partnering with medical device manufacturers who aren’t accustomed to manufacturing under the FDA (e.g., Ford and Tesla)? What are the major concerns here?
How has the response been from the medical device manufacturing supply chain? Have they mobilized in step with the OEMs to enable the manufacture of these critical products?
Looking ahead, do you think the medical device supply chain will shift geographies and some of it will emerge more prominently within the U.S.?

Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or would like to suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss recent coverage of a two-minute COVID-19 test that had miscommunicated obtaining emergency use authorization from the FDA. We look at actions the FDA is taking around these types of incidents and also about the potential issues with a relaxing of regulatory rules around certain products during this pandemic. Specifically, we address a number of questions, including:

We saw a 2-minute COVID-19 test being reported on that incorrectly claimed to have Emergency Use Authorization. The company claimed a misunderstanding. What should companies be doing to ensure they don’t make this mistake as well?
Is there a concern of future misunderstandings from companies seeking to help, but not accustomed to working with the FDA?
Does a company who has gained an EUA for a new device still need to seek a traditional regulatory pathway for approval/clearance?
What does the FDA’s relaxing of regulatory rules mean to medical device manufacturers?
Reports on the mortality rate for patients put on ventilators differs greatly, but in looking at a fair amount of data, it seems the number is approximately 66 percent. As a result, is the race to make more ventilators the best action or are we really without another choice at this stage since we don’t know who will survive and who won't?
Is the FDA taking action against any type of misinformation and/or outright lies about a product’s ability to help address COVID-19?

Listen to this episode and see what you think of the concerns brought up regarding the effort against COVID-19. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we can address your ideas/inquiries/suggestions in a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss questions raised by news of medical technology being rolled out to help battle the COVID-19 virus. Topics such as what Emergency Use Authorization means to how non-manufacturers of medical devices can now produce products for the effort such as ventilators. Specifically, we address a number of questions, including:

What is coronavirus?
We’re hearing quite a bit about Emergency Use Authorization, primarily around tests for COVID-19. What does that mean exactly?
Does EAU lower the regulatory burden compared to other pathways to market?
To address the need for ventilators, companies like Ford and GM are changing over production to help. How does this happen when the FDA has likely never stepped foot into these facilities?
With all the rushed approvals/clearances of new medical supplies, is there a concern regarding safety?
What is the situation for companies with existing devices (already on market) that can be modified to help with the battle against COVID-19?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the concern surrounding the use of EtO for medical device sterilization. Questions have been raised as to the safety of the amount that’s been detected in the air around facilities that provide this type of sterilization process. Specifically, we address a number of questions, including:

How common is EtO for sterilization?
How does it compare to other methods?
Why is it used so frequently?
What are the problems with EtO?
Do you expect EtO to go away?
What is the “root cause” of this problem? Could it have been avoided?
What type of regulatory pathway requires a notification to the FDA for a change of sterilization process?
What is the FDA’s EtO sterilization pilot program for changing vendors?
What are the most important takeaways from this issue for medical device manufacturers?

Several references were mentioned during this podcast and you can locate those items by clicking on each one.

FDA Website: Ethylene Oxide Sterilization for Medical Devices
FDA Innovation Challenge: Ethylene Oxide Sterilization for Medical Devices
- Challenge 1: Identify New Sterilization Methods and Technologies: The goal of this challenge is to encourage the development of new approaches to device sterilization methods or technologies for medical devices that do not rely on ethylene oxide.
- Challenge 2: Reduce Ethylene Oxide Emissions: The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.

Listen to this episode and see what you think of the challenges currently surrounding EtO sterilization. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s pilot of an interactive 510(k) template called eSTAR (electronic Submission Template and Resource). This electronic template would be used by companies submitting a 510(k) application so as to try to avoid administrative rejection, one of the most common causes of submission rejection. Specifically, we address a number of questions, including:

What is the eSTAR program?
What is the goal of this program?
What is FDA seeking from companies interested in participating in the trial?
For what types of devices/510(k) submissions can eSTAR be used and which types can it not be used?
What does the form ask for?
Is FDA offering incentives to encourage manufacturers to use eSTAR?
What challenges do you foresee with this template? Has the FDA neglected to consider anything?
If this template goes into effect, do you expect it to speed up 510(k) submissions and/or the processing of them?
Would you encourage a company to participate in the pilot if they meet the criteria?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. We mention what medical device manufacturers should be concerned with for less than satisfactory testing protocols, and how the FDA may not even be the worst thing they should be worried about. Specifically, we address a number of questions, including:

Are there certain areas of human factors the FDA is emphasizing or paying closer attention to?
Do you have suggestions or real-world examples on how a company may perform human factors testing?
How does human factors testing for a medical device differ based on where the product is intended to be used (for example, in the home versus in a hospital room or used by a physician versus the patient directly)?
What type of trouble with the FDA can a company get into for not accomplishing human factors testing in a satisfactory manner?
What are the key takeaways device manufacturers should consider with regard to human factors/usability?

If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here.

Listen to this episode and see what you think of the FDA’s human factors requirements. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. Medical device manufacturers need to ensure they are not only satisfying this need, but also fulfilling any potential liability involved. Specifically, we address a number of questions, including:

What is human factors as it relates to medical device development?
Were human factors always required by the FDA?
What is the difference between human factors testing and a clinical trial?
What types of medical devices are required to go through human factors validation testing?

If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:

What is change management and why is it important?
How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?
Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?
- Aesthetic change, such as color or size of a font?
- Design change, such as the shape or size of the device?
- Material change, such as the replacement of one material with another or the combination of two materials?
- Labeling change, such as modifying an existing claim or adding a new one?
- Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?
- Software change, such as for a security update or to add functionality?
- Supply chain change, such as a testing vendor or something many may need to address, sterilization change?
How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?
Do you have a suggested process to handle change and more importantly, can you defend it?
What is the relationship between change management and product liability?
What can happen if a company mishandles their change management procedures?
What are the most important takeaways for listeners concerned with change management?

Listen to this episode and see what you think of the tips and best practices for handling change management. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:

What is change management and why is it important?
How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?
Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?
- Aesthetic change, such as color or size of a font?
- Design change, such as the shape or size of the device?
- Material change, such as the replacement of one material with another or the combination of two materials?
- Labeling change, such as modifying an existing claim or adding a new one?
- Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?
- Software change, such as for a security update or to add functionality?
- Supply chain change, such as a testing vendor or something many may need to address, sterilization change?
How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?
Do you have a suggested process to handle change and more importantly, can you defend it?
What is the relationship between change management and product liability?
What can happen if a company mishandles their change management procedures?
What are the most important takeaways for listeners concerned with change management?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for medical device manufacturers to use performance criteria in place of a predicate device for clearance. This option, previously known as an Abbreviated 510k, is only available for a select group of well-understood devices that meet FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Specifically, we address a number of questions, including:

What is the Safety and Performance 510k?
How does it differ from other variations of the 510k, such as the traditional version or the Special 510k?
When should a manufacturer consider using this 510k?
How does using performance criteria differ from citing a predicate device?
Is this simply another way to get “me too” products to market quicker or is there more to it than that?
Is this a incentivized way to have companies use more recent products for the comparison without implementing a hardline “10 year” directive?
What are the most important takeaways for device manufacturers with regard to this 510k pathway?

If you’d like to review the FDA’s Safety and Performance Based 510(k) program guidance document (finalized September 2019) before listening to this podcast, you can find it by clicking here.

Listen to this episode and see what you think of the Safety and Performance Based 510(k). If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:

What is the Special 510(k) program and how does it differ from the standard 510(k) program?
When is it appropriate for a device manufacturer to use this program?
In January 2018, we discussed the then new alternative 510(k) (click here to listen to that podcast). How is this different from that?
Is this yet another specialized version of the 510(k) to better address the industry needs? Are we creating too many “special case” 510(k) variations or is this ultimately a good thing?
What are the most important takeaways of this guidance listeners should keep in mind?

If you’d like to review the FDA’s Special 510(k) program guidance document (finalized September 2019) before listening to this podcast, you can find it by clicking here.
Listen to this episode and see what you think of the Special 510(k). If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the brand new (in fact, yet-to-be-launched) Safer Technologies Program (click to review the guidance). Since it was only recently introduced, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:

What is the safer technologies program?
How does this program differ from the Breakthrough Designation Program?
So like BDP, STeP is not a regulatory pathway on its own, correct?
What are the criteria for eligibility into STeP?
What are the mechanics of STeP?
Is STeP an already active program?
Are the BDP and now STeP part of an effort by the FDA to encourage true innovative technologies and perhaps disrupt the history of incremental innovation within the industry?
I know the FDA is hosting a pair of webinars to help explain the program. Can you tell us why there are two of them and only a day apart?

Further, there is the mention of two webinars being conducted by the FDA that are relevant to this new regulatory option. You can find them via the following links. (Click the name of the webcast for information about how to view it.)

Webinar—Safer Technologies Program: Draft Guidance (scheduled for November 6, 2019.)
Webinar—Safety and Performance Based Pathway Performance Criteria (scheduled for November 7, 2019.)

Listen to this episode and see what you think of the Safer Technologies Program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidance documents. As they can be coupled together, we discussed both in one podcast. They are:

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (August, 2019) (Click here to read the guidance.)
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August, 2019) (Click here to read the guidance.)

Specifically, we address a number of questions, including:

Can you please provide a brief overview of what's in these guidances and what their purpose is?
Why is PMA, HDE and de novo included but 510k is NOT included in this guidance?
When is higher risk acceptable and what is the tie-in to the term uncertainty?
What else is important in these guidances and what are the most important takeaways for listeners?

Listen to this episode and see what you think of these two benefit risk determination guidances. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guidance). Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:

What is the purpose of the Breakthrough Devices Program and why does it exist?
Is the BDP a “pathway” to market like the 510k or PMA?
How early in the product development lifecycle should we consider a BDP?
What are the requirements of the Breakthrough Devices Program?
What are the mechanics of the process?
What goes into the BDP Pre-Sub Package?
What is the benefit of BDP status?
What if you don’t like FDA’s decision, can I appeal?
Is there a database of BDP devices?
Should we issue a press release announcing our BDP designation?
What’s the most important thing to remember about the BDP program?

Listen to this episode and see what you think of the Breakthrough Devices Program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (although still substantially less than the 510(k) and PMA) regulatory pathway available to medical device manufacturers. Since it is not nearly as common as the two primarily used pathways, the De Novo is not nearly as understood as them. In order to shed light on when this option could be most beneficial or be the best option for a regulatory submission, we attempt to provide an overview of it—a De Novo 101, if you will. Specifically, we address a number of questions, including:

What is the De Novo regulatory pathway?
How does the De Novo differ from the PMA and 510(k) regulatory pathways?
For what situation or type of device is the best case to use the De Novo pathway?
When shouldn’t the De Novo be used?
Do you have any suggestions or best practices for using a pre-sub meeting when planning to use the De Novo pathway?

Listen to this episode and see what you think of this regulatory pathway. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the subject of my latest Editor’s Letter, which appeared in the June issue of MPO (click here to read that Letter). It features yet another PR hit on the industry along with recommendations on what can be done to fix the problem (click here to read the NY Times Editorial Board statement). Of course, those fixes are rather general in how they are presented, but we dig into each of the three and share our own thoughts on the proposed solutions. Specifically, we address a number of questions, including:

Should products that are intended to reside in the body for an extended period of time require a PMA pathway? How would that compare to the current protocol?
Would an "implantable 510(k)" be a middle ground to address the issue—does not require a full PMA, but updates to implantable products can’t go through the standard 510(k) pathway either?
Might making sub-pathways or application specific pathways open up a problematic can of worms or would application specific approvals be a good idea?
What are the problems with the current system for post-market surveillance?
The statement claims that some companies don’t do appropriate post-market surveillance even when ordered. Why wouldn’t the FDA step in when this occurs and withdraw the company’s ability to market a product if they aren’t fulfilling their responsibilities?
Does the fact that the device industry funding the FDA’s work make them “customers” as the statement claims? Are the fees contingent on speed of approval and the least restrictive pathway possible?

Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancellation of the FDA’s alternative summary reporting program, the reasons it existed, why it was cancelled, and what manufacturers will need to do going forward. Specifically, we address a number of questions, including:

What is the alternative summary reporting program?
Was the reporting of the “discovery” of this program fair or was it media hype?
Why did the FDA recently cancel the program?
What will medical device manufacturers be required to do now?
What is the ultimate result of this ban/change?
What are the takeaways and/or lessons to be learned?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify.

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In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discussion of a recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around the timeline for the communication with the agency, types of 483s involved, definition of non-binding, what happens if a manufacturer ignores the FDA recommendation, and the most important takeaways from the guidance.

Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify.

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In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around what this guidance is, what’s new about it, and whether or not it’s actually something we need. Specifically, we address a number of questions, including:

What’s lead to this new guidance? Do we really need it?
Why is FDA doing more inspections?
What is the goal of this guidance/program?
What is the difference between Form 483 and Warning Letter?
What is the process described in this guidance?
What does FDA respond with?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify.

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In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s letter from March 15, which provided a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeffrey Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. Specifically, we address a number of questions, including:

What were the main contents of this announcement with regard to the evaluation of materials by the FDA?
Are there certain materials they are expected to target early in this review process?
What are technology-specific guidances and how do they relate to this effort?
Will the FDA ban specific materials if they do not meet a certain criteria or have too high an incidence of reactions among patients?
Will this effort ultimately lead to a regulatory pathway to approve materials for medical device manufacture?
Does having a review process for materials that would be approved for use in medical devices run counter to allowing for a broad selection of materials for a given device and ultimately limit options for innovation?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s announcement of their effort to modernize the 510(k) regulatory pathway. This podcast is an extension of the MPO January/February Editor’s Letter on the same topic. (Click here to read that Editor's Letter.) Specifically, we address a number of questions, including:

Late last year, the FDA announced their efforts to modernize the 510(k) clearance pathway. Predicate devices seems to be a focal point. Is there a reason for the agency to seek to cut off the predicate device at 10 years or is that really just an arbitrary number they selected?
If we were to cut off predicate devices at a certain time from being used, are we doing a disservice to all stakeholders involved? Do older predicate devices still offer advantages to the regulatory approval process?
Is this a reactionary move to the bad press the FDA (and industry as a whole) suffered last year, such as the release of the findings from the International Consortium of Investigative Journalists and The Bleeding Edge documentary or was this already in the works?
Is the current version of the 510(k) pathway worth saving or is it long since outdated from when it was first launched?
In my Editor’s Letter, I reference an article that’s also running in the same issue, which focuses on value-based healthcare. In that article, the author, Vicki Anastasi of ICON, explains that a PMA pathway for device approval could be a better option for a company from a financial or reimbursement standpoint. Do you agree?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of personalized medicine on the medical device sector. Specifically, we address a number of questions, including:

As far as we’re concerned with regard to the medical device industry, what is personalized medicine?
For the few devices that have been “personalized” for an individual, how has the FDA handled their approval process?
What are the challenges to pursuing personalized medicine given the current regulatory environment as it relates to finished devices?
What are the most significant changes that would need to occur within the regulatory environment to enable the review and approval of personalized medicine technologies?
What is the impact on the manufacturing side with regard to regulating protocols involved with the development of personalized medicine technologies (for example, additive manufacturing and 3D printing)?

There was also reference made to a previous podcast on the topic of regulating the practice of medicine. This relates to the use of additive manufacturing technologies within the healthcare space, such as fabricating an implant right in the OR. Click here to listen to that podcast.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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This is part 2 of a two-part podcast series. If you haven't listened to the first portion yet, click here to first listen to that part.

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO, My Holiday Wish List (for Industry) (click here to read that Letter). In this Letter, I outlined a few things that I would like to see for the benefit of the medical device industry. The items included an improved image for the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 2 of this two-part podcast series, we continue the "wish list" discussion with a focus on pain management technologies and their opportunity to grow in popularity given the anti-opioid environment. We also discuss the reimbursement process and the opportunity for improvement there.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO, My Holiday Wish List (for Industry) (click here to read that Letter). In this Letter, I outlined a few things that I would like to see for the benefit of the medical device industry. The items included an improved image for the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 1 of this two-part podcast series, we address the first item, an improved image, and discuss the recent "black eyes" suffered by the medtech industry, such as The Bleeding Edge documentary and an investative report that cited dangerous medical devices. We also discuss announced changes the FDA intends to introduce such as the 510k Modernization effort.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the October issue of MPO, Regulating the Practice of Medicine (click to read that Letter). In it, I pose several scenarios regarding the industry’s direction and whether the FDA’s mission needs to be altered such that it would ultimately regulate the practice of medicine to some degree. This is primarily based upon a comment from a reader who offered feedback based on my Editor’s Letter in MPO’s sister publication, ODT. That comment is shared and Mike and Sean discuss it, along with several other points brought up in the October MPO Letter.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we conclude our conversation on the Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. Throughout all three parts of this podcast series, we highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this third and final part include:

The dismissal of nine reviewers from the FDA who brought up concerns regarding certain processes and products.
The lobbying power of the medtech and pharma sectors.
The call for less innovation by several people in the documentary.
A J&J executive admitting on film during a deposition that they were aware of issues with their mesh product.
The observation that doctors seemed to require more evidence to abandon a product they were using then it took to initially have it approved.
The money paid to doctors by the medtech industry.

Before listening to the podcast, it would be best to view the documentary via Netflix.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this part include:

Alleged recommendation by FDA for the da Vinci Surgical System to be submitted as a 510(k) rather than as a PMA as originally submitted by Intuitive Surgical.
Clinical trials for drugs compared to those for medical devices
Footage of the Essure review meeting and comments made during the meeting
The MAUDE event reporting system

Before listening to the podcast, it would be best to view the documentary via Netflix.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we begin a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this first part include:

Overall impressions of the documentary
The statement that a recalled device can be used as a predicate device for 510(k) clearance.
The impact and concerns involved with a “daisy chain” of device reviews or “predicate creep” within the regulatory 510(k) review process.
Should implantable devices be required to have a removal protocol included in its regulatory submission in order to gain approval/clearance?

Before listening to the podcast, it would be best to view the documentary via Netflix.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a relatively new FDA regulatory review option—the Breakthrough Designation Program. Do you have questions about this program, how it impacts the device review process, what types of products are accepted, or other inquires? If so, this podcast is perfect as Mike explains a variety of factors that would impact a company’s decision as to whether the program is right for their product. Specifically, the following questions are addressed:

What is the breakthrough designation program?
How does a manufacturer apply for breakthrough designation?
Why are nearly half of breakthrough designation applications rejected and what should be done to avoid that?
What are the options for a company if its breakthrough designation application is rejected?
Are there non-regulatory advantages of obtaining breakthrough designation, such as public relations, fund-raising, etc.?

As mentioned during the podcast, further information about the Breakthrough Designation Program can be found at the FDA’s website in its draft guidance, which can be viewed here: Breakthrough Devices Program Draft Guidance [PDF file].

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue the 15 year anniversary theme that ran throughout the June 2018 issue of MPO and within my lastest Editor’s Letter that appeared in that issue, The More Things Change... (click to read that Letter). In it, I take a look back at the very beginnings of MPO and see what topics were relevant then that still resonate today within the magazine and industry. Given that theme, in this podcast, we discuss lessons learned from the last 15 years of getting products through the FDA and into the market. The 15 “best practices” (or at least factors to keep in mind during the development of a new product) are provided to help ensure a smoother ride through the regulatory approval or clearance process. Following is a quick list of these 15 tips along with the timestamps in case you are interested in hearing only a few (but hopefully, you stick around to gain insights on all 15). Expanding on each of these, Mike Drues provides his “lessons learned” for each.

Mike Drues’ 15 Tips for Getting a New Product Through the FDA
1. This is a poker game in every sense—(00:56)
2. Consider regulatory from the beginning—(01:57)
3. Employ a competitive regulatory strategy—(03:22)
4. Use label expansions to your advantage—(05:00)
5. No submission should ever be rejected—(07:05)
6. Communicate early and often with FDA—(08:52)
7. Don't treat FDA as your enemy—(11:10)
8. Don’t be the regulatory police—(13:40)
9. Think globally—(16:40)
10. Don’t reinvent the wheel—(17:33)
11. Don't just copy others—(18:33)
12. Know all your options—(19:32)
13. Don’t be myopic about risk—(19:44)
14. New is not necessarily your friend—(20:30)
15. Design your label like you design your device—(21:50)

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the May issue of MPO, The Power of My Voice (click to read that Letter). In it, I provide my own opinions on the technology, how it’s being used in medical devices, and how it could potentially be used for healthcare in the future. I also offer an example of a partnership between the Mayo Clinic and an Israeli company, Beyond Verbal, where voice-enabled technology is being tested as a diagnostic tool for coronary artery disease. I don’t, however, get into the regulatory concerns and potential pitfalls of voice-enabled technology so we discussed it on this episode of Mike on Medtech. Sharing his own thoughts on this topic, Mike Drues delves into the FDA’s oversight of voice-enabled medical devices and how they are treated.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the April issue of MPO. Click here to read that Letter. In it, I reach out to a number of industry experts on regulatory strategies and compliance to ask about a number of changes happening worldwide. One of the primary topics is the European MDR and how its transformation will affect companies’ strategies for the launch of their product. Specifically, the potential of the U.S. to become a “first to market” target going forward versus what has been an EU/CE mark first strategy for quite some time. Having his own comments on this topic, I posed similar questions to Mike during this episode to get his insights and what shifts he saw as potential outcomes of the MDR changes.

During the discussion, there is mention of a previous podcast topic—the Alternative 510(k). Click here to listen to that podcast.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the March issue of MPO. Click here to read that Letter. In it, I bring up a potential future view of healthcare and more specifically, how technology is delivered. I ponder if hospitals or doctor’s offices will employ the use of 3D printing to develop devices, implants, and instruments. One aspect of this topic, however, I was unable to address within the Letter was the regulatory and liability issues that go along with such a plan. As such, that’s the topic of discussion for this episode of Mike on Medtech. Listen to this episode and then see if you think this practice will become accepted in the near or far-off future, or will it never materialize at all.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two terms that are sometimes used interchangeably, but are, in fact, unique in purpose and definition—quality and regulatory. Should they be best treated as separate entities or addressed as a unit? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion:

What’s the difference between quality and regulatory?
Should we separate quality and regulatory?
Would we have fewer problems if we did not separate them?
What are the challenges for the future?
Real world and medical device industry examples provided.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recently announced alternative 510(k) pathway that attempts to trim the time to clearance for medical device manufacturers. Is it, however, an option that already exists packaged in a new wrapper or is it a truly new option put forth by Gottlieb's FDA? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion:

What is the “new” alternative 510(k)?
What are the types of 510ks and how do they differ?
What does “least burdensome” mean?
Does abbreviated 510k mean less time or less work for the company?
How does this compare to what’s available in the EU?
Which is a better system between the new MDR and this 510k?
What are the lessons to be learned/advice moving forward?

For Further Reference
Check out the following links for more information about this topic.

New Steps to Facilitate Beneficial Medical Device Innovation
The Least Burdensome Provisions [PDF]
What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss what the implementation of a regulatory approval pathway for biomaterials would mean for medical device manufacturers, patients, and the healthcare industry. While such a pathway doesn’t currently exist, the potential advantages are explored. Further, the competitive advantage such a pathway could offer to materials manufacturers and suppliers is presented. Specifically, the following questions and topics are addressed in this discussion:

Currently, can biomaterials be approved by FDA?
Drugs are approved, and a drug is sort of a “biomaterial” so shouldn’t biomaterials be approved?
If we haven't had a biomaterial approval pathway thus far, why do we need one now?
How many companies developing new medical devices vs. how many companies developing new biomaterials?
What are device manufacturers more likely to do: develop a new device using an existing material vs. developing a new device using a new material? Which would you choose?
Would there be advantages to having a biomaterials approval pathway?
Would there be disadvantages to having a biomaterials approval pathway?
What is the likelihood of this happening?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of an FDA pre-sub (or pre-submission) prior to making a formal submission of a 510(k) or PMA to the agency. While a number of companies are taking advantage of this, as of right now, still free opportunity, many others are not. When submissions are being rejected at such high percentages (Mike offers the numbers in this podcast), it only makes sense for more companies to utilize this opportunity. Specifically, the following questions are addressed in this discussion:

What is a “pre-sub” and why should engineers need to care about it?
How early in the product development lifecycle should companies involve FDA?
What is a pre-sub lite?
What part in a pre-sub do engineers play, say with regard to testing matrix?
In September, we received guidance revisions with regard to the pre-sub. What was of significance in these revisions?

You can review the pre-sub guidance discussed during the podcast at the following URL: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program (CDRH, Sept. 2017)

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of human factors (or ergonomics or useability) in medical device design, the FDA’s increased interest in its use, and how different users impact the device development (such as patient/home use versus physican/hospital use). Specifically, the following questions are addressed in this discussion:

What exactly are human factors with regard to the development of medical devices?
Last year, the FDA put out human factors guidance for medical device manufacturers. Have human factors always been a part of the FDA’s processes in some way or is it a relatively new element?
How do manufacturers or how should manufacturers conduct human factors testing?
As more devices are being sent home and used outside a healthcare environment, can you share the considerations for human factors development with devices used directly by patients?

Also, during this discussion, reference is made to two FDA guidance documents relevant to the use of human factors with medical device development. You can find those here:

List of Highest Priority Devices for Human Factors Review [PDF]
Applying Human Factors and Usability Engineering to Medical Devices [PDF]

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the passage of MDUFA IV and the changes that are associated with it. Further, we discuss the potential impact this law will have on medical device innovation. In an era of politicians calling for greater healthcare technology and a reduction of healthcare costs, stagnating innovation in medtech seems to be counterintuitive to this demand; unfortunately, that’s exactly what MDUFA IV could do. This law could adversely impact the design and development of medical devices based on companies seeking to avoid the increased fees. Examples of companies changing their product submission strategy are also shared. Specifically, the following questions are addressed:

This is the fourth version of MDUFA, which has been around for quite some time now. Why is this latest version significant?
What are the significant changes in this version of MDUFA ?
What about those companies who are currently in the submission process? What should they do?

Get more information regarding the MDUFA IV legislation via the following links:

Overview: Medical Device User Fee Amendments (MDUFA)
Specific Fee Schedule: FY 2018 MDUFA User Fees

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:

What is off-label use as it relates to a medical device?
What are the limitations of off-label use? Where is the real line between what’s allowed and what’s not?
How are off-label use and real-world evidence connected?
Can a device manufacturer advertise off-label use without going to jail?
How might FDA’s view of advertising off-label use change in the future?

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed:

What’s the difference between a material and a biomaterial?
What’s the difference between a biocompatible material versus a biofriendly material?
How is a biostable material different from a bioabsorable/biodegradable materials?
Do bioabsorables pose additional challenges?
Do the regulatory rules for biomaterials differ from the ones that are currently followed for more traditional materials?
What’s your response to companies who would rather not attempt to introduce a new material (or biomaterial) to the regulatory approval process?

Check out the guidance mentioned in this podcast—ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact 3D printing has made on the current medical device industry, the challenges that are restricting greater use, and a couple of examples of bleeding edge applications that will likely play a substantial role in medtech and healthcare very soon. Always an interesting topic, this podcast likely represents only the first of a series of discussions that center around 3D printing in healthcare.

Check out the video mentioned in this podcast where we discuss the FDA’s additive manufacturing guidance.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the significance of reimbursement as it relates to product development. Not all medical device designers and engineers make the necessary connections between these two seemingly unrelated topics. In reality, however, the two need to be considered carefully alongside regulatory issues to ensure a delicate balance among all three is discovered. At that point, product development should begin in earnest.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent Editor's Letter that appeared in the March 2017 issue of MPO. In it, I wrote about a blog Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, authored regarding findings of recent hospital inspections as related to medical device reporting. Suffice to say, changes are needed with regard to the reporting of incidents by those involved in healthcare. How might we resolve the issue? Listen to this episode to hear what suggestions are made.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of real world evidence in the medical device approval process, which has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). Further, we seek to gain some additional insights on what real world evidence actually is, why it matters to medical device manufacturers, and how they might be able to make efficient use of it.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Medtech Matters: Recent Episodes

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