MedTech Speed to Data: Recent Episodes
Key Tech
Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
Many conditions can elevate or depress the intracranial pressure (ICP) of fluid pushing on the brain, potentially seriously impacting patient health.
However, the only ways to measure ICP require specialized invasive techniques that are too risky for most patients.
In Episode #26 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers talks with Ryan Myers, CEO and Co-founder of CranioSense, about developing portable, non-invasive ICP measurement technologies.
Everybody likes to feel warm and cozy, but we all know someone that can’t keep themselves warm. This is a particular problem for women who have undergone preventive or therapeutic mastectomies. The implants used in reconstructive surgery often feel cold, literally chilling women to the core.
Kristen Carbone designed Brilliantly Warm, a wearable technology to solve a problem that she had herself: keeping warm following a preventive double mastectomy and implant reconstruction.
A former museum curator, Kristen had no background in engineering or business, but she had a powerful idea. She started with a prototype that was connected to a drill battery, and now has a low profile, wearable technology that delivers safe, natural-feeling warmth to the body.
The device slips easily into any bra and is controlled by an app, making it an almost invisible solution for women who want to feel warmer and more comfortable. Brilliantly Warm was initially designed for mastectomy patients, but since its launch, Kristen discovered it’s also being used by nursing moms, for menstrual cramps, and people with chronic conditions who constantly feel cold.
Here in Episode 20, Key Tech’s Andy Rogers talks with Brilliantly Founder and CEO Kristen Carbone about the hows and whys of Brilliantly Warm and how data – or sometimes the lack of it – shaped the journey from idea to marketplace.
Need to know:
- Feel the need. Kristen understood the need for the product from her personal experience.
- Get a lawyer and accountant you love. Find people who focus on start-ups, who can help you make deals, and help you stay compliant with regulations.
- Take the fastest track to the market. Brilliantly Warm is sold directly to consumers. For them, it was a quicker way to ROI. And because it’s a consumer product, Brilliantly Warm is not subject to FDA med-tech regulations.
- Work the web. Brilliantly has a robust website that sells the product and also offers content to help address some of the issues cancer survivors face: sexual dysfunction, medical bills, talking to kids about hereditary cancer, and living well after treatment.
- Start small. Brilliantly began with small product runs, so the company was not sitting on large inventory. That gave them the flexibility to make improvements along the way based on customer feedback about product size, shape, and even color.
The nitty-gritty
Breast cancer affects about 1 in 8 women in the U.S., and those women who have had a mastectomy and reconstructive surgery often feel cold because implants will actually act as a heat sink and pull heat away from the body’s core.
Until now, women have had to create D-I-Y warming solutions, such as using chemical hand warmers or electric heating pads; these can result in discomfort, burns, and even melted implants, necessitating additional surgery. Therefore, safe temperature control was a critical product requirement for Brilliantly Warm. Once a setting is selected in the app, the wearable warms up, with three temperature settings and a built-in thermometer that ensures it never exceeds 111 degrees F.
In the earliest stages of development, Kristen found herself in a data desert. There was virtually no market research about breast cancer survivors, no research to support the product for investors or even much research on women-founded businesses. * So she did what any enterprising entrepreneur would do: she built a database herself. Through what she terms “shameless networking,” Kristen talked to hundreds of women who had similar experiences and assembled enough anecdotal information to convince investors and customers and get the product off the ground.
Turn anecdotes into science - by assembling a large body of anecdotal information and seeking constant feedback from the breast cancer survivor community, Kristen created compelling evidence of market need.
Use what you got – among the few nuggets of data that Carbone could find was that women have a 30% slower metabolism than men, that 80% of people are willing to use wearable technology, and that feeling warm and comfortable improves productivity, all of which strengthened her case.
Create a data feedback loop for your customers. Kristen talked to hundreds of breast cancer survivors and previvors. Through those conversations, she confirmed the need and recognized that the opportunity to help women feel better was much bigger than a single product. Through a wide range of content on the Brilliantly website, Kristen is connecting with the community of women navigating life after breast cancer with a curated resource of products, services, and information.
After a jump-start into the direct-to-consumer market, Kristen and her team are now three years into R&D with its flagship product, Brilliantly Warm. Though the company is still in the VC stage, the product is approved for HSA and FSA expenditures. Now, they’re exploring the efficiencies of the B2B market and insurance reimbursement. And working on new applications for warming technology.
This is an inspiring story of by-the-bootstraps entrepreneurship. Give it a listen here . You’ll be happy you did.
*According to a February 2021 article in Harvard Business Review, only 2.3% of venture capital funding goes to start-ups founded by women.
Each year,millions of people in the U.S.require some sort of neurosurgery due to injury, disease, or genetic condition. They often undergo multiple procedures and face long, painful recoveries. This inspired Jesse Christopher to start tinkering with his kid’s toys in his garage, which was the beginning of Longeviti Neuro Solutions.
Starting from this humble beginning, Longeviti pioneered the development of a low-profile intracranial device platform in 2016, in partnership with Johns Hopkins: the first customizable platform to address a growing need for patients undergoing complex brain surgeries. Today the company is pioneering new solutions for brain surgeries and has brought several FDA-cleared implants to market.
In Episode 19, Andy Rogers talks with Longeviti Founder and CEO, Jesse Christopher, about the journey from garage to CEO’s office, and the data that helped along the way.
Need to know:
- Advocacy groups can guide innovation. Listen to physicians and patients to keep the user front-of-mind during development.
- Embrace the grind. Founding and operating a startup takes fortitude and trust.
- “Lean in” to the FDA. They’re receptive to questions, and can provide great insights, and resources. Also, check out FDA preceptorship programs.
- Plan. Plan. And plan some more. Set a calendar each year so that planning is visible to all, while being mindful of this wisdom from heavyweight Mike Tyson, “Everybody has a plan until they get punched in the face.”
The Nitty Gritty
Longeviti’s Clearfit® disc implants are designed to reconstruct the skull’s natural contour after surgery, and allow for post-operative imaging using ultrasound, instead of more costly MRI or CAT scan procedures. Their InvisiShunt™ supports location and orientation while restoring the natural contour of the cranium for patients with conditions such as hydrocephalus. InvisiShunt is a single-use, sterile implant made to fit different areas of the skull.
These devices are “windows into the brain” that allow doctors to monitor tumors, observe fluid drain, and to use ultrasound instead of more costly MRI or CAT scans for diagnosis and easy access monitoring (ultrasound imaging is not possible on an adult because of the attenuation abilities of the skull).
Of course, a lot of hard data went into the engineering and manufacture of these devices, including material selection, contour, and manufacturing specs. But the secret to Longeviti’s success so far lies in how the company has been able to manage” soft” data.
Market knowledge – before starting Longeviti, Jesse had 20 years’ experience in the field with a Fortune 300 company.
Company culture – in any start-up, you’re flying by the seat of your pants. But establishing a culture that fosters creativity, accountability, and open communication helps build a strong cohesive team. Humility helps.
Education – as with any new technology, real success lies in the ability to educate people about the use and the advantages of your device. Longeviti relies on several pillars:
- On-brand initiatives
- Physician courses, society meetings, and conferences
- Working with hospitals to “follow the dollars”
- Patient advocacy groups, whose feedback can guide innovation
It’s a marathon run, gathering data to hit critical mass. But these grassroots efforts pay off in real-world terms: research that points to statistical significance, achieving standards, and getting all-important reimbursement codes.
Investor relations – a start-up can’t survive without regular infusions of capital. So keeping investors happy–and focused on a success that may be years in the making–is critical. Communication and transparency are the rules. It’s just as important to understand their need for revenue. Show them a path to profitability. Create multiple plans for success. Tell them where you see opportunities for growth. And toot your horn when you find pockets of success.
Longeviti is a great story that truly captures the med-tech entrepreneurial spirit. And the discussion is chock-full of great info.
Helpful Links:
www.longeviti.com
www.hydroassoc.org/hydrocephalus/
Coagusense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients to help them maintain warfarin dosage within a therapeutic range. In the latest version of their device, they actually removed connectivity features to accommodate the needs of their older, less-tech-savvy self-testers. Therefore, they had to go back to the FDA with more bench data for re-approval.
Andy Rogers talked with Mike Acosta, EVP/Head of Compliance at Coagusense, and later recapped some of the lessons learned with Senior Electrical Engineer Jake Cowperthwaite. Andy and Jake have an informative discussion about how to define performance requirements when you’re aiming for FDA approval.
Need to know:
- Make sure the performance requirement is objectively verifiable by a measurable test result, functional demonstration of performance, simulation analysis, and/or visual inspection.
- Plan for the number of prototypes you’ll need to create confidence in your statistics. Large companies may have their own internal mechanism to create a plan. Startups can consult with the FDA.
- Understand the regulatory considerations for seamless FDA approval. It’s a good idea to meet with the FDA prior to submission to outline your requirements. The earlier you have regulatory buy-in, the better.
The nitty gritty:
Rule Number One is to make sure that the performance of the device is objectively verifiable. For example, simply stating “the device shall be easy to use” is vague and subjective and won’t cut it with the FDA.
Write your requirement in a way that can be verified through: testing and measuring results, a functional demonstration of performance, analysis via calculations or simulations, or visual inspection. A well-written requirement is specific with clear criteria, for example if your product was a pump, a performance requirement could be: “the aspiration pump shall have X flow rate within Y bounds”. If it meets that requirement, you’re ready to move on. Don’t over-spec.
Three things the FDA is looking for:
- Above all, efficacy and safety
- Accuracy
- Is your device novel technology or based on a predicate device?
At the test bench, start with a good understanding of how many prototypes you’ll need to have statistical confidence in your results. Sample size will depend on the data needed; an on/off switch won’t require a large sample size, but testing with different operators – as with in-home devices – will need a substantial data set.
In some cases, it’s possible to short-cut the process early in development by testing multiple variables at once. This will yield a lot of data, which can then be analyzed. You’ll find some variables meaningful and others not, but understanding these variables and their sensitivity early in product development has great value and can save money in producing fewer prototypes.
USEFUL LINKS
https://coag-sense.com/about-us/
https://www.greenlight.guru/
There’s nothing like finding a partner with a map when you're exploring new territory.
CoaguSense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients who have been prescribed warfarin. Their Coag-Sense® device monitors blood clotting rates and helps patients maintain rates within a therapeutic range. It’s designed for both professionals and patient self-testers. As with any MedTech device, there were plenty of regulatory hoops to jump through. So they looked for outside help and found it with Greenlight Guru, a company that provides an out-of-the-box electronic quality management system specifically designed for MedTech companies.
Listen in as Andy Rogers talks with Mike Acosta, EVP/Head of Compliance, CoaguSense, and Wade Schroeder, Medical Device Guru at Greenlight Guru, to learn how outsourcing can facilitate speed to data and get you to market more efficiently.
NEED TO KNOW:
- Understand the market by getting users' feedback—what they want/need versus “if you build it, they will come.” Go out there and get that information.
- An outside partner can provide a built-in knowledge base.
- In the med tech industry, quality for the sake of compliance is no longer enough.
- COVID pandemic challenges have delayed FDA review time.
THE NITTY-GRITTY:
According to the FDA, about two million people in the United States take warfarin to prevent blood clots and to prevent stroke in people with atrial fibrillation, heart disease, or artificial heart valves.
So CoaguSense was poised to capitalize on a large market. But as a small company with a new technology, the path to regulatory approval could have been long, tortuous, and costly.
Greenlight Guru came to the table with a purpose-built platform that could manage all the quality, regulatory, clinical, and product development activities across the entire device lifecycle. And having the design control aspect upfront helps all the way.
Coag-Sense is now a market leader, and they’re working on a 3rd Gen simpler version to meet the needs of their older patients. Every step of the way, data drove the decisions.
Fast data. The Coag-Sense® meter directly measures clot formation in seconds.
Procedures and templates from Greenlight Guru were audit-ready to align with regulations, including ISO 13485 and FDA CFR Part 820, and provide a traceable source of truth.
Independent diagnostic testing facilities (IDTFs) can be used to manage call-in results from self-testers, even if a device lacks connectivity.
Developing a “downgraded” next-gen version without connectivity for elderly patients
The Gen 3 version of Coag-Sense actually has fewer bells and whistles in response to the needs of older in-home self-testers who are less tech-savvy. Here are the hows and whys:
Consider elderly patients' desire for simple devices - Many older people don’t have computers at home or are not savvy with smartphones; they don’t want or need connectivity. These patients are more commonly managed by IDTF’s who can manage self-testers.
Build in time for FDA reviews - First, a Gen 3 FDA review is more challenging than a Gen 2 review. You’ll need to show more performance data: FDA wants to see data comparing operator to operator. In addition, the classic 30-day review for 510k is now taking almost a year, with older reviewers retiring and new reviewers coming on board.
Be ready with a plan for post-market surveillance - IVDR - Capturing post-market surveillance data is required now and will feed back for potential improvements.
Find partners who continually evolve – CoaguSense partnered with Greenlight for an out-of-the-box solution for QMS & documents, but just as important for keeping up with what needs to be reviewed in international markets and traceability mapping too.
It all adds up to one interesting discussion. Listen in.
USEFUL LINKS:
https://coag-sense.com/about-us/
https://www.greenlight.guru/
As medical devices keep advancing, the consumables used in testing and therapeutics are moving forward as well, far beyond grandpa’s diabetes test strips. New semiconductors, circuitry, and sensors, along with automated production, bring a whole new spectrum of functionality within reach for consumables.
The burgeoning at-home market is driving demand and the growth of body-worn therapeutics and delivery devices. But with new functionality comes new risks, and among the biggest risks is human error. To paraphrase Murphy’s Law, “Anything that can be misused, will be misused.”
Complex consumables are our topic du jour. Mechanical Engineers Will DeMore and Andy Rogers engage in a far-ranging discussion of the ins and outs of consumables development, how to avoid pitfalls, and how to engineer your way to success.
Need to know:
- The critical importance of interfaces
- How to “goof-proof” your system
- Why user experience drives design
- Common pitfalls that slow development and increase costs
The nitty-gritty:
Consumable products, whether they’re for in-home or clinical use, fall into two categories: single-use, such as blood-test strips, or multiple-use, such as CPAP masks. Each has its own special considerations. But regardless of whether your device is single-or multiple-use device, a therapeutic device, testing device, or drug delivery system, interfaces are the areas where your product will succeed or fail.
Interfaces are where you’ll encounter the most constraints and most complexity in design. For example, a body-worn consumable in a home setting has an interface between the device and user, the device and electronics, the device and its physical space, as well as the device and the digital world, i.e., smartphone app.
Keep the user experience topmost in your mind and your design. It pays to put some time into “poka-yoking” your product. (Poka-yoke is the Japanese term for "mistake-proofing.") It can be as simple as a “This side up” sticker, color-coding, or creating a plug-in that only works one way, a la Apple.
Consider number and types of sensors needed. If you’re dealing with gases or liquids, you’ll need a reliable seal to prevent backflow and cross-contamination – preferably with haptic feedback – so your user knows when the connection is secure. For multi-use consumables, factors like ingress protection, cleanability, and durability, come into play.
Depending on the type of device, you can upgrade interfaces at development or add them later. The important thing is to take a risk-based approach in your design. Think ahead and design to assembly to reduce time and scrap. Think about the cost vs. benefit of upgrades. And, of course, safety first.
The bottom line on complex consumables, whether starting from scratch or adding new functionality to an existing device, is to look for places to add value. Optimize the user experience. Add new data or new connectivity. Prompt the user when it’s time to re-supply. The more you succeed in simplifying a complex consumable for the user, the more successful your product will be.
HELPFUL LINKS:
https://sixsigmadsi.com/poka-yoke/
When you’re trying to add new functionality to existing technology, the data you need won’t be presented on a silver platter. Sometimes, you don’t even know what the right data is until you find it. This was the case with RevMedica, a start-up that’s developing a new hybrid robotic laparoscopic stapler technology.
Following Andy Rogers’ talk with RevMedica, he and electrical engineer Rachael Scott discussed the search for data when designing new functionality into existing platforms.
Need to know:
- Cost is a driver in a hospital environment.
- Look at the competitive field and at other technologies that could enable your technology.
- Understand what your customers want and how they work; function and features define your architecture.
- Be ready to demonstrate the added value of the features you’ve designed in.
The nitty-gritty:
Clinicians want it all when it comes to medical technology, but they don’t want to pay for it all, especially in the highly competitive hospital market. So when you’re adding new functionality to existing systems – or even developing a disruptive new technology – you must pick and choose features that will make your product stand out without breaking the bank.
There are a few ways to find and evaluate the data you need to successfully bring your product to market.
- Understand your customers. Listen to what they want and need, and understand how your product affects their workflow. Get user feedback throughout the development process. Clinicians perform many different tasks, so big changes can lead to non-compliance, which reduces efficacy.
- Know when to hold ’em and when to fold ’em. Consider how far along the development path you can go before you pivot by setting milestones. And look to the data to make the “go or no-go” decision. For example, RevMedica’s original idea was to develop a full-on robotic technology. Months into development, it became apparent that a hybrid model was the way to go, and they had the smarts to make the switch.
- Look for savings in manufacturing. Costs can be amortized for durable components, so deciding which components are durable and which are disposable is a critical decision. Seek ways to design multiple parameters into one sensor. This also affects the sustainability of your product – an increasingly important issue. In addition to opening up a new world of ideas, sustainability can be a competitive advantage in the marketplace.
- Design for the outcome you want. Consider what happens when the task you’re enabling is performed correctly, and design to that outcome. Once again, this is where user data is invaluable. This helps you evaluate your feature set and ensures that you’re creating the right architecture for the platform.
Above all, remember, there’s power in the data, and collecting the data as you develop new products helps inform another generation of technology.
Helpful Links:
https://www.revmedica.comHome | revmedica
Following the data leads to a breakthrough idea in laparoscopic surgery.
Sometimes a technology starts off in one direction, but the data leads developers somewhere else entirely. This is the case for RevMedica, an early-phase medical device company, and manufacturer.
The first product in development at RevMedica is a cybernetic laparoscopic surgical stapler. The development of this device may transform the $4.5B surgical market by matching a reusable power module with a disposable sterile body. But it didn’t exactly start that way.
Recently, Tom Wenchell CEO, and Robert Satti CTO, of RevMedica talked with Andy Rogers of KeyTech about how a venture to create a full robotic surgery platform turned into an even better idea, by following the data path.
Need to know:
· Sometimes data can lead you in a new direction. Follow it.
· Start-ups must learn to do more, with fewer prototypes
· Data mapping puts performance on view for users and investors
· There’s a balancing act between development and marketing
The nitty-gritty
Surgical stapling is a workhorse technology. Staplers are used every day to dissect and/or ligate soft tissue in abdominal and thoracic cavity surgery.
Surgical staplers are nothing new. But the mechanical devices – and even the powered devices – have well-known drawbacks. They don’t fit every hand, can be tiring to use, create waste, and rely on the surgeon to feel his or her way around inside the soft tissue.
RevMedica’s technology is designed to effectively bridge the gap between the instrument and the surgeon’s hand. It’s a hybrid device, not a full robotic system. It’s designed to give surgeons a tool to make better decisions in the OR and create better patient outcomes.
Different types of data have shaped each step of the development:
Market data drove initial development. As RevMedica Interviewed surgeons, their original concept for a full robotic stapling device fell by the wayside, and the hybrid model began to emerge.
Competitive data helped refine and develop the hybrid concept. They looked at entire systems to find inefficiencies in mechanical and powered devices. It became apparent that a hybrid architecture enabled better articulation, smart firing, and a significant competitive advantage: the durable component can remain sterile for multiple procedures. And durable components reduce the waste of “one-and-done” mechanical staplers. This way, RevMedica can provide more value, at a lower cost, without all the bells and whistles or full-on robotics.
Ergonomic data from workflows and job functions surrounding the device as well as the way the device works with tissue provided valuable insight. Different aspects of workflow in OR were scored and ranked, then aggregated in spreadsheets and graphs. By making the data visual, RevMedica developers created a useful tool to define user needs, evaluate performance, and demonstrate the viability and value of the technology for investors.
Give the episode a listen!
Learn more about RevMedica: https://www.revmedica.com/
Get feedback early to fast-track your robotics design.
Start-ups that inherit robotic prototypes from universities or research labs often get caught up trying to get a product out the door. Instead, they should focus on designing a product that will be competitive in the market. Following a chat with Dave Saunders, CTO at Galen Robotic, Andy Rogers sat down with Key Tech Sr. Mechanical Engineer, Danica Mackesey, to discuss the challenges and pitfalls of designing medical robotics.
Need to know:
- Get frequent feedback from end-users. If they don’t have complaints, get nervous.
- View the system as a whole. It’s all too easy to get lost in the weeds.
- Make sure that your designs are manufacturable. This may seem obvious, but it’s as big as the difference between theory and practice.
The nitty-gritty:
The first step in designing for quality is to determine the requirements of the robotics system, including the when, where, and how the system will be used and what features are needed. Once the features have been determined, it’s time to consider how well they work for the end-user. This is the audience participation segment of product development, where user input can save you lots of time and trouble.
In robotic surgery, surgeons need to feel comfortable and confident with the device. For example, consider the ergonomics of handles and the effects of repetitive motions. Monitors should be easy to view. Of course, a high-voltage robotic system must be safe (Your mantra is, “IEC 60601, IEC 60601, IEC 60601…”), and it also must fit into the environment of the operating room without danger of tipping over or dangling cables, and out of the way of surgical drapes. The earlier you tackle these issues, the better.
Temper your forward-thinking design with some down-to-earth risk management. For instance, what happens if the robot stops working in the middle of a procedure? That kind of thinking leads you to designing-in overrides and safety systems.
Finally, the answers to many of your design questions (and challenges) are often as near as the phone or email. Ask your end-users. Ask your component manufacturers – they have almost as much riding on your success as you do, and they can provide valuable advice.
Give it a listen!
The data you need to design a multi-use surgical robot
Surgical robots can do all sorts of things better than humans. But human doctors have a breadth of experiential knowledge and instinct robots cannot replicate anytime soon. Understanding that difference is the key to designing a successful robotic platform. Galen Robotics is expanding the benefits of minimally invasive surgeries by enabling precise surgical maneuvers through human-machine cooperation.
Andy Rogers of Key Tech and Dave Saunders, CTO at Galen Robotics, discuss the challenges of designing surgical robots and the importance of collecting key data early in the design process.
Need to know:
- Identify a clinical application that has value for the surgeon
- Get feedback early and often
- More prototypes yield more data
- Multiple applications help justify cost
- Converting qualitative data to kinematics is key to optimizing performance
The nitty-gritty:
Robots are transforming surgery, making it faster, safer, and less invasive. But the majority of surgical robots on the market today are one-trick ponies.
Galen has a unique technology for delicate ear, nose, and throat (ENT) procedures that could have many applications. Leveraging different types of data gave Galen Robotics an advantage in the market.
A priori knowledge. Galen recognized an unmet need in the marketplace and licensed a concept that was initially developed at Johns Hopkins, so they didn’t have to start from scratch. The robot is not the surgical tool; it is a stabilizing platform that holds and manipulates an ordinary surgical tool similar to power steering in a car. Galen Robotics engineers capitalized on the fact that surgeons know how to use the tools of their trade; they just need a helping hand to use the tools more effectively.
This collaborative approach enables surgeons to focus on what they do best –analyze the situation and decide on a course of action– because the surgical robot stabilizes the instruments and facilitates the procedure.
Observational data. Engineers went into the OR to see which aspects of specific procedures surgeons found the most challenging to see first hand the scale of motion delicate ENT procedures require. This information proved valuable in driving components choices and materials.
Qualitative data. Surgeons have performed head and neck surgeries for decades, so they know what a successful surgery “feels” like. They already have the touch. In this case, engineers were able to use kinematics to turn this trove of anecdotal information into Quantitative data.
Quantitative data. Engineers then quantified surgical movements to adjust the “feel” and “tune out” normal hand tremor. This made surgical motions performed by the surgeon feel more natural. They also added in range-of-motion safeguards to help prevent accidental damage to surrounding tissues.
Prototyping is essential throughout the whole development process . The more, the better– because no matter how crude– each prototype yields valuable user feedback. For example, one Galen Robotics prototype was modeled on the children’s game “Operation”. Doctors at a conference tried to beat the robot, picking a small part out of a slot. Only one succeeded. And Galen Robotics’ concept was validated.
But ultimately, one of the most innovative ideas Galen Robotics is developing may not be their engineering, but a unique go-to-market plan. A plan that helps hospitals avoid the capital-intensive cost of adding another surgical robotic platform, by licensing a Galen Robotics device once it’s approved.
Give it a listen.
HELPFUL LINKS:
https://www.galenrobotics.com/
Clinical and in-home trials are different, but the essentials are the same –solid data, foresight, and flexibility.
Clinical trials are understandably rigorous, but in-home trials add a few wild cards into the mix. Andy and Jake spoke with Steve Schaefer, CEO of CoolTech, about this exact topic in the previous episode.
Here, Andy and Jake dig into in-home trial design and execution from a product development perspective.
Need to know:
- Approach trials with confidence in your device, backed up by data
- Know your user: clinical users are different from home users
- Evaluate the device against all applicable standards, and verify, verify verify.
- Stay lean, stay simple
The nitty-gritty
By now, it’s pretty clear that the future growth of med-tech points towards in-home testing and therapy. But you have to jump through more hoops from prototype to commercialization for in-home devices. As the Boy Scout motto says, “Be prepared.”
Plan for change. Start with a change control process in place so that you don’t make changes that could negatively affect performance down the road. Evaluate your device against all applicable standards at appropriate milestones.
Know your user. Clinical users are different from your home user, and each will need different training to use and evaluate the device correctly.
Keep it simple. A clinical device may not need all the bells and whistles of a commercial device, so keep it as simple as you can. With in-home trials, you don’t have trained clinicians and engineers on hand to monitor the process, so once again, make it simple for users to get it right the first time. For example, with the MiHelper in-home trials, CoolTech used disposable tubes and masks to simplify use and facilitate the trials; commercial products will be multiple use.
To get from trial to commercial success, you need to:
- Connect the dots. Make sure your core parameters match
- Lock down the software
- Review features and edit if needed
- Perform a gap analysis
- Understand impact of all changes
- Trace data back to clinical device
There are more details and more insight in the podcast. Check it out.
CoolTech Part 2: Get through trials faster, with fewer tribulations.
Here, Andy Rogers and Jake Cowperthwaite continue their talk with Steve Schaefer, CEO at CoolTech, about the quest for data with MiHelper: a new in-home therapy device.
MiHelper is a drug-free way to treat migraines, cooling the patient with air. The design for the device was piggy-backed (pun intended, as they used a porcine animal model for the original device) onto an existing cooling platform –CoolStat– used for a totally different type of therapy. Even though the platform itself was proven, MiHelper still had to go through the twists and turns of trials because it was a de novo device in this application.
Need to know:
- Understand the commercial product requirements before you start
- To get from clinical trials to home trials as quickly as possible, develop platforms concurrently
- Drive value every step of the way
- Essentials to bridge the gap from trial to commercialization: market, pricing, and reimbursement models
The nitty-gritty:
Oxygen therapy has been used to treat migraines in the past, but devices were too bulky and complex for at-home use, until a prototype study at Johns Hopkins indicated that room temperature air could do the job. When CoolTech worked with their engineering partner to adapt their existing CoolStat evaporative cooling platform, the objective data panned out, and patients reported relief from migraines using the device. So MiHelper was born. That was the easy part, relatively speaking.
The thorny path is the road to clinical trials, in-home trials, regulatory approval and ultimately, commercialization. For clinical trials in this case, a subject had to develop a migraine, travel to the hospital, receive the therapy, and then report about relief – a lag time of several hours.
At-home trials require an additional level of device confidence, which is being achieved through design verification, biocompatibility testing, and electrical safety & EMC testing. There are more wild cards, starting with shipping the device to test subjects. (CoolTech found a contract manufacturer who could drop-ship and re-process them). Recruiting test subjects was done through social media, and because the data is digital, the study center doesn’t have to be local, allowing for larger sample sizes. Data tracking and security is another big issue that CoolTech solved with a one-way app.
To speed the whole process along, CoolTech developed the trial device and in-home platforms concurrently. To support at-home trials, CoolTech is using a “small-but-mighty” team of in-house people and contractors, which allows for flexibility and quick response. This way, they can channel resources into generating high-quality evidence and driving value.
The MiHelper trials have yielded a couple of valuable tips for any start-ups going into home trials.
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Try to partner up with emerging companies using convergent technologies.
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Partners could range from privately funded research to oversight by a clinic, or anything in between.
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When evaluating data, it’s the quality of the evidence, not the name on the paper, that counts.
The market for in-home therapy is growing by leaps and bounds. And the profit potential is huge. But get your ducks in a row before you jump into the pond. That way, the path from drawing board to commercialization will be smoother and more straightforward.
There’s more. The whole story is right here, and well worth a listen.
HELPFUL LINKS:
https://www.cooltechcorp.com/
https://www.nih.gov/
You don’t know where test data will lead, but you can follow it if you plan aheadA few weeks ago Andy and Jake Cowperthwaite spoke with Steve Schaefer, CEO of CoolTech, about designing your device as a platform. Steve’s company was able to use their temperature management platform to develop two devices, for two distinct applications.
They were able to achieve this by designing enough flexibility into the initial design, which is what Andy and Jake discuss in depth this time around.
Need to know:
- Design the device as a platform with flexibility to facilitate future changes
- Let the end user tell you what the ideal architecture should be
- The more data logging, the better
- Four critical areas to allowroom for improvements: software, electronics,, mechanical modules, and service access
The nitty-gritty:
When thinking about flexibility, there are four core elements to keep in mind.
Flexibility in Software Design
Plan for software upgrades and how you will deliver them. Plan to log as much data as possible, because you never know what data you will need.
Flexibility in Electrical Design
Ensure your power supply can support new features. Include hooks on circuit boards for future sensors and actuators.
Flexibility in Mechanical Design
Focus on modularity, so you can change parts of the hardware without impacting the entire device.
Flexibility in Serviceability
Focus on easy access to internal components, and make disassembly and reassembly as easy as possible.
While you can’t plan for everything, doing preformative testing early, and letting your prospective end users tell you what the ideal product architecture and use case should be. This way, once you get into a trial, the development changes are very technical in nature, rather than being due to the device not being easy to use.
For a great example of how to do this, take a listen to our interview with Steve Schaefer.
HELPFUL LINKS:
https://www.cooltechcorp.com/
https://www.nih.gov/
How to get from “data” to “device”: one cool story.
What data you need, where you get it – and most importantly – what you do with it, all determine whether a medical device will be successful. Of course, every technology has its own set of caveats, but it always helps to hear from people who have been there.
In this episode, VP of Business Development Andy Rogers, and Senior Electrical Engineer/Partner Jake Cowperthwaite, both of Key Tech, talk with Steve Schaefer, CEO at CoolTech, about the quest for data with CoolStat: a new way to manage patient temperature in fever that can develop following a stroke, traumatic brain injury, seizure, or metabolic encephalopathy.
There are other technologies that manage patient temperature, but CoolTech partnered with a engineering team to build a way build a better mousetrap. CoolStat generates filtered air that’s delivered to the patient via a nasal mask air tubing set. It cools through evaporative cooling, using room temperature air. CoolStat is smaller and lighter than existing devices; it reduces side effects like shivering which can lead to complications – and shortens treatment time.
Need to know:
● Understand the commercial product requirements before you start
● Your regulatory path depends on your specific device
● Go where the data leads
The nitty-gritty:
The initial data that drove CoolStat’s development was collected from tests on pigs, who have similar physiology to humans. In this case, because they were seeking objective data – rate of cooling, rate of air flow and efficiency of cooling – CoolTech was able to save time by using existing temperature probes and storage software.
The first results were okay, but less than optimal. For many companies, this can be a go/no-go point, where you decide to fish or cut bait. CoolTech opted to pause the study, make changes, and go back to the FDA with an improved device.
Finding human subjects for testing was another challenge. Patients are typically unconscious in the ICU, so getting family consent is laborious, especially during the COVID pandemic. Patient data is recorded on CRF’s and validated within 24 hrs. so engineers can quickly make changes based on this real-world info.
CoolTech found that partnering with outside resources, such as the National Institutes for Health (NIH) university hospitals, and end-user associations can help to expedite development. Clinical studies will be completed soon. Now the critical numbers for CoolStat are the savings that hospitals can reap using this exciting new technology.
Listen in for more data. And more details.
HELPFUL LINKS:
https://www.cooltechcorp.com/
Managing Blood When Evaluating Consumable / Durable Medical Devices
“Blood is thicker than water” the old saying goes. There’s truth in that adage, especially when it comes to designing and running de-risking experiments of blood processing systems.
Whole blood is a two-phase fluid, comprised of both cells and plasma. Under pressure, it’s fickle and unpredictable. And those unique fluidics present distinctive challenges in designing medical devices.
Blood management is the central concept in cardiac care, the largest segment of the medical device market. As the home care market continues to grow and devices become smaller, blood management becomes a more and more critical design issue.
This month, Mechanical Engineer Katie Goetz and Andy Rogers of Key Tech talk blood: how it poses problems in medical device design, and how to get blood to do what you want it to do.
Need to know:
Why blood fluidics are different
How to engineer your device for optimum flow control
How storage methods, freshness of samples, and interactions can affect test results
How to deal with bubbles
The nitty-gritty:
A blood analog may work fine in the early stages of testing, but nothing replaces testing with the real thing. Whole blood is thick and complex, and the viscosity varies due to many factors. That makes for some challenges when you want to make blood flow the way you want it in a complex consumable. Blood differs from person to person too, so medical devices must be capable of dealing with a wide range of conditions. Blood also interacts with metals, plastics, and air differently, which can also skew test results, so proper cleaning of prototypes is critical. And then there’s foaming, which adds risk and time to your test planning.
Even the logistics of blood are complex. Anyone who’s doing testing needs to be trained how to work with blood and clean it up. Ordering blood takes a few days, and sample blood may need to contain additives like EDTA or other anticoagulants, so when you are designing and running experiments, you have to take this into account.
As we said, blood is complicated. But if you take it step-by-step, and follow the protocols, you can make blood behave the way you want it to. And you’ll make your device all that more robust.
Helpful links
https://www.iso.org/standard/38421.html
Decrease Time-to-Market by Developing Medical Device Software “In the Spirit” of IEC-62304
Getting any new medical device to market is a race against time, and it’s so tempting to jump in and start coding from the get-go. But hold your horses – you’ll save time in the long run, and potentially improve the valuation for your company, by following the spirit of IEC-62304 throughout each stage of development.
This standard impacts the entire software development lifecycle: from initial requirements and coding to release and maintenance. Understanding when and how IEC-62304 applies can potentially save you months of backtracking in the race to get your device to market.
Check out this video as Computer Engineer Jamie Kendall and Andy Rogers lay it all out and explain how “working in the spirit” of the standard can keep you on track, on time, and in compliance, particularly when developing non-regulated devices.
Need to know:
- How to define the right architecture
- The trade-offs of building documentation as you go vs. retrofitting
- How existing code libraries and re-using compliant modules built to the IEC-62304 standard can keep you from “re-inventing the wheel”
- What tools can make the process smoother?
- How 62304 compliance can affect company valuation.
The nitty-gritty:
IEC-62304 lays out a unified process for evaluating safety in medical devices sold in the US and EU. The software safety classification, Class A, B, or C determines the safety-related processes you’ll need to use.
With non-regulated medical devices, you’re working within a highly-structured environment, without the formalized legislative pressure. Choosing to focus on specific areas of IEC-62304, even without the requirement, balances the key factors of time and risk management. And when you understand precisely how the regulations apply, you can stay in compliance without going for all-out unit testing at each stage of development.
It’s important to identify interfaces from the very beginning. Think through what goes where: for instance, what should be firmware and what should be PC-based software. You can use pre-engineered software or existing code/ libraries for things that are not unique to the system (stepper motors, pump etc.) so you’re not reinventing the wheel at each stage.
For example, using a single micro-controller on your platform gives you a good reusable framework for low/mid-level modules, especially when these are designed to IEC-62304. In addition, you can use a methodology like AGILE project management, tools like ReSharper, or static analysis techniques to help you maintain quality and compliance.
Keeping within “the spirit” of 62304 at each stage of development allows you to focus on key parts of the system and make needed changes in days versus weeks. By adding value to your device in this way, you’re building value for your entire company.
Helpful links
https://www.iso.org/standard/38421.html
Focus on The Assay to Improve Overall IVD System Development
Assay performance should be the priority when developing complex cartridge and instrument systems. The Assay is King! As assays are becoming more complex, taking an “inside-out” approach to IVD System Development is optimal for project success.
This approach starts with first defining what the assay needs to do, then figuring out how to automate that process on the cartridge, and only then focusing on what a commercially viable instrument will look like. This leads to reduced costs, shortened timelines, and superior diagnostic performance. Put another way, the assay team should be the customer when architecting and developing IVD Systems—the chemistry should drive the project.
How to implement the inside-out approach
Define the Assay First
The assay is where the magic happens and is where the intellectual property lies. That IP is what drives future acquisitions by global diagnostic players. For example, Roche recently acquired GenMark along with the ePlex system that Key Tech helped develop, to broaden its molecular testing portfolio.
At the end of the day, the instrument serves the cartridge and the cartridge serves the assay. Before starting any product design work, you need to understand whether the chemistry is locked down. Is the benchtop assay working? If not, it may make sense to wait until it is, to avoid costly rework later.
Our CEO and Co-Founder, Jenny Regan, stresses the importance of solidifying assay performance before instrument design:
“Anyone can design a beautiful instrument that doesn’t work. It’s easy to do because it is a tangible milestone for investors and developers alike. The pressure to do that and make something that looks great before doing the nitty-gritty, difficult work of making a working assay is all too easy to fall into.”
Collaborate on Menu Planning Early
It is critical to not only understand the lead assay, but also what other assays are being planned so that both cartridge and instrument can be planned accordingly. Early collaboration with the assay team will ensure that fewer changes and post-market updates need to be made. This approach also affects speed of regulatory approval, since most changes that need to be made to the cartridge or instrument, to support a new assay, will require applying for re-approval.
For example, consider reagent quantity. If your lead assay requires eight reagents, but a few others need ten onboard, you need to ensure that the planned cartridge design takes that extra requirement into account and leaves space for the additional two.
Sample type is another consideration. If the lead assay is going to work with a saliva sample, but a future panel will use a stool or blood sample, you need to ensure the cartridge is designed to be able to handle the future, additional sample types.
De-Risk and Validate Assay Automation Early
Because a working assay is the end goal, it’s critical to get working automated cartridge/instrument prototypes to the assay team early so they can validate that the chemistry is still working, and to design a workflow for their assay. It needs to be easy for the assay team to collect data and interact with these early prototypes.
Often, this means developing test fixtures for each critical step in the assay process. When translating an assay from the bench to the cartridge, there could be steps that only work part of the time on the bench. These must be confirmed to work 100% of the time on the cartridge. Or there could be steps that always work on the bench, but are extremely complex to automate, requiring validation to see if that specific step is even practical in an automated instrument.
At Key Tech, we have a proprietary software platform for hardware interaction, called KeySharp, that allows the assay team to control a prototype instrument while seeing a graphical engineering view of what the cartridge and instrument are doing. With this tool, they have a way to interact with the prototype, adjusting and testing variables, and designing a workflow for their assay.
Constant Collaboration for Real-Time Feedback
The “assay is king” approach requires an ongoing conversation between the engineering team and the assay team, and a consistent feedback loop.
The traditional outside-in approach often creates unnecessary constraints on the assay team by forcing them to operate within an engineered product that was developed without them in mind. If the assay team has tweaked the bench assay to generate a better or quicker result, the design may not be able to support it.
Pivots and updates in the bench assay are commonplace, so constant communication is the only way to anticipate and adapt the development effort in a timely way.
Parallel Development of Cartridge and Instrument
Oftentimes, three teams are working on a project – assay team, cartridge team, and instrument team – which makes efficient development exponentially more difficult. Especially if coordinating across multiple organizations.
On the other hand, parallel cartridge and instrument development by a single interdisciplinary team eliminates conflicting priorities and incentives between vendors. This integrated approach helps your IVD system get to market faster, as both instrument and cartridge are developed under one roof toward a common goal. Ultimately serving the assay, designing the cartridge and instrument in parallel reduces your overall development process time and cost.
Not all design and development firms offer both IVD cartridge and instrument design expertise to support a successful assay. Ben Lane, our Director of Engineering, shares,
“Our claim of integration is truly the case. We have cartridge designers and instrument designers who are literally sitting next to each other and talking to each other all day long.”
In Summary
Assays are becoming more and more complex, and ensuring that platform development actually serves the assay is critical. Placing your assay and engineering teams in constant collaboration and tackling de-risking, menu planning, and validation early in the process will lead to project success.
The market for medical devices for home use is projected to grow more than 20% to over $7 billion by 2027, driven by increased awareness of the importance of self-monitoring, an increase in lifestyle-driven diseases such as diabetes, and – in no small part– infectious diseases such as COVID.
But the home environment is a far cry from the usual clinical setting, and it presents unique challenges in product design. Key Tech’s Rachael Scott, Sr. Engineer, and Andy Rogers, VP of Business Development, talk about the challenges and provide valuable insights.
What you need to know:
- How to work within the regulatory frameworks (FDA ANSI/AMMI 60601 -1 safety standards HIPAA, and more)
- Why the home environment is more demanding than a clinical setting
- When is the best time to test and de-risk
- Where your design can go wrong and how to prevent it
The nitty-gritty:
Begin with a good understanding of the home environment. These considerations affect your choices in electrical safety, screen size, GUI design, portability, and durability. Expect the unexpected; untrained users, children, and pets are just a few wild cards that should figure in your design. Make sure you have a way to offload and disseminate results in a user-friendly way. Interfaces are always critical, especially where HIPAA compliance is required.. Above all, get your prototypes into a home environment early in the design stages, and give them this reality check frequently.
Helpful links:
https://www.fda.gov/media/84830/download
A successful pharmaceutical device takes the entire drug journey into consideration - from manufacturing to packaging, to shipping, and finally patient administration.
As drug delivery moves from the hospital to the home or other remote environments with untrained users, you need to consider end-user challenges along with technical fluidic control challenges to provide accurate dosage and delivery.
Pharmaceutical devices are becoming more powerful., moving higher volumes of fluid over longer periods of time, all while remaining small, inexpensive to ship, and simple to use - often in remote settings. Empathizing with all users along the drug journey is key to balancing these often competing interests and, ultimately, commercial success.
Hear Key Tech’s engineers discuss how to solve these seemingly unsolvable drug delivery challenges.
At Key Tech we specialize in end-to-end product development for medical, industrial and consumer products, but the largest segment of our business is in vitro diagnostic (IVD) platforms. So we understand what it takes to take an IVD device from bench to market. Over the years, we’ve built an interdisciplinary team of scientists, engineers, and designers to partner with companies large and small. But for many companies, it makes sense to develop product development capabilities in-house. So here are a few tips about putting your own team together, from people who have been there before.
Understanding Risks, Tradeoffs, and Prioritization in Your Next Automated Assay Development Program:
1. Product Strategy
Working backwards from the commercial goal, the purpose is to understand key drivers of product architecture and identify technical risk. Driving decision-making throughout development: intended price target and use case.
- Ease of Use
Identify which areas of the eventual product are most valuable to automate, and which are better left as manual user steps. Understand the risks and tradeoffs between the complexity of automation and the likelihood of human error.
- Sensitivity Analysis
Break down assay steps and establish clear technical requirements for each step, as well as their interdependencies. Allow the engineering team to know what variables need further study to accurately assess technical risk.
- Consumable/Durable Interface
Focus on device functionality and where features will reside in the system: what belongs on the cartridge and what belongs on the instrument to achieve performance and system requirements?
- Reagent Handling
Consider how reagents will be introduced to the assay: through durable containers at large runs or on the consumable in small doses. Reagent handling dictates high-level architecture decisions, best addressed early for optimal product architecture.
- Fluidic Control
Precise liquid handling is a core challenge in assay automation. Identify how liquids, and typically air, will be controlled in a reliable, repeatable way, consider automation solutions for fluidics control, and address contamination sensitivity.
- Temperature Management
Develop methods for measuring and controlling temperature by understanding the effects on the instrument, cartridge, and assay performance.
- Algorithm Development
The data processing algorithm is often the core value proposition and differentiator being brought to market. Two factors ensure a clinically actionable test result: understanding the limits and constraints of the algorithm and recognizing the instrument requirements that the algorithm demands.
- Tech De-Risking Methods
Identify what risks need to be mitigated and where various de-risking methods should be deployed. Methodology options include creating testbeds, modeling and simulation, and subcomponent specialist consulting.
- Scale
The framework bookend considers the impacts of high quantities and long-term use on the instrument and cartridge reliability, cost, and performance. Understand whether the device can work in large numbers and what strategies should be employed to improve reliability and performance while containing cost.
Welcome to med tech speed to data, a key tech podcast, where we interview med tech leaders about the critical data-driven decisions they make during their product development process.