Medical Product Outsourcing - Podcasts: Recent Episodes
Sean Fenske
Mike Drues and Sean Fenske review CAPAs, what they are, how they are used, and if there’s a potentially better approach.
Mike Drues and Sean Fenske discuss what a company should do if they get a 483 or warning letter from the FDA.
Mike Drues and Sean Fenske look at new FDA guidance around RWE and discuss how it can be used within regulatory submissions.
Mike Drues and Sean Fenske review medtech’s history of dangerous devices that have negatively impacted patients.
Mike Drues and Sean Fenske discuss some recent news about unsafe medical devices and falsified test data.
Mike Drues and Sean Fenske look at the medtech-centric items on the list and discuss why they are a concern.
Mike Drues and Sean Fenske take a look at the purpose of IRBs and the role they play in a medical device clinical trial.
Mike Drues and Sean Fenske review the attempts being made to pay for innovative technology as designated by the FDA’s Breakthrough program.
Mike Drues and Sean Fenske discuss three recent guidances put out by the agency in an attempt to bolster the regulatory pathway.
Mike Drues and Sean Fenske discuss the reasons for the increase in recalls for manufacturing issues and how to avoid them.
Mike Drues and Sean Fenske discuss an FDA guidance that would outline how AI or ML technologies could be allowed to evolve without new submissions.
Mike Drues and Sean Fenske discuss why and how a medical device manufacturer might use a device that went through a recall as a predicate for a new product.
Mike Drues and Sean Fenske discuss why medical device manufacturers continue to rack up the same types of 483s from FDA inspections.
Mike Drues and Sean Fenske continue the discussion on the controversy involving LDTs and whether the FDA should regulate them.
Mike Drues and Sean Fenske review the controversy surrounding lab developed tests and discuss whether or not it makes sense for FDA to regulate them.
Mike Drues and Sean Fenske discuss what happens when the emergency use authorization period ends and what device makers need to do then.
Mike Drues and Sean Fenske review the term and discuss what types of devices are exempt, as well as the meaning of the term itself.
Mike Drues and Sean Fenske look at the promotion of off-label use for a medical device and the ways in which it can be done successfully.
Mike Drues and Sean Fenske review the agency’s Intended Use rule that was made final last year and discuss its impact on labeling.
Mike Drues and Sean Fenske look at the FDA’s Special Controls that are tied to Class II medical devices and how they can be leveraged by a company.
Mike Drues and Sean Fenske review the latest guidance on Refuse to Accept and why the occurrence happens much too often.
Mike Drues and Sean Fenske discuss recalls with a specific focus on voluntary recalls, why they occur, and how to be ready for one.
Mike Drues and Sean Fenske discuss how a letter to file is to be used, when to use it, and how to avoid problems with FDA.
MPO's Sean Fenske speaks with Dr. Juliana Blum of Humacyte about the company’s regenerative medicine product.
MPO's Sean Fenske speaks with Andy Doraiswamy of Koya Medical about providing compression therapy on-the-go.
MPO's Sean Fenske speaks with Mike Favet of NeuroPace about a strategic partnership and what it means for those suffering from epilepsy.
MPO's Sean Fenske speaks with Elad Walach of Aidoc about the incorporation of AI in radiology.
Mike Drues and Sean Fenske discuss what may be missing from the FDA’s regulatory oversight and opportunities they could offer.
MPO's Sean Fenske speaks with David Fischel of Stereotaxis about his company’s unique robotic surgical system.
MPO's Sean Fenske speaks with Dr. Deepak Khuntia of Varian about the firm’s one-second radiation system for tumors.
MPO's Sean Fenske speaks with Moshe Safran of RSIP Vision about the emerging tools that are moving imaging forward.
Mike Drues and Sean Fenske discuss why cybersecurity is important to the Agency and how to address challenges involved with it.
MPO's Sean Fenske speaks with Dr. Tamir Wolf of Theator about the benefits of capturing surgical procedures on video.
MPO's Sean Fenske speaks with Amit Phadnis of GE Healthcare shares his predictions on healthcare technology and the changes it will cause.
MPO's Sean Fenske speaks with Andrew Ekdahl of DePuy Synthes about the company’s quest to achieve knee restoration rather than replacement.
MPO's Sean Fenske speaks with Kathy Lee-Sepsick of Femasys about how the company is addressing infertility as well as preventing pregnancy.
MPO's Sean Fenske speaks with Dr. Asha Parekh of Front Line Medical on the functionality of the company’s device and how it can help save lives.
MPO's Sean Fenske speaks with Bryan Lord of Pristine Surgical about the advantages of single-use endoscopes and why they are necessary.