Podcasts

Mike on Medtech: Binding vs. Nonbinding FDA Feedback

Mike Drues and Sean Fenske discuss what’s required of companies who receive nonbinding feedback from the FDA.

Sean Fenske, Editor-in-Chief 06.10.20

Mike on Medtech: Real World Evidence Revisited

Mike Drues and Sean Fenske discuss real world evidence and several reasons why it’s not being used by medical device manufacturers for regulatory review.

Sean Fenske, Editor-in-Chief 05.14.20

Mike on Medtech: FDA Pre-Sub Best Practices

Mike Drues and Sean Fenske discuss the most important factors to keep in mind when preparing to meet with the FDA during a pre-sub meeting.

Sean Fenske, Editor-in-Chief 04.24.20

Contract Manufacturing | Diagnostics

Medtech Matters: AdvaMed's Scott Whitaker on Medtech's COVID-19 Response

MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.

Sean Fenske, Editor-in-Chief 04.17.20

Mike on Medtech: COVID-19, Part 2

Mike Drues and Sean Fenske discuss issues involved with misinformation around products to help treat COVID-19 and relaxed regulatory rules.

Sean Fenske, Editor-in-Chief 04.08.20

Mike on Medtech: COVID-19, Part 1

Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.

Sean Fenske, Editor-in-Chief 04.01.20

Packaging & Sterilization

Mike on Medtech: EtO Sterilization Concerns

Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.

Sean Fenske, Editor-in-Chief 03.30.20

Mike on Medtech: FDA's eSTAR Program

Mike Drues and Sean Fenske discuss a pilot the FDA is conducting that would have the agency providing an interactive 510(k) template to submitting firms.

Sean Fenske, Editor-in-Chief 03.03.20

Testing

Mike on Medtech: Human Factors/Usability, Part 2

Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.

Sean Fenske, Editor-in-Chief 02.03.20

Testing

Mike on Medtech: Human Factors/Usability, Part 1

Mike Drues and Sean Fenske discuss the importance of human factors within the regulatory landscape and how it came to matter to FDA.

Sean Fenske, Editor-in-Chief 02.03.20

Mike on Medtech: Change Management, Part 2

Mike Drues and Sean Fenske discuss the potential implications for a medical device manufacturer who mishandles the reporting of a change to a device.

Sean Fenske, Editor-in-Chief 01.20.20

Mike on Medtech: Change Management, Part 1

Mike Drues and Sean Fenske discuss the procedures and best practices for handling change management for a variety of potential revisions to a device.

Sean Fenske, Editor-in-Chief 01.20.20

Mike on Medtech: Safety and Performance Based 510(k)

Mike Drues and Sean Fenske discuss an “abbreviated” 510(k) option for specific, well-understood devices that doesn’t use a predicate.

Sean Fenske, Editor-in-Chief 12.05.19

Mike on Medtech: The Special 510(k) Program

Mike Drues and Sean Fenske discuss a 510(k) option for modifications to a company's legally marketed medical device.

Sean Fenske, Editor-in-Chief 11.13.19

Mike on Medtech: Beyond 510(k)/PMA—Safer Technologies Program

Sean Fenske and Mike Drues discuss another new program from the FDA—the Safer Technologies Program (STeP)—and the details of it.

Sean Fenske, Editor-in-Chief 10.17.19

Mike on Medtech: Benefit-Risk Determinations

Sean Fenske and Mike Drues discuss two FDA guidance documents that focus on considerations and uncertainty in making benefit-risk determinations.

Sean Fenske, Editor-in-Chief 09.16.19

Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

Sean Fenske and Mike Drues discuss a relatively new program from the FDA—the Breakthrough Devices Program—and what it offers to medtech manufacturers.

Sean Fenske, Editor-in-Chief 08.06.19