Podcasts

Mike on Medtech: Multiple Function Device Products

Mike Drues and Sean Fenske discuss what a Multiple Function Device Product is and how the FDA's guidance impacts manufacturers.

Sean Fenske, Editor-in-Chief 09.17.20

Mike on Medtech: Breakthrough Designation Program Update

Mike Drues and Sean Fenske revisit the breakthrough designation program and talk about the changes that have occurred since its inception.

Sean Fenske, Editor in Chief 08.28.20

Mike on Medtech: 50th Episode—A Look Back

Mike Drues and Sean Fenske look back at the previous 49 episodes and highlight a variety of topics covered in this anniversary episode.

Sean Fenske, Editor-in-Chief 08.10.20

Mike on Medtech: Combination Products Update

Mike Drues and Sean Fenske discuss a recently issued compliance program and what it means for manufacturers of combination products.

Sean Fenske, Editor-in-Chief 07.09.20

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