Podcasts

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

Sean Fenske and Mike Drues discuss the third most common regulatory pathway—the De Novo—clearing up details about its advantages and when it's used.
Sean Fenske, Editor-in-Chief 07.02.19
Mike on Medtech: The NYT Editorial Board Statement

Sean Fenske and Mike Drues discuss the recent comments made by the Board about the medical device industry and FDA.
Sean Fenske, Editor-in-Chief 06.17.19
Mike on Medtech: The Alternative Summary Reporting Program

Sean Fenske and Mike Drues discuss the recently announced cancellation of the alternative summary reporting program and the reasons for it.
Sean Fenske, Editor-in-Chief 05.24.19
Mike on Medtech: A Pre-Sub for 483s, Part 2

Sean Fenske and Mike Drues continue a discussion regarding a recently released FDA guidance focused on communication with the agency over a 483.
Sean Fenske, Editor-in-Chief 05.09.19
Mike on Medtech: A Pre-Sub for 483s, Part 1

Sean Fenske and Mike Drues discuss a recently released FDA guidance that outlines a specific communication protocol to address certain 483s with the agency.
Sean Fenske, Editor-in-Chief 05.09.19
Materials

Mike on Medtech: FDA's Material Evaluation

Sean Fenske and Mike Drues discuss the FDA's announcement that the agency will review materials used in the manufacture of medical devices.
Sean Fenske, Editor-in-Chief 04.02.19
Mike on Medtech: 510(k) Modernization

Sean Fenske and Mike Drues discuss the potential changes coming to the 510(k) regulatory pathway and examine the issues around predicate devices.
Sean Fenske, Editor-in-Chief 01.25.19
Mike on Medtech: Personalized Healthcare

Sean Fenske and Mike Drues discuss the impact personalized healthcare is having on the medical device industry and the challenges faced.
Sean Fenske, Editor-in-Chief 01.03.19
Neurological

Mike on Medtech: Holiday Wish List, Part 2

Sean Fenske and Mike Drues continue their discussion of the industry's "wish list" for the coming year and beyond.
Sean Fenske, Editor-in-Chief 12.11.18
Mike on Medtech: Holiday Wish List, Part 1

Sean Fenske and Mike Drues share their thoughts on what the industry might be looking for in the coming year.
Sean Fenske, Editor-in-Chief 12.04.18
Mike on Medtech: Regulating the Practice of Medicine

Sean Fenske and Mike Drues discuss the FDA's regulation of healthcare (or lack thereof) and if changes need to be made.
Sean Fenske, Editor-in-Chief 10.26.18
Mike on Medtech: The Bleeding Edge, Part 3

The conversation on The Bleeding Edge documentary concludes in this portion of the three-part podcast series.
Sean Fenske, Editor-in-Chief 09.26.18
Surgical

Mike on Medtech: The Bleeding Edge, Part 2

The discussion over the controversial Netflix documentary continues between Sean Fenske and Mike Drues in this episode.
Sean Fenske, Editor-in-Chief 09.07.18
Surgical

Mike on Medtech: The Bleeding Edge, Part 1

Sean Fenske and Mike Drues begin a multi-part series on the controversial Netflix documentary on the medtech industry.
Sean Fenske, Editor-in-Chief 09.05.18
Mike on Medtech: Breakthrough Designation Program

Sean Fenske and Mike Drues discuss the FDA's Breakthrough Designation Program and address common questions.
Sean Fenske, Editor-in-Chief 08.10.18
Mike on Medtech: 15 Tips for Getting New Products Through FDA

Mike Drues provides insight to Sean Fenske on what he's learned about getting devices through the FDA over the last 15 years.
Sean Fenske, Editor-in-Chief 07.03.18