Podcasts

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

Digital Health | Electronics

Mike on Medtech: Voice-Enabled Medtech

Sean Fenske and Mike Drues discuss voice-enabled medtech and its potential in healthcare.

Sean Fenske, Editor-in-Chief 05.17.18

Mike on Medtech: Changing Pathway to Market?

Sean Fenske and Mike Drues discuss the changing MDR for CE mark and its impact on the “first to market” route companies take.

Sean Fenske, Editor-in-Chief 04.25.18

3D/Additive Manufacturing

Mike on Medtech: 3D Printing Healthcare at the Point of Care

Sean Fenske and Mike Drues discuss the regulatory implications with 3D printing devices at a healthcare facility.

Sean Fenske, Editor 03.23.18

Mike on Medtech: Quality vs. Regulatory

Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.

Sean Fenske, Editor-in-Chief 03.02.18

Mike on Medtech: The 'New' Alternative 510k

Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.

Sean Fenske, Editor 01.29.18

Materials

Mike on Medtech: Regulatory Approval Pathway for Biomaterials

Mike Drues and Sean Fenske discuss the potential advantages of implementing an approval pathway for biomaterials.

Sean Fenske, Editor 01.02.18

R&D & Design | Testing

Mike on Medtech: Pre-Sub with the FDA

Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.

Sean Fenske, Editor 11.06.17

R&D & Design | Testing

Mike on Medtech: Human Factors

Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.

Sean Fenske, Editor 10.09.17

Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation

Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.

Sean Fenske, Editor 09.07.17

Mike on Medtech: Off-Label Use

Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.

Sean Fenske, Editor 08.25.17

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