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Mike on Medtech: The Bleeding Edge, Part 1

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.

By Sean Fenske, Editor-in-Chief09.05.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we begin a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this first part include:

  • Overall impressions of the documentary
  • The statement that a recalled device can be used as a predicate device for 510(k) clearance.
  • The impact and concerns involved with a “daisy chain” of device reviews or “predicate creep” within the regulatory 510(k) review process.
  • Should implantable devices be required to have a removal protocol included in its regulatory submission in order to gain approval/clearance?

Before listening to the podcast, it would be best to view the documentary via Netflix.

Once the other parts are posted to the website, they will be shared here as well.

Listen to the podcast streaming via the player or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Once finished, click here to listen to Part 2, available now.

Click here to review other episodes of Mike on Medtech.
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