The Bleeding Edge, Part 2—Mike on Medtech

The Bleeding Edge, Part 2—Mike on Medtech

The discussion over the controversial Netflix documentary continues between Sean Fenske and Mike Drues in this episode.

By Sean Fenske, Editor-in-Chief09.07.18
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue 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 part include:

  • Alleged recommendation by FDA for the da Vinci Surgical System to be submitted as a 510(k) rather than as a PMA as originally submitted by Intuitive Surgical.
  • Clinical trials for drugs compared to those for medical devices
  • Footage of the Essure review meeting and comments made during the meeting
  • The MAUDE event reporting system

Before listening to the podcast, it would be best to view the documentary via Netflix. Also, if you haven't listened to part 1 of this discussion, click here to do so.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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 at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to listen to part 3 of the discussion.

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