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Mike on Medtech

Real World Evidence—Mike on Medtech

Sean Fenske and Mike Drues delve into the use of real world evidence in medtech regulatory approval processes and what matters to manufacturers.

Real World Evidence—Mike on Medtech

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use of real world evidence in the medical device approval process, which has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). Further, we seek to gain some additional insights on what real world evidence actually is, why it matters to medical device manufacturers, and how they might be able to make efficient use of it.

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.

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