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Mike on Medtech: Real World Evidence Revisited

Mike on Medtech: Real World Evidence Revisited

Mike Drues and Sean Fenske discuss real world evidence and several reasons why it’s not being used by medical device manufacturers for regulatory review.

By Sean Fenske, Editor-in-Chief05.14.20
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use (or lack of use) of real world evidence. This discussion is a sort of update on the first Mike on Medtech podcast, which offered an introduction to real world evidence. Specifically, we address a number of questions, including:

  • Can you please provide a quick refresher on what real world evidence (RWE) is within the context of the FDA’s world?
  • How was the agency viewing the use of real world evidence for a medical device’s regulatory pathway at the time?
  • What does the actual use of real world evidence look like today?
  • Why hasn’t real world evidence seen the implementation the agency was expecting or hoping to see? What are the challenges?
  • Should medical device manufacturers be using RWE?
  • What are the most important takeaways device manufacturers need to keep in mind with regard to the use of RWE?

You can click here to listen to the aforementioned first podcast about real world evidence from 2017.

Listen to this episode and see what you think of the use of real world evidence and whether it’s something your company should be looking to use for your next label expansion. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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.

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