Examining Institutional Review Boards—Mike on Medtech

Examining Institutional Review Boards—Mike on Medtech

Mike Drues and Sean Fenske take a look at the purpose of IRBs and the role they play in a medical device clinical trial.

By Sean Fenske, Editor-in-Chief03.06.24
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:

  • Could you please explain what an IRB or institutional review board is?
  • If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?
  • Are there situations in which I would not need an IRB approval prior to a clinical trial?
  • Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?
  • What information do I need to provide to the IRB for its review?
  • What kind of timeline should I expect with the IRB review process?
  • Do I have any recourse if the IRB review comes back not in my favor?
  • What are the takeaways?

Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. 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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