Medical Device Manufacturing Recalls—Mike on Medtech

Medical Device Manufacturing Recalls—Mike on Medtech

Mike Drues and Sean Fenske discuss the reasons for the increase in recalls for manufacturing issues and how to avoid them.

By Sean Fenske, Editor-in-Chief10.03.23
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for recalls. Specifically, the following questions are addressed:

  • Before we get into the reasons around why, can give a very brief overview of what exactly a device recall is?
  • Medical device recalls aren’t new, so why are we taking a closer look at them today?
  • Should we have been able to see this coming? Was this foreseeable?
  • Are all of these recalls, or really any recalls, equal in terms of how serious they are?
  • Can you explain what is meant by faulty manufacturing? Are machines making bad parts and it’s not being recognized?
  • Who’s job is it to set the specs?
  • Why the sudden increase? In 2022, recalls hit their lowest level in a decade. So what changed that now in 2023, they are at such a high level?
  • Moving forward, what could we do/should we do to mitigate these risks and minimize residual risk for devices in the future?
  • What are the takeaways?

Listen to this discussion and see if you feel more comfortable about avoiding a recall. 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.

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