In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices that unfortunately ended up being quite dangerous even though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documentary, The Bleeding Edge, was discussed but others are new. Specifically, the following questions are addressed:

• First Mike, can you provide a definition of what a dangerous device is?
• As I mentioned in the introduction, we previously discussed the 2018 documentary The Bleeding Edge, which featured some dangerous devices. How far back do dangerous devices go though? Are these a relatively newer problem?
• Another publisher’s website featured a slideshow of four dangerous devices. But do you have any sort of idea of how many others there may have been?
• With all the regulations in place, regulatory professionals that work in this industry, and FDA oversight, how do any “dangerous devices” make it to the market?
• Should we be adding regulations to address these devices so they don’t happen again?
• What are the takeaways?

Listen to this discussion and see what you think of the system we have to attempt to prevent these types of devices from getting to market. 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 [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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