In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the subject of my latest Editor’s Letter, which appeared in the June issue of MPO (click here to read that Letter). It features yet another PR hit on the industry along with recommendations on what can be done to fix the problem (click here to read the NY Times Editorial Board statement). Of course, those fixes are rather general in how they are presented, but we dig into each of the three and share our own thoughts on the proposed solutions. Specifically, we address a number of questions, including:

• Should products that are intended to reside in the body for an extended period of time require a PMA pathway? How would that compare to the current protocol?
• Would an "implantable 510(k)" be a middle ground to address the issue—does not require a full PMA, but updates to implantable products can’t go through the standard 510(k) pathway either?
• Might making sub-pathways or application specific pathways open up a problematic can of worms or would application specific approvals be a good idea?
• What are the problems with the current system for post-market surveillance?
• The statement claims that some companies don’t do appropriate post-market surveillance even when ordered. Why wouldn’t the FDA step in when this occurs and withdraw the company’s ability to market a product if they aren’t fulfilling their responsibilities?
• Does the fact that the device industry funding the FDA’s work make them “customers” as the statement claims? Are the fees contingent on speed of approval and the least restrictive pathway possible?

Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

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