Medtech Matters

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 speci