Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we begin a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this first part include:  Overall impressions of the documentaryThe statement that a recalled device can be used as a predicate device for 510(k) clearance.The impact and concerns involved with a “daisy chain” of device reviews or “predicate creep” within the regulatory 510(k) review process.Should implantable devices be required to have a removal protocol included in its regulatory submission in order to gain approval/clearance?Before listening to the podcast, it would be best to view th