Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss what the implementation of a regulatory approval pathway for biomaterials would mean for medical device manufacturers, patients, and the healthcare industry. While such a pathway doesn’t currently exist, the potential advantages are explored. Further, the competitive advantage such a pathway could offer to materials manufacturers and suppliers is presented. Specifically, the following questions and topics are addressed in this discussion: Currently, can biomaterials be approved by FDA?Drugs are approved, and a drug is sort of a “biomaterial” so shouldn’t biomaterials be approved?If we haven't had a biomaterial approval pathway thus far, why do we need one now?How many companies developing new medical devices vs. how many companies developing new biomaterials?What are device manufacturers more likely to do: develop a new device using an existing material vs. developing a new device using