Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed: What’s the difference between a material and a biomaterial?What’s the difference between a biocompatible material versus a biofriendly material?How is a biostable material different from a bioabsorable/biodegradable materials?Do bioabsorables pose additional challenges?Do the regulatory rules for biomaterials differ from the ones that are currently followed for more traditional materials?What’s your response to companies who would rather not attempt to introduce a new material (or biomaterial) to the regulatory approval process?Check out the guidance mentioned in this podcast—ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Listen to the podcast