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 streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at [email protected] and we’ll try to respond in an upcoming Mike on Medtech podcast.

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