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Mike on Medtech: Regulatory Approval Pathway for Biomaterials

Mike on Medtech: Regulatory Approval Pathway for Biomaterials

Mike Drues and Sean Fenske discuss the potential advantages of implementing an approval pathway for biomaterials.

By Sean Fenske, Editor01.02.18
In this 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 a new material? Which would you choose?
  • Would there be advantages to having a biomaterials approval pathway?
  • Would there be disadvantages to having a biomaterials approval pathway?
  • What is the likelihood of this happening?

Listen to the podcast streaming via the player below or you can download the MP3 file, load it onto your player of choice, and listen at your convenience.



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 a potential regulatory approval pathway for biomaterials, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Click here to review other episodes of Mike on Medtech.
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