Biomaterials: Is there a better way for FDA to regulate them?

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The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials?

Mike Drues thinks the answer is “yes.”

“It really will encourage companies to use new materials and not be hamstrung with materials that have been … used for decades or in some cases even a century,” said Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA.

Drues, who is president of Vascular Sciences, also says the new approval pathway needs to be specific enough to prevent potentially costly and even life-threatening mistakes.

In MDO’s latest podcast, Drues¬†discusses how the medical device industry might go about proposing a new FDA approval pathway that prequalifies innovative materials.

How do you know your technology is disruptive enough to break conventional wisdom?

textadimage Stan Rowe knows a little something about bringing disruptive technology to market. The current Edwards Lifesciences CSO was in on the ground floor of two of medtech's most disruptive treatments, stents and transcatheter aortic valve replacement.

On December 12th, Rowe will sit down with MassDevice editor Brad Perriello for a long ranging discussion about the inside story on how these technologies came to market and what Rowe learned along the way.


Register now with the code "TAVR" and save 15% today.

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