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Demystifying the De Novo Process

Global Medical Device Podcast powered by Greenlight Guru

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The Pros and Cons of Going the Danova Pathway?

The danova pathway is that you are getting a chance to really create a new product category. You're going to be helping the fda figure out how to regulate this product category for people that want to try to copy you in the future. So inevitably, there's going to be folks trying to have a muto device or or copy this new innovation. If it's that disruptive, people onto want to do it.

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