From Idea to Market: Ep 6 - The Valley Between Idea and Approval
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What actually happens between building a medical device and getting it approved? In this episode of From Idea to Market, we walk through the regulatory valley that separates a working prototype from a cleared product — and why so many promising innovations stall right here.
This is the stage where progress stops being about what you can build and starts being about what you can prove. Joe Schwab breaks down the FDA's device classification system, the critical difference between 510(k) and PMA pathways, and why the gap between regulatory clearance and reimbursement has become…
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