STAT March 22, 2024
In a recent survey of U.S. companies, medical device makers reported spending $31 million on average to bring a new product to market under the Food and Drug Administration’s 510(k) pathway for those similar to devices already approved. These costs balloon to more than $90 million for new Class III devices that progress through the more rigorous premarket approval pathway. Device makers face myriad obstacles, including traditional practice patterns and consumer behavior, existing economic relationships and dependencies, and, in some cases, regulatory barriers. The latter, while designed to ensure safety and effectiveness, often serve to solidify the market dominance of incumbents.
The rise of ride-sharing companies like Uber and Lyft represents a striking example of a new, and arguably better,...
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