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Innovation and Invention in Medical Devices: Workshop Summary
Bouxsein closed the session with an anecdote about Uwe Reinhardt that illustrates this difference in the roles of FDA and HCFA. Reinhardt once told an audience like this one that they may not realize it but there are two ways of doing a tonsillectomy, both equally effective. They achieve the same result, the same outcomes, the same risk, but one is far more elegant than the other and costs 20 times as much. Reinhardt asked, “What should HCFA do? Should they just go ahead and pay for both of them or should they make a decision to pay for the cheaper one and not for the more expensive one?” Then he stopped. The audience, of course, was on the edge of their seats saying, well, what is the second procedure. Finally they could not take anymore and called out for Uwe to please tell them what is the second procedure. “Oh”, he said, “I thought you knew. It is transurethral.”