I’ve been using the metaphor of “throwing pebbles in a stream” to describe the effect of regulation on innovation. No single regulation or regulatory activity is going to deter innovation by itself, just like no single pebble is going to affect a stream. But if you throw in enough small pebbles, you can dam up the stream. Similarly, add enough rules, regulations, and requirements, and suddenly innovation begins to look a lot less attractive.
A new study entitled ”FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies“ makes this point very well. The study, supported by the Medical Device Manufacturers Association and the National Venture Capital Association, found lots of ‘pebbles’–inefficiencies and lags in the system of approval that added up to a big problem. Survey respondents viewed
current U.S. regulatory processes for making products available to patients (the premarket process) as unpredictable and characterized by disruptions and delays…..[as well as ] inefficient and resource intensive
To read the full, original article click on this link: Pebbles in the Stream: Does the FDA Slow Medical Technology Innovation?
Author: Michael Mandel
