Industry News

FDA Slowing Down Med-Tech Innovation in the U.S

Industry News

A recent study reveals medical innovation is less accessible to U.S patients than it is for their Europeans counterparts due to regulatory challenges at the U.S Food and Drugs Administration.

Conducted by Josh Makower, M.D., consulting Professor of medicine at Stanford University, CEO of ExploraMed Development and Venture Partner at NEA and Aabed Meer, an M.D.-MBA candidate at Stanford University and Lyn Denend, a Stanford University research associate; the study, which took form of a survey, gathered responses from 204 companies comparing their experiences working with the FDA to their experiences working with European authorities.

As a result, only 16 percent of the respondents rated their overall experience with the FDA very good or excellent while 75 percent were very satisfied with the European process. U.S regulatory process is seen as unpredictable, inefficient, expensive and characterized by disruptions and delays. This can be viewed as discouraging for inventors who can make their products available much faster in Europe.

For instance, respondents answered that seeking pre-market approval, it takes an average of 54 months in the U.S from first communication to being approved to market the device compared to an average of 11 months in Europe, for high risk devices.

These delays are reflecting on the patients as well, U.S patients wait two years longer than Europeans for the same technology such as spine, hypertension or obesity devices.

Dr. Makower precise the FDA has to make changes quickly warning that otherwise, inventors and patients will seek overseas what they cannot access in the USA, taking valuable jobs and revenues with them.

Today, the question on everyone's lips: Is the US losing its leadership position in medical technology innovation?

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