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Silicon Valley Health-Tech Wrestles with the FDA

The FDA's recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)

The FDA’s recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)

By Christina Farr

Health care entrepreneurs are a different breed than most entrepreneurs. Rather than hunkering down to build a cool product, they need to think about regulation and red tape — right from the start.

Ignoring the FDA and pushing ahead with a product is not a viable option.  

As boring as it may sound, health-tech founders need to develop a relationship with the U.S. Food and Drug Administration (FDA). This process might drag on for some time, as this authority has the unenviable job of overseeing an explosion of new medical technology, whether it’s a new electronic health record or a device that turns your smartphone into an ear scope.

As the recent enforcement action against genetic testing firm 23andMe demonstrated, ignoring the FDA and pushing ahead with a product is not a viable option.

In recent years, Silicon Valley’s entrepreneurs have become increasingly critical, attacking the agency’s antiquated processes in a string of interviews and op-eds. Continue reading