- Category: Business
- Published on Saturday, March 05 2011 04:58
- Written by Rod Hughes
- Hits: 928
Longtime New England medical device manufacturing executive Paul LaViolette pulled no punches in a recent opinion piece published in the Boston Herald:
Reform the way the U.S. Federal Food and Drug Administration regulates new medical device technology or see U.S. workers’ jobs fleeing to Costa Rica. He actually specified the country's name.
"If federal officials don’t fix the way America vets innovative new medical technologies, local leaders may have to worry more about losing firms to Costa Rica than California." LaViolette wrote.
He blasted the FDA system as being "inefficient and unpredictable," resulting in "putting thousands of local jobs and billions of dollars of economic activity at risk—and may cause America to give up its mantle as the world’s leading medical innovator."
Certainly, the recent expansion of Boston Medical's investment in Costa Rica seems to at least partly support his point. As a remedy he called for a thorough and speedy overhaul of FDA's regulatory system.
Last December, he told a MassDevice gathering that the U.S. environment for investment in new technologies was "depressed" and charged that not only was the FDA “raising the bar” on its requirements but also severing industry interaction with the agency.