The rate of medical innovation in the United States has fallen behind global competitors as manufacturers and investors struggle to work through inefficient regulatory processes, said medical industry and manufacturing leaders speaking at a Cleveland Clinic conference Oct. 3.
A panel of speakers, which included
Xerox Corp. Chairman and CEO Ursula Burns and
St. Jude Medical Inc. CEO Daniel Starks, discussed various topics related to the challenges the medical industry faces bringing new innovations to market in the United States. The panelists were participating in the Cleveland Clinic's 2011 Medical Innovation Summit taking place in Cleveland Oct. 3-5.
Several speakers criticized the Food and Drug Administration for its lack of efficiency and transparency during the approval process for new medical devices.
"Unfortunately, our partners in the FDA tend to be running business looking in the rearview mirror; they're not out in front of us," says John Sheets, senior vice president of corporate research for
Boston Scientific Corp.
In the current regulatory environment, it's easier for Boston Scientific to introduce a product in Singapore or Europe than it is in the United States, Sheets says.
Japan used to be one of the last developed countries to approve a medical product – now it ranks ahead of the United States, says Starks.
"We have technology available in Japan now that will not be available in the United States for some time to come," Starks says.
The FDA is underfunded and needs more resources, including people with technologically advanced knowledge who can better understand more sophisticated products, Starks says.
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