FDA Regulations Stifle Medical Device Innovation

Oct. 3, 2011
Top industry professionals say regulatory burdens hamper progress.

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.

Starks also called for lower corporate taxes and more research and development tax credits, similar to those offered in other competing countries, to foster more innovation.

Electronic patient information is another major issue the medical industry must address to improve efficiencies and reduce patient costs, according to the panel. Xerox is one of the major technology providers involved in developing electronic medical record platforms.

While health care providers have been implementing the technology for several years, the industry's next challenge is utilizing the data, says Xerox's Burns.

For instance, digital records could offer doctors the opportunity to make procedural decisions based on the immediate availability of patient data, says Delos "Toby" Cosgrove, CEO of the Cleveland Clinic.

The first day of the three-day event concludes this evening with an address from General Electric Co. CEO Jeffrey Immelt.

See also:

GE's Immelt: U.S. Could Learn From India's Health Care System

About the Author

Jonathan Katz | Former Managing Editor

Former Managing Editor Jon Katz covered leadership and strategy, tackling subjects such as lean manufacturing leadership, strategy development and deployment, corporate culture, corporate social responsibility, and growth strategies. As well, he provided news and analysis of successful companies in the chemical and energy industries, including oil and gas, renewable and alternative.

Jon worked as an intern for IndustryWeek before serving as a reporter for The Morning Journal and then as an associate editor for Penton Media’s Supply Chain Technology News.

Jon received his bachelor’s degree in Journalism from Kent State University and is a die-hard Cleveland sports fan.

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