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

Popular Sponsored Recommendations

How Manufacturers Can Optimize Operations with Weather Intelligence

Nov. 2, 2023
The bad news? Severe weather has emerged as one of the biggest threats to continuity and safety in manufacturing. The good news? The intelligence solutions that build weather ...

Turning Your Frontline Workforce into a Competitive Advantage: A Comprehensive Guide

Sept. 19, 2023
In this guide, we'll explore how manufacturers are using digital technologies to preserve the bottom line and maintain growth by enabling and empowering their #1 asset - their...

Digital Production Tracking: How Connected Platforms with No-Code Deliver Value

Sept. 19, 2023
Manual tracking lacks the real-time visibility manufacturers need to identify root causes and remain competitive. Digital, connected production tracking is crucial for your operations...

The Benefits of Continuous Thermal Monitoring

Oct. 17, 2023
Read this eBook to learn more about collecting and using data intelligently to improve performance.

Voice your opinion!

To join the conversation, and become an exclusive member of IndustryWeek, create an account today!