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Medical Device Approval Plagued By Unhealthy Delays

The opinions expressed by columnists are their own and do not necessarily represent the views of

Europeans have long extolled centralized planning and tolerated large government bureaucracies. But when it comes to approving medical devices, Europe has taken a decidedly decentralized approach — to the great benefit of patients and health care workers. It is an example the United States would do well to follow.


Consider the field of cardiology. A national medical conference, such as the American Heart Association Scientific Sessions, gives you a glimpse into the future. For many American physicians attending these conferences, the future of innovative new therapies in the U.S. is actually the present — as currently practiced by their European counterparts.

Owing to onerous regulations from the U.S. Food and Drug Administration, American doctors sometimes wait years to offer innovative devices and treatments that are often the standard overseas. Nowhere is this delay in new device deployment more evident than in cardiology.

Patients with severely diseased heart valves may have a maximum of one to two years of life expectancy upon diagnosis. There was once a time when state-of-the-art medical care in the U.S. drew these patients here from around the world. Now, increasingly web-wise American patients, aware of the latest medical breakthroughs, travel overseas to receive some of the best treatments.

One example: Transcatheter aortic valve implantation, or TAVI, is a catheter-based option for treating diseased heart valves without carrying the risks associated with open surgery. This novel approach for treating high-risk patients with valvular heart disease has been approved for use in Europe since 2007. Over the past year, long-term data emerging from European cardiology practices demonstrating the advantages of TAVI have sparked significant interest in the American cardiology community.


TAVI is anticipated to clear FDA hurdles by 2012. That's a five-year delay for the U.S., compared with European authorities.

But TAVI is not an isolated case. A study conducted by John Makower, consulting associate professor at Stanford's Biodesign Innovation program, demonstrated that the FDA delays approval by two years, on average, for low-to-medium-risk medical devices, compared with Europe; approval of high-risk devices in the U.S. took 31/2 years longer than in Europe.

Perhaps in response, the FDA finally announced this month its openness to considering reforms to the review process for innovative medical devices. The current premarket review process for new medical devices has been fraught with uncertainty, often requiring companies to produce further unanticipated testing and data for proven products. Regulations force device manufacturers to replicate time- and cost-consuming studies in the U.S., despite the existence of reputable equivalent scientific data gathered overseas.

In contrast to the FDA, the European Medical Devices Directive allows privatized, notified bodies to test device safety to provide the stamp of European market approval.

Last week, the House Energy and Commerce Committee's Subcommittee on Health held a hearing on medical device regulations. In his testimony, Mark Deem of San Francisco Bay area medical device incubator The Foundry blamed the unpredictability of FDA regulatory delays for driving U.S. business to Europe.


"We develop our products here and then run the same large, multicenter randomized trials we would otherwise have conducted in the U.S. overseas," he said. "We are then staying [in Europe] to commercialize the products while we decide when and if to approach the FDA."

Much of the bureaucracy inherent in the FDA approval process has been driven by calls for increased patient safety. However, despite the speed of the privatized European device approval process, there have been no sacrifices in patient safety. A report by the Boston Consulting Group released earlier this year found that the medical device recall rate was similar in the U.S. and Europe.

This is no small issue in an economy still groping to recover from recession. The U.S. is not only at risk of losing its leadership role when it comes to medical innovation but also the jobs associated with the industry.

During the House subcommittee hearing, Mr. Makower highlighted an example from his study of a U.S. firm moving its primary operations to Europe: "The company planned to shut down its U.S. production facility and move another 30 to 40 manufacturing jobs to Europe," he said. "In this particular example, all future growth was also planned overseas. Keeping in mind that every medtech job is indirectly responsible for another 4.47 jobs in the national economy, the effect on U.S. employment could be sizable."


With device approval delays costing companies more than $500,000 per month, on average, according to Mr. Makower's study, the transfer of business away from the U.S. is driven by the basic instinct for a company to survive.

Five-year delays before visualizing profits may hurt a company's bottom line. However, the consequences of a long delay for a patient who does not have the same luxury of time may be far more grim.

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