by Mark Leahey

This report originally appeared in the July 2010 issue of DOTmed Business News

If things continue the way they're going, the United States' position as the leader in medical technology and innovation is at risk. As the U.S. Food and Drug Administration's (FDA) premarket review process has become less predictable, U.S. companies are headed overseas to market their products in Europe.

Back in 2008, a handful of anonymous FDA product reviewers raised concerns with the current premarket review process. This vocal minority created an environment where FDA managers and reviewers have become much more risk-adverse, and at times reluctant to provide a reasonable pathway to market. Though the anonymous reviewers provided no evidence to back up their concerns, they succeeded in slowing down innovation and improvements to patient care.

Losing the medical technology market to Europe is disconcerting. It means patients in the United States will not have timely access to safe and effective products. Further, companies that manufacture and sell products create well-paying jobs for Americans. All of that is lost as the market moves overseas.

Small medical device and equipment companies are especially hard hit financially in this current environment. There are countless stories of a completed trial that has been approved by the FDA, and upon completion, the FDA tells the companies to add in another 50 subjects to its trial or extend follow-up another two years. The message is essentially, "Good, but not good enough," with the goal posts constantly moving.

Those might seem like minor issues to the average person, but increasing a clinical trial size by 50 patients or adding follow-up years is prohibitively expensive, and doesn't necessarily add benefits to patients. Given the significant dollars associated with these post-trial requests, smaller companies often don't have the ability to raise more funds to satisfy these requests and continue operations. As a result, patient care, innovation and jobs suffer.

For example, companies spend about $1 million every month during development of a medical device. Adding two years to a clinical trial would cost an additional $24 million, and that's not factoring in costs for the product once cleared or approved. Increasing a clinical trial size from 100 to 150 patients can cost companies millions more. As it is, some companies spend more than $100 million before they're given a chance to market in the United States, and these figures rise every day. This is detrimental to patient care, innovation and job creation.

In the current regulatory environment, it is difficult for medical device manufacturers to work with little to no predictability and transparency in the review process. This isn't to say the premarket review process shouldn't be rigorous. There shouldn't be any shortcuts. The Medical Device Manufacturers Association (MDMA) is in full support of appropriate clinical data as required to ensure patient safety, but the real problem stems from this lack of predictability. If the process becomes more stringent, it should be because evidence has proven stricter guidelines will produce safer, more effective products.

It's important to point out that no medical product is 100-percent-risk-free. There is always a risk-benefit analysis with all medical products. Proponents of a stricter process want to eliminate all risk before a product is cleared or approved. But that means that millions of patients will end up waiting for a technology that could improve or even save their lives and some may not have that time to spare.

Companies should be required to demonstrate that their products have a reasonable assurance of safety and efficacy. At that point, it's up to the physicians and patients to evaluate their specific situation and determine an appropriate treatment.

While there haven't been any formal changes made to the premarket review process, companies have been experiencing, for nearly two years, huge obstacles in getting their products cleared for commercialization. Before any changes are implemented, it is critical that all parties and decision-makers communicate with each other so that everyone realizes exactly what is at stake. It is essential that data should be presented to show that not only is there a problem with the current process, but any changes will indeed address any existing deficiencies. In the end, patient care and innovation must be the driving force behind any decisions.

MDMA appreciates the openness of the FDA leadership and has had excellent interactions with its staff as they examine the 510(k) premarket review process. The association wants to make sure patients have timely access to safe and effective products, but if pressure on the FDA results in adding requirements that don't ultimately enhance scientific evidence or improve patient care, it will have lasting, detrimental effects.

Mark Leahey is the president and CEO of the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that advocates for entrepreneurial medical technology companies. He has led MDMA since 2002 and has overseen the growth of the association which now has more than 250 members. Leahey currently sits on the Medical Devices Committee for the Food and Drug Law Institute (FDLI) and the Editorial Advisory Board of Medical Product Outsourcing.