An interesting report was released last Friday by Advamed (Advanced Medical Technology Association) comparing medical device recalls in the European Union and the United States. The report’s findings may appear to be anticlimactic to those unfamiliar with the medical device climate: class I safety recalls (the most urgent kind) happen at about the same rate in the European Union and the United States. A 2010 study of U.S. medical device recalls by Ralph Hall, presented at IOM in July and AEI in November, came to similar conclusions. The similarity of our safety records doesn’t necessarily merit attention. But the Food and Drug Administration (FDA) approves the most novel devices years behind the EU, in part due to significantly greater clinical requirements that take years to fulfill. You have to wonder why the FDA takes longer to approve devices if the result is not greater safety.
These and other reports are continuing to draw attention to this intriguing and important sector, which is vastly different from that of pharmaceuticals (see the latest Health Policy Outlook by John E. Calfee and Gabriel Sudduth). Small businesses and entrepreneurs are key drivers of innovation in the device world. They have to respond to technological changes that can have lifecycles of two to three years, one of the reasons that blockbuster devices don’t exist as big drugs do. Competition is never far behind.
Over the last year, FDA has done well in many ways in seeking to streamline one branch of the device review process. This process (called 510(k), after its legislative origin) encompasses nearly all devices entering the market, including dental implants, some cardiology equipment, and most laser devices. Among the agency’s recommendations are better guidance to help businesses wade through the bureaucratic categorization, better staff training, and (yet more) guidance on labeling requirements. The process is still very expensive, involving $30 million or more in total R&D costs per device.
Patients and health consumers should hope for similar improvements in the “PMA” (“pre-market approval”) FDA approval process through which novel high-risk devices pass. These devices must be tested in large clinical trials that in the United States can easily take five years or more to complete (remember: technological life cycles can be well under five years) at substantial cost. In the European Union, a clinical trial can be completed in a year.
Excess requirements and regulation for medical devices increase the cost and lengthen the timeline of innovation and development, with little benefit for patients. The FDA needs to work on reducing its risk aversion, to the benefit of American patients.
Look for more on this comparison of novel device approvals in the European Union and United States from AEI’s John E. Calfee later this year.
Gabriel Sudduth is a research assistant at AEI.