FDA's Role in Fostering the Development of Better Medical Devices
By Jeff Shuren, M.D., J.D.
Director of FDA’s Center for Devices and Radiological Health
Infusion pumps are the ubiquitous beeping boxes in health care facilities that IV lines run through and meticulously drip lifesaving drugs and fluids into patients. They are used in hospitals and homes and, without a doubt, they are a medical marvel. And, to us at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (Center for Devices), there is little doubt that they are also machines with safety risks.
These machines rank in the top ten of both the FDA’s medical device adverse event list and the medical device recall list. But 87 recalls in the last five years have not produced the next generation of devices. At best, the recalls have led to temporary fixes without addressing the systemic and underlying concerns. Recalls produced patches on top of patches.
To address this and other similar challenges, we are taking a balanced public health approach – to protect and promote public health – by assuring that medical devices on the market are safe and effective while also facilitating innovation.
To speed the development of safer, more effective infusion pumps and other devices, we have created a unique set of tools. For example, infusion pumps need the right software to operate properly. In collaboration with the University of Pennsylvania, we developed open-source software that manufacturers can build on or use as a benchmark for their own products. We recently offered to perform diagnostic evaluations on manufacturers’ software at any stage of development – even before they come to us for approval -- to identify potentially problematic issues as early as possible.
Another way that the FDA can help improve devices is to use the unique vantage point the FDA has across entire segments of the medical device industry. Companies applying for permission to market their device must submit the device design, production information, and sometimes clinical data. This information, which is generally confidential, gives FDA’s own experts incomparable insight that allows us to spot problems common to an entire segment of the device industry. We can then work to resolve such common problems, for example by obtaining input through public problem-solving workshops, as we did with infusion pumps.
Today, we are holding another type of meeting, different from the problem solving workshop just mentioned, focusing broadly on the federal government’s role in device innovation.
The Council on Medical Device Innovation is comprised of the FDA, the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Defense, the Defense Advanced Research Projects Agency, and the Department of Veterans Affairs. At this meeting, we will be asking industry and the public what can be done to encourage innovation to address unmet public health needs, including identifying any regulatory inefficiencies.
We know that regulatory predictability promotes innovation giving greater confidence in the development process for medical devices. In part, predictability helps secure funding from investors necessary to bring a device to market. Right now, the Center for Devices is reexamining the most commonly used premarket review pathway for devices to allow a product to enter the market, known as the 510(k) program. We hope to identify steps to strengthen the 510(k) program, including increased predictability. The FDA will issue its preliminary findings and recommendations for public comment on the 510(k) process in the coming weeks.
The FDA is also reaching out to its regulatory counterparts in other countries to share information about device problems and to collaborate on mutual solutions. Device problems may not be confined to the geographic area where they occur - a device that injures patients when used in Europe may similarly harm patients if used in the United States.
The FDA believes it has to be tough and fair, but the agency also has to be smart. In addition to finding potential problems and ordering recalls, it must also play a role in helping to solve the problems FDA identifies by working with industry, practitioners, patients, and the public to collectively improve public health. As a result, we believe the agency can play a more productive role in getting better medical devices to patients faster.