The U.S. FDA and the Veterans Health Administration (VHA) announced a collaboration intended to help accelerate American medical device innovation to further improve and benefit public health.
Veteran Affairs’ VA Ventures Innovation Institute, located in Seattle, will host up to 12 FDA staff to foster robust collaborations between the two agencies. The FDA staff will focus on the regulatory science—the science for evaluating the benefits and risks of new products—while VA staff will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.
The organizations will work toward developing and disseminating new tools designed to test the safety and effectiveness of medical devices and emerging technologies. These “off-the-shelf” testing tools will provide innovators with straightforward, reproducible, and cost-effective testing methods throughout the product development cycle. Providing standardized tests can help streamline the regulatory evaluation process, accelerating the time it takes for products to reach patients by increasing predictability in the product development process. This effort may also reduce risks for early innovators that might not have access to more elaborate testing systems.
“Both the FDA and VA need to stay at the forefront of new medical technology development, and the science of evaluating new technology. This strategic alignment between our organizations creates a unique environment to achieve shared objectives for accelerating patient access to safe, innovative and effective medical devices,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We are eager to gain valuable insight from VHA clinicians and scientists using a real-world perspective, and we look forward to working with our federal colleagues to help ensure Veterans and all Americans have access to the most innovative medical solutions and technologies to improve their health and quality of life.”
Collaborative efforts between the VHA and FDA will initially focus on interoperable systems which can exchange health information automatically for the diagnosis and treatment of patients. An increasing number of medical devices, such as ventilators and fluid resuscitation systems, will be controlled autonomously based on inputs from a variety of sensors. Ensuring appropriate function of both the sensors and the systems is a vital goal for this emerging and exciting area. Future areas of the collaboration will include the development of test methods for devices that can be used at a distance through, for example, 5G networks. These devices have the potential to enhance medical treatment for patients in remote and underserved populations.
“By working side by side, VA and FDA will leverage our combined strengths and expertise to bring the most promising health care technology innovations to Veterans – and Americans at large – faster than ever before,” says Shereef Elnahal, MD, VA’s Under Secretary for Health. “Additionally, the co-location in Seattle will allow us to tap into important health care-adjacent technology markets. We look forward to working closely with the FDA to improve the health and wellness of Veterans and all Americans.”
The partnership between the VA Ventures Innovation Institute and the FDA’s Center for Devices and Radiological Health aims to provide a valuable opportunity which can lead to lower-cost medical advances and improve technologies and capabilities required for equitable healthcare.