The agencies intend to provide developers of devices and new technology with off-the-shelf tools that can help streamline regulatory review and get products to patients faster. FDA staff from the Center for Devices and Radiological Health (CDRH) will focus on regulatory science. Their partners at the VA’s Veterans Health Administration (VHA) will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.
The FDA said these “straightforward, reproducible and cost-effective testing methods” for use throughout the product development cycle could also lead to lower-cost medical advances and reduce risk for early innovators.
Initially, they’ll focus on interoperable systems that automatically exchange health information for the diagnosis and treatment of patients. The FDA pointed to an increasing number of medical devices such as ventilators and fluid resuscitation systems that will be controlled autonomously based on a variety of sensors and systems.
Later areas of focus include the development of medical device testing methods for devices that can be used at a distance through communications technology such as 5G networks. Other emerging technologies that the collaboration might focus on include immersive technologies, machine learning and artificial intelligence, additive manufacturing and wearable technologies.
“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,” CDRH Director Dr. Jeff Shuren said in a news release yesterday.
The group’s location in the Seattle metro — home to the headquarters of such as Amazon and Microsoft as well as significant offices for Google, Apple and other tech giants — “will allow us to tap into important health care-adjacent technology markets,” VA Under Secretary for Health Dr. Shereef Elnahal said.
“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,” Elnahal said in the news release.
Medical device testing collaboration project leaders and staffing levels
Key personnel and other details were identified in a memorandum of understanding approved by the two agencies last week.
On the FDA side, the project manager is Division of Biomedical Physics Director Zane Arp and the program manager is Associate Director for Strategic Partnerships and Innovation Dorn Carranza. The FDA organizational sponsor is Office of Science and Engineering Laboratories Director Ed Margerrison.
For the VHA, the project manager is Office of Healthcare Innovation and Learning Deputy Chief Dr. Beth Ripley and the program manager is Office of Healthcare Innovation and Learning Director of Strategy Joshua Patterson. The VHA organizational sponsor is Office of Healthcare Innovation and Learning Chief Dr. Ryan Vega.
The five-year deal includes office, laboratory and prototyping space in Seattle for up to eight full-time-equivalent employees (FTEs) from FDA to be on-site daily.
The FDA will initially place up to four FTEs in fiscal 2023 and double that number in fiscal 2024 based on initial outcomes and funding.
Bringing these employees together could also pay off by “fostering a culture of inter-governmental collaboration by placing staff from FDA with VHA in a shared federal space,” the agencies said in their agreement.