FDA and VA Partner on Innovative Medical Device Testing in Seattle

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dr Beth Ripley is the Medical Device Testing Collaboration project manager for the VA. [Photo courtesy of the Department of Veterans Affairs]

The Seattle Department of Veterans Affairs’ VA Ventures Innovation Institute will enlist up to a dozen FDA employees in a new collaboration to develop and share new tools for testing the safety and efficacy of medical devices.

The agencies intend to provide developers of devices and new technologies with ready-made 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) provide the clinical context for test development and provide hands-on training and other in-depth experiences for innovators wishing to use the tools.

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The FDA said these “simple, reproducible, and inexpensive test methods” for use throughout the product development cycle could also lead to more cost-effective medical advances and reduce risk for early innovators.

Initially, they are focusing on interoperable systems that automatically exchange health information for diagnosing and treating patients. The FDA pointed to an increasing number of medical devices, such as ventilators and liquid ventilation systems, that are autonomously controlled based on a variety of sensors and systems.

Later areas of focus are the development of medical device test methods for devices that can be deployed remotely through communication technologies such as 5G networks. Other emerging technologies that the collaboration could focus on include immersive technologies, machine learning and artificial intelligence, additive manufacturing and wearable technologies.

“We’re committed to gleaning valuable insights from VHA clinicians and scientists from a real-world perspective, and we look forward to working with our federal colleagues to ensure veterans and all Americans have access to the most innovative medical solutions and technology to help.” them to improve health and quality of life,” said CDRH Director Dr. Jeff Shuren in a press release yesterday.

The group’s location in the Seattle metro area — home to the headquarters of Amazon and Microsoft, as well as significant offices of Google, Apple and other tech giants — “will allow us to develop important healthcare-adjacent technology markets,” VA Under said Health Secretary Dr. Shereef Elnahal.

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“Working side-by-side, the VA and FDA will leverage our combined strengths and expertise to bring the most promising innovations in health technology to veterans — and Americans at large — faster than ever,” Elnahal said in the press release.

Project leader for collaboration on medical device testing and staffing

Key personnel and other details were identified in a Letter of intent approved by the two agencies last week.

On the FDA side, the project leader is Zane Arp, director of the Division of Biomedical Physics, and the program leader is Assistant Director, Strategic Partnerships and Innovation, Dorn Carranza. The FDA’s organizational sponsor is Ed Margerrison, Director of the Office of Science and Engineering Laboratories.

For the VHA, the project manager is the Deputy Head of the Office of Healthcare Innovation and Learning, Dr. Beth Ripley, and the program manager is the Office of Healthcare Innovation and Learning Director of Strategy Joshua Patterson. The VHA organizational sponsor is Dr. Ryan Vega, Head of the Office of Healthcare Innovation and Learning.

The five-year contract includes office, laboratory and prototyping space in Seattle for up to eight FDA full-time employees (FTEs) who will be on site daily.

FDA will initially deploy up to four FTEs in FY2023 and will double that number in FY2024 based on initial results and funding.

Bringing these employees together could also pay dividends by “encouraging a culture of interstate collaboration by housing FDA employees with VHA in a common federal space,” the agencies said in their agreement.

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