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VA and FDA partner to speed up medical device delivery



The agencies will work together to create testing methods, tools and training that supports medical device innovators throughout the product development cycle. 

WHY IT MATTERS

Veterans Affairs staff will provide the clinical context for test development while U.S. Food and Drug Administration staff evaluate the benefits and risks of medical devices to accelerate the time it takes for them to reach patients. 

VA staff will also provide hands-on training for product developers at the Seattle incubator, which connects the Veterans Health Administration to academics, start-ups and industry through public-private collaboration. 

Having FDA in-house will also enable the VHA to tap into healthcare-adjacent technology markets, according to the announcement. The FDA will also benefit from the VA Ventures collaboration.

“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,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, in the prepared statement.

VA Ventures’ mission is to transform ideas for emerging technologies into tangible solutions by maximizing talent and knowledge and to make the VHA an industry leader in point-of-care manufacturing.

According to the VA website, the VHA Office of Advanced Manufacturing has three advanced manufacturing hubs in Charleston, South Carolina; Richmond, Virginia and Seattle, Washington with Cleveland, Ohio; Milwaukee, Wisconsin and Pittsburgh, Pennsylvania ramping up. The OAM hubs have the capabilities, including 3D printing, to develop and manufacture medical devices.

“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,” said.

THE LARGER TREND

The VA has collaborated with other agencies and organizations to advance medical devices and remote patient monitoring.

Through a two-year cooperative research collaboration with UL, the VA tested products to create standards and certifications for medical device cybersecurity. Compliance with UL 2900, the resulting standard, enhanced endpoint security and improved the balance of network security controls with product security controls, according to researchers.

When asked about the benefits of remote patient monitoring – especially in underserved populations with disproportionately high rates of chronic disease and other barriers to care – one industry expert noted that rapid adoption of medical devices and monitoring technologies increased patient access.

“As healthcare further shifts from a fee-for-service to a value-based care approach, care delivery is shifting from an in-clinic, episodic, reactive model of care to one that is continuous and proactive, and a blend of in-clinic and remote. RPM is an effective way to ensure all patients are able to receive the quality, continuous care their condition requires,” Dr. Lucienne Ide, founder and chief health innovator at Rimidi, told Healthcare IT News last year.

ON THE RECORD

“By working side by side, VA and FDA will leverage our combined strengths and expertise to bring the most promising healthcare technology innovations to Veterans — and Americans at large — faster than ever before,” said VA Under Secretary for Health, Dr. Shereef Elnahal, in the announcement.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org

Healthcare IT News is a HIMSS publication.



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