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VA and FDA Partner to Accelerate Medical Device Delivery

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

BECAUSE IT IS IMPORTANT

Veterans Affairs staff will provide the clinical context for test development, while US Food and Drug Administration staff will assess the benefits and risks of medical devices to speed the time they take to reach the patients.

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

Having the FDA in-house will also allow the VHA to tap into technology markets adjacent to health care, according to the announcement. The FDA also wants to benefit from the collaboration of VA Ventures.

“We look forward to gaining valuable insights from VHA physicians 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 your health and quality of life,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the prepared statement.

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

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

“Both the FDA and VA must stay at the forefront of developing new medical technologies and the science of evaluating new technologies. This strategic alignment between our organizations creates a unique environment to achieve shared goals to accelerate patient access to safe medical services.” innovative and effective. devices,” she said.

THE BIGGEST TREND

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

Through a two-year cooperative investigation collaboration with UL, the VA tested products to create standards and certifications for medical device cybersecurity. Compliance with UL 2900, the resulting standard, improved endpoint security and improved the balance of network security controls with product security controls, according to the 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 the rapid adoption of medical devices and monitoring technologies increased patient access.

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

IN THE REGISTRY

“Working hand-in-hand, the VA and FDA will leverage our combined strengths and experience to bring the most promising health care technology innovations to veterans, and Americans as a whole, faster than ever before,” said VA Assistant Secretary for Health, Dr. Shereef Elnahal, in the ad.

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

Healthcare IT News is published by HIMSS.

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