VA and FDA partnership to accelerate delivery of medical devices

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

why does it matter

Veterans Affairs staff will provide the clinical context for developing tests while FDA staff evaluate the benefits and risks of medical devices to speed up the time it takes to reach 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.

According to the announcement, the FDA’s presence within the company will enable VHA to tap into the healthcare adjacent technology markets. The FDA will also benefit from the VA Ventures collaboration.

“We are eager to gain valuable insights from clinicians and scientists at VHA 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 capabilities,” said Jeff Shorin, director of the Center for Devices and Radiological Health at VHA. Food and Drug Administration, in the prepared statement “Health and Quality of Life.”

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

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

“Both FDA and VA need to stay at the forefront of new medical technology development and the science of new technology evaluation. This strategic alignment between our organizations creates a unique environment for achieving shared goals to accelerate patients’ access to safe, innovative and effective medical services. devices,” he said.

Big trend

The Department of Veterans Affairs has collaborated with other agencies and organizations to develop medical devices and monitor patients remotely.

Through a two-year collaborative research In cooperation with ULVA tested products to create cybersecurity standards and certifications for medical devices. According to the researchers, compliance with UL 2900, the resulting standard, enhanced endpoint security and improved the balance of network security controls with product security controls.

When asked about Benefits of remote patient monitoring — particularly in disadvantaged 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 has increased patient access.

“With healthcare shifting more from a fee-for-service approach to a value-based approach to care, care delivery is shifting from an in-clinic, episodic, interactive model of care to a continuous and proactive, combination of clinic and remote model. RPM is an effective way to ensure that all Patients focus on the quality and ongoing care their condition requires,” said Dr. Lucien Ide, founder and chief health innovator at Remedy, Healthcare IT news last year.

on record

“By working in tandem, VA and FDA will leverage our combined strengths and expertise to deliver promising healthcare technology innovations to veterans — and Americans in general — faster than ever before,” said Undersecretary for Health Affairs Dr. Sherif Al-Nahal. , in the advertisement.

Andrea Fox is Senior Editor at Healthcare IT News.

Healthcare IT News is a HIMSS publication.

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