The agencies will work together to create testing methods, tools and training that support medical device innovators throughout the product development cycle.
WHY IS IT IMPORTANT
Veterans Affairs personnel will provide the clinical context for test development while U.S. Food and Drug Administration personnel will assess the benefits and risks of medical devices to speed up the time it takes 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 with academia, start-ups and industry through public-private collaboration.
The FDA’s in-house presence will also allow the VHA to tap into healthcare-adjacent technology markets, according to the announcement. The FDA will also benefit from the collaboration of VA Ventures.
“We look forward to gaining valuable insights from VHA clinicians and scientists using a real-world perspective, and we look forward to working with our federal colleagues to help ensure that veterans and all Americans have access to innovative medical solutions and technologies to improve their health and quality of life,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the prepared statement.
The mission of VA Ventures is to turn emerging technology ideas into tangible solutions by maximizing talent and knowledge and to make VHA a leader in the point-of-care manufacturing industry.
According to the VA website, the VHA Office of Advanced Manufacturing has three advanced manufacturing centers in Charleston, SC; Richmond, Virginia and Seattle, Washington with Cleveland, Ohio; Milwaukee, Wisconsin and Pittsburgh, Pennsylvania are stepping up. OAM hubs have the capabilities, including 3D printing, to develop and manufacture medical devices.
“The FDA and VA must remain at the forefront of the development of new medical technologies and the science of evaluating new technologies. This strategic alignment between our organizations creates a unique environment to achieve common goals to accelerate patient access to safe, innovative and effective medical devices,” said.
THE GREAT TREND
The VA has collaborated with other agencies and organizations to advance medical devices and remote patient monitoring.
Thanks to a two-year cooperative research collaboration with UL, the AV has tested products to create standards and certifications for medical device cybersecurity. According to the researchers, compliance with UL 2900, the resulting standard, improved endpoint security and improved the balance between network security controls and product security controls.
Asked about the benefits of remote patient monitoring — especially in underserved populations with disproportionately high rates of chronic conditions and other barriers to care — an industry expert noted that the rapid adoption of medical devices and monitoring technologies is increasing access for patients.
“As health care shifts from a fee-for-service approach to a value-based approach to care, the delivery of care is shifting from a clinical, episodic and responsive model of care to a continuous and proactive, and a mix of in-RPM is an effective way to ensure that all patients are able to receive the ongoing quality care their condition needs,” said Dr. Lucienne Ide, Founder and Innovator in head of health at Rimidi. Health Informatics News Last year.
“Working side-by-side, VA and the FDA will leverage our combined strengths and expertise to bring the most promising technological innovations in healthcare to veterans – and Americans in general – faster than ever before” , said VA Undersecretary of Health Dr. Shereef Elnahal. , in the ad.
Andrea Fox is the editor of Healthcare IT News.
Healthcare IT News is a HIMSS publication.
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