The agencies will work together to create testing methods, tools, and training that support medical device innovators throughout the product development cycle.
WHY IT IMPORTANT
Veterans Affairs staff will provide the clinical context for trial development while U.S. Food and Drug Administration staff assess the benefits and risks of medical devices to expedite time they reach the patient.
VA staff will also provide hands-on training for product developers at the Seattle incubator, which connects the Veterans Affairs Health Administration with academics, startups, and industry through partnerships. public private affairs.
According to the US announcement, having the FDA would also allow VHA to enter adjacent healthcare technology markets. The FDA will also benefit from the VA Ventures partnership.
“We look forward to gaining valuable insight from VHA physicians and scientists using a real-world perspective, and we look forward to working with our federal colleagues to help ensuring veterans and all Americans have access to the most innovative health technologies and solutions to improve health and quality of life,” said Jeff Shuren, Director of the Center for Health and Devices FDA radiology, said in the prepared statement.
VA Ventures’ mission is to turn emerging technology ideas into tangible solutions by maximizing talent and knowledge, and making VHA a leader in the care manufacturing industry. health.
According to the VA website, VHA’s Advanced Manufacturing Office has three advanced manufacturing centers in Charleston, South Carolina; Richmond, Virginia and Seattle, Washington with Cleveland, Ohio; Milwaukee, Wisconsin and Pittsburgh, Pennsylvania are on the rise. OAM centers have capabilities, including 3D printing, to develop and manufacture medical devices.
“Both the FDA and the VA need to be at the forefront of new medical technology development and the science of evaluating new technologies. This strategic alignment between our organizations creates a unique environment in which to achieve these goals. The common goal is to promote patient access to safe, innovative and effective medical devices,” said.
TREND TO BIGGER WOMAN
The VA has worked with other agencies and organizations to improve medical devices and monitor patients remotely.
Through a two-year collaborative study collaborate with UL, VA has tested products to create standards and certifications for medical device cybersecurity. According to the researchers, compliance with UL 2900, the resulting standard, enhances endpoint security and improves the balance between cybersecurity controls and product security controls.
When asked about benefits of remote patient monitoring – especially in underserved populations with high rates of chronic disease and other barriers to care – an industry expert noted that the rapid adoption of medical devices and Surveillance technology has increased patient access.
“As healthcare continues to shift from a value-for-service approach to a value-based care approach, care delivery will shift from a room-based care model. examination, in episodes, reacts to a continuous and proactive model of care that is a combination of-clinic and telemedicine RPM is an effective way to make sure all patients can get it. the quality, continuity of care their condition requires,” said Dr. Lucienne Ide, founder and director of medical innovation at Rimidi. IT news about healthcare last year.
ON PROFILE
“By working together, the VA and FDA will leverage our combined strengths and expertise to deliver the most promising healthcare technology innovations to Veterans – and Americans at large. – faster than ever,” said VA Health Minister Dr. Shereef Elnahal, in the announcement.
Andrea Fox is the senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a HIMSS publication.
