FDA Kicks Off Next Gen Home Healthcare Device Development Program
With an aim of supporting both patients, medical device developers and policymakers, the FDA’s Center for Device and Radiological Health (CDRH) has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions and expansion of decentralized trials.
The “Home as a Health Care Hub” program, a collaboration between the agency, patient groups, providers and other device industry stakeholders, will see the design of augmented reality/virtual reality (AR/VR) home models that can be used as sandboxes for designing and evaluating at-home healthcare solutions.
Specifically, CDRH has hired an architecture firm specialized in designing “innovative buildings with health and equity in mind … to consider the needs of variable models of a home and tailor solutions with opportunities to adapt and evolve in complexity and scale.”
The initial prototype will focus on rural and lower-income dwellings with a goal of advancing health equity and is expected later this year.
This “prototype is the beginning of the conversation – supporting device developers’ novel design approaches, helping providers consider opportunities to educate patients and extend care options, generating discussions on value-based care paradigms, and opening opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home,” CDRH Director Jeff Shuren said.
“To increase access to healthcare and maximize health outcomes, it is critical that the delivery of personalized care has people at the center,” Shuren said. “By shifting the care model from systems to people, the healthcare system can triage scarce resources to those with the most urgent and critical needs and tailor personalized care for those managing chronic conditions.”
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