CDRH Unveils Home as a Health Care Hub’s Idea Lab to Help Reimagine How New and Existing Medical Technologies Can Be Incorporated Into the Home
FOR IMMEDIATE RELEASE
December 30, 2024
The following is attributed to Michelle Tarver, M.D., Ph.D., director of the FDA's Center for Devices and Radiological Health (CDRH)
Today, the Center for Devices and Radiological Health (CDRH) is unveiling an Idea Lab, as part of the Home as a Health Care Hub initiative, to help innovators, providers, and patients reimagine the home as an integral part of the health care system.
The Idea Lab includes a virtual reality prototype, named Lilypad™, which will give users an immersive experience inside various affordable homes of representative people living with diabetes, a chronic condition that impacts millions of Americans. Lilypad™ will be housed in the online Idea Lab and will provide a realistic look into the challenges and barriers people face navigating their medical conditions in their daily lives.
The Idea Lab will also include insights from patients, caregivers, providers and experts, tours of different types of affordable housing environments, and landscape research into design opportunities ripe for innovation. These insights and resources are intended to help the FDA, innovators, and other interested parties better understand how current medical devices fit into people’s homes and lives. Lilypad™ will allow users to visualize and build integrative solutions, including innovating new home use devices, and imagine ways to adapt existing devices to better meet the patients’ needs in the home environment. It may also help identify opportunities to optimize patient use of the technologies, as well as serve as a virtual test environment for medical technologies.
We chose people living with diabetes as a test case given the prevalence and burden of disease, the importance of medical devices and lifestyle in managing the condition and preventing comorbidities, and the mobilized patient organizations and provider groups that are well-positioned to contribute to solutioning. The effort was informed by insights from patients and families living with diabetes, as well as patient organizations that support their needs to better understand the barriers faced by this population and the potential for a significant transformation in how they can manage their conditions.
The current health care system focuses primarily on how health care is delivered, through hospitals, clinics, and providers—rather than the patients themselves. This has contributed to the inability to meet the health care needs of millions of people who have no or limited access to health care systems. According to the Centers for Disease Control and Prevention, diabetes also costs the U.S. health system more than $300 billion annually, representing a 35 percent increase over the past decade, which is disproportionately borne by underserved communities. Focusing care and clinical evidence generation on patients where they live may help to address some of the challenges that patients face. Home use medical devices, including digital health technologies, can play a critical role in shifting the way care is delivered to meet the needs of the person rather than the system. Some models that have examined care delivery at home have found high patient satisfaction, better adherence to recommended care, and potential cost savings to the health care system.
At CDRH, we believe medical technology is the bridge to transitioning health care delivery to the home where more people can access it. Home-based medical technology can also support wellness, prevention of chronic diseases, and early detection of conditions that can be treated sooner and at a lower cost to the health care system.
By ensuring open access to Lilypad™ through the Idea Lab, our goal is to help device developers consider novel design approaches, as well as encourage providers to consider opportunities to educate patients and extend care options tailored to a home-based approach. By starting the conversation about how we can reimagine health care in the home environment, we also hope to generate discussions about transforming care paradigms and opportunities to bring clinical trials and other evidence generation processes to all patients, including underserved populations, through use of medical technologies in the home.
CDRH is committed to connecting groups from across the health care ecosystem and beyond to create momentum in this space and encourage a fundamental shift in the way care is delivered to better meet the needs of the people we serve.