The Food and Drug Administration recently launched a home health initiative intended to improve health equity. The initiative, announced by the agency’s Center for Devices and Radiological Health in late April, will consider people’s lived environments as part of device design and clinical trial access.
Many people across the U.S. have difficulty accessing the healthcare system, as well as clinical trials used to generate evidence for medical devices. In particular, people from racial and ethnic minority groups and people who live in rural communities and lower-income neighborhoods are affected the most by these system challenges, CDRH Director Jeff Shuren and CDRH Deputy Director for Transformation Michelle Tarver wrote in an announcement for the initiative.
The program is intended to flip the usual course of device design by starting with people with the fewest resources and designing solutions that work in their homes.
Tarver said in an interview that the idea came out of feedback from a patient advisory committee meeting in September 2023 and public docket comments posted earlier that year on how to advance home devices.
“In those conversations, we consistently heard the importance of understanding people's homes and the conditions in which they live and the challenges in those conditions,” Tarver said.
To start, the FDA will look at homes across the country, including in urban and rural settings and lower economic communities, keeping cultural considerations in mind, Tarver said. The agency will work with an architecture firm to develop three augmented reality/virtual reality-enabled home prototypes, for an apartment, a single-family home and an accessory dwelling unit. The prototypes are expected to come together later this year.
Some of the characteristics developers will consider include the types of walls in a house, WiFi infrastructure and cellular capabilities and whether there is running water, as well as other features that impact the ability of a device to perform optimally in the home, Tarver said.
Stakeholders will also meet with patients, caregivers, providers, and members of the medical device and consumer technology industries, “so they have a good idea of what kinds of devices will be there, what kind of care will be delivered and what people’s lives are like to live with this condition,” she added.
The program will also consider how a person with multiple medical devices integrates them and how those devices share data with the users’ healthcare providers.
The Home as a Health Care Hub initiative will initially focus on diabetes care, because of the health disparities that exist and ability to make an impact on health equity.
More than $300 billion was spent on medical costs for diabetes in the U.S. in 2022, a 35% increase over the past decade, which has disproportionately been borne by underserved communities and communities of color, according to the FDA.
The condition itself also has a wide continuum, from being diagnosed with pre-diabetes, to being diagnosed with diabetes and using glucose monitors, insulin pumps and medications to manage the condition. Diabetes can also cause other comorbidities as it progresses, including heart disease, kidney failure, blindness and amputations.
“As people age at home with that condition, what are all the things we need to think about?” Tarver said.
The conversations with patients about their experiences might bring to light unmet needs, even in discussions around their homes, according to Tarver. She also hopes the prototypes will help companies envision ways to make their product work in someone’s home and fit into a person’s life in a way that is not intrusive.
“This is the beginning of a conversation,” Tarver said. “This is exploring and trying to set up an environment where … multiple stakeholders can share their perspectives so that we can build toward a solution that will actually impact healthcare outcomes.”
