ARTICLE SUMMARY:
In April, the device center announced a “Health Care at Home” initiative, in which virtual reality home environments will be constructed as a tool for device makers and others to consider the real-world conditions in which patients increasingly must interact with medical equipment. Michelle Tarver, CDRH’s deputy director for transformation, spoke to Market Pathways about the project’s goals and its emphasis on health equity.
Medical devices must be designed not only to treat or diagnose health conditions in particular patient populations, but also to be used successfully by people working in particular environments. A maker of a surgical device, for instance, must consider the realities of the modern operating room and surgical teams. Issues like device interoperability and human factors have increasingly put place- and people-based design requirements on the radar of industry, regulators, and the healthcare community alike. But this aspect of device design is only getting more complicated.
One major reason for the uptick in complexity is the ongoing shift of more and more healthcare into the unpredictable environments of peoples’ homes. In the face of provider shortages, cost increases, and the overall challenge of delivering care to people who may be isolated from the healthcare system due to geography, resources, or other factors, care that would have traditionally been provided in a hospital or other facility is increasingly happening in the home. Particularly in the wake of the pandemic, the healthcare system is increasingly embracing home-based care, including for instance, the growth of “hospital at home” programs.
“I think, typically, that folks, when they're developing a device or technology, they're thinking about their one widget, but not thinking about how it integrates in a constellation of other devices and then has to be incorporated into someone's daily life. And we're trying to create and foster that discussion.”
This presents opportunities for medtech makers, but it also raises big questions: is your device prepared for safe and effective use in situations where the Wi-Fi is spotty, there are sanitation challenges, or extended family continuously flows in and out of a patient’s space? FDA says it wants to elevate questions like these, that is, how to design devices to work better in real-world home environments, particularly for populations that might be lacking proper attention by the current system. To do that, the agency is launching an initiative called “Home as a Health Care Hub” to create virtual/augmented reality protypes of different home environments. The agency announced the initiative April 23 and says it plans to have the hub completed by the end of the year.
The plan, Michelle Tarver, MD, PhD, CDRH’s deputy director for transformation, explained to Market Pathways in a recent interview, will be to collaborate with providers, patient groups, and device companies to engage with the digital environments as a way to influence future device design, with an eye toward health equity and an initial focus on patients with diabetes.
