Challenges and solutions to advancing heath equity with medical devices- ktkadakia et al.
. These higher prices can also trickle down to both Medicare and privately insured patients in the form of increased out-of-pocket costs, which could discourage them from using devices or increase the financial burden of care. Breakthrough devices authorized on the basis of their potential to address health inequities could therefore risk replacing one access barrier with another.
The FDA could consider modifying its proposed reforms to BDP to include expectations for premarket and postmarket testing. For such studies, the FDA could apply new legal requirements for clinical trial diversity to ensure enrollment is sufficiently representative to provide evidence of disparity reduction.
Addressing medical device disparities will also require action beyond the BDP to address the systemic drivers of inequity, including diversifying clinical trials, measuring outcomes across diverse populations and improving device access and affordability. By taking a broader view of disparities, the FDA will be better positioned to maximize the public health benefits of new medical technology.US FDA.
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