Risk and data availability key to regulating health equity in device development

The US medical device industry supports considering health equity in the development of their products but urged the Food and Drug Administration (FDA) to consider the paucity of data available at the time of clinical study planning and to take a risk-based approach in any future requirements.

In August 2024, FDA Center for Devices and Radiological Health (CDRH) released a discussion paper seeking feedback on incorporating health equity considerations in the development of medical device clinical studies (RELATED: CDRH issues discussion paper exploring health equity for medical devices, Regulatory Focus 08 August 2024).

In the discussion paper, FDA outlined three areas that could be used to ensure that a clinical study reflects the intended-use population for a medical device, including evaluating how the burden of disease varies in the intended-use population; understanding variation in the etiology, progression, and prognosis of disease; and evaluating how the device could potentially affect outcomes across the study population

Sharing best practices

The Advanced Medical Technology Association (AdvaMed) agreed with FDA on the “urgent public health need” for medical technologies that reduce barriers to achieving health equity and called the discussion paper “helpful and informative.”

However, AdvaMed commented that health equity issues relating to a specific medical device trial are typically unique to the device and study and should be addressed within that trial. “These issues are not universally applicable to all clinical trials or devices. Ensuring health equity often depends on factors related to the specific medical device and its therapeutic area,” AdvaMed wrote.

AdvaMed called on FDA to share any best practices that the agency identifies as it begins reviewing Diversity Action Plans. The group also encouraged FDA to collaborate with other federal entities, including the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS) and the National Institutes of Health (NIH), in achieving its health equity goals.

AdvaMed Medical Imaging Division commented, noting that since most medical imaging products do not require clinical studies during the pre-market review process, the standards process could play a significant role in advancing health equity.

“The safety and efficacy of imaging technologies are supported by a robust consensus standards ecosystem. These standards establish clear and consistent requirements for numerous aspects of all imaging modalities and are an important part of FDA pre-market review for imaging technologies,” AdvaMed Medical Imaging wrote. “We would welcome the opportunity to work with the FDA and other interested and affected stakeholders through established consensus standards development processes to develop standards that advance health equity.”

Human factors and AI

ECRI, a nonprofit organization that provides independent medical device evaluations, was supportive of CDRH’s plan to develop a framework for when a device should be evaluated in diverse populations to support marketing authorization.

“In the design of clinical studies and device evaluations, ECRI strongly advocates for Human Factors validation studies that are fully representative of the population that is intended to use the device and executed with the appropriate statistical rigor to capture a more accurate picture of the devices’ performance in diverse populations,” the group wrote.

ECRI suggested several variables that FDA should consider when developing a medical device health equity policy, including:

Human factors engineering principles
Impact of artificial intelligence on equality in patient care
The growth of medical devices in complex and varied home settings
The complexity of comorbidities in at-risk populations

“Additionally, assessment of the risk for products using a scale such as patient demographics should inform structured postmarket follow-up via registries or special studies or Human Factors evaluations. This is especially true for Artificial Intelligence applications in devices, Software as a medical device or Software incorporated into a medical device,” ECRI wrote.

Risk-based approach

AbbVie noted that the considerations in the discussion paper raise “a higher bar of data analysis” than the agency’s Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies draft guidance, which recommends that the incidence or prevalence of a condition within a demographic group should inform enrollment goals. “We recommend CDRH acknowledge the possible sparsity of data on the impact of demographic characteristics to the disease/condition,” AbbVie wrote in comments to the FDA.

AbbVie added that at the time sponsors develop a clinical study plan they may not yet know the impact of a device on certain demographic groups. AbbVie suggested that CDRH allow sponsors to propose an analysis as part of the study. “For example, a sponsor may assess the primary endpoint(s) by race, ethnicity, age, gender, etc., to elucidate the difference between various demographics. This may include assessing patient-reported outcomes (PROs) by race, ethnicity, etc.,” the company commented.

AbbVie also recommended that CDRH take a risk-based approach since well-understood device types may have little risk of differences in safety or effectiveness by demographic characteristics. “CDRH should provide sponsors the flexibility to design diversity action plans that are relevant to their specific device types and indications, with appropriate rationale,” AbbVie wrote.

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Risk and data availability key to regulating health equity in device development

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