FDA’s Quest to Address Disparities in Medical Devices for Women



By Sarah Wells Kocsis, MBA, SWHR Vice President of Public Policy

Recognizing sex and gender disparities and the pressing issues they present for the health of women, the U.S. Food and Drug Administration (FDA) recently launched the Health of Women Program to foster and advance device innovation for women.

Housed within FDA’s Center for Devices and Radiological Health (CDRH), the Health of Women Program encourages researchers to take sex and gender into consideration in order to improve health outcomes for patients and device users. For example, prosthetic knees designed to reflect anatomical differences between women and men are improving orthopedic function.

At SWHR’s March policy meeting, the program’s director and chief medical officer, Dr. Terri Cornelison, spoke about the rationale behind the program. “Every cell is sexed and every person is gendered. These differences may contribute to the course and outcome of scientific advances of conditions that affect all organ systems in the human body,” she said. “Exploring and understanding unique issues related to the performance of medical devices in women is critical to protecting and promoting the health of all women.”

At the end of 2019, FDA released a strategic plan for public feedback that outlines priority areas for the Health of Women program:

  1. Collect, analyze, and report sex- and gender-specific data more consistently.

    Improved availability and use of sex- and gender-specific data — basic, non-clinical and clinical — surrounding medical device premarket submissions and post-market surveillance.

  2. Coordinate and lead an integrated approach across CDRH offices, in partnership with innovators and researchers, to analyze current and emerging issues related to the health of women.

    This includes exploring strategies, technologies, and device-specific study paradigms, and developing center-wide policies and outreach activities related to the health of women.

  3. Develop a “research roadmap” for the health of women medical device ecosystem to address unmet needs and promote the advancement of regulatory science related to the health of women.

    Cornelison said she hopes to establish a portfolio of women-specific device efforts and involve the direct input of women.

“Our intent is to embrace a framework that is both driven by science and based on least burdensome principles that foster the tools necessary to consider how sex and gender are factored into research designs, device development, and analyses of studies in humans, vertebrate animals, tissue cultures, and primary cell lines, when such are appropriate and/or necessary” Cornelison said.

SWHR strongly supports FDA’s efforts to recognize and address these important priorities for women’s health in the medical device realm. In formal feedback on the program’s strategic plan, SWHR emphasized the gaps in women’s health device development and ways in which CDRH can lead industry in addressing these disparities.

SWHR also called for robust, ongoing stakeholder involvement as the program moves forward and underscored the need to reduce barriers to patient participation within device research. For women and people of color, who have often been excluded from medical research, it is crucial to make participation easier using techniques such as telecommunication and reimbursement for patient time and transportation.

Additionally, SWHR asked the FDA to ensure sex- and gender-related data collection takes into account a variety of demographic factors, including age, race, and ethnicity, to ensure that these efforts truly address the needs of all women.

SWHR looks forward to working with the FDA as it finalizes and implements these strategies to improve women’s health in the field of medical devices.

By Sarah Wells Kocsis, MBA, SWHR Vice President of Public Policy

Recognizing sex and gender disparities and the pressing issues they present for the health of women, the U.S. Food and Drug Administration (FDA) recently launched the Health of Women Program to foster and advance device innovation for women.

Housed within FDA’s Center for Devices and Radiological Health (CDRH), the Health of Women Program encourages researchers to take sex and gender into consideration in order to improve health outcomes for patients and device users. For example, prosthetic knees designed to reflect anatomical differences between women and men are improving orthopedic function.

At SWHR’s March policy meeting, the program’s director and chief medical officer, Dr. Terri Cornelison, spoke about the rationale behind the program. “Every cell is sexed and every person is gendered. These differences may contribute to the course and outcome of scientific advances of conditions that affect all organ systems in the human body,” she said. “Exploring and understanding unique issues related to the performance of medical devices in women is critical to protecting and promoting the health of all women.”

At the end of 2019, FDA released a strategic plan for public feedback that outlines priority areas for the Health of Women program:

  1. Collect, analyze, and report sex- and gender-specific data more consistently.

    Improved availability and use of sex- and gender-specific data — basic, non-clinical and clinical — surrounding medical device premarket submissions and post-market surveillance.

  2. Coordinate and lead an integrated approach across CDRH offices, in partnership with innovators and researchers, to analyze current and emerging issues related to the health of women.

    This includes exploring strategies, technologies, and device-specific study paradigms, and developing center-wide policies and outreach activities related to the health of women.

  3. Develop a “research roadmap” for the health of women medical device ecosystem to address unmet needs and promote the advancement of regulatory science related to the health of women.

    Cornelison said she hopes to establish a portfolio of women-specific device efforts and involve the direct input of women.

“Our intent is to embrace a framework that is both driven by science and based on least burdensome principles that foster the tools necessary to consider how sex and gender are factored into research designs, device development, and analyses of studies in humans, vertebrate animals, tissue cultures, and primary cell lines, when such are appropriate and/or necessary” Cornelison said.

SWHR strongly supports FDA’s efforts to recognize and address these important priorities for women’s health in the medical device realm. In formal feedback on the program’s strategic plan, SWHR emphasized the gaps in women’s health device development and ways in which CDRH can lead industry in addressing these disparities.

SWHR also called for robust, ongoing stakeholder involvement as the program moves forward and underscored the need to reduce barriers to patient participation within device research. For women and people of color, who have often been excluded from medical research, it is crucial to make participation easier using techniques such as telecommunication and reimbursement for patient time and transportation.

Additionally, SWHR asked the FDA to ensure sex- and gender-related data collection takes into account a variety of demographic factors, including age, race, and ethnicity, to ensure that these efforts truly address the needs of all women.

SWHR looks forward to working with the FDA as it finalizes and implements these strategies to improve women’s health in the field of medical devices.