Sedgwick issues compliance advice for biomedical research

Sedgwick, a global provider of technology-enabled risk, benefits, and integrated business solutions, has advised medical device manufacturers to look at the mix of men and women in medical tests and ensure that sex and gender data are part of their analysis and reporting.

This advice follows the finalisation of the Health of Women Program Strategic Plan by the US Food and Drug Administration (FDA), which aims to support women's health, strengthen regulatory science, and identify and address current and emerging issues in medical device research and regulation.

According to the Center for Devices and Radiological Health (CDRH), biomedical research has been historically focused on male subjects, with 88% of research for diseases more prevalent in women being conducted on male subjects. Therefore, in many cases, current data might be incomplete due to the lack of female representation in studies.

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With the finalised strategic plan aiming to set out a portfolio of women-specific device efforts and strategies to close research gaps, Sedgwick has emphasised the plan’s three main priorities:

• Sex- and gender-specific analysis and reporting: Improve availability, analysis, and communication of sex- and gender-specific information for the safe and effective use of medical devices to improve and better understand medical performance in women;
• Integrated approach for current and emerging issues to women's health: Strengthen internal health science programmes and initiatives across CDRH to improve the overall health and quality of women's life; and
• Research roadmap: Create a guide for navigating the health of women's medical device ecosystem, address identified gaps and unmet needs related to women's health through targeted resources, and promote the advancement of regulatory science related to women's health.

Moving forward, Sedgwick expects further shifts in medical device regulation regarding women's health.

“By staying up-to-date on this development now, companies can ensure they will remain compliant with FDA regulations and that all consumers are safe when using their devices,” the firm said on its blog.