On average, women will use medical devices more than men during their lifetimes. Based on this, FDA regulators are looking for effective ways to create gender-specific medical devices for women. In early August, FDA regulators shared news of an initiative to develop gendered medical devices. In a congressional report required through Section 907 of the FDA Safety and Innovation Act, officials explored how women and other demographics help support the approval of medical devices through clinical trials. To gain a better understanding of how women impact clinical trials for medical devices, regulators explored 37 premarket approval applications in 2011. Based on these results, FDA regulators note that sponsors provide and analyze clinical data about women in many unique ways.

In particular, the report highlighted a workshop by the Center for Devices and Radiological Health. This workshop was designed to explore how the health of women (HoW) is linked to medical device use.

The HoW initiative includes three broad goals. One goal includes the development of innovative clinical studies, technology and innovative strategies. Another goals hopes to address unmet needs and identified gaps through the use of targeted resources. Finally, officials hope to improve communication between providers and women.

By improving the quality and consistency of healthcare-related communication, officials hope to find new ways to ensure the safety and efficacy of medical devices used by women. To make this happen, hundreds of representatives from advocacy groups, federal agencies, healthcare, academia and industry joined together to brainstorm effective ways to find solutions to clinical research needs.

This initiative was based on draft guidance released on December of 2011 (and also noted in the 907 report by FDA regulators). In the draft, officials at CDRH outlined expectations for sex-specific enrollment in data analysis, clinical studies and the dispersal of study-related information. Officials hope that the final guidance can provide a solid framework for guiding the analysis and communication of device clinical studies that involve women.

In addition, the HoW program by CDRH hopes to complement this initiative through the development of partnerships with other key players. Officials believe that communication information about gender differences to the medical device industry, clinical investigators and health care professionals can improve patient outcomes.

Taken as a whole, officials believe that laying this groundwork out can ensure that women are considered in device innovation and research agendas. By guiding the clinical community and industry to focus on women, officials believe that providers will be in a better position to understand how gender-specific treatment options can impact patient outcomes.

Officials will release an Action Plan in 2014.