17 Feb 2022 --- As part of the US Food and Drug Administration’s (FDA) ongoing efforts to protect and promote the health of women, the Center for Devices and Radiological Health (CDRH) is unveiling its Health of Women Program Strategic Plan. Established in 2016, the CDRH Health of Women program was developed to address the importance of sex- and gender-specific issues arising from medical technology design and development, clinical trial design and other medical device-related matters.
Since its inception, the program has been working toward a better understanding of how medical devices - those developed specifically for women as well as those developed for people of all sexes and genders – perform, and explore unique issues in the regulation of medical devices related to female health. Understanding that sex and gender differences factor into a person's unique experience with medical devices and treatment outcomes, CDRH developed its strategic plan.
Click to EnlargeTerri Cornelison is Chief Medical Officer at the CDRH. Source: CDRHSince first producing and releasing proposals in September 2019, the organization has received and considered public feedback with the newly-updated plan detailing a framework. In doing so, CDRH aims to further the FDA's mission by protecting and promoting the health of women, strengthening regulatory science and identifying and addressing current and emerging issues in medical device research and regulation.
“As scientists and the medical community continue to learn more about sex and gender differences, we are learning that both sex (an individual's biological characteristics) and gender (the social construct by which one may define oneself) may play significant roles in the course and outcome of conditions that affect all human organ systems,” says Terri Cornelison, Chief Medical Officer and Director of the Health of Women Program at the CDRH. “While sex and gender are interrelated, they are not necessarily mutually exclusive and their interactions may affect physiological reactions, presentation of disease and treatment outcomes.”
The FDA set up and formally created the Health of Women Program Strategic Plan in the CDRH as it recognized the “importance of addressing sex- and gender-specific issues in medical technology design, development, and implementation”. The plan, designed to be integrative and cross-cutting, prioritizes the patient experience and leverages partnerships across CDRH. It aims to establish a portfolio of women-specific device efforts and strategize around gap areas to inform its research.
“We envision a groundbreaking, modern program to explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space but across a woman’s lifetime,” say Cornelison and Binita Ashar, Director of the Office of Surgery and Infection Control Devices.
Click to EnlargeBenita Ashar of the Office of Surgery and Infection Control Devices. Source: CDRH“Health of Women encompasses health conditions that are specific to women, as well as conditions that are more common or more serious in women, have distinct causes or manifestations in women, have different outcomes or treatment options in women, or have higher morbidity or mortality in women. Historically, biomedical research - from non-clinical cell research to animal studies to clinical human research - has overwhelmingly been conducted in patients assigned as male at birth.”
Commenting on the importance of reflecting women’s health care needs, Cornelison and Ashar share: “Representation in research is a critical component to understand how medical products, including medical devices, interact with individuals of different sexes and genders. Appropriate representation provides the foundation to develop safer, more effective, high-quality devices for their intended populations and can help improve health outcomes for women.”
The FDA hopes the Health of Women Program Strategic Plan will impact the health and beauty industry by empowering patients to make personal choices that are right for them, with improved availability, analysis and communication of sex and gender-specific information regarding aesthetic device treatment outcomes. Sharing that there are several medical devices in the industry for aesthetic use, Cornelison and Ashar detail examples including:
- Dermal fillers, which may be injected into the face and hands to improve the appearance of facial lines and volume loss caused by age or certain medical conditions.
- Breast implants for increasing breast size, reconstruction after breast cancer surgery or trauma, correction of developmental defects and to correct or improve the result of previous surgery.
- Lasers for cosmetic surgery (for example, to remove tattoos, scars, stretch marks, sunspots, wrinkles, birthmarks, spider veins, or hair).
- Laser and other thermal devices for body contouring.
The FDA notes that it continues to focus on increasing the safety of medical devices for all patients. Commenting on what this concentration on safety extends to, Cornelison and Ashar state: “This includes addressing information gaps around sex and gender for patients, ensuring they have easy to understand and readily available information to make the best decisions for their personal health, in addition to the important discussions regarding the benefits and risks of these devices with their health care provider.”
Three core principles and priorities were set out by the FDA in its Health of Women Program Strategic Plan.
Priority 1 – 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 the performance of medical devices in women
- Optimize CDRH practices for consistent sex- and gender-specific data collection, analysis, and reporting
- Ensure CDRH’s policies evolve with current science
Priority 2 – An integrated approach for current and emerging issues related to the health of women
- Strengthen internal health science programs and initiatives across CDRH, working together with CDRH offices and customers, to create actions to improve the overall health and quality of life for women
- Coordinate and lead an integrated approach to analyze current and emerging issues related to the health of women
- Explore innovative strategies, technologies and device-specific study paradigms
- Develop center-wide policies and outreach activities related to the health of women
Priority 3 – Research roadmap
- Develop a research roadmap for the health of women device ecosystem
- Address identified gaps and unmet needs related to the health of women through targeted resources
- Promote the advancement of regulatory science related to the health of women
The FDA landed on the three core priorities due to their prominence in the BPC and health care industry today. In 2013, the FDA held a workshop entitled the CDRH Health of Women (HoW) Program: Educate, Enable, Enlist and Explore – How to Improve the Health of Women. It sought public input on the priority activities for its framework and was a foundational step in launching the CDRH Health of Women Program. Three years later, the FDA formalized its creation.
The terminology, “health of women”, Cornelison and Ashar share, encompasses not only health conditions uniquely specific to women, but conditions that are more common or more serious in women. The health of women also extends far beyond reproductive, gynecologic, or breast health to include the whole of female health and wellbeing.
“Our mission is to protect and promote the health of all women, both as a collective, and as individuals,” Cornelison and Ashar say. “We are guided by science to embrace all health of women subpopulations, including sexual and gender minorities. With the implementation of these three strategic priorities, we aim to deepen our understanding of how medical devices work for women and continue our efforts to help assure that medical devices – those developed specifically for women, and those developed for all people – optimally align with the considerations of usability and performance in women. In this way, we hope to achieve the highest quality of innovation, safety and effectiveness for every patient.”
The FDA plans to continue to work with customers to build a coordinated registry network for women’s health technologies. In addition, it intends to leverage existing registry networks for devices used for both men and women to evaluate for sex- and gender-specific differences.
By Natasha Spencer-Jolliffe, BPC Insights Senior Journalist