Evaluating Women's Health Products and Therapies
Women's health products and therapies, a growing sector sometimes called femtech, encompass consumer products, pharmaceuticals, medical devices, and treatments designed to address health conditions unique to women or conditions that manifest differently in women because of their anatomy and physiology. Example products and treatments include contraceptive devices and pharmaceuticals, densitometry, breast implants, obstetrics/gynecology biopsy and imaging, and urogynecology devices.
Women's health issues are unique in many ways. Many common diseases, such as colon cancer, cardiovascular disease, depression, and anemia present differently or more frequently (e.g., autoimmune diseases) in women. Additionally, aside from pregnancy, childbirth, and menopause, common conditions unique to women's health include osteoporosis, breast and reproductive cancers, and subfertility. Women also have different susceptibilities to orthopedic implant failures and reactions to implanted materials compared to men. Successfully treating women with these unique diseases and health conditions may require novel approaches.
Unique Needs, Big Opportunities
Women live longer than men and use more health care resources; among women, 89% reported at least one medical expense during 2016 compared to 80% of men. Women also had average medical expenditures that were almost 30% higher than men’s expenditures in 2016. They represented more than half of Medicare and Medicaid beneficiaries in 2017. Yet, many products available to address women’s health conditions were developed decades ago, when the term “women’s health products” was not in common use, or without input from women as developers, providers, or users.
Women are also under-represented in clinical trials because they are asked less frequently to participate and opt out more frequently than men. Even though women are increasingly part of product research & development and regulatory review teams, men still compose a majority of the individuals in science and engineering fields, potentially overlooking the female perspective during product development.
Demonstrating Value - Health Economics
Health interventions involving devices and drugs are often evaluated in terms of the value that they provide to patients and/or society as a requirement for approval in many countries and before they are included in formularies or covered by insurers in the United States. Value can be measured in terms of costs and/or by the impact on health-related quality of life, as well as the impact on families and employers. These measures of value are routinely used to communicate with regulators, payers, and healthcare providers. However, there are unique issues in estimating and interpreting value for women and women’s health products. Differences in how women report health-related quality of life, pain, and treatment satisfaction can affect their responses and evaluations of treatment.
A Need for Multi-disciplinary Thinking – How Exponent Can Help
Women’s health products require an integrated multi-disciplinary approach that considers gender-specific influences, unique anatomy and physiology, lifestyle, and economic impact on health and wellness. Exponent’s engineers and scientists assist clients with a wide range of relevant expertise across practices in biomedical engineering, human factors, health economics, epidemiology, exposure science, toxicology, health risk assessment, and medicine. Representative project experience includes:
- Evaluating potential chemical exposures and health risks associated with the use of feminine hygiene and sexual wellness products
- Conducting systematic scientific literature reviews on potential effects of exposures to chemicals used in women’s health products, with specific focus on adverse female reproductive endpoints and endocrine disruption
- Biocompatibility evaluations of implantable medical devices for women as part of pre-market applications for regulatory approval
- Pre-clinical mechanical and/or accelerated aging tests
- Clinical study design, including diseases and products that impact women
- Technical analyses related to product liability and/or intellectual property disputes of women’s health products
- Health economics or outcomes assessments