Evaluating Women's Health Products & Therapies

How can Exponent help you increase the value of women's health products and therapies?

Women's health is a growing sector encompassing consumer products, pharmaceuticals, medical devices, and treatments designed to address health conditions that are unique to women or that manifest differently in women because of their anatomy and physiology or health behaviors.

Common conditions unique to women — aside from pregnancy, childbirth, and menopause — include osteoporosis, breast and reproductive cancers, and subfertility. Women also have different symptom presentation for common chronic diseases such as stroke or other cardiovascular conditions and women have distinct susceptibilities to orthopedic implant failures and reactions to implanted materials compared to men. 

Yet many products now available to address women's health conditions were developed decades ago, when the term "women's health" was not in common use and products were developed without specific, deliberate input from women as developers, providers, or users.

Unique needs and opportunities in women's health products

Making sure women are represented in relevant clinical trials and real-world observational studies to support the capture of real-world evidence and product development and validation activities is an important step toward improving women's health and demonstrating therapeutic value.

Approval for many health interventions involving devices and drugs often depends on the value they provide to patients and society, measured in terms of their costs and their impacts on quality of life. These measures of value are routinely used to communicate with regulators, payers, and healthcare providers. However, there are unique issues in understanding and estimating value for women and women's health products. These include differences in how women report on health-related quality of life factors, such as pain or treatment satisfaction, that affect evaluations of the effectiveness of women's treatments.

Exponent provides stakeholders with an integrated multidisciplinary approach that considers gender-specific influences; women's unique anatomy, physiology, behavioral, and lifestyle factors; and the economic impact of women's health products on health and wellness for the development of safer, more effective women's health products in a market projected to reach $51.3 billion globally by 2025. 

Realizing the benefits of digital health technologies for women

Digital health technologies (DHTs), such as wearables, apps, and sensors, enable providers to track disease progression and clinical burden outside of traditional settings. For women and other underrepresented and underserved populations, DHTs can help foster earlier diagnoses and improve treatment effectiveness and safety in the real world both through the generation of real-world evidence (RWE) and expanding access to life-saving care. The field of leveraging DHTs for women's health is part of a growing sector often referred to as "femtech."

Recent advances include:

• Machine learning and predictive analytics to document user patterns and trends 
• Real-time tracking of biosensor data 
• Integration with smart devices that allows users to share data with healthcare providers in real time

Digital solutions can also help mitigate bias against women by enabling communication with healthcare practitioners around triggers or patterns that may differ from symptom presentation in males. By analyzing bias in the use of DHTs, device manufacturers, pharmaceutical companies, and other tech and life science companies can increase the effectiveness of products and therapeutic interventions, improving women's health outcomes.