It’s time for medtech to get serious about women’s health

Femtech (or female technology), a term initially coined by Ida Tin (the founder of the period tracking app Clue), refers to products, services, applications and software designed to improve or support women’s health. While there are various ways to define women’s health, ZS defines women’s health as any condition that affects women solely, disproportionately or differently within their biology, treatment, or social contexts. This includes diseases or conditions that: 

• Are unique to women, such as pregnancy, menopause, endometriosis, cervical and ovarian cancers
• Disproportionately affect or manifest differently for women, such as autoimmune disorders, migraines, cardiovascular disease and breast cancer
• Require different interventions for women, such as mental health

Women’s health and health equity more broadly have gained significant traction during the past few years. The women’s health industry is estimated to reach around $60 billion by 2027, growing at a 15.6% compound annual growth rate (CAGR), which exceeds the growth of many sectors of medtech. Furthermore, the vast majority of healthcare decision-making is being made by women, who are spending nearly 30% more per capita than men on healthcare, with a combined purchasing power of $20 trillion per year.

We believe this market opportunity should pique the interest of medtech strategics looking to drive growth and improve overall health outcomes for women and gender-expansive individuals. However, large medtech companies seem to be slow to engage in this rapidly expanding sector. Some companies, such as Hologic and CooperSurgical, have full and impressive portfolios focused on women’s health, but many others have only a few products targeting conditions primarily affecting women. The market growth is being driven by many small and emerging players that are meeting patient demand. We’re expecting that market growth to continue with significant white space. So where are the opportunities? This article will explore historic trends that have driven a lack of engagement in this industry and make predictions on the evolution of women’s health, including how medtech should engage in the future.

We see three primary reasons that medtech isn’t fully engaged in women’s health. If the industry is going to realize success in this space, it needs to address and overcome all these historical and regulatory challenges, including:

The lack of clinical data for women’s health

Product development and M&A activity in the medtech industry is centered on clinical data. Historically, women’s health has received less attention in medical research and product development. This lack of attention is primarily due to women’s exclusion in clinical trials and lack of representation in research. It was not until 1994 that the FDA established the Office of Women’s Health by congressional mandate to advocate for the participation of women in clinical trials and the analyses of data by sex. Prior to 1990, women of childbearing age were excluded from clinical trials entirely. It may be surprising, but much of the data mentioned in the medical community predates the 1990s, resulting in knowledge gaps in conditions, diagnoses and treatments related to women. These knowledge gaps have made, and continue to make, women’s health a lesser-known area for medtech.

Today, women represent approximately half of participants in U.S. clinical trials, but the percentages are not so equivalent across disease categories. For example, only 35%-40% of participants in trials related to cardiovascular disease are women. Many disease categories that affect women have few trials and minimal funding. Likewise, women of color and women with disabilities continue to be underrepresented.

Risk aversion

Large medtech companies often prefer to invest in areas with proven market success, clear evidence and a path to reimbursement to ensure an expected return on investment. Women’s health, although growing, is hampered by the clinical data gaps mentioned, and the clinical evidence from the last 10-15 years is often viewed as being relatively new. Many women’s health products are now consumer-focused and do not go through the traditional regulatory paths; instead, they target out-of-pocket payment by consumers themselves. Because of this, medtech giants may perceive the market as being a higher-risk investment compared to other more established sectors.

Regulatory and reimbursement hurdles

Medical device development and commercialization involves complex regulatory requirements and approvals. Navigating these hurdles can be time-consuming and resource-intensive, deterring prominent medtech players from entering something considered “new.” Some women’s health products and procedures are considered quality of life products and procedures, which are often excluded from payer reimbursement evaluations. So even with regulatory approval, the reimbursement opportunity is not necessarily guaranteed. An exception may be for digital health products in the space where we see evolving paths to reimbursement that offer some promise—and certain payers have cited the importance of quality of life issues in this regard. We hope this trend indicates a shift toward a more favorable regulatory and reimbursement environment for women’s health; however, change is slow.

The growing demand for women’s health solutions and stark unmet needs present immense opportunities for both existing and new market entrants. We have seen an increase in investments in women’s health, particularly by the venture capital and private equity communities, driving the industry’s expansion; patients continue to demand innovative products. The U.S. government also has jumped on the bandwagon by launching the White House Initiative on Women’s Health Research, which we expect to motivate the private sector.

Increasing awareness, research and collaboration opportunities will change the landscape in the coming years. As the women’s health sector continues to evolve, the following are our predictions for how major medtech companies may begin to recognize the potential for innovation and growth.

Prediction 1: The industry will invest in clinical data for women, especially for underserved diseases

We have already started to see healthcare institutions and companies invest in diversity in clinical trials (such as sex and race) and make it a priority in their clinical research. A good example of this is Weill Cornell’s 2023 announcement of the ROMA:Women trial, which is the first cardiac surgery trial in women and explores the use of grafting techniques in coronary artery bypass grafting (CABG). We expect this to continue throughout the industry with increased visibility.

We also expect investment in research in underserved disease states, including endometriosis and polycystic ovary syndrome (PCOS). More than half of women living with endometriosis or PCOS are undiagnosed; on average, an endometriosis diagnosis is delayed by 10 years. By investing in clinical data to better understand underserved disease states, stakeholders across the healthcare industry, including medtech, will bring more patients into the funnel and have a direct impact on patient diagnosis and treatment.

Prediction 2: There will no longer be one care pathway for both men and women

In conditions that disproportionately affect women or manifest differently for women, there will be investment in understanding those differences along the care pathway from diagnosis to treatment. Cardiovascular disease is the leading cause of death for women, yet it has been reported that women do not receive the same level of care as men and are more likely to have symptoms dismissed by providers, less likely to be prescribed statins and have poorer outcomes in certain procedures, such as CABG. Likewise, in patients diagnosed with atrial fibrillation, women are less likely to undergo catheter ablation (considered the gold standard of care) than men, more likely to be diagnosed later and less likely to be referred to a specialty clinic for the condition. We believe a greater focus on and understanding of sex-specific differences in these conditions will drive different care pathways for women and men.

The AHA has published sex-specific guidelines on stroke, but there is an opportunity to go further and pursue women-centric research, which enhances the safety and outcomes of diagnosis and treatment and can result in more sex-specific standards of care. This will build on the ongoing investment in medtech as a whole to think about the broader disease and personalization in care rather than a single point of intervention.

Prediction 3: The consumer-product-to-medical-device route will prevail, so medtech players who are close to the patients will be better suited to play in women’s health

Nearly one-fifth of products considered femtech are consumer products. Several have become FDA-approved medical devices, receiving marketing clearance after commercializing via the direct-to-consumer (DTC) path initially. Mosie Baby, an at-home artificial insemination kit that helps patients in their fertility journey, is a recent example. We predict that menopause products, such as thermal relief bands and cooling clothing, will follow this path next to expand access to more women. Companies who are closer to the patient will have the right to win. A deep understanding of the patient and consumer-focused capabilities, such as DTC and direct-to-patient (DTP) marketing and e-commerce, will be critical for medtech companies following this route, partnering with women’s health startups and influencing customer behavior. As most medtech companies target hospitals and physicians, patient engagement may be a new muscle for some to learn.

Prediction 4: Medtech players with strong digital solutions and capabilities will have an advantage when entering the space

The healthcare industry continues to move toward a more digital future. Digital health is growing at a CAGR of about 25%, and we still see continued investment in the space. Likewise, internal digital capabilities, such as advanced analytics, data integration, machine learning and AI, are accelerating. This is no different in women’s health, and we argue that the surge in investment may result in a technology leapfrogging, as we see with Alife, which offers an AI software to optimize IVF outcomes. Strategic medtechs that already have solutions, infrastructure and capabilities built around a digital future will be more likely to develop digital solutions in women’s health or successfully acquire and integrate companies in the space, especially those focused on earlier patient identification and capture.

Prediction 5: Medtech will invest in more inclusive portfolios

The medtech industry has done a nice job making DEI a strategic imperative for their organizations, and it’s time to start bringing those principles to their portfolio. Having a more diverse and inclusive portfolio of products and solutions that focus on delivering better health outcomes for all of their patients is a very real and obvious way of demonstrating core DEI values, and putting money where your mouth is. We encourage medtech companies to address the inequity more thoughtfully in their portfolios when investing in R&D, evaluating potential expansion opportunities and tailoring existing offerings with more personalized treatment for both women and men.

Prediction 6: Collaboration and public-private partnerships are required

AdvaMed, a large and influential medtech trade association, has praised the Women’s Health Research Initiative. Lishan Aklog, one of the association’s chairs said, “AdvaMed has made health equity a top priority, bringing together our medtech companies to focus on this issue and ensure the specific needs of female patients are reflected in clinical trials, research and product development.” We predict that large medtech players will be tapped for greater participation in government research, lowering the barrier to entry. We also believe that traditional medtech players will collaborate with startups, smaller players and investors, forming joint ventures and exclusive selling agreements. We’re seeing some of this already start to emerge.

Women’s health and femtech have grown significantly in recent years, with many companies and startups driving innovation. As the space continues to expand, medtech strategics must play a more important role in improving the overall well-being and health of women globally. With continued innovation, investment and a focus on inclusivity, we believe that medtech has the potential to propel and revolutionize women’s health by bringing more patients into the funnel at the right time with the right solution. This will not only transform lives, close care gaps and forge a future where every woman can thrive but will also have a positive business impact overall. When we approach the opportunity through this lens, the potential impact goes far beyond mere numbers and market size. We are excited to see it happen.

The Women’s Health Expertise Hub brings together ZS expertise across the full spectrum of healthcare to help clients meet the unique needs of women and gender-expansive individuals. If you are interested in learning more, contact us.