It's Not What You Think: Evaluating Your Right to Play in Women's Health

After years of conducting user research in women's health, here's what catches innovators off guard: the view from the exam room, the home, or even your own body is dangerously incomplete. These aren't careless teams. In fact, they're usually clinicians working to solve the real problems they face every day. Their intentions are good, the market opportunity is massive. Untapped precisely because it's been ignored for so long. 

But when we put their clinical assumptions next to actual patient research, the gap is always bigger than expected. The challenges patients navigate extend far beyond what anyone observes in a procedure room. And that blind spot between personal experience and population reality is exactly where well-intentioned solutions go to die. 

The riskiest assumption? Believing that your experience, existing data, or "common sense" tells you enough about women's health to build a safe, successful product. 

So what is it then? 

Medical device product development has been built for decades on male‑centric data. This isn't ancient history. The FDA formally excluded women of childbearing potential from early-phase clinical trials from 1977 until 1993. For sixteen years, “we” systematically removed half the population from foundational drug and device research. The legacy of that decision still shapes what we know and, more importantly, what we don't.(1)  

 When you design based on incomplete or unrepresentative evidence, you're not just taking clinical risk, you're making a commercial bet on a market you don't actually understand. 

These assumptions rarely announce themselves. They hide in design shortcuts that feel like efficiencies.  

How these assumptions show up in your products: 

• Using legacy datasets that over-represent adult men, skewing assumptions about grip strength, reach, and ergonomics for physical devices and wearables 

• Treating women as "small adults"—assuming miniaturization alone addresses anatomical and physiological differences 
• The "shrink it and pink it" approach: repackaging existing products in smaller sizes or feminine colorways and calling them women-specific (women are looking at you, razor companies) 

These patterns repeat across underserved groups. Pediatric patients aren't scaled-down adults—their rapidly changing physiology demands distinct dosing, safety, and usability considerations. Racial and ethnic minorities remain underrepresented in most device studies, meaning real-world performance can diverge significantly from trial results. When you rely solely on legacy datasets, you're betting your roadmap on populations that may not match your actual users at all. 

The real-world consequences 

In women’s health, the knowledge gap shows up everywhere(2).  Take the exercise ECG(3,4), a cornerstone cardiac diagnostic. Since 1995, we've known that standard criteria detect coronary disease with 67% sensitivity in men but only 51% in women. The test literally misses heart disease in half the women who have it. When researchers developed gender-specific criteria, sensitivity in women jumped to 91%. Yet three decades later, we're still using the same male-derived standards. 

This diagnostic failure happens in a broader context of systematic neglect. Heart disease is still the number one killer of women, yet awareness is moving backward. In 2009, 65% of women knew heart disease was their leading killer. By 2019, that dropped to 44%. Among young women and women of color, the decline was even steeper. 

The medical system isn't prepared to close this gap. Only 22% of primary care doctors feel well-prepared to assess cardiovascular risks in women. Just 42% of cardiologists say the same. When 70% of physician trainees report inadequate training in gender-based medicine, every tool they use from ECG interpretation to risk scores to treatment protocols operates from that knowledge deficit. 

Women experiencing heart attacks wait longer for care, receive less aggressive treatment, and have worse outcomes. They're less likely to receive statins for high cholesterol, blood thinners for AFib, or timely interventions during cardiac events. The symptoms themselves (fatigue, nausea, jaw pain instead of crushing chest pain) are still called "atypical" despite affecting half the population. 

Metal-on-metal hip implants, once considered a breakthrough, failed at rates up to four times higher in women than other bearing surfaces. Researchers analyzing over 400,000 hip replacements found this disparity persisted even after controlling for other variables. Testing had been concentrated in male populations, and the assumptions simply didn't translate.  

Chronic conditions like endometriosis have well‑documented diagnostic delays that average many years globally, driven by lack of awareness, stigma, and normalization of pain(5). If your device, diagnostic, or digital tool is built around how disease behaves in textbook male bodies, you are likely underestimating both unmet need and the difficulty of reaching the right users. 

When gaps get expensive 

Knowledge gaps rarely show up as a single catastrophic failure. They erode value over time. Product development has historically been male-centric, and the consequences extend far beyond fit and finish. In women’s health, diagnostic delays for conditions like endometriosis can mean years of repeat visits, inconclusive imaging, and misdirected treatment before a correct diagnosis is made. That delay shapes everything from market sizing and patient journey assumptions to health economic models, because the real pathway is longer, more fragmented, and more costly than your slide deck suggests. 

On the acute side, atypical cardiac symptoms and longer delays in recognizing heart attacks in women have been linked to worse outcomes, with evidence that women both wait longer to seek care and experience longer delays in receiving definitive treatment. A diagnostic or decision‑support tool that encodes a narrow view of “typical” symptoms can inadvertently amplify that disparity rather than mitigate it. Even seemingly simple physical products can run into trouble: investing heavily in a brace, wearable, or home‑use device built around average male dimensions may leave a significant share of women unable to use it comfortably or accurately, driving returns, non‑adherence, and brand damage that is difficult to quantify but easy for investors to recognize. 

Behind the scenes, teams often discover too late that off‑the‑shelf anatomical models are effectively cartoons of female anatomy; rigid, generic, and missing crucial variation across life stages. When a team finally invests in realistic, stage‑appropriate models and user testing, design decisions can shift dramatically, revealing how much earlier investment in realistic representations would have reduced rework. By the time those insights emerge, engineering budgets and investor patience may already be strained. 

Questions that suggest you’re not ready yet 

You don’t need perfect information to enter a market. But you do need enough to avoid building on fantasy. Red flags include: 

• Where does your data come from? If your assumptions about anatomy, physiology, or behavior rely mainly on historical male-dominant datasets without validation in your target segment, you're carrying unpriced risk. 
  

• How much time have you spent with actual users? Not clinicians describing patients, but real women across ages, races, and life circumstances. The teenager whose pain gets dismissed as 'drama' faces different barriers than the woman in perimenopause whose symptoms get attributed to 'normal aging.' The single professional navigating symptoms alone has different challenges than the mother juggling medical appointments around childcare. Women of color often face longer diagnostic delays than white women. Women from cultures that stigmatize gynecological discussions may never report symptoms at all. Two user interviews won't reveal how age determines whether pain is believed, how race compounds diagnostic delays, or how caregiving responsibilities reshape treatment adherence. You need systematic observation across populations 
  

• Who is in the room when decisions are made?. When the people making product and portfolio decisions do not include members of the population you serve, blind spots around feasibility, desirability, and trust are almost guaranteed.  

• Are you planning to “start broad and specialize later.” In markets with long diagnostic delays and entrenched inequities, waiting to specialize until after launch often means discovering too late that your early claims, labeling, and evidence package do not match real‑world use.  

If several of these resonate, you have work to do. That does not mean you should abandon the opportunity; it means you need a different strategy for building the knowledge you do not yet have. 

What strong market access and product development readiness looks like 

 Teams that succeed in underserved markets share specific behaviors: 

• They invest early in audience discovery and ethnography. Rather than relying solely on clinician opinion, they watch how users move through their actual days, at home, across life stages, managing privacy fears and caregiving demands that can make or break adoption. 
  

• They build their own datasets. When off‑the‑shelf data are thin, biased, or outdated, these teams design targeted studies to answer the questions that matter most for their device: usability in real‑world bodies, performance under typical and atypical symptoms, or outcomes in subgroups that were missing from legacy research. This might mean a small but carefully designed feasibility trial, a structured observational study, or a post‑market evidence plan that is in place before launch, not as damage control afterward. 
  

• They insist on realistic representations. From anatomical models that accurately reflect female or pediatric anatomy at relevant stages, to simulations and test protocols that match real patterns of use, they treat fidelity as a risk‑reduction investment rather than a nice‑to‑have. This is especially critical in devices intended for childbirth, menopause, pelvic health, or pediatric interventions where textbook diagrams can be dangerously misleading. 
  
• They build diverse, empowered teams. Representation of target users on advisory boards, in research teams, and among decision‑makers is treated as a core design input, not a compliance checkbox. Those voices are empowered to challenge assumptions about features, risk tolerance, and value propositions, ensuring that “user need” means more than what the default demographic in the room would prefer. 

The uncomfortable truth about market entry 

Here's what makes this challenging: The very knowledge gaps that create opportunity also create risk. The market is "untapped" precisely because it's been systematically understudied. You're simultaneously trying to close a care gap and a knowledge gap, often with the clock ticking on funding runways and development timelines. 

This paradox applies whenever you're entering a market where existing knowledge doesn't represent your users—whether that's women's health, pediatric populations, racial and ethnic minorities, or any group historically excluded from research. The same questions apply. The same gaps threaten success. 

The companies that succeed don't pretend these challenges don't exist. They acknowledge what they don't know, invest in learning it, and build that discovery into their development process from the start. They recognize that understanding your users isn't a barrier to market entry—it's the foundation for it. 

How Veranex can help 

Many teams recognize their knowledge gaps but are unsure how to close them without stalling development. This is where structured support from research and market access experts can accelerate progress rather than slow it down: 

• Research & Strategy: Ethnographic and qualitative studies, participatory design sessions, and targeted evidence‑generation plans that surface unmet needs, real‑world workflows, and the contexts that shape adoption in women’s health and other underserved populations.  

• Commercial Strategy & Market Access: Early value narratives, access and reimbursement strategies, and stakeholder mapping that reflect the true patient journey—including diagnostic delays, care fragmentation, and equity considerations—so your economic story matches how care is actually delivered. 
  

• Lifecycle risk management: Ongoing assessment of how new evidence, policy changes, or shifts in the reproductive‑health and data‑privacy landscape might affect adoption of digital tools and connected devices targeting women and other sensitive populations. 

If you are uncertain whether you have the right to play in women’s health, pediatrics, or any historically underserved segment, that uncertainty is a valuable signal. The time to confront it is well before your launch, certainly before you reach design freeze, let alone before you making your regulatory submission; not after you discover that a promising device has been approved or cleared and landed in a market it was not designed to serve.  

A structured readiness assessment turns, "It's not what you think," into concrete next steps that reduce risk and ultimately accelerate your path to market. 

About Research & Strategy at Veranex

Research & Strategy is where Veranex makes sure you are solving the right problem before you invest in solving it well. Grounded in ethnographic research, workflow mapping, and market-access intelligence, this team defines the opportunity space and value story that will guide design, engineering, human factors, and commercial decisions. Insights do not sit in slideware: they flow straight into Product Design & Engineering, Human Factors, and Commercial Strategy & Market Access, shaping design inputs, claims, and evidence needs. Because the same iCRO team carries that insight into preclinical, clinical, and regulatory work, you avoid reinvention, late pivots, and wasted capital. 

About the author: 

Annika Hey serves as a Principal Design Researcher at Veranex, bringing over 15 years of experience in harnessing systems thinking to solve complex challenges. She excels at connecting insights across diverse contexts, identifying underlying patterns and relationships between different elements. This ability allows Annika to uncover deeper insights that drive meaningful innovation and translate research findings into actionable, research-driven strategies for our clients. 

Citations

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC4800017/

2. http://orwh.od.nih.gov/toolkit/recruitment/history 
3. https://www.heart.org/en/news/2024/02/09/the-slowly-evolving-truth-about-heart-disease-and-women  
4. https://www.ahajournals.org/doi/10.1161/01.cir.92.5.1209  
5. https://www.york.ac.uk/news-and-events/news/2024/research/diagnosis-endometriosis-delay/