The investment case for women’s health innovation has never been stronger. The global market sits somewhere between $15 and $30 trillion, venture capital interest is accelerating, and public attention has finally caught up to the scale of the unmet need.¹,² Yet companies with the right science, the right team, and real clinical urgency are still stalling out because the regulatory and market access system they’re navigating was not built with women’s health in mind.
The companies that break through treat regulatory strategy, clinical evidence, and market access as a single integrated program from the start, not a sequence of hurdles to clear one at a time. What follows are 6 of the most consequential hurdles in women’s health MedTech, drawn from direct experience across regulatory submissions, clinical programs, and market access engagements.
Hurdle 1: You’re often building without a regulatory map
For many women’s health applications, the regulatory framework that would normally guide development simply does not exist yet. Innovators in spaces like menopause management, pelvic floor health, or gynecological diagnostics frequently find there is no established product code, no clear predicate device, and no published guidance that speaks to their device type.³ The frameworks governing medical devices evolved largely from data and design contexts that centered on male or mixed populations. Under 21 CFR Part 884, which governs obstetrics and gynecology devices, there are provisions better aligned to male equivalents than to the female devices seeking clearance under the same code.
The absence of a map is not the absence of a path. Teams that engage the FDA before formal submission to clarify expectations and align on the evidence standard consistently fare better than those who arrive with a completed package and an unresolved predicate problem. Global regulatory compliance in women’s health often starts with building the framework, and regulators who understand the space welcome that conversation.
Hurdle 2: The evidence base was built without you
For decades, women were excluded from clinical trials or enrolled in numbers too small to support meaningful subgroup analysis. The FDA restricted women of childbearing potential from multiple early-phase studies from the 1970s through the early 1990s.4 That policy was reversed, but the data gap it created did not disappear.
The downstream effect is that innovators in women’s health are often working without the foundational evidence needed to establish context for their own submissions. Predicate comparisons are harder to draw, and baseline benchmarks may not reflect female physiology.
The FDA’s emphasis on “generalizability” (the extent to which a study’s findings can be extended meaningfully to the intended patient population) has become a defining lens for review.5 Thoughtful clinical trial management that centers on generalizability from protocol design through site selection gives programs a structural advantage. Companies investing in inclusive evidence now are building a competitive position that is difficult to replicate later, because the data have to exist before regulators will accept them.
Hurdle 3: Blanket exclusion criteria narrow your future options
The risk associated with investigational devices is often mitigated through strict exclusion criteria in clinical trial protocols. When these trials are complete and the risk profile is better understood, many companies fail to make the investment to expand trials to study effects on previously excluded patients. Blanket exclusions like pregnancy risk, hormone variation, and certain comorbidities that are common in women may seem like a clean way to reduce confounding. However, they frequently create problems at the labeling stage. A bone health device trial used a hemoglobin threshold based on U.S. population norms that excluded a significant portion of women in Japan, where the normal range is lower.6 The science was sound; the assumption was not.
Strong clinical trial recruitment strategies for women’s health start by pressure testing every exclusion criterion before the protocol is locked. In practice, that means:
- Reviewing each exclusion against the intended use population, recognizing that for premarket studies the intended patient population is often refined after the trial is complete
- Flagging criteria derived from male or U.S.-only reference ranges for population-specific validation (e.g., hemoglobin thresholds that do not reflect normal values across global female populations)
- Evaluating whether a confounding factor justifies exclusion or can be managed through stratification or subgroup analysis, which is especially relevant in women’s health where hormonal variation and reproductive status are often treated as confounders rather than clinically meaningful variables
- Leveraging decentralized trials and remote data collection to mitigate geographic bias, provider bias, and site-of-care bias — not only to reach underserved populations, but to improve the generalizability of findings across the full intended use population
Hurdle 4: A broad indication does not guarantee a broad label
A related and distinct challenge emerges when a broad indication statement meets a narrow study population. In women’s health, it frequently happens that a device intended for all postmenopausal women, or for the full spectrum of a condition like endometriosis, is studied in a population so restricted by exclusion criteria that the resulting label reflects only a fraction of the intended market.
The assumption is that this can be corrected in negotiations with the FDA. It rarely is. Regulators approve labeling that reflects the population actually studied, and recovering from a mismatch means additional studies, additional time, and resources that most growth stage women’s health companies cannot absorb.
The fix requires discipline early. As part of a coherent regulatory strategy, the indication statement, the inclusion and exclusion criteria, and the labeling target all need to be reviewed together before the protocol is finalized. For a menopause management device with a 10-to-12-year evidence journey ahead of it, getting that alignment wrong early compounds across every subsequent study and submission. Alignment at that stage prevents a negotiation at the submission stage that teams are unlikely to win.
Hurdle 5: Reimbursement treated as a downstream decision
A breakthrough device that doesn’t get reimbursed is an expensive prototype. Yet reimbursement strategy continues to be treated as something that happens after regulatory clearance in too many women’s health development programs. A significant portion of women’s health conditions lack established CPT codes or carry reimbursement pathways designed around older clinical frameworks that don’t map onto new device categories.
Pelvic floor devices, remote menopause monitoring tools, and emerging diagnostic platforms for conditions like endometriosis or polycystic ovary syndrome are frequently cleared before any coverage pathway exists for them. Building health economic evidence only after clearance means starting from scratch at the moment commercial traction is most urgent.
Companies making real progress integrate reimbursement planning into clinical trial design from the beginning. That integration looks like:
- Selecting clinical endpoints that satisfy both regulatory reviewers and payer requirements simultaneously
- Engaging market access consulting expertise before the trial is locked, not after submission
- Building health economic evidence into the evidence plan as a primary output, not an afterthought
- Mapping CPT code gaps and coverage pathway complexity during protocol development, while study design can still respond to what’s found
Payers and regulators are asking different questions about the same data. Teams that design studies to answer both simultaneously don’t have to choose between speed to approval and speed to coverage.
Hurdle 6: Market access is not a launch activity
Regulatory clearance opens a door. It does not guarantee entry. In women’s health, where clinical champions needed to drive adoption may not yet be in established referral networks, getting a product into the right health systems requires planning that starts well before clearance. Unlike cardiovascular or orthopedic devices where established KOL networks and procurement channels are well-established, many women’s health categories (e.g., menopause management, gynecological diagnostics, pelvic health) are navigating health system relationships that are still being created.
The average hospital system onboarding process for a new supplier takes approximately two years.7 For a startup navigating that independently across dozens of systems, the timeline is prohibitive. The companies scaling most effectively identified strategic partners early — established players with existing approved supplier status, health system relationships, and access to key clinical decision-makers in their target market.
Women’s health innovation is increasingly founder-led by people with deep clinical insight and real patient connection, but who may lack the institutional networks that accelerate procurement, trial site access, and key opinion leader engagement. Women’s health innovators are also more likely to be entering spaces where those networks don’t yet exist in the same form, which means building market access infrastructure alongside building the product, not after it. Investors and commercial partners who bring those networks carry access that the company cannot build fast enough on its own.
The Common Thread
Each of these hurdles shares a root cause. They emerge when regulatory, clinical, and market access planning are treated as separate, sequential activities rather than a single integrated strategy. Teams that bring those disciplines to the same table early and repeatedly are the ones that reach patients without rebuilding their programs along the way.
Women’s health is not a niche. It is a comprehensive clinical need, a generational market opportunity, and a patient imperative. RQM+’s medical device regulatory strategy consulting services span the full product life cycle, with regulatory, clinical, lab, and reimbursement expertise working as one integrated team.
Building or scaling a women’s health innovation? Connect with RQM+ to stress test your regulatory and market access strategy before small gaps turn into big setbacks.
References
- Women’s Health Access Matters (WHAM). (2024). WHAM Report: Investing in Women’s Health Research. https://whamglobal.org/
- Her Health Equity. (2025). Presented in RQM+ Live! #87, “Built for Her: Funding, Fixing, and Fueling the Next Era of MedTech.” March 2025.
- Callanan, M., & Kladakis, S. RQM+ Live! #87. March 2025. (Panelist commentary on regulatory framework gaps in women’s health.)
- Institute of Medicine (US) Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies; Mastroianni, A.C., Faden, R., Federman, D., editors. (1994). Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies: Volume I. National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK236531/
- U.S. Food and Drug Administration. (2023). Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies
- Kladakis, S. RQM+ Live! #87. March 2025. (Panelist commentary; hemoglobin reference range example.)
- Fayer, M. RQM+ Live! #87. March 2025. (Panelist commentary; hospital onboarding timeline estimate.)
