Stacey B. Lee, JD, CEO at Praxis Pacisci
Regulatory inefficiency in healthcare isn’t merely bureaucratic—it’s a market distortion with measurable economic costs. Nowhere is this more evident than in the FemTech sector, where outdated frameworks impose significant burdens and delay the introduction of innovative health technologies for women. Recent analyses show that approximately 60% of FemTech start-ups identify regulatory compliance as their primary barrier to market entry. The cost of navigating this system can exceed US$1 million per product, while the approval process itself can take up to two years—delays that are especially crippling for early-stage companies. These obstacles don’t just hinder innovation; they limit access to advanced healthcare solutions for half the population, suppressing both health outcomes and economic growth.
Despite being projected by McKinsey to reach US$60 billion by 2027, the FemTech sector remains severely undercapitalised. According to Rock Health’s 2023 digital health funding report, FemTech received just 1.4% of healthcare R&D funding. This misallocation of capital does not stem from weak market potential, but from regulatory ambiguity that discourages investment. Venture capital naturally gravitates towards technologies with clearer regulatory pathways—even when they’re less impactful. The result is market inefficiency at scale, where breakthrough innovations are sidelined in favour of safer regulatory bets.
A market-based regulatory solution
The impact of regulatory inefficiency extends beyond medical devices. Recent FTC settlements with fertility apps over privacy violations underscore the lack of regulatory consistency in digital health. Meanwhile, the potential expiration of federal telehealth flexibilities in 2025 poses a substantial threat to the momentum of virtual women’s health services. According to the Centre for Connected Health Policy, these flexibilities—which ended on 31 March 2025—could disrupt care delivery models that have proven both cost-effective and patient-centred during the pandemic era. These examples illustrate that the issue is not limited to a single regulatory bottleneck—it reflects a broader, systemic inefficiency suppressing growth across the healthcare innovation ecosystem.
The history of FDA modernisation shows that removing regulatory inefficiencies typically enhances both market efficiency and safety by bringing innovations into proper frameworks faster. When regulatory frameworks keep pace with innovation, markets function as they should: rewarding breakthrough technologies that solve real problems while generating economic returns. The FemTech sector offers a perfect opportunity to demonstrate this principle in action, with benefits extending far beyond women’s health to the broader economy.
Melissa Wallace Co-founder of Fierce Foundry
Lately, I’ve found myself immersed in books that explore the state of women’s health—one that stands out is The XX Brain by Dr Lisa Mosconi. While it offers valuable guidance, it also makes one thing abundantly clear: we still don’t fully understand the female brain. Not enough research has been done to prevent conditions like menopause-related cognitive decline or Alzheimer’s in women—and that lack of understanding isn’t due to complexity.
Women’s health has long been underfunded, overlooked and dismissed in both BioTech and medicine. And while this isn’t new, recent political shifts have made things even worse. The Trump administration’s deliberate defunding of federally supported public health programmes delivered a devastating blow:
- NIH funding freezes and cuts to indirect costs halted academic research progress
- Grants for maternal health, HIV prevention and DEI programs were terminated
- Layoffs, graduate programme disruptions and researcher exits followed
- Public health data—especially concerning gender, race and LGBTQ+ identity—was suppressed or deleted
It’s no wonder the pipeline for women-centred research is drying up.
Conditions like endometriosis, PCOS, autoimmune disease, infertility and maternal mortality are still misunderstood and underdiagnosed simply because there hasn’t been enough incentive to study them.
And yet, innovation is happening. The rise of FemTech and women-led biotech startups is pushing the industry forward, toward what’s projected to be a US$1 trillion market by 2027.
We’re seeing breakthroughs that wouldn’t have happened without a female-centred lens:
- A therapeutic vaccine for cervical cancer
- Inhalable oxytocin that will save the lives of women in childbirth—especially in low-resource settings
- A new osteoarthritis treatment, MOTYS, developed from placental tissue by Doron Therapeutics, a women-led company
- Targeted therapies for reproductive health conditions like PCOS and endometriosis, areas historically ignored by traditional biotech
But here’s the truth: without capital, these breakthroughs may never scale. And we’ll continue to see women suffer from preventable conditions while waiting on innovation that’s been deprioritised for decades.
When venture capital passes on women’s health, it’s not just an ethical failure—it’s a financial misstep. Women make over 80% of healthcare decisions. They represent a massive and underserved market. And the data backs it up:
- For every US$1 invested in women’s health, there’s a US$3 return in economic growth
- Closing the gender health gap could boost the global economy by US$1 trillion annually by 2040
- A US$350 million investment in women’s health research can generate US$14 billion in economic returns within just a few years
Women’s bodies have been under-researched, underfunded and underestimated. I work with female founders every day who will redefine health for women and families. But they can’t do it alone. It’s time we change that—not just for fairness but for our future.
Dr Helen Messier, MD, PhD, Chief Medical and Science Officer, Fountain Life
BioTech innovation has never been more promising, yet much of it has historically overlooked female biology — not out of malice, but due to outdated models. For decades, women were underrepresented in clinical trials and many medical protocols have been built around male physiology. As a result, we’re still catching up on understanding how women’s bodies respond uniquely to drugs, diagnostics and disease.
Female-focused BioTech research isn’t just about equity — it’s about efficacy. Women’s health encompasses far more than reproductive systems. Cardiovascular disease presents differently in women. Autoimmune disorders disproportionately affect them. Hormonal changes influence everything from metabolism to brain health. And yet, research tailored to these biological nuances remains grossly underfunded.
We’re seeing real breakthroughs in areas like ovarian cancer detection, hormone-responsive conditions and perimenopausal care — but these are often led by under-resourced labs or startups. Without sustained, dedicated investment, promising therapies for half the population risk falling into the so-called ‘valley of death’ between discovery and delivery.
Funding female-focused BioTech is also an economic opportunity. Women drive 80% of healthcare decisions and are increasingly seeking precision-based, preventative solutions. The more we invest in research that reflects their realities, the more innovation we unleash for everyone.
In the era of AI, omics and longevity science, we must ensure women’s health data isn’t an afterthought. It should be a foundation. That’s how we build a BioTech future that’s both cutting-edge and truly inclusive.
