Closing the Gap: Why Women’s Health Research Must Drive Medical Device Innovation

Why Women’s Health Must Drive Medical Device Innovation

There is a well-documented gap in medical research when it comes to women. Over decades, clinical trials have skewed heavily male, and the female anatomy was underrepresented in medical education. Conditions that disproportionately or exclusively affect women have been systematically underfunded. The consequences of that gap have not stayed within the laboratory setting; they have followed women into the clinics and operating theatres which shapes the devices that are designed to treat them.  

As someone who has spent my early career in sexual and women’s health, I am constantly reminded of what happens when device development is not grounded in the realities of female physiology and lived experience. With that said, I have also seen what becomes possible when it is. The medical device industry is at a pivotal moment in time and the case for putting women’s health research at the centre of innovation has never been stronger. 

The Gender Gap in Medical Research and Its Impact on Medical Devices

The 1977 FDA guideline that excluded women of childbearing potential from early-stage clinical trials was not reversed until 1993. By that point, an entire generation of medical devices and diagnostic tools had been developed and deployed with very limited female data underpinning them. The ripple effects of those consequences are still felt today. 

If you consider the field of pain management for example, research has consistently shown that women experience and report pain differently to men yet pain assessment methodologies and clinical treatment protocols have historically been developed and validated predominantly on male subjects. This is also prevalent in the field of cardiology. Where the ‘classic’ symptoms taught in medical training, and that are reflected in clinical diagnostic protocols, are predominantly male presentations. Women are still being misdiagnosed as a result. 

Women’s health-specific conditions have fared even worse. Endometriosis, polycystic ovary syndrome (PCOS), pelvic floor dysfunction and perineal trauma during childbirth are among the conditions and events that remain underserved by the medical device pipeline and this isn’t because the need is absent but is because the research culture and commercial incentives haven’t historically prioritised them. 

Why Research Must Lead Medical Device Development in Women’s Health

What the fields of sexual health, reproductive medicine and women’s health nursing have always understood (and what MedTech must embrace) is that research cannot be bolted on at the end of the development of a device. It must be the foundation. This means beginning with a deep interrogation of the clinical problem itself and asking the following questions: 

• Who is affected?  
• What does the evidence say about how and why? 
• What does the patient experience look like? 
• How does that shape what ‘success’ means for a device?
• What gaps exist in current standard of care? 
• Are those gaps rooted in a lack of innovation, a lack of research or both? 

Women’s health practitioners are uniquely positioned to bring this evidence-led thinking into MedTech. We are trained to work with conditions that are complex, and frequently stigmatised and dismissed, this means that we have developed a discipline around building rigorous cases for why a clinical problem matters and what the data say about how to address it. That discipline is exactly what early-stage device development needs.

Perineal Trauma in Childbirth: An Overlooked Opportunity for Medical Device Innovation

Perineal tearing during childbirth affects the majority of women who give birth vaginally, estimates suggest up to 90% of first-time vaginal births experience some degree of perineal trauma. Severe tears which are classified as third or fourth degree obstetric anal sphincter injuries (OASI) occur in approximately 3-4% of vaginal births in the UK. These injuries can lead to long-term consequences including chronic pain, incontinence, sexual dysfunction and can have significant psychological impact.  

Despite such a staggering prevalence, the clinical toolkit for preventing perineal trauma has remained largely unchanged for decades. Many prevention strategies have primarily focused on the technique and practitioner skill as opposed to exploring device-based solutions. A reflection, in part, of how little attention the problem has received from the medical device innovation community. 

This is beginning to change. Companies working at the intersection of obstetric care and device development, are developing devices specifically aimed at reducing perineal tearing during delivery, and are demonstrating what becomes possible when midwifery and women’s health expertise are brought directly into the design process. The clinical insight doesn’t just inform the product brief, it shapes the design questions, outcome measures as well as the regulatory strategy.

How MedTech Can Improve Women’s Health Through Better Research and Device Design

Bringing women’s health research into medical device development is not simply a matter of equity (though it is that too). It is a matter of effectiveness. Medical devices that are designed without adequate understanding of female physiology and patient experience are not just more likely to fail clinically but they are also far more likely to face regulatory challenges and struggle commercially in a market that is increasingly attuned to these gaps. There are several practical shifts the MedTech industry can make.

Firstly, ensure that women’s health specialists are embedded in device development teams from the earliest stages and not just brought in as consultants once a prototype already exists.

Secondly, invest in generating the clinical evidence that these conditions currently lack as opposed to relying on extrapolated data from adjacent fields or male-dominated trials.

Finally, take the patient voice seriously: women’s health has a strong tradition of participatory research and that approach translates powerfully into important factors such as medical device usability, acceptability and real-world outcomes. 

We are noticing that regulators and investors are increasingly scrutinising the evidence base for devices targeting female populations. Therefore, companies that build their foundation on robust and women-centred research will not only produce better products, they will also be better positioned to bring those products to market.

The Future of Women’s Health in Medical Device Innovation

The medical device industry has an opportunity here and increasingly, a responsibility to close the gap that decades of male-default research created. Women’s health isn’t a niche. It’s half the population and it’s a space rich with unmet clinical need as well as rigorous research tradition.

The devices that will define the next decade of women’s healthcare will be built by teams that understand this. The question we now pose to the MedTech industry is whether it will lead that change or follow it.

References

• McKiever, M., Frey, H. & Costantine, M.M. Challenges in conducting clinical research studies in pregnant women. J Pharmacokinet Pharmacodyn 47, 287–293 (2020). https://doi.org/10.1007/s10928-020-09687-z
• National Institutes of Health (NIH). NIH Inclusion Outreach Toolkit: How to Engage, Recruit, and Retain Women in Clinical Research History of Women’s Participation in Clinical Research. Updated 2024. Available at: https://orwh.od.nih.gov/toolkit/recruitment/history
• Paller CJ, Campbell CM, Edwards RR, Dobs AS. Sex-based differences in pain perception and treatment. Pain Med. 2009;10(2):289–299. doi: 10.1111/j.1526-4637.2008.00558.x
• Al Hamid A, Beckett R, Wilson M, Jalal Z, Cheema E, Al-Jumeily Obe D, Coombs T, Ralebitso-Senior K, Assi S. Gender Bias in Diagnosis, Prevention, and Treatment of Cardiovascular Diseases: A Systematic Review. Cureus. 2024 Feb 15;16(2):e54264. doi: 10.7759/cureus.54264. PMID: 38500942; PMCID: PMC10945154.
• Royal College of Obstetricians and Gynaecologists (RCOG). Perineal tears during childbirth [Internet]. London: RCOG; [cited 2026 Mar 10]. Available from: https://www.rcog.org.uk/for-the-public/perineal-tears-and-episiotomies-in-childbirth/perineal-tears-during-childbirth/
• Care of a third of fourth degree tear that occurred during childbirth (also known as obstetric anal sphincter injury OASI) [Internet]. London: RCOG; 2019 [cited 2026 Mar 10]. Available from: https://www.rcog.org.uk/for-the-public/browse-our-patient-information/care-of-a-third-or-fourth-degree-tear-that-occurred-during-childbirth-also-known-as-obstetric-anal-sphincter-injury-oasi/
• Crook L, McInnes RJ. The postnatal effects of perineal trauma on maternal psychological and emotional wellbeing: a longitudinal study. Eur J Obstet Gynecol Reprod Biol. 2024. https://doi.org/10.1016/j.ejogrb.2024.01.035

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