Clinically proven, but for whom? The gender blind spot in drug and device development

When medicine defaults to male physiology, “clinically proven” becomes a dangerously incomplete promise for half the population. Despite decades of progress, women’s under-representation in clinical trials and persistent design blind spots continue to raise an uncomfortable question about who the evidence is actually proven for and what the cost is when women are not appropriately included.

The Medical Technology Association of Australia’s (MTAA) Women’s Health MedTech Summit brought together researchers, clinicians, industry and policy leaders in a setting designed not for comfort, but for accountability. The evidence hierarchies in medicine still too often assume male biology as the norm, then retrofit “sex differences” as an afterthought.

A structural shift is now underway in research governance. From 1 January this year, all applicants to National Health and Medical Research Council (NHMRC) and Medical Research Future Fund (MRFF) grant programs are required to explicitly state how sex and gender have been incorporated into their research design and to justify when they are not.

Prue Torrance, General Manager and COO of the NHMRC, framed the intent in unapologetically reformist terms, saying “We are hopeful that that will then really change the dial, making every single researcher think about these questions, incorporate them and hold them to account.”

But senior researchers warn that policy alone is not transformation. Professor Bronwyn Graham, Director of the Centre for Sex and Gender Equity in Health and Medicine at The George Institute for Global Health, put it more directly.

“If we just take women and insert them into the current research landscape, we are missing out on answering questions that are really pressing to women that could never have been asked in studies that were only being conducted on males,” said Professor Graham.

The consequences of that design failure become sharper in neurotechnology. Brain stimulation devices used in Parkinson’s disease and intractable psychiatric conditions have largely been validated in male-dominant datasets. This creates a critical blind spot when those same technologies are applied to women, particularly given what is known about neurobiological change across the female lifespan. Pregnancy, for example, is associated with widespread and enduring changes in brain structure and function, including reductions in grey matter volume linked to neural circuit specialisation, as well as shifts in the distribution of inhibitory and excitatory neurotransmitter receptors, mechanisms that are directly targeted by brain stimulation therapies.

The concern raised is not simply about whether these devices “work” in women in a general sense, but whether the current research paradigm is asking the wrong questions entirely. Much of the existing trial design is framed around male-centric assumptions of baseline brain activity, without systematically accounting for variables such as pregnancy history, menstrual cycle stage, or hormonal contraception use, all of which influence treatment response in women. As a result, simply including women in existing trials, without redesigning the underlying research questions, risks reproducing the same knowledge gap in a larger dataset.

Yet even perfect data separation is insufficient without analytical discipline and reporting integrity. Associate Professor Cheryl Carcel, clinical neurologist and Head of the Brain Health Program at The George Institute for Global Health, stressed the downstream risk of stopping at statistics alone.

“We need to disaggregate the results or analyse it by sex, and then that needs to be reported and interpreted,” said Associate Professor Carcel.

That interpretive failure is not theoretical. The Alzheimer’s therapy Leqembi (lecanemab) has become a case study in how even well-powered trials can mislead if subgroup results are not meaningfully interrogated. In a landmark trial, the drug showed an overall slowing of cognitive decline of 27%, but sex-stratified results revealed a stark divergence: 43% in men versus 12% in women. Side-effect rates were similar, yet reporting and interpretation of those risks were widely criticised as inadequate, triggering significant scientific backlash.

Pregnancy and lactation remain another persistent blind spot, where women are routinely excluded from clinical trials due to perceived risk complexity. But exclusion does not eliminate risk, it merely relocates it. The downstream consequence is clinical improvisation, decisions made at the bedside by clinicians using drugs and devices never evaluated in the very populations receiving them.

For A/Professor Fiona Brownfoot, obstetrician at Mercy Hospital for Women and co-founder of women’s health startup Kali Healthcare, the solution is not abstract. It is structural reintegration of women, including pregnant women, into research ecosystems.

“Only by working with women and developing things for them, we’re going to push the dial and equalise healthcare, bringing those pregnant women back into clinical trials,” said A/Professor Fiona Brownfoot, obstetrician at the Mercy Hospital for Women and co-founder of start-up Kali Healthcare.

But she also pointed to a less discussed barrier: capital. Women’s health innovation remains structurally underfunded, and investor perception often lags behind clinical need.

“Trying to convince investors that this is something that’s really worth investing in, it’s a challenge. If we reimburse women’s health better, we could really push device development because there’d be a lot more funding to be able to see that benefit in bringing forth novel medical devices,” emphasised A/Professor Brownfoot.

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