Insight
Five critical factors for the commercialisation of women’s health technology
With high growth forecast for women’s health technology, it’s an attractive area for innovation. But joining the dots between concept development and commercial returns is not easy.
Sagentia Innovation has identified five critical factors for women’s health technology commercialisation that apply to start-ups and the innovation teams of established medical industry players alike.
1. Understand the unique challenges of the women’s health technology landscape
Venture capital (VC) investment in women’s health technologies has made some progress in recent years. In the context of challenging wider market conditions, average deal size reached a new high of USD $10.4million in 2023.
While this is a welcome gain, VC investment in women’s health technology is a fragment of that for the overall healthcare market. Part of the problem is the lack of historic commercial data.
It’s hard to create reliable predictive models for return on investment in an emerging market segment.
Data gaps also affect products’ ability to satisfy regulatory requirements, and the ability of regulatory authorities to ascertain risk.
Registration tends to be quicker, cheaper, and more straightforward for products with a similar use case and mode of action to others already on the market.
Innovative products with no predicate and/or insufficient data on target users can face a longer regulatory review process, putting them at a commercial disadvantage.
These data challenges will take time to resolve, but governmental initiatives for women’s health provide a welcome boost in the meantime. The Women’s Health Strategy for England has set out priorities for conditions including menstrual health and menopause, the World Economic Forum launched a Global Alliance for Women’s Health, and the US White House Initiative on Women’s Health includes USD $100million in federal funding.
2. Consider a stepwise approach to commercialisation
A sound value proposition is the cornerstone of successful commercialisation in all capacities of women’s health technology product.
Encompassing market and technology factors as well as user insights, it helps crystalise the ‘what’, ‘why’, ‘how’, and ‘who for’ of product development.
These factors underpin the product roadmap, but the actual journey can be iterative to balance risk. In other words, a simple product with basic functionality and limited health claims will likely achieve regulatory clearance more easily and get to market more quickly.
Traditionally, product developers might achieve this by starting out with a Minimum Viable Product (MVP) that satisfies basic usability requirements.
However, the development of women’s health technologies can be well-served by the principles of Minimum Lovable Product (MLP) development.
Rather than simply focusing on usability for early iterations of a product, an MLP ensures the overall experience is convenient, comfortable and enjoyable.
User feedback on the MLP can inform subsequent iterations, and data surrounding its use by or for women may support future regulatory applications.
This approach can also facilitate a more seamless transition from early adoption to the mainstream market, resulting in quicker commercial returns.
(Find out more about MLP in our whitepaper: Minimum Lovable Product – Using empathy to make your product fly here).
3. Align regulatory strategy with product development from the outset
A lack of regulatory insight at the start of product development can stall progress later in the go to market journey.
It’s important to understand which regulatory path a product is likely to take, as this impacts regulatory authorities’ data requirements. This in turn may shape key decisions during design and development.
Often, the first step is to determine whether a product will be classified as a medical device or a consumer device. This is not always as straightforward as it sounds.
A product’s intended purpose, audience, and claims all impact its classification and the regulatory path it will follow. If in doubt, seek advice on this matter at the earliest opportunity.
For products targeting the UK market, the Medicines and Healthcare Products Regulatory Agency has published flowcharts to help determine device type and medical purpose (available here).
It’s also a good idea to align regulatory strategy with commercial goals.
As described above, a simple iteration of the product which gains regulatory clearance relatively quickly can pave the way for a longer-term pipeline.
These later products build on the value proposition making stronger, substantive claims and/or satisfying user needs more effectively.
In some cases, it may be beneficial to target the consumer market initially, transitioning to a medical launch later. This was the approach taken by Bloomlife.
Its wearable sensor detects contractions in the third trimester of pregnancy, with statistics displayed via an app. Initially launched as a consumer pregnancy tracker, the company later received FDA clearance for a prescription-based device.
Pivoting to a medical product classification enabled Bloomlife to centre its messaging on high-risk pregnancies.
4. Apply an empathy-led approach across the entire product experience
Unmet needs that trigger women’s health technology innovation are just one part of the value proposition equation.
Delivering true value – and commercial success – demands deeper understanding of how users will access and engage with the product.
This is where empathetic insights come to the fore. Addressing wider pain points as well as the target health issue can enhance commercialisation, stimulating uptake via ‘market pull’ rather than ‘technology push’.
For instance, understanding factors that may inhibit or facilitate women’s likelihood to seek help for a given health issue can shape strategic decisions, such as whether to aim for consumer or medical device classification.
The INNOVO non-invasive urinary incontinence treatment from Atlantic Therapeutics (now acquired by Caldera Medical) illustrates this point. In 2018 INNOVO obtained FDA clearance as a prescription only device under the De Novo pathway since there was no predicate on the market.
However, Atlantic Therapeutics quickly moved to obtain over the counter (OTC) FDA approval via a 510(k) in 2020.
Figures suggest that only one in five women seek help for incontinence from their doctor, largely due to stigma. So, it’s likely that this shift to a direct-to-consumer model was a strategic move to improve product accessibility and adoption.
5. Monitor women’s health technology success stories
Ongoing commercial activity in women’s health technology is a valuable indicator of market condition. It can also act as a useful barometer of future market performance.
Right now, acquisitions of women’s health technology start-ups are cause for optimism.
Activity of note includes the abovementioned acquisition of Atlantic Therapeutics by Caldera Medical, an established player in surgical products for conditions including pelvic organ prolapse, polyps, and fibroids.
And Maven, the first women’s health start-up in the US to become a unicorn (valued at more than USD $1billion), acquired London-based Naytal which provides virtual clinics for women.
There have also been some significant fundraising success stories.
In June 2024, Amber Therapeutics secured USD $100million for its adaptive neuromodulation therapy to treat mixed urinary incontinence in women. This is the largest ever round of Series A funding awarded to women’s health.
Then in July 2024 Cook Medical announced the intent to sell its reproductive health portfolio to Astorg. This indicates that private equity investors are beginning to express interest in the women’s health technology space.
Start-ups are not the only businesses making strides with new women’s health technologies.
Roche received CE mark approval for its Elecsys Anti-Müllerian Hormone Plus immunoassay blood test in January 2024. This can be used as an alternative to transvaginal ultrasound for the diagnosis of polycystic ovarian syndrome.
Another new diagnostic blood test, from Thermo Fisher, predicts the risk of pre-eclampsia. This gained FDA approval in May 2023.
From researching the landscape for new trends or start-up partners, to developing women’s health solutions, designed with the user in mind, we’re excited about what the future holds for this space and proud to be driving the conversation.
Read more here.
GSK said its ovarian cancer drug shrank or cleared tumours in more than 60 per cent of patients in an early trial as CCO Luke Miels pushes faster development.
The company said that in an early-stage trial, Mocertatug Rezetecan, known as Mo-Rez, shrank or eliminated tumours in 62 per cent of patients with ovarian cancer after chemotherapy had failed, and in 67 per cent of those with endometrial cancer.
Hesham Abdullah, GSK’s global head of cancer research and development, said: “Treatment of gynaecological cancers remains a major challenge, with a pressing need for new therapies that offer improved response rates.
“With Mo-Rez we now have compelling evidence of a promising clinical profile.”
GSK acquired the Mo-Rez treatment, an antibody-drug conjugate, from China’s Hansoh Pharma in late 2023 and has trialled it in 224 patients around the world, including the UK, over the past year.
Only a few patients needed to stop treatment because of side effects, the most common being nausea.
It is given every three weeks by intravenous infusion, meaning directly into a vein.
Combined with data from a separate intermediate trial in China, the results have given the British drugmaker the confidence to go straight to late-stage trials, with five clinical studies planned globally in the next few months, including on patients in the UK.
Speaking to journalists before the conference, Abdullah described Mo-Rez as a “key asset” in the company’s growing cancer portfolio.
It is expected to be a blockbuster drug, with peak annual sales of more than £2bn, which GSK hopes will help it achieve its 2031 sales target of £40bn.
A few years ago GSK did not have any cancer drugs on the market, but it now has four approved medicines and 13 in clinical development.
Last year, oncology generated nearly £2bn in sales, up 43 per cent from 2024, with sales of its endometrial cancer drug Jemperli rising 89 per cent.
Self-employment is linked to lower rates of high blood pressure, obesity, diabetes, poor health and binge drinking in Hispanic women, research suggests.
The findings, published in the peer-reviewed journal Ethnicity & Disease, suggest work structure may be related to cardiovascular disease risk among this group.
Dr Kimberly Narain is assistant professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA, senior author of the study, and director of health services and health optimisation research for the Iris Cantor-UCLA Women’s Health Center.
She said: “Hispanic women experience a disproportionate burden of heart disease compared to non-Hispanic women. This is the first study to link the structure of work with risks for heart disease among this group of women.”
The researchers examined 2003 to 2022 data from the Behavioral Risk Factor Surveillance System to assess the association between self-employment, cardiovascular disease risk factors and health outcomes for Hispanic women.
The data included 165,600 Hispanic working women. Of those, about 21,000, or 13 per cent, were self-employed rather than working for wages or a salary.
Overall, the researchers found that self-employed women were less likely to report cardiovascular-disease-associated health problems.
They were also about 11 per cent more likely to report exercising compared with their non-self-employed counterparts.
Specifically, they found that self-employed Hispanic women had a 1.7 percentage point lower chance of reporting diabetes, roughly a 23 per cent decline.
They also had a 3.3 percentage point lower chance of reporting hypertension, roughly a 17 per cent decline.
The study also found a 5.9 percentage point lower chance of reporting obesity, roughly a 15 per cent decline.
It found a 2.0 percentage point lower chance of reporting binge drinking, roughly a 2 per cent decline.
It also found a 2.5 percentage point lower chance of reporting poor or fair overall health, roughly a 13 per cent decline.
The relationship between heart disease risks and the structure of work among Hispanic women was not driven by access to healthcare or differences in income, Narain said.
In fact, the decrease in high blood pressure linked to self-employment was nearly as large as the decrease in high blood pressure linked to being in the highest income group.
The study has some limitations.
The researchers relied on self-reported outcomes, which might be less reliable among ethnic and racial minorities and those from a lower socioeconomic background.
In addition, the researchers’ definition of poor mental health does not entirely match the accepted definition in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.
They also did not have data allowing them to examine the specific types of occupations held by the women.
The study design also cannot prove any causal relationship between self-employment and cardiovascular disease risk, which is a subject the researchers will explore.
“The next step in the research is to conduct studies that are able to better assess if the structure of work is a cause of higher heart disease risks among Hispanic women.”
Narain said this.
Study co-authors are Lisette Collins, who led the research, and Dr Frederick Ferguson of UCLA.
Grants from the Iris Cantor-UCLA Women’s Health Center-Leichtman-Levine-TEM program and the UCLA National Clinician Scholars Program supported the research.
Working from home is linked to 0.32 more children per woman when both partners do it at least once a week, research across 38 countries suggests.
The study found that among working adults aged 20 to 45, estimated lifetime fertility, meaning children already born or fathered plus plans for future children, rises when one or both partners work remotely.
In the US, the increase was even higher at 0.45 children per woman.
On average, women whose partners did not work from home had 2.26 children.
When the woman worked from home at least one day a week, this rose to 2.48. When both partners did so, it increased to 2.58.
If the man worked from home at least one day a week, the increase was more limited at 2.36 children.
The research, by Steven J. Davis and colleagues and published as a working paper by the National Bureau of Economic Research, points to three possible explanations.
Remote working may make it easier to balance childcare with paid work, leading some couples to have more children.
Families with children may also be more likely to look for remote roles. Or the growing availability of those roles may lift fertility by opening up more parent-friendly jobs.
“All three stories align with the idea that WFH jobs make it easier for parents to combine child rearing and employment,” the report suggests.
The pattern held both after the pandemic, between 2023 and 2025, and before it, between 2017 and 2019.
The implications for national fertility rates vary mainly because working-from-home rates differ widely between countries.
Among workers aged 20 to 45, the share working from home at least one day a week ranges from 21 per cent in Japan to 60 per cent in Vietnam. The UK ranks third globally and leads Europe at 54 per cent.
The report estimates that, if “interpreted causally”, remote working accounts for 8.1 per cent of US fertility, equal to about 291,000 births a year as of 2024.
The researchers note that while this may sound modest, it is larger than the effect of government spending on early childhood care and education in the US.
“Bringing WFH rates to the levels that currently prevail in the United States, United Kingdom, and Canada has the potential to materially boost fertility in many other countries,” the report suggests.
However, the research cautions against broad policy approaches, saying the desire for remote work varies widely between individuals, and that it is not practical in every job or organisation.
“Thus, policy interventions that push for a one-size-fits-all approach to working arrangements are likely to yield unhappier workers and lower productivity,” it warns.
A UK Parliament report has also found that remote and hybrid work can boost employment, with parents, carers and people with disabilities likely to benefit most from more flexible working options.
Entrepreneur2 weeks agoThree sessions that show exactly where women’s health is heading in 2026
Menopause4 weeks agoCalifornia plans US$3.4m menopause care overhaul
Pregnancy3 weeks agoHow NIPT has evolved and what AI NIPT means in 2026
Menopause3 weeks agoWatchdog bans five ads for women’s heath claims
Entrepreneur4 weeks agoWHIS USA 2026 announces first ticket release for landmark Women’s Health Innovation Summit
Mental health4 weeks agoMenopause has no lasting impact on cognition, research finds
News2 weeks agoTwo weeks left to make your mark in women’s cardiovascular health
Opinion3 weeks agoQ1 momentum: Female founders are advancing, but the system still hasn’t caught up