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Five critical factors for the commercialisation of women’s health technology

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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.

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The technology exists: Why are women still waiting?

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By Jane Lewis, chief operating officer, chief financial officer and women’s health lead, ABHI

For years, the conversation around women’s health has rightly focused on recognition.

Recognition that women wait longer for diagnosis. Recognition that symptoms are too often dismissed or normalised. Recognition that healthcare systems have historically been designed around male biology, leaving gaps in research, evidence and care.

That recognition matters. But awareness alone will not improve outcomes.

The challenge facing women’s health today is no longer simply identifying the problem. It is acting on the solutions already available.

At ABHI’s Women’s Health Summit earlier this year, leaders from across healthcare, government, academia and industry came together to discuss the future of women’s health.

One message emerged repeatedly throughout the day: we do not have an innovation problem.

Across medical devices, diagnostics, digital health and genomics, there are already technologies capable of transforming outcomes for women.

From self-sampling approaches for cervical screening and non-invasive diagnostics to AI-enabled tools and advanced imaging, innovation is happening. The question is whether healthcare systems can adopt it quickly enough.

Too often, promising technologies become trapped in pilot programmes, fragmented procurement processes or lengthy implementation pathways. Evidence generation, commissioning and adoption are frequently treated as separate challenges rather than part of a single journey.

The consequence is that innovations capable of improving quality of life and reducing pressure on health services take years to reach the women who could benefit from them.

This matters because women’s health extends far beyond reproductive health.

Historically, many discussions have centred on fertility, pregnancy and gynaecological conditions. These remain critically important, but they represent only part of the picture.

Women experience cardiovascular disease differently to men. They are disproportionately affected by autoimmune conditions. They face distinct health challenges throughout their lives, from adolescence to healthy ageing.

                            Jane Lewis

Yet healthcare systems often continue to approach these issues in isolation.

A woman does not experience her health in separate compartments. Pregnancy, cardiovascular risk, menopause, mental health and musculoskeletal conditions are interconnected.

Healthcare systems need to reflect that reality through more integrated, life-course approaches to care.

There has never been a better opportunity to do so.

Across the NHS, the shift towards prevention, community-based care and digital transformation aligns closely with the needs of women’s health.

Women’s Health Hubs are already demonstrating the benefits of bringing services together around the needs of women rather than organisational boundaries. Digital technologies are helping to identify risk earlier and support more personalised care.

Innovation can help deliver all three of the NHS’s major transformation ambitions: moving from treatment to prevention, from hospital to community, and from analogue to digital care.

But innovation alone is not enough.

Closing the women’s health gap also requires us to address longstanding gaps in research and evidence.

Women remain underrepresented in many areas of clinical research, and sex-disaggregated analysis is not always applied consistently. The result is that clinical pathways and treatment decisions are often based on evidence that does not fully reflect female physiology.

Better data, stronger research participation and greater focus on female-specific and female-predominant conditions will be essential.

There is also a compelling economic case for action.

Women’s health is often framed as an equality issue, and equality remains central. But poor health affects workforce participation, productivity and economic growth.

Improving outcomes for women benefits not only patients, but employers, healthcare systems and wider society.

Yet despite this, women’s health innovation continues to attract only a fraction of the investment directed towards other areas of healthcare.

That is beginning to change.

Across the UK and internationally, momentum is building. Governments, investors, researchers and innovators increasingly recognise that women’s health is both a societal necessity and an economic opportunity.

The conversation has moved on significantly in recent years. Topics that were once overlooked are now firmly on the policy agenda.

The next challenge is ensuring that awareness translates into action.

The technologies exist. The evidence is growing. The policy direction is increasingly clear.

ABHI is increasingly taking this agenda beyond national boundaries. Through our engagement with international industry associations, policymakers and healthcare leaders, we are working to ensure that women’s health is recognised as both a health and economic priority.

We are helping to shape discussions on innovation, regulation, investment and adoption, while sharing lessons from the UK with partners around the world.

Whether addressing the gender health gap, improving access to diagnostics or accelerating the uptake of new technologies, international collaboration will be essential.

The challenge now is not recognising the need for change, but delivering it.

Women have waited long enough for acknowledgement of the problem. They should not have to wait any longer for the benefits of the solutions that already exist.

ABHI is the UK’s leading industry association for HealthTech. Its members, ranging from multinationals to small and medium-sized enterprises (SMEs), develop and supply technologies spanning everything from syringes and wound dressings to surgical robots, diagnostics, and digitally enabled healthcare solutions. ABHI’s 400 member companies represent approximately 80% of the UK HealthTech sector by value.

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Women with PMOS should have annual NHS checks, new guidance says

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Women with PMOS should receive annual NHS checks to spot related health risks sooner, according to new draft guidance.

Polyendocrine metabolic ovarian syndrome (PMOS) is a complex condition that can have wide-ranging effects across the body.

It affects around one in eight women and was formerly known as polycystic ovary syndrome. It was renamed in May to better reflect its broader effects.

Draft guidance from the National Institute for Health and Care Excellence (NICE) calls for quicker diagnosis and better monitoring.

Marie Anne Ledingham, consultant clinical adviser for women’s and reproductive health at NICE, described the recommendation for a “simple” annual review as an “important step”.

She said: “This new guideline will help improve consistency of care, increase awareness of the condition, and support earlier diagnosis and management.”

PMOS is a major cause of female infertility. Symptoms can include irregular or absent periods, difficulty becoming pregnant, excessive facial or body hair, weight gain, hair loss, oily skin and acne.

An estimated three million to four million women have the condition in the UK, but NICE says it remains underdiagnosed and inconsistently managed.

The proposed annual reviews would cover current symptoms and longer-term health risks linked to the condition, including diabetes and heart disease.

NICE says lifestyle changes and treatment could help prevent more serious illness.

There is no cure for PMOS, but NHS treatments can help manage its symptoms. These include hormone support and fertility drugs.

The draft guideline does not recommend laser or light therapies for hair reduction because of the cost.

Many women report difficulty understanding the possible cause of their symptoms or experience delays before receiving a diagnosis.

When doctors suspect PMOS, they may use blood tests to assess hormone levels and ultrasound scans to look for the multiple follicles often seen on the ovaries of those affected. Follicles are small, fluid-filled sacs in which eggs develop.

The draft guideline sets out when healthcare professionals should suspect the condition and how women should be assessed and diagnosed.

It also says PMOS should not be ruled out in women who have been through the menopause.

The condition is thought to be more common among black, Asian and mixed-ethnicity women. NICE says healthcare professionals should consider this when assessing symptoms.

PMOS can also have a significant effect on mental health and quality of life, with depression and anxiety described as common among women with the condition.

Women planning a pregnancy should receive advice on weight, diet, nutrition, exercise, sleep and mental health, according to the guidance.

The draft guideline is open for consultation from 1 July to 11 August 2026, with feedback invited from healthcare professionals, patients and the public.

The final guideline is expected to be published in December 2026.

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Insight

The danger of ‘efficiency culture’ in women’s mental tech

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By Somayeh McKian, a member of the clinical advisory board of Vea, the AI-powered mental health journal app

The danger of efficiency culture in women’s mental tech is that we are inadvertently optimizing the very patterns that drive our collective burnout.

When we look at the explosive growth of the femtech sector, the dominant narrative remains focused on speed, tracking, and passive compliance.

We build apps that treat a woman’s emotional state like a broken supply chain or a medical deficit that needs to be optimised, streamlined, or forced into submission.

But true psychological resilience cannot be quantified by a simple mood slider or an algorithmic checkmark.

As a psychotherapist and gender studies scholar, my research into the lived experiences of women, particularly how cultural mandates and bodily surveillance are pathologised, reveals a deep-seated form of suffering.

When women constantly say “yes” while meaning “no,” or ignore a chronically depleted body to maintain a rigid role, they are living out what I call an “inkless life.”

It is a blank manuscript in which their physical and emotional existence has been entirely authored by external critics, medical charts, and the “Discourse of the Other.”

They aren’t suffering from an efficiency problem; they have been stripped of the agency to author their own skin.

If femtech platforms simply digitise these rigid, externalised “shoulds,” they risk becoming high-tech tools of compliance rather than portals of liberation.

The investment community and health tech innovators need to realise that the next frontier of mental health tech isn’t about managing symptoms on the fly; it is about existential archaeology.

We must build digital spaces that serve as a “corporeal pen,” transforming self-reflection from a passive hobby into a defiant, existential act.

True innovation lies in helping women find the meaning, the latent metaphors, and the unique tasks already written into their struggles and transforming inherited pain into a human achievement.

This is exactly the structural paradigm shift we are anchoring at Véa. Instead of building superficial tracking logs, our architecture treats life as a manuscript.

We design clinical narrative journeys that help women decode where their internal boundary scripts were written, recognize how somatic depletion is a truth-teller, and wield phrases like “stop it” not as external policing, but as internal, defiant boundaries.

If we want to build a sustainable ecosystem for women’s health, we must stop funding platforms that merely help women endure their exhaustion more efficiently.

In the intersection of meaningful life and technology, we look at the human spirit not by its current restrictions but by its latent potential for change.

It is time to back technologies that give the fluent soul a sharp new set of instruments to rewrite its own narrative.

Somayeh McKian is a certified psychotherapist, in-training logotherapist, gender studies scholar, published author and part of Véa’s clinical advisory board.

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