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.
Insight
WUKA and Royal Yachting Association partner to support women and girls in sailing
WUKA has announced a groundbreaking partnership with the Royal Yachting Association (RYA), including RYA Scotland and RYA Northern Ireland, supporting women and girls in sailing.
Building on WUKA’s growing #TackleAnything campaign – which has already reached thousands of girls across sports in the UK – this collaboration brings practical period solutions into sailing.
Together, WUKA and the RYA are committed to breaking down barriers so periods never limit confidence, participation, or performance on the water.
Ruby Raut, WUKA founder & CEO, said: “Partnering with the RYA has been incredibly important for us at WUKA.
“Sailing is an amazing way for women and girls to build confidence, and periods shouldn’t hold anyone back from enjoying the water or reaching their full potential.
“Through this partnership and our #TackleAnything campaign, we’re proud to provide practical solutions and innovative products that help female sailors feel comfortable, confident, and free to focus on learning, performing, and having fun.
“Breaking down barriers and supporting women to tackle anything — on land, at sea, and everywhere in between – has never felt more meaningful.”
WUKA, which stands for Wake-Up Kick Ass, shares the RYA’s commitment to inclusivity and empowerment.
In 2023, WUKA launched #TackleAnything, a campaign supporting women, girls and sportspeople with periods. Since its launch, the initiative has reached 3,576 girls across 46 clubs and partnered with a range of sports across the UK – from Scottish Gymnastics to Titans wheelchair basketball – helping young athletes play without limits and stay confident, comfortable, and in the game.
The brand offers period-friendly aquatic apparel and practical solutions that help women train and compete with freedom of movement and total assurance.
Through this partnership, WUKA will provide innovative period swimwear for young sailors across key RYA programmes, including the NI Sailing Team, the RYA Scotland Performance Pathway Programme, and the British Sailing Pathways Talent Academies.
By combining WUKA’s mission to challenge stigma with the RYA’s commitment to inclusion, the partnership ensures young sailors can focus on what matters most – learning, performing, and enjoying their time on the water – with confidence and comfort. RYA members will also receive a 10 per cent discount on WUKA products.
Sailing offers incredible benefits for women and girls, but time on the water can present unique challenges -particularly during menstruation.
Together, WUKA and the RYA are providing practical solutions that remove these barriers, helping young sailors participate fully and confidently in the sport.
Sara Sutcliffe, RYA CEO, said: “At the RYA, we have been making strides to break down barriers for women of all ages to help ensure they can experience the water in a supportive and positive environment.
“From education workshops and practical sessions, we want to make sure our female sailors are empowered and this partnership is another great example of how we can demonstrate possible tools to equip them to succeed”.
This partnership is part of the RYA’s wider commitment to making sailing a sport where women and girls can thrive. Alongside initiatives such as the Female Futures Group, the Women’s Race Officials Programme and all new Talent Academy Female Future’s Camps; it demonstrates a continued focus on removing barriers and creating meaningful opportunities across every stage of the sailing.
WUKA’s involvement ensures that practical solutions are available on the water, from innovative period swimwear to support resources, helping young sailors feel fully equipped and confident during training and competition.
By integrating these tools into RYA programmes, WUKA brings a new level of comfort and assurance to female athletes, allowing them to focus entirely on performance, enjoyment, and growth in the sport.
For any women and girls looking to learn more about sailing, visit www.rya.org.uk.
For more information on WUKA visit www.wuka.co.uk.
Cancer
Study links changing population to low London screening rates
London’s shifting population is holding down breast screening uptake, experts have said, with the capital at 62.8 per cent in 2024, below the NHS’s acceptable 70 per cent threshold.
The London Assembly Health Committee recently heard that the capital faces distinct challenges compared with the rest of the country and that these issues must be addressed.
Josephine Ruwende, a cancer screening lead at NHS England, said frequent moves within the rented sector and the cost-of-living crisis pushing people out of London had made it difficult to reach eligible patients, which she described as “population churn”.
She said: “This is people changing addresses and then not updating their GP, this then affects the invitation process because GP details are used to identify individuals who are eligible.
“In boroughs where we have the highest population churn, we see it strongly associated with lower uptake.”
She noted that even in the wealthiest boroughs there can be high levels of movement, with around 40 per cent of residents changing address within a year.
Such areas also tend to have more people who own second homes or spend long periods abroad, making it harder for the NHS to keep contact details up to date.
As a result, screening invitations may be sent to out-of-date addresses or to people who are overseas.
Leeane Graham, advocacy lead at Black Women Rising, which supports women of colour with a cancer diagnosis, said there were cultural barriers, fear and a mistrust of the health service due to previous experience within communities.
She said: “If you’ve never been for a breast screening before, the thought of having a mammogram can be really, really terrifying.”
Helen Dickens, from Breast Cancer Now, said other reasons included a lack of understanding of breast screening, along with concerns about discomfort, trust and practical issues such as travel.
She said: “We have amazing public transport and we feel that we’ve got great accessibility, but we also know that we don’t have screening centres in every borough.
“We know that for some women that barrier of transport and access will still be a really big reason why they’re not attending screenings.”
NHS London launched its first screening campaign last year in response to the figures, aiming to increase detection at an earlier stage.
Features
The hidden cost of “business as usual” in gynecologic surgery
A Common Surgery with Outsized Consequences
Hysterectomy and myomectomy are among the most frequently performed surgeries worldwide.
Minimally invasive and robotic approaches have delivered clear benefits at the point of care, including shorter hospital stays, faster recovery, and fewer complications.
To remove the uterus or fibroids through small incisions, surgeons use a technique known as morcellation, in which tissue is cut into smaller pieces for extraction during surgery.
However, when tissue is cut without containment, those short-term gains can be offset by downstream harm.
The risks fall into three interconnected categories:
- dissemination of undiagnosed malignancy
- spread of benign tissue, including endometriosis and parasitic fibroids
- legal and financial exposure linked to off-label device use
Crucially, these costs often surface years after the original procedure and rarely where the original cost savings were realized.
Cancer Dissemination: A Known and Preventable Risk
The risk of occult uterine malignancy in women undergoing surgery for presumed benign fibroids is well documented.
The U.S. Food and Drug Administration has estimated this risk at approximately 1 in 350 women, prompting repeated safety communications recommending tissue containment during morcellation.
When morcellation is performed without containment, undiagnosed cancer will be dispersed throughout the abdominal cavity, effectively upstaging disease from localised to disseminated.
The clinical implications are profound, and so are the economic consequences.
Treatment costs for early-stage uterine cancer typically range from $40,000 to $60,000. Once disease becomes disseminated, costs can exceed $150,000 to $300,000, excluding indirect costs such as lost productivity, long-term disability, and caregiver burden.
Beyond treatment expenses, litigation related to morcellation-associated cancer spread has resulted in multi-million-dollar settlements, particularly during the power morcellation litigation wave of the mid-2010s. Several cases explicitly tied disease progression to tissue dissemination during surgery.
From a system perspective, a single preventable dissemination event can negate the cost savings of hundreds of minimally invasive procedures.
Benign Tissue Seeding: The Long Tail of Surgical Cost
Cancer is not the only concern.
Uncontained morcellation has also been associated with the spread of benign tissue, including parasitic fibroids and iatrogenic endometriosis, conditions that may present years after the index surgery.
Endometriosis alone represents one of the most expensive chronic gynecologic conditions. Multiple health economic studies estimate annual per-patient costs of $12,000 to $16,000, with lifetime costs exceeding $100,000, driven by repeat surgeries, chronic pain management, hormonal therapy, and fertility interventions.
While the financial impact may surface years later, downstream harm is increasingly traced back to the index procedure, including the choice between FDA-cleared containment and off-label alternatives used during tissue extraction.
Off-Label Use and the Quiet Accumulation of Liability
One of the least visible, but most consequential, dimensions of morcellation risk lies in off-label device use.
Many tissue bags currently used during morcellation are not FDA-cleared for prevention of tissue spillage during organ cutting and removal. While off-label use is common in medicine, it carries distinct legal and financial implications when complications occur.
Risk management guidance from MedPro Group, one of the largest medical malpractice insurers in the United States, has repeatedly warned that off-label use increases professional liability exposure in three key ways:
1. Burden of justification
When an FDA-cleared alternative exists, the legal burden shifts to the surgeon to prove that off-label use met the standard of care.
2. Informed consent vulnerability
Standard consent language may be insufficient for off-label device use, increasing exposure to failure-to-warn claims if complications arise.
3. Changed liability dynamics
Off-label use alters traditional liability dynamics, increasing scrutiny on clinical decision-making at the hospital and surgeon level.
Legal scholarship published in Clinical Orthopaedics and Related Research has echoed these concerns, noting that courts increasingly allow off-label status to be considered in malpractice cases, particularly when patient harm occurs and safer alternatives were available.
Recent U.S. court decisions have further reinforced that while off-label use is generally permitted, it is not immune from civil liability and, in rare but serious circumstances, criminal consequences when tied to demonstrable patient harm.
FDA Guidance Exists, Adoption Lags Behind
Regulatory expectations around morcellation are no longer ambiguous. The FDA has consistently called for tissue containment during tissue cutting to mitigate the risks of cancer and tissue dissemination.
Yet real-world adoption remains inconsistent.
A 2025 survey reported by News-Medical found widespread gaps in safe tissue containment during laparoscopic gynecologic surgery.
Respondents cited variability in training, institutional protocols, and access to FDA-cleared containment systems. Many surgeons reported reliance on improvised or non-cleared solutions despite growing awareness of regulatory and legal risk.
The result is a widening gap between guidance and practice, one that is increasingly visible to regulators, insurers, and hospital leadership.
Who Ultimately Pays?
The economic impact of uncontained morcellation does not fall on a single stakeholder.
- Hospitals face litigation exposure, rising malpractice premiums, re-operations, and reputational risk.
- Surgeons shoulder personal liability, heightened scrutiny around informed consent, and evolving standards of care.
- Payers absorb downstream oncology costs, chronic disease management, and repeat interventions.
- Patients bear the heaviest burden, including preventable morbidity, fertility loss, financial toxicity, and erosion of trust.
Taken together, these costs far exceed the price of prevention.
From Clinical Risk to Market Response
This growing recognition of risk has begun to reshape the market.
Before regulatory scrutiny intensified, power morcellation was widely adopted because it saved time, reduced operating room burden, and supported high procedural throughput.
It represented a multi-billion-dollar global market, supported by major surgical device manufacturers and deeply embedded in minimally invasive gynecologic practice.
The withdrawal of power morcellation from many hospitals did not eliminate the clinical need for efficient tissue extraction. Instead, it created a prolonged gap between surgical efficiency and acceptable risk.
That gap is now beginning to close.
With the emergence of FDA-cleared tissue containment systems designed specifically for morcellation, hospitals are reassessing whether power morcellation can be responsibly reintroduced in a manner aligned with regulatory guidance, patient safety, and liability mitigation.
This has significant implications for operating room efficiency, surgeon ergonomics, and system-wide cost management.
One example is Ark Surgical, a U.S.-focused surgical technology company advancing safety-first approaches to tissue extraction.
Its double-wall, airbag-like LapBox containment chamber was developed to support FDA-aligned morcellation while integrating into existing laparoscopic workflows, an increasingly important consideration as hospitals evaluate not just procedural efficiency, but long-term risk exposure.
Ark Surgical is currently in an active investment round, reflecting broader investor interest in technologies that address regulatory-driven risk while unlocking previously constrained markets.
More broadly, capital is flowing toward solutions that make it possible to restore clinical efficiency without reintroducing legacy risk.
The Cost Question Is No Longer “If,” but “When”
Healthcare systems already absorb the cost of uncontained morcellation through litigation, chronic disease management, repeat interventions, and loss of trust.
What has changed is visibility.
As clinical data, regulatory expectations, and market solutions converge, the question is no longer whether containment matters, but whether healthcare systems can afford to continue treating it as optional.
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