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.
Black women in the UK want clearer, more accessible breast cancer screening information, research has found.
The study looked at why Black African and Black Caribbean women are less likely than white women to attend breast screening.
Researchers at the University of Surrey held focus groups and interviews with 47 Black African and Black Caribbean women aged 50 to 71.
Women in this age group are routinely invited for NHS breast screening.
The researchers said only 45 per cent of Black women attend screening, compared with 63 per cent of white women.
Anietie Aliu, lead author, postgraduate researcher at the University of Surrey and registered nurse, said: “Diagnosing breast cancer early can dramatically improve a person’s chance of survival.
“Breast cancer screening plays an important role in this by identifying the cancer and ensuring a person receives speedy treatment.
“Despite the importance of screening, Black women are less likely to attend appointments than white females.
“This puts them at risk of a potential cancer being diagnosed late and spreading to other areas of the body. We need to understand what is preventing Black women from attending these appointments and help identify ways to remove such barriers.”
The study found a need to increase awareness of breast cancer screening, especially among women less familiar with the service.
Some women, particularly those born outside the UK, knew little about breast screening before receiving their first invitation.
Others questioned why they needed screening when they had no symptoms.
The importance of trusted conversations was also identified.
Researchers found that some Black women expected their GPs to speak to them about breast screening, particularly before they reached screening age.
Although NHS breast screening is organised through national screening services, researchers said GPs often have established relationships with patients and may be well placed to offer brief advice on preventive care, including breast screening.
Participants called for stronger links between GP practices, breast screening services and Black community champions.
They said this could help women receive trusted information, ask questions and feel reassured.
Faith and religious beliefs also shaped decisions for some women.
Some Black African Christian women said illness, including cancer, was not permitted by God in their bodies, while others saw screening as a personal choice that did not conflict with Christian faith.
Muslim women highlighted the importance of being able to state their religion on medical appointment forms to help ensure they were seen by a female mammographer.
A mammographer is a healthcare professional trained to carry out breast screening scans.
Aliu added: “Breast screening can save lives, but our findings show that attendance is shaped by multiple factors, not just awareness, although awareness remains important.
“Women need relatable screening information, reassurance, flexible appointments and services that are accessible within their communities.
“Many felt that invitation letters were too formal, and that leaflets and media imagery did not reflect them, making it harder to relate to screening.”
Dr Afrodita Marcu, senior research fellow at the University of Surrey and member of the research team, said: “We need a more collaborative approach, where primary care, screening services and community voices work together to support women before, during and after the invitation.”
The researchers said future breast screening interventions should be designed with Black women, rather than for them.
They said user-friendly and culturally relevant resources, developed with communities, healthcare professionals and screening services, could improve understanding, reduce fear and make breast screening feel more accessible and reassuring.
Dr Robert Kerrison, associate professor of cancer care at the University of Surrey, said: “There is no question that breast screening can be lifesaving, but we need to make it easier for women to understand, access and feel reassured by the programme.
“This means improving communication, addressing practical barriers and making sure healthcare professionals and community partners are supported to provide clear and trusted information.”
The team has also explored healthcare professionals’ perspectives and worked with stakeholders to develop user-friendly materials with Black women.
Researchers said this co-designed approach could help ensure breast screening messages are culturally relevant, practical and shaped by the people they are intended to support.
News
“Women’s voices should be heard and pain should never be ignored,” says Wales’s first Women’s Health Minister
Women’s pain should not simply be endured, Wales’s first women’s health minister has said.
Delyth Jewell said she was determined to tackle the normalisation of pain in women’s healthcare and ensure women’s voices are listened to.
Speaking during a Women’s Health Summit at the Temple of Peace on Thursday, July 16, she said: “For too long, women’s health has been treated as an afterthought. No woman should be afraid to speak up about pain or things that don’t feel right.
“Women should be believed about their bodies, and I am determined to change the culture that has let too many women down.”
She added: “Women’s voices helped create the Women’s Health Plan. Now we’re making sure those voices continue to shape what comes next.”
The summit brought together clinicians, researchers and women with lived experience to tackle the normalisation of pain in healthcare and identify how women’s voices can better shape NHS services.
Lived experience means insight from people who have personally gone through a health issue or used healthcare services.
The event focused on pain linked to clinical procedures and long-term health conditions, drawing on research evidence, clinical expertise and women’s personal experiences.
Following the summit, minimum standards for service user engagement will be drafted to ensure women’s voices continue to influence the delivery and future priorities of the Women’s Health Plan.
Service user engagement means involving people who use health services in decisions about how care is designed, delivered and improved.
Work will also begin to refresh and strengthen the plan, including gathering feedback directly from women across Wales.
The NHS Wales Women’s Health Plan was developed after discovery work in 2022, when women across Wales shared their experiences of healthcare.
Many said they had not felt listened to, had symptoms dismissed or had lived with pain for years before receiving a diagnosis.
Hosted by Amanda Ducach, CEO, and Morgan Rose, chief science officer, EmaEQ
Healthcare companies have spent the last two years hearing the same advice: get AI into your product. Few have been told what that actually takes.
Most default to the fastest option. Plug in a general-purpose model, wrap it in a chat window, and call the box checked. It looks like progress on a roadmap slide. It rarely holds up once a real patient is on the other end of it.
We’ve spent years building AI specifically for healthcare, and the lesson that keeps repeating itself is simple: accuracy is not the same thing as trust, and trust isn’t something you bolt on after launch. It has to be part of how the system is built from the first line of code, not a feature added once regulators or users start asking questions.
That distinction is the whole reason clinical accuracy gets treated as a checkbox instead of a discipline. A model can sound confident and still be wrong in ways that matter enormously in a health context.
Knowing the difference, and building for it deliberately, is what separates AI that’s genuinely safe for care from AI that’s simply fast to ship.
On July 20th, we’re hosting a live conversation about exactly this: what companies should be paying attention to before they choose an AI to build with, what clinical accuracy really requires, and the pillars we hold every AI system to before it gets anywhere near a patient’s care.
The Healthcare AI Playbook Webinar: July 20th, 1:30-2pm EST, live on LinkedIn.
Register here: https://www.linkedin.com/events/7482643171823509504?viewAsMember=true
If your team is building anywhere near healthcare, or evaluating what’s already in your product, this is the conversation we think the industry needs right now.
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