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How to remain successful in the tough world of FemTech

By Gloria Kolb, Co-Founder & CEO – Elitone

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It is well documented that FemTech companies, often founded and run by females, face a tougher uphill battle to get investment. Sadly, there is a continuing, historical negative bias towards female-founded and female-led companies, as highlighted by female founders in Forbes last year. 

Accessing investment and capital is the first hurdle, which often faces blatant sexism by male-dominant investors and VCs, market misconceptions and a stigma attached to female-led enterprises.

But, the challenge doesn’t stop when funding is secured.

Notwithstanding the fact that we are finally starting to have open, honest and supportive discussions around topics that affect women, including birth, menstruation, gynaecological issues, menopause and pelvic health, amongst others, female founders are still not experiencing the same support when starting or running businesses that their male counterparts benefit from.

Like every business, the challenge becomes about growing a company that is financially and operationally viable for the long term, whilst staying relevant to consumers.

But that can be even harder if you’re not given the same level of support needed.

Despite the FemTech sector’s huge growth in recent years, the appetite for funding is still missing.

In my experience many investors assume the market is saturated due to the number of products and struggle to understand and distinguish between the various FemTech solutions. 

It’s clear that female-founded and FemTech companies do well to actually get off the ground, and thereafter it’s the way these companies navigate producing relevant, effective and desired products, whilst successfully balancing the financial accounts, that is the difference between success and failure in the long-term.

The journey Elvie has experienced is an example of the challenges faced in FemTech.

It started as one of the most well-known, trailblazing sector businesses in the UK in 2013, with its ‘taboo-busting’ pelvic floor trainer.

It later launched the Elvie Pump, a fully in-bra breast pump, in 2018, and most recently pivoted its product offering to launch a bassinet.

Elvie was initially a start-up success story; since its launch raising in excess of $186 million in investment, however, recent sales figures were declining whilst debts were rising.

The good news for the sector is that Willow, the San Francisco start-up that made its name with wearable breast pumps, is acquiring Elvie.

But the question remains, how did a first-of-its-kind FemTech company go so wrong? The investment was there, so was it a lack of financial and operating diligence that caused it to fall?

In the female pelvic floor space alone, Viveve, which raised $113M was delisted from Nasdaq in 2023 when it failed to meet its incontinence endpoints, Incontrol Medical, which was the first to bring pelvic floor health to the home, folded shortly after the pandemic, and Liberty filed for bankruptcy.

So what lessons can be learnt? Why is it so difficult for FemTech hardware companies to succeed? 

Firstly, more education is needed around the issues females face that result in the development of FemTech hardware. Education is tricky in today’s society.

Things are slowly changing on the back of the conversation opening up in recent years on menstruation and menopause, but there is still a long way to go and female conditions such as incontinence and bladder leaking are still somewhat taboo, embarrassing and not spoken about often enough in mainstream or on social media. 

What’s more, what I have found while developing Elitone is that the issue of incontinence, pelvic health and bladder leaks is often a secret for those that experience it.

The desire to keep it hidden, without discussing with friends, family or the medical profession, exacerbates the lack of awareness and understanding around the condition.

People are ashamed, but don’t need to be.

Elitone is on a mission to ensure women feel empowered to speak about what can become a huge affliction.

I started the company precisely because I was suffering post-partum and couldn’t find effective solutions on the market. 

We work hard to evolve and grow Elitone, to ensure there will always be a reliable, effective and accessible solution for the millions of women who suffer.

The way we do this is to ensure our financial and operational management is solid and provides the basis for continued success. 

At one point, start-ups were told “grow fast or die”, or scale at any cost and worry about profitability later.

That may well work for software and internet-based products, but by definition FemTech is hardware and we believe that approach doesn’t work.

Our success is based on old-fashioned common sense; we are careful about our costs, we are quick to shut down marketing efforts that don’t show returns, and everything is a test first.

We already know Femtech is harder to get funded, so every dollar counts.

So, although our growth has been slower than some others, the real secret to success is creating a product that is truly loved and works!

— Gloria Kolb is the CEO and co-founder of Elitone, the first non-invasive, FDA-cleared, wearable treatment for women with urinary incontinence. 

Elitone’s accolades include winning Best New Product by My Face My Body, Sling Shot, finalist in Women Startup Challenge, and CES’ Innovation Award. As an inventor with 30+ patents and advocate for women’s health, Gloria has been featured in Forbes as a Top Scientist Driving Innovation in Women’s Health, TechRound’s Top Women in Tech, Boston’s “40 Under 40” and MIT Review’s “World’s Top Innovators under 35.”

She has engineering degrees from MIT and Stanford, and an Entrepreneurship MBA from Babson College.

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WUKA and Royal Yachting Association partner to support women and girls in sailing

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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.

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Study links changing population to low London screening rates

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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.

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The hidden cost of “business as usual” in gynecologic surgery

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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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