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The Theranos wake-up call: You can’t ‘fake it till you make it’ in biotech

By Fiona Law, partner and patent attorney at IP law firm Potter Clarkson

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Fiona Law

Fiona Law, partner and patent attorney at IP law firm Potter Clarkson, reflects on the lessons the Theranos case teaches us about patents, confidence and being a female founder.

Talk in the biotech community has lasered on whether the Theranos case has set the sector back. It was a tale of caution for many investors and it is easy to think that they might be more reluctant to pour money into biotech start-ups.

That is not necessarily the case. Instead, it has sharpened their focus on due diligence.

I get to work with talented biotech founders – many of them women – and like many, I followed the rise and fall of Elizabeth Holmes with great interest. The story is both a warning sign, and a reminder to look carefully at the intangible assets when valuing a company.

Part of my job is preparing founders for pitching to investors. The number one thing I am trying to teach the female founders I work with is to be more confident. This is especially true for specialist sectors like life sciences.

While male founders tend to oversell their company and technology, women are reluctant to shout about their achievements. As a result, they often miss out on crucial investment and this can halt progress in sectors such as femtech, where the companies are predominantly run by women.

A few days ago, in its State of European Tech report, Atomico revealed that a meagre one per cent of overall VC funding went to female-only founding teams this year, a two per cent decrease from 2021. This is a massive problem that the industry needs to address, for example through encouraging more women to enter the ecosystem, both in investor and advisory roles.

The funding problem is also partly linked to women’s tendency to downplay their accomplishments, rather than shouting about them.

I believe that investors also need to look very carefully at how they are framing questions to women founders as opposed to their male counterparts, to ensure gender parity and to allow for the inherent personality differences.

For example, “Don’t you see competitor X as a massive threat to your business?” is more adversarial and negative than simply asking, “What is your strategy for dealing with any threat that competitor X may pose”?

That is one of the reasons why Theranos’ rise was so fascinating. A woman who confidently claimed her company’s blood testing technology would revolutionise the US healthcare system. With her bold strapline and conviction, she was an inspiration to many female founders.

 

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Seeing a female-founded company valued at US$9bn, back in 2015 when Silicon Valley was even more heavily male-dominated, was a breath of fresh air.

However, while many female founders could do with an injection of chutzpah when speaking to investors, Holmes has become the poster child for taking it too far. She may have taken inspiration from Steve Jobs, but what she failed to see is that selling iPhones isn’t the same as selling blood tests.

You can’t “fake it until you make it” in biotech, where people’s health and the regulations that protect them are sacrosanct. A brand and the promise of life-enhancing technology, with an allowance for some major glitches along the way, just doesn’t wash.

You need verifiable data backed up by a defensible and protectable intellectual property strategy which can be a combination of patents, trade secrets and data.

As a patent attorney, it is particularly frustrating to see a case such as Theranos cast doubt on the industry, and on female founders, especially confident ones.  IP due diligence should have revealed serious red flags.

Theranos had granted patents on their devices, which may have given investors a false sense of security, but commercially-focused IP due diligence should have taken into account the regulatory strategy and looked more deeply at the patents, rather than just seeing if they exist.

The lack of regulatory approval and the absence of supporting data in the patent applications should have prompted further investigation. The fact that Holmes also named herself as an inventor on so many patent applications when she was not doing the research should have raised a red flag about her personal integrity.

Although it is a cautionary tale, Theranos’ story actually provides an opportunity to educate founders, and investors, about the importance of having a solid IP strategy and seeking professional advice on how and when to tackle this.

Founders should ensure they’re focused on protecting their intellectual property from the get-go. They should be able to clearly articulate to investors how their patents will map to any regulatory approval and how the data support the invention. Investors should always look beneath the surface of a patent.

As someone at the centre of healthtech innovation, I can assure you investors are still on the lookout for promising start-ups. Now though, they will look far closer at the technology, and indeed intellectual property, underpinning the company’s value. This is no bad thing.

I like to compare the process to selling a car. The allure of polished bodywork and shiny alloy wheels may draw a buyer in, but they’ll want to know what features it has, how smooth the ride will be and what guarantees it comes with. The same rules apply to healthtech founders.

Holmes was something of an isolated case. There are still plenty of founders working on exciting technologies to solve some of our biggest health issues, and it is important we encourage them.

Any innovation within healthtech is fundamentally a positive because it’s propelling the market forward and data-driven services and products stand to have the biggest impact. The data demonstrate true innovation, which is far more likely to earn scientific appeal and investor interest, rather than aesthetics.

It’s never been easy, even less so in the current climate, so let’s not make it harder. We need to make sure confidence is not a dirty word and that female founders get the support they need to ensure it’s well-placed and verifiable.

 

Fiona Law is a partner and patent attorney at the IP law firm Potter Clarkson.

Opinion

How the UK’s ‘pharmacy first’ policy will change women’s healthcare

By Katherine Bridges, head of brand and clinical lead at the pharmacy app Charac

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On the January 31, the UK government will roll out its long-awaited “pharmacy first” policy, a measure designed to cut the size of the NHS backlog – which currently stands at around 7.6 million patients.

With “pharmacy first”, patients suffering from various lesser ailments – such as sore throats and shingles – will be directed to their local pharmacy as their first port of call.

Pharmacies will also be able to supply certain prescription medicines. It is hoped that this will ease pressure on Britain’s seriously overstretched hospitals and GPs.

The policy is set to transform healthcare provision in the UK, which is important for women’s health across the country. If the policy can be carried through successfully, women’s access to NHS will improve in a number of ways. The success of “pharmacy first” will, however, rely on a big technological upgrade to Britain’s 11,500 high-street pharmacies.

Improving women’s access

This shift of several key medical functions to Britain’s pharmacies will give women easier access to important medicines and treatments. For instance, under “pharmacy first” patients will be able to pick up prescription medicine for urinary tract infections (UTIs) from pharmacies; previously this required a GP appointment beforehand.

This change will be especially valuable for women, given that this ailment disproportionately affects women, with roughly 50 per cent experiencing one over the course of their lives.

Crucially, under the new policy, women will also be able to purchase contraceptive pills at their pharmacies without seeing a GP. It is vitally important, but easily prescribed and administered medications such as this that will see “pharmacy first” freeing up countless of hours of GP and hospital time.

Further, the reduction of pressure on GPs and hospitals will improve women’s access to critical medical procedures and treatments. For instance, the policy will put a dent in the NHS’s mastectomies backlog, which is currently putting thousands of women in the UK at a greater risk of breast cancer.

Femtech critical to making a success of “pharmacy first”

Of course, “pharmacy first” represents a very large administrative and operational task for Britain’s high-street pharmacies.

It is uncertain whether these pharmacies, in their current state, will be able to meet the challenge. Community pharmacies are often small and family run. As such, they find it difficult to afford key labour-saving technologies that cut costs and free up time.

These pharmacies’ internal systems are often ramshackle and antiquated. Many still run on paper, making everything from prescriptions to payroll arduous and time-consuming.

It is clear that these pharmacies will need to undergo a big technological upgrade as the policy is rolled out this year. Femtech will play a key role in this effort.

Femtech technologies could help pharmacists manage the transition to a greater scope of provision. For instance, femtech companies, such as Vivoo’s at-home women’s UTI test, could help pharmacists manage the task of treating this common women’s ailment.

Another would be the online self-assessment system Tuune, which matches women to the contraceptive treatment appropriate to their particular hormonal profile.

Innovations like these will be an essential part of women’s healthcare in the age of “pharmacy first”, driving efficiencies in high-street pharmacies and expanding women’s access to treatment.

The future of health tech will empower women

Other health technologies will help amplify the impact of femtech. Apps, such as Charac, offer a dashboard for both pharmacists and their customers, allowing customers to book pharmacy appointments and get their prescriptions delivered to their door.

These kinds of accessible, integrated health tech systems that will prove so valuable in the age of “pharmacy first” will also help improve patient outcomes for women. One of the primary hindrances to better healthcare for women is a lack of information and access.

Research by the Department of Health and Social Care revealed that around 85 per cent of British women did not feel comfortable talking to their GPs about their physical health, and a similar percentage can remember an occasion where they did not feel listened to by medical professionals.

Similarly, knowledge of women’s health issues is often low: less than one in five UK women felt that they had enough information on menstrual health, and less than one in 10 felt they knew enough about gynaecological conditions.

What’s clear is that a lack of information and access is leading to worse health outcomes for women than men, but health tech can make a valuable contribution – streamlining appointments and prescriptions, raising public awareness of health conditions and the treatment services that women can access and making patient outcomes and healthcare more equal.

As “pharmacy first” becomes policy, we have a chance to use the latest developments in femtech and health tech to both make a dent in the NHS backlog, and to put women’s healthcare on a surer foundation.

Katherine Bridges is head of brand and clinical lead at the pharmacy app Charac.

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Opinion

Transforming women’s health: a bold roadmap to a more equitable future

By Kavelle Christie, director of the gender equity and health justice program at Community Catalyst

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Equity lies at the heart of progress, demanding a healthcare system that not only provides affordability and accessibility but also centres the distinctive needs of women.

The deliberate inequities affecting Black, Indigenous, and Latinx women, transgender women, those in rural communities, women with disabilities and those with low incomes underscore the urgent need for transformative change.

From alarming maternal mortality rates among Black and Indigenous women to abortion bans, limited healthcare access in rural areas, discriminatory practices against women with disabilities and stigmatisation faced by Black, immigrant, and transgender women, these inequities demand a comprehensive reimagining of our healthcare system.

A robust, truly transformative healthcare system is the cornerstone of a thriving society and it is time for the nation to prioritise women’s health.

Expanding Medicaid in the ten remaining states and extending postpartum coverage to 12 months in every state are crucial steps in dismantling barriers that impede women’s health.

Additionally, improving Black maternal health outcomes and the preservation and enhancement of reproductive rights, which encompasses unfettered access to abortion care, comprehensive family planning services and contraceptives, form other vital pillars.

Improving Black maternal health outcomes

Maternal health remains a significant concern, particularly among Black women. Passing the federal Black Maternal Health Momnibus, introduced by Rep. Underwood and Sen. Booker, can help address inequities and promote access to quality maternal care.

In addition to passing the Momnibus, it’s time for the US to invest in an ethical supply chain to ensure the improvement of necessary pre- and postpartum drug delivery. By guaranteeing the consistent availability of essential medications, we can enhance the overall quality of care.

Power and control over women’s bodies

Every woman should have the autonomy to make informed decisions about her body and reproductive health.

Policies that fail to centre marginalised communities perpetuate existing power imbalances and exacerbate health disparities. Not only is it time to pass the federal Women’s Health Protection Act to re-establish a national right to abortion to create a just healthcare system for women, but it is likewise vital to implement policies that monitor and account for the funding and actions of crisis pregnancy centres  and anti-abortion maternity homes.

These often-unregulated places disseminate misleading information about abortion care, manipulate women and can come with deeply conservative ideologies, such as mandatory church service attendance in exchange for shelter and additional restrictions on reproductive choice.

Building a better healthcare system means we closely monitor and regulate crisis pregnancy centres and maternity homes, ensuring they provide comprehensive, unbiased, and evidence-based information and care to women without imposing ideological beliefs.

It is also essential to note that anti-abortionists are swiftly rolling out policies that would even prevent women from travelling on highways to access abortion services.

These predatory webs of restrictions to deprive us of our freedom are not merely about abortion rights; this is about who has power over you, who has the authority to make decisions for you and who is going to control how your future is going to be.

Therefore, to build a better healthcare system for women, we must fiercely defend abortion rights and dismantle any barriers that may obstruct women’s ability to make choices about their bodies and reproductive health.

We must give women back the power to control their own bodies, especially for those most impacted who have the least resources, who can’t afford to lose a job, who don’t have access to childcare, who have no access to healthcare and who face many more systemic barriers.

Transparency in healthcare decision-making processes is also vital. This extends to hospital ethics committees, which often make critical decisions about abortion access, but whose membership is often shrouded in secrecy.

For a more just healthcare system, we must eradicate this wall of secrecy and ensure transparency in these committees’ composition and decision-making process.

Women deserve to know that their healthcare decisions are made with impartiality and respect for their rights.

Protecting gender-affirming care

Gender-affirming care for transwomen is a critical component of comprehensive healthcare.

This specialised care involves a range of medical, psychological, and social interventions to align an individual’s physical characteristics with their gender identity. Key elements may include hormone therapy, gender confirmation surgery, mental health support, and ongoing medical monitoring.

Gender-affirming care is not only a matter of medical necessity for transwomen but is also closely tied to mental health, overall wellbeing, and a sense of self.

Creating a healthcare environment that offers inclusive, affordable, and accessible services for transwomen is essential to a holistic approach that acknowledges and validates their gender identity, ultimately contributing to better health outcomes and improved quality of life.

Kavelle Christie is the director of the gender equity and health justice program at Community Catalyst, a national health advocacy organisation that works alongside organisational partners across 45 states and territories to build people power and create a health system rooted in race equity and health justice.

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Opinion

The impact of menopause and ageing on urinary incontinence in women

By Lydia Zeller, CEO at Pelvital USA

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Lydia Zeller, CEO at Pelvital USA

The natural processes of menopause and ageing are not the biggest challenge women face when it comes to incontinence. The biggest challenges are the historic silence and assumption that our only options are pads or surgery.

One of the most rewarding aspects of my role as CEO of Pelvital is amplifying the conversation around women’s health, especially on historically stigmatised topics like urinary incontinence (UI) and menopause.

If you suffer from bladder leaks, you’re not alone. Research from 2022 shows more than 60 per cent of US women suffer some form of bladder leaks. It is unacceptable that an issue impacting over half of women has historically been kept quiet and stigmatised.

Women are led to believe that bladder leaks are a natural part of being a mum or growing older. That is not true. Although bladder leaks are common, they are not normal, and women should not accept them as such.

Fortunately, there are effective options for treating leaks and education is the first step in self-advocacy – one of the reasons why I love talking about this topic.

First, let’s talk about the different types of UI. Stress urinary incontinence presents as accidental leakage associated with activities like sneezing, laughing, coughing, or jumping.

Urge incontinence (including overactive bladder) involves the sudden urge to urinate followed by involuntary loss of urine. Mixed incontinence is the combination of stress and urge incontinence. Stress urinary incontinence (SUI) is the most common form and is often caused by weakened pelvic floor muscles.

While one in three mothers report SUI within three months of childbirth, UI prevalence indisputably increases with age: 62 per cent of women in their 40s have UI compared to 68 per cent of women in their 50’s, 72 per cent in their 60s and 83 per cent in their 70s.

But does menopause cause incontinence? Yes and no.

Menopause is defined as the natural event of a woman’s final menstrual cycle. It is associated with reduced functioning of the ovaries due to ageing, resulting in lower levels of oestrogen, progesterone, and testosterone.

While these steep hormonal drops don’t directly cause incontinence, they cause thinning of the tissues in the pelvic floor muscles during perimenopause (the time around menopause when your ovaries gradually stop working).

Combine this thinning with common unresolved pelvic floor weakness or injury (e.g. caused by pregnancy, childbirth, pelvic surgery, falls) and/or with common changes associated with ageing (e.g. lowered fluid intake, lowered activity, constipation) – and urinary incontinence can result.

Stress urinary incontinence is most often caused by weak pelvic floor muscles – and menopause-related changes exacerbate that weakness.

Pelvital on-staff pelvic health doctors of physical therapy Shravya Kovela and Leah Fulker describe how this works in a blog on the menopause / incontinence connection: Weak pelvic floor muscles are unable to contract properly to close the urethral sphincter where urine escapes the body.

When paired with hormonal changes of menopause and the resulting changes in tissue flexibility or elasticity of the vulva, vagina, and urethral sphincter, urinary incontinence will appear or worsen.

Furthermore, discomfort in the vulva and vagina associated with menopause-related vaginal dryness or pain may lead pelvic floor muscles to compensate, worsening urinary incontinence.

Interestingly, menopause and ageing do not equally impact incontinence. Menopause transition has been found to correlate with stress urinary incontinence, whereas increasing age and risk factors such as anxiety, BMI, and new onset diabetes correlate with both stress and urge incontinence. And new onset of SUI is highest in perimenopause as opposed to postmenopause.

But the natural processes of menopause and ageing are not the biggest challenge women face when it comes to incontinence. The biggest challenges are the historic silence and assumption that our only options are pads or surgery.

Tragically, according to the Study of Women’s Health Across the Nation (SWAN) – a historic study to define menopause transition and “characterise its biological and psychosocial antecedents and sequelae in an ethnically and racially diverse sample of midlife women” – fewer than 40 per cent of incontinent women even seek treatment from their healthcare provider.

Women are uncomfortable bringing this topic up with their providers and when they do, too often are dismissed without options.

Menopause gaslighting is occurring to women because historically there has been a significant lack of clinically proven conservative options for women who do not wish to have surgery.

Pelvic floor physical therapy has been the shining light here, but a mere one per cent of physical therapists specialise in the pelvic floor, resulting in significant access gaps.

The continued uptick in virtual pelvic health physical therapy options is a big positive, increasing access and enabling women to fit treatment into their lives. Similarly, evidence-based in-home treatment options allow women flexibility and clinicians the ability to extend their clinic walls and deliver conservative care at scale, with outcomes very similar to surgery.

This conversation is incomplete without mention of economics and gender equity. Not only has research into women’s health been historically massively underfunded, but women bear disproportionate out-of-pocket costs.

Specific to UI, 70 per cent of costs are borne by the woman. And that is also completely unacceptable. I am proud to be part of the growing cohort of femtech companies creating change and step by step moving towards broad access and insurance coverage. Women deserve no less.

Lydia Zeller is CEO at Pelvital USA, Inc., a Minnesota based femtech company providing products to restore pelvic floor health. Flyte by Pevital is an FDA-cleared novel in-home treatment for female urinary incontinence.

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