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Opinion

Regulating femtech: how embracing regulatory oversight can enhance women’s health innovation

By Bethany Corbin, healthcare innovation and femtech attorney

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Bethany Corbin

The tension between technological innovation and consumer protection has long dominated the digital health regulatory landscape.

As an attorney, I’m often privy to innovators’ concerns that enhanced regulation could stifle innovation, particularly in emerging markets. While it’s no secret that heavy-handed regulation could discourage desirable innovation, it’s also important to recognise the beneficial role that regulation plays for both consumers and innovators.

Given the constantly evolving femtech environment, many founders wonder how they can drive meaningful regulatory outcomes without creating unnecessary hurdles along their path to commercialisation. I believe femtech innovators can accomplish this objective by developing public-private partnerships with regulators to shape the future of women’s health regulation.

The first step to developing a meaningful public-private partnership with government regulators is to honestly identify and acknowledge the shortcomings in our beloved femtech industry.

In a world where start-up economics drive product development, it’s necessary to take a step back and identify the harms that lax regulatory frameworks can have on consumers of femtech products. By proactively pinpointing areas in which femtech is not living up to its potential, founders and femtech advocates can help shape future regulatory agendas.

In my opinion, there are at least two key areas of femtech that could benefit from enhanced regulatory oversight. The first area is data privacy, particularly in countries like the US, which do not have comprehensive privacy legislation.

Following the overturn of Roe v. Wade, many consumers lost trust in the femtech industry and deleted their femtech applications. This loss of trust was not only fueled by the lack of national privacy standards in the US, but also stemmed from companies’ downstream data sales to third parties—such as data brokers and social media giants.

To date, there has been little recognition that the heightened sensitivity of reproductive health data demands heightened data protection regulations, and many femtech apps operate in a regulatory void.

The second area craving regulation concerns the review and approval of femtech devices for accuracy before they hit the market.

While the majority of femtech companies offer consumer devices, applications, and software, many of these products are not subject to regulatory scrutiny (such as review by the Food and Drug Administration) because of the generally low risks they pose to consumers.

This means that a significant number of software-based femtech devices are not reviewed or regulated by government agencies prior to launch. This lack of pre-launch review means that many femtech devices are not required to satisfy safety and accuracy standards and that inaccurate devices can flood the market.

For example, the Organization for the Review and Care of Health Apps found that 85 per cent of the femtech industry’s most downloaded apps did not meet quality thresholds and had significant clinical assurance concerns. Yet, consumers have no method of vetting these femtech products or meaningfully choosing between accurate and inaccurate devices.

Acknowledging the need for heightened regulatory oversight of data privacy and device accuracy can benefit both consumers and femtech companies.

Consumers benefit by having stricter standards in place to protect their sensitive health data and ensuring a threshold level of device accuracy. This allows consumers to regain trust in the very industry that is meant to empower them.

Femtech companies, in turn, benefit not only from increased product adoption that accompanies enhanced consumer trust, but also from the fact that privacy and accuracy can now become market and product differentiators.

Companies that build privacy-centric and accurate products can capture significant market share by aligning their product designs with consumer values. This also helps to discourage “get rich quick” innovation in women’s health by companies that are not dedicated to women’s wellbeing.

Once femtech founders and advocates identify and acknowledge areas that are ripe for regulatory oversight, they should partner with the appropriate government entities to develop regulatory agendas in these areas.

Public-private partnerships are necessary to avoid top-down regulatory efforts that can inadvertently ignore the realities associated with developing, marketing, and scaling femtech products. Top-down regulation involves regulatory agendas set solely by government agencies, who oftentimes lack on-the-ground experience and expertise that founders and advocates bring to the table.

Collaboration can result in mutually beneficial outcomes, as the public and private sectors can capitalise on each other’s strengths and experiences to build the future of women’s health innovation together. When the femtech industry becomes an active participant in regulatory activities, it can integrate diverse perspectives and resources into the conversation and help develop solutions that can quickly adapt to technological change without stifling future femtech innovation.

In a world of constant change, I fully believe that femtech founders and advocates should be at the forefront of regulatory discussions that concern the femtech industry.

Our practical expertise is vital to helping regulators understand legislative gaps and weaknesses that can harm consumers, while also developing innovative solutions that won’t suppress innovation.

Only through public-private partnerships can we make our voices heard and become drivers of the standards and legislation that will someday govern our industry.

Bethany Corbin is a healthcare innovation and femtech attorney on a mission to help thought-leading companies revolutionise women’s health. Through her company, FemInnovation, Corbin partners with emerging companies at the forefront of healthcare transformation to ensure they are building robust, scalable, and legally compliant businesses focused on enhancing health equity. 

Opinion

How tech in retail can improve customer experience

By Victoria Roberts, Victoria Roberts Marketing

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Tech in retail is transforming the shopping experience. Despite the popularity of online shopping, brick-and-mortar retailers are investing in technology to support steady revenue and customer loyalty.

Technology in Retail: Changing Shopping Habits

With technical advancements in a wide range of industries, many people estimated that in-person visits to clothing stores would soon die out because online shopping offered more convenience. 

Retail footfall year-on-year change in the UK April 2024, by location.

Retail footfall saw a decrease of 7.2 percent in April 2024 in the United Kingdom (UK), driven by shopping centres.

However, retail businesses have the potential to attract more customers than ever before if they embrace the opportunities new technologies have to offer. 

Here’s how tech in retail can improve the customer experience for the better. 

Streamlined Checkout Process

One of the many great things about technology is its ability to streamline time-consuming tasks.

We all know the frustration of standing in line at the checkout while the person at the till counts their cash at snail’s speed.

It’s frustrating and takes up precious time.

Retailers are aware of this and they know it’s causing a loss in customers. So, they’re taking action. 

Now, retailers are utilising the benefits of technology to streamline the in-store checkout process.

Payment solutions like a portable card machine let customers purchase through contactless payment either by tap-to-pay on their phone or contactless cards. 

Card machines can help speed up your overall checkout time, reduce long queues in your store and incentivise impulse purchases.

Additionally, with many card machines for small businesses being portable, retailers can accept payments from anywhere – whether in-store or at a pop-up event. 

RFID Tags

RFID tags are essentially sensors that allow retailers to manage a real-time inventory.

RFID tags track items as they are taken off shelves and moved from one place to another.

RFID tags are a great way to monitor products and customer habits so that the in-store experience can be optimised to boost sales and increase convenience. 

RFID tags are also being used to improve the customer experience by providing product information, allowing customers to request new sizes, and even including the ability to call store assistants for some in-person support.

This high-tech solution is transforming the way people shop and supporting retailers with their inventory management like never before.

Smart Screens

Smart screens have been around for a while now.

You’ve likely come across them when filling up your drink at a restaurant and choosing from the array of options. 

However, smart screens aren’t just limited to restaurants.

They’re now available in retail; improving the customer experience by supporting a more convenient shopping experience.

Clothing retailers are utilising touchscreen technology to help customers view products and build their wardrobes.

Smart screens offer retail customers the convenience of online shopping in-store.

By enhancing the customer’s experience in this way, retailers are seeing an increase in sales and customer loyalty.

Self-Service Machines

Self-service machines have been in supermarkets for many years now.

And they’ve made quite the impact, reducing queues and eliminating the need for small talk at the till.

Reports reveals the number of self-checkouts in supermarkets have increased from 53,000 to 80,000 over the past five years

But now, self-service machines have made it into retail stores and they are changing how shoppers checkout. 

While retail stores offer in-person assistance at the till, many people are shy to approach real people and would rather purchase their shopping without any interaction.

Retailers hoping to boost customer satisfaction and retention are utilising this technology to improve their service.

Digital self-scanners in retail stores allow shoppers to look up products, scan prices, and purchase items independently.

There’s no need to ask for help or stand in a queue at the till.

This allows for a seamless shopping experience and keeps customers returning time and again.

Chatbots

Chatbots in retail stores are harnessing the convenience of technology to offer the convenience of an in-store shopping assistant.

Rather than trailing around the store in search of help, customers can communicate with a Chatbot and receive an immediate and personalised service.

Whether it’s a question about sizing, prices, or an item’s availability, chatbots are a great way for retailers to offer one-to-one customer support without hiring extra staff. 

What’s more, this kind of customer service can become tiring for humans who get fed up answering the same questions repeatedly.

So, Chatbots are a great alternative. They allow customers to receive support as and when they need it.

Click and Collect Services

We all love the convenience of click-and-collect at the supermarket.

Someone else does your shopping, bags it, and all you need to do is pick it up? Yes, please! 

Now, click and collect is being introduced in retail stores to help retailers market their products, boost sales, and sell to more customers. And it’s working.

The click-and-collect economy in Northern Ireland is worth over £1.34bn.

Click-and-collect technology isn’t just a convenient, money-saving option for customers, it’s also a great way for stores to attract more customers through their doors. 

In-store Virtual Reality Experiences

Retail brands are harnessing the power of virtual reality to heighten the in-store shopping experience.

Virtual reality allows shoppers to explore a product within a virtual environment.

For example, people shopping for clothes can get a better idea of how they’d look by virtually trying them on. 

Virtual reality is supporting in-store purchases by making shopping more accessible and convenient.

Whether shoppers want to visualise a product in a particular space or they want to understand how an item of clothing might look (but they don’t have time to try it on) virtual reality makes this possible.

Virtual reality gives customers the confidence they need to make a purchase.

Summary

Technology has had a significant impact on people’s lives; changing the way we do almost everything – from shopping and banking to work and social interactions.

And the retail industry is no exception.

As you can see, technology is transforming the way we shop.

It’s improving the customer experience by giving back control which in turn builds trust and increases loyalty. 

Retailers introducing technology into their stores are not only setting themselves apart from the competition, but they’re setting themselves up for success.

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Opinion

The continued struggle for female representation in drug trials  

Dr Janet Choi, chief medical officer at Progyny

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Dr Janet Choi, chief medical officer at Progyny

The exclusion of women from drug trials undermines efforts to ensure equitable and effective healthcare for all individuals.

In 2002, the Women’s Health Initiative (WHI) was forced to pause its study on hormone therapy’s effect on menopause symptoms due to results showing it increased the risk for breast cancer, stroke and heart disease, and thrombotic events like pulmonary emboli.

Over 20 years later, in May of this year, JAMA published a review of this study and determined that, given current available hormone therapy formulations as well as risk/benefit analysis, younger menopausal women may actually derive significant benefits from menopausal symptom relief with appropriately prescribed hormone therapies.

The initial study had looked at women who were older and typically years post-menopause – the average age of the study participants was 63.3 years – and the age-related changing of blood vessels, among other things, may be the key to shifting from greater risk to greater benefit with hormone therapy.

I wish this more measured summary of the study’s findings and recommendations had been headlined back in 2002 – and I imagine thousands of my OB/GYN colleagues and billions of menopausal women over the years feel the same.

Yet, due to these 2002 over-generalised published findings, doctors and patients shied away from hormone therapy, which led to unnecessary suffering for many symptomatic menopausal women.

The irony of the WHI study is that after decades of women being excluded from clinical research, Congress finally passed an act in 1993 requiring that the National Institute of Health (NIH) enrol women and persons of colour in clinical trials.

On the heels of this landmark decision, the intentions of the WHI study were excellent – a first of its kind for women – but may have unintentionally set back women’s health innovation.

The reality

If you’re wondering why we are just now reevaluating and reinterpreting findings made in a 2002 women’s health study you may (or may not) be shocked to learn that while there is growing inclusion of women into research trials, they are still underrepresented in key therapeutic research areas, such as cancer and cardiovascular disease.

Excluding women from drug trials can have several harmful consequences. First, it can lead to a lack of understanding about how medications affect women differently than men, as their physiological responses may vary due to hormonal and metabolic differences, among other factors.

This can result in ineffective or potentially harmful treatments for women. It can also hinder progress in medical research by preventing the development of sex-specific treatment approaches.

Additionally, while the amount of research conducted on the behalf of women has grown in the past two decades, research involving pregnant women has been restricted.

This leads to a limited understanding of how best to medically care for pregnant women: for example, less than 10 per cent  of prescription medications have been studied enough to understand the impact in pregnancy on both the woman and her foetus.

While the NIH and American College of Obstetricians and Gynecologists (ACOG) both acknowledge pregnancy as a “medically complex” state that can alter metabolism of medications, and the course of various diseases, increased pregnancy-specific data needs to be collected to optimise the care of women in pregnancy.

Another recent, glaring case study: initial COVID vaccination trials did not include pregnant women, which led to restrictions on the availability of the vaccines as well as restrictions of the use in pregnant women with dire consequences – as unvaccinated pregnant women are more likely to develop severe COVID infections requiring ICU admissions and are more likely to develop other pregnancy-related complications like preeclampsia and preterm birth.

How do we move forward?

The exclusion of women from drug trials undermines efforts to ensure equitable and effective healthcare for all individuals.

It’s crucial for the government and pharmaceutical companies to put more resources and funding into women’s health so we can have a deeper understanding of how to treat diseases that impact over half of the population, for more female and diverse talent to enter the medical field – either as doctors, researchers, healthcare executives – and to incorporate how biological sex can affect medical treatment into provider education.

And, for pregnant women, the answer was proposed by ACOG back in 2015: “A more careful examination…points to the need for evidence-based consideration of pregnancy exposure in research rather than broad exclusion of all pregnant women”.

If evidence demonstrates minimal risk to the foetus as well as potential benefit to the pregnant woman, why should she be denied the right to give informed consent to enrol in a clinical trial?

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Opinion

‘Women are left in limbo’: how telemedicine can cut down NHS gynaecology waiting times

By Kat James, director of new projects at Consultant Connect

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Almost 600,000 people in England are waiting for gynaecology treatment. It is clear the current system is not fit for purpose.

The NHS, across the board, is struggling to reduce waiting lists, but gynaecology health, in particular, has been sent to the back of the queue.

Referral numbers are about 60 per cent higher than pre-pandemic, which represents one of the three highest specialties in terms of volume increase since pre-COVID.

Not only are women left feeling neglected, but longer wait times also result in them needing more complex treatment or even emergency admissions to hospital.

Then, there is also the impact on family life, work, and women’s mental health. A survey of the Royal College of Obstetricians and Gynaecologists found that four-fifths (80 per cent) of women said their mental health has worsened due to the wait and that one in four of those whose mental health had deteriorated, pain was given as a reason.

More than three-quarters (77 per cent) of women said their ability to work or participate in social activities had been negatively impacted.

One of the main stumbling blocks impacting patient waiting times is the disconnect between primary and secondary care. Often, patients who have faced long waits for their appointment are discharged after their first hospital appointment and told that their care is best taken care of by their GPs.

The good news is that new ways of working better connect primary and secondary care and ensure patients receive the right treatment first time. If applied at scale, these solutions considerably reduce waiting lists.

For example, giving GPs immediate access to speak to a consultant on the phone for specialist advice and guidance for their patient. In ordinary circumstances, a GP would have to call the hospital switchboard or send a written advice request which might take days to be answered.

Often, these queries would go unanswered or aren’t transferred to the correct department, resulting in patients being referred sometimes unnecessarily or presenting at a busy A&E department.

Technology like Consultant Connect allows GPs to directly “hunt down” a specialist consultant from a pre-defined rota for expert advice via a phone call, ensuring GPs can direct their patients to the right care first time. This service is available for gynaecology in almost 50 NHS areas across the country.

In Coventry, for example, a 54-year-old patient presented with obvious advanced gynaecological cancer. While the two-week wait referral had already been made, the GP couldn’t move the appointment sooner than 14 days later.

Meanwhile, the patient started deteriorating, and the GP considered an urgent admission. The GP used Consultant Connect and, within seconds, was connected to a gynaecologist, who then arranged for the patient to be scanned that day. The patient got the care they needed and avoided an acute admission.

In June 2023, the service expanded to cover a menopause advice and guidance line as referral data in one local area showed increased referrals relating to menopause-specific questions, many of which did not require to be seen in a hospital setting.

This meant that trusts weren’t seeing patients who needed to be seen, and patients with menopause symptoms were on waiting lists for a prolonged duration without management plans.

With the new Consultant Connect Menopause line, GPs can get through to a consultant with special interest in menopause matters within 26 seconds.

Data shows that 87 per cent of calls resulted in the GP receiving “enough” advice for their patient to benefit from an immediate treatment plan via their GP rather than waiting for a hospital appointment with a specialist unnecessarily.

Another way to tackle the wait problem is to leverage remote ways of working, which opens access to a new pool of workforce that otherwise wouldn’t exist.

Consultant Connect runs a network of NHS consultants who review gynaecology referrals remotely, with no need to travel to local hospitals and with consultants choosing their own working hours. This is often attractive to consultants who work part-time in hospital or are on parental leave, for example.

For patients, it means they get access to treatment plans faster: the remote working consultant determines the urgency of a referral and writes up a management plan, which means that treatment can start immediately.

Often, the health problem can be resolved through this plan, and for those still needing to be seen, it means they come to their first appointment on a more informed basis.

At the same time, it ensures patients are on the correct pathway, and any diagnostic test needed for a diagnosis are initiated in a timely manner.

Last year, Consultant Connect’s team triaged over 5,000 gynaecology referrals across the UK, resulting in 43 per cent of referrals being safely removed from the waiting list.

Many of these patients were returned to their GP with a treatment plan devised by the consultant. By fast-tracking urgent cases, women are not put through unnecessary stress and pain while waiting to be referred to a gynaecologist. Among these referrals, one in ten cases were upgraded to the urgent and suspected cancer pathways.

By reviewing current systems to make them more joined up and to allow for efficient ways of working, we can speed up care for women and make sure that clinicians have the right tools to help the NHS deal with the mounting gynaecology backlog.

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