Innovation In FemTech: Personal Health And Wellness

"When women take care of their health, they become their own best friend." - Maya Angelou

Recent years have seen a boom in personal health and wellness monitoring and optimisation. At one extreme, we see biohackers aiming to slow or reverse ageing and, in some cases, pursue biological immortality. At the other, we see people using simple apps to keep track of their weight, an increased awareness of food supplements, and the use of electronic pain-management devices to ease the effects of living with pain.

Within this space, innovators are helping women to take their health into their own hands, with products and services designed to enable women to build a fuller picture of their own health, to flag when something may be going wrong, or to begin to manage symptoms and pain without having to wait for a medical appointment.

According to reports on the gender health gap, women generally spend 25% more of their lives in poor health than men do. Painful periods cost the UK economy over £500 million in sick days, and one in 10 women who were working while experiencing menopause symptoms have left a job due to those symptoms. A recent report from Endometriosis UK found that, in the UK, the average time to receive an endometriosis diagnosis, a condition thought to affect one in 10 women, has risen to nine years and four months from their first GP visit with symptoms.

Postpartum conditions can also have lifelong impacts on women. Women with adverse pregnancy outcomes have been found to be at higher risk of hypertension within two to seven years of giving birth; preeclampsia has been linked to an increased risk of stroke later in life, and urinary incontinence is a maternal morbidity known to affect up to 40% of women following pregnancy and childbirth.

Whilst the surge in ‘wellness maxxing’ can be seen across the sexes, it is easy to see why, against this background, women can be particularly drawn to technology that promises to help them improve their health and wellbeing independently.

Wearables, such as smart watches and rings, and phone-based apps can be a useful tool to allow consumers to keep track of their bodies’ baselines and to highlight changes or fluctuations. This information can help to close the health gap and reduce diagnosis timescales by providing women with long-term data to present to their health providers, or to provide an early indication of an oncoming illness or change in condition. Oura has recently announced a new proprietary large language model designed specifically for women’s health, which uses clinical resources alongside personal biometric signals (obtained from a user’s Oura ring) and long-term trends to provide the user with more personalised, accurate, and context-driven guidance. For further discussion on apps and data-driven advances in FemTech, and the IP considerations around them, see our previous article FemTech – Apps and Digital Innovations.

Innovators are also looking for ways to address recurring pain and other effects associated with menstrual cycles, maternal morbidity, female hormonal disorders, and the menopause. Samphire Neuroscience and Unpause are two companies harnessing neurostimulation for these purposes. Samphire’s headband delivers neurostimulation to promote neuroplasticity in regions of the brain associated with mood and pain regulation. This stimulation is paired with Samphire’s app, in which a patented algorithm personalises sessions to a user’s symptoms, cycle, and life stage, to help maintain balance during hormonal shifts. Unpause has developed the Unpause Loop, a smart wearable device worn on the wrist or neck which automatically detects a hot flush and uses neuromodulation to reset the body’s internal thermostat to provide relief from temperature fluctuations. Contrelle is an insertable device that physically supports the bladder and urethra to reduce leakage associated with stress urinary incontinence, effectively mimicking pelvic muscles, which are weakened during pregnancy and childbirth and further weakened during menopause.

Elsewhere in personal healthcare, FemTech is providing alternative or more user-friendly options for at-home testing. Salistick^TM is the first rapid saliva-based pregnancy test. It uses various technologies to standardise sample collection, amplify analytes, and remove possible inhibitory substances to allow early pregnancy detection from a simple saliva sample. 68% of women surveyed said that they would choose a saliva-based test over a urine-based one, indicating that many women are not satisfied with the only at-home option previously available to them.

Health monitoring technology is also being harnessed for newborn care and breastfeeding, where data collection can help to monitor and track infant or maternal wellbeing, and reduce the mental load on new parents. Coroflo’s nipple shield includes a flow measurement sensor to detect how much milk is flowing through it, allowing users to monitor feeding and to compare how feeding volumes are changing over time. Owlet’s monitoring sock wraps around a baby’s foot to track health parameters such as pulse rate, oxygen levels, and sleep cycles, alerting parents to potential issues when certain readings fall outside of a given range.

Innovators in this sector invest heavily to provide reliable, accurate products and services that offer a positive user experience. Intellectual property (IP) can help to protect these innovations, allowing innovators to recoup this investment.

As these products and services are targeted directly at consumers, it is important that they are associated with a trusted brand and have an appealing look and feel. This is where trade marks and design rights can be particularly useful. We have discussed some ways in which these rights can be relevant to FemTech innovations, and some potential pitfalls and complications to be aware of, in our earlier article Innovation in FemTech: Safety and Product Design.

The products discussed above are only a small snapshot of the world of women’s personal health and wellness technology, and a single product can combine a variety of technologies and concepts. Patents can be strategically employed to protect such complex products from multiple angles, targeting both individual components or functions, and the interactions between various parts. Several approaches are available to build a portfolio of patents around a given product, and the best filing strategy will depend on many factors including the stage of development, funding availability, and the territorial markets to be targeted. These considerations are very situation-specific, and speaking to an IP professional can help innovators to assess what strategies may be most promising for them.

For example, if a product is still in development, but beta versions will soon be made available to the public, it is important to consider whether to capture the concepts that are being disclosed in a patent application. Subsequent innovations might then warrant their own patent applications that may give rise to later-expiring rights, creating a series of IP rights for competitors to navigate.

On the other hand, if an invention is in its final form, it is worth considering disclosing all of the relevant concepts in a single ‘omnibus’ patent application. Whilst, in many jurisdictions, it is only possible to claim a single ‘inventive concept’ in a given patent at the time of grant, applicants can file an omnibus application to ensure that all of their inventive concepts will benefit from the same filing date, and then file ‘divisional’ applications to pursue any additional inventive concepts not pursued to grant in the parent application. This route can be particularly beneficial if an innovator is awaiting funding or is not yet fully committed to a given market, as it preserves the right to pursue the various inventive concepts, whilst deferring a portion of the filing fees.

When seeking to protect a physical device, or part thereof, it is important for an innovator to think beyond their exact vision when drafting their patent application, to safeguard against competitors making marginal changes to avoid the scope of protection but nevertheless using the same inventive concept. If, for example, the prototype is a bracelet with four buttons and a screen, then careful consideration should be given as to whether the core concept would still work if the device were instead a pendant, if one button were replaced with a toggle, or if user interaction occurred via a speaker rather than the screen. Applicants should consider whether these kinds of variations, which do not affect the core function of the device, are covered by the scope of the claims and exemplified in the description. When preparing an application, a patent attorney can help with distilling an innovation down to its core, essential components, and with drafting the application in a way that safeguards against various design-arounds. The same considerations should be applied when assessing the scope of a design registration application: attorneys can help applicants identify which features shape the overall impression and which can be disclaimed.

Patents can be used not only to protect physical and digital components, but also to protect functions and processes. However, various patent offices, particularly the EPO, have strict rules which prevent patents from being granted for methods for treatment of the human body by surgery or therapy. This can make it difficult to protect the function or process embodied in a healthcare innovation, not least because the exclusions vary across jurisdictions. When drafting and prosecuting applications in this area, patent attorneys qualified for the relevant jurisdiction can help innovators to identify whether it is worth pursuing protection for a function or process in a given application, or whether the claims can be reframed to avoid the exclusion from patentability. Considering each national or regional right in a multi-jurisdictional patent family individually, and with professional guidance, rather than taking a one-size-fits-all approach, can maximise the scope of protection and minimise unnecessary costs.

The complexity of innovative products in the personal health and wellness sector can make it difficult to know where to start when pursuing IP protection, and innovators may think that a robust IP strategy might not be worth the investment. However, given women’s longstanding desire to take greater control of their health, and the fact that women influence around 80% of household purchasing decisions, it is clear that protecting innovations in this space has the potential to generate significant rewards. Consulting IP specialists can help innovators to identify and focus on the IP rights that are most likely to benefit them in the longer term.