Femtech: when women’s health goes technological

The term «femtech» stands for «female technology» and denotes technology-based products and services that address the health needs of women, or of people with female biology. These include digital applications, diagnostics, medical devices, wearables and telemedicine offerings for areas such as menstruation, fertility, contraception, pregnancy, the pelvic floor, sexual health and the menopause. Increasingly, diseases that affect women disproportionately or that take a different course in them are also included, for example endometriosis, migraine, autoimmune diseases or cardiovascular diseases.[1]

The expression was coined in 2016 by the Danish entrepreneur Ida Tin, co-founder of the cycle app Clue. The coinage helped to make a previously fragmented market visible and more tangible for research, funding and product development.[2] Femtech is not, however, a medical discipline of its own, nor is it a mark of quality. The term covers both regulated medical devices with clinical data and ordinary wellness apps whose recommendations have barely been scientifically examined.

More than health apps coloured pink

The medical need behind the development is real. Many complaints specific to women have historically been little investigated, normalised, or viewed primarily from a male-shaped research perspective. Digital technologies can help to document symptoms longitudinally, make changes visible and capture data from those affected in everyday life that has hitherto been hard to access.[3]

A patient can, for example, record bleeding duration, pain intensity, mood, sleep, migraine, gastrointestinal complaints or medicine intake over several months. Such structured records can support the medical conversation and make patterns visible that might be missed in a one-off history-taking. Large data sets from cycle apps show at the same time that menstrual cycles vary considerably and that simple calculations based on a standardised 28-day cycle do not do justice to the reality of many users.[4]

The technology cannot, however, replace diagnostics. An app can document that severe pain occurs regularly. But it cannot reliably distinguish whether primary dysmenorrhoea, endometriosis, adenomyosis, an infection, a fibroid or another cause is present. With endometriosis in particular, considerable diagnostic delays persist.[5] A professionally designed interface must therefore not be confused with medical validity.

Between self-determination and self-measurement

Femtech products can give users more knowledge about their own bodies and improve access to low-threshold support. This is particularly relevant for complaints that those affected are reluctant to talk about out of shame or because of social taboos. At the same time there is a risk of pathologising normal bodily fluctuations. Anyone recording temperature, bleeding, sleep, mood and symptoms daily obtains more data, but not automatically more certainty.

Predictions are moreover frequently presented as more precise than they actually are. With cycle apps, forecasts rest on the data entered, on statistical models and in part on additional measurements such as basal body temperature. Missing entries, irregular sleep times, illness, alcohol, travel, breastfeeding, shift work or irregular cycles can considerably affect their informative value. Even extensive data sets always contain what are known as tracking artefacts: an apparently unusually long cycle can arise, for example, because a bleed was not entered.[6]

This becomes particularly critical when an app is intended to serve not only for observation but for contraception. A simple menstrual calendar is not a reliable contraceptive. Apps that display fertile days can have very different functions and regulatory classifications. Only applications expressly intended for contraception and certified accordingly as a medical device may be regarded as a digital contraceptive method. Even then their effectiveness depends heavily on correct and consistent use.[7]

The blind spot: highly sensitive health data

Cycle, fertility and pregnancy data are among the most intimate personal information there is. Apps may additionally store details of sexual contacts, the wish to have children, contraception, miscarriages, medicines, mood or diagnosed conditions. Studies and technical analyses show that some applications transmit data to analytics, marketing or advertising services, or request more access rights than would be necessary for their core function.[8]

For a recommendation it is therefore not enough to look only at functions and user ratings. What also matters is whether it is clearly explained which data are collected, where they are stored, whether use without a real name is possible, which third parties are involved and how data can be completely deleted. Free, advertising-financed business models deserve particular attention. A high download count is proof neither of data protection nor of medical quality.

Regulated, or merely convincingly marketed?

With digital health offerings, the intended purpose defined by the manufacturer is decisive. An app that merely documents information can be offered as a general health or lifestyle application. As soon as software is intended for diagnosis, treatment, monitoring or contraception, it may have to be classified in regulatory terms as a medical device. The authorities pursue a fundamentally risk-based approach here.[9]

In Switzerland, unlike medicines, medical devices are not individually authorised by Swissmedic. Responsibility for conformity assessment and market access lies first with the manufacturer and the conformity assessment bodies involved; Swissmedic is responsible in particular for market surveillance.[10] A CE marking, or regulatorily correct market access, thus shows that the legal requirements for the given intended purpose have been met. It does not, however, automatically mean that a product is clinically superior to every alternative.

How relevant the intended purpose is, is shown by a Swiss court decision on a fertility app: an application intended to be used for contraception was classified as a medical device and had to undergo a corresponding certification procedure.[11] For pharmacy counselling, a simple rule follows: the greater the possible health harm of a wrong recommendation, the higher the requirements for evidence, regulation and individual assessment must be.

Which femtech products can pharmacies recommend?

A defensible recommendation should not rest on trendy design or the manufacturer’s self-presentation alone. Sensible products are those whose functional principle is medically plausible, whose field of use can be clearly delimited and for whose underlying intervention at least robust evidence exists. A distinction must be made here between evidence for the product category and clinical proof of effectiveness for the specific branded product.

Clue for cycle and symptom documentation

Clue can be recommended as a cycle and symptom diary when users wish to document their menstrual course, complaints and possible patterns in a structured way. The application allows the recording of, among other things, bleeding, pain, mood, sleep and further symptoms. It is offered by a company based in Germany that expressly invokes science-based content and data protection under European law. According to the company, the health data are processed for the core service and stored on servers within the European Union.[12]

The recommendation must, however, be clearly delimited: a cycle tracker is suited to observation and to preparing a medical conversation, not to reliably diagnosing ovulation or to contraception. Fertile windows displayed must not be equated with a medically tested contraceptive method. Counselling should also point out that only data actually needed should be entered and that the privacy and sharing settings should be checked.

Natural Cycles as a digital contraceptive method — but only after thorough counselling

Natural Cycles occupies a special position among cycle apps, because the application was expressly developed as a digital contraceptive method and regulated as a medical device. It combines cycle information with regular temperature measurements and classifies days as fertile or not fertile. The company states an effectiveness of 93 per cent with typical use and 98 per cent with perfect use. Published cohort data have examined contraceptive effectiveness under everyday conditions.[13]

A recommendation «with a clear conscience» is nevertheless possible only under clear conditions. The user must understand that on fertile days she has to abstain from vaginal intercourse or use an additional barrier method. The method requires regular measurements and high adherence. Professional societies point out that fertility-based methods are less reliable than long-acting reversible contraceptives or many hormonal methods.[14]

Natural Cycles is therefore not a blanket recommendation for customers for whom pregnancy absolutely must be avoided. The method is less suitable where, among other things, the daily routine is very irregular, where consistent use is difficult, or where the use of condoms or abstinence on fertile days is not realistic. The pharmacy should offer open-ended contraceptive counselling and make clear that the app does not protect against sexually transmitted infections.

Perifit Care or Care+ for guided pelvic floor training

Perifit combines an intravaginal pressure probe with an app and provides visual biofeedback during pelvic floor contractions. The product is intended to support pelvic floor exercises and to address complaints in stress, urge or mixed urinary incontinence in particular. The American FDA describes the device as a perineometer for strengthening the pelvic floor musculature with smartphone-based biofeedback.[15] The pelvic floor trainer is already available in Swiss pharmacies.[16]

The basis of the recommendation is above all the well-established effectiveness of correctly performed pelvic floor training. For Perifit itself there are, among other things, real-world data from several thousand users indicating a possible improvement in incontinence symptoms. Because of the study design, however, these data are less informative than an independent randomised controlled trial.[17]

The device can be useful above all for women who find it difficult to sense the right musculature, or who train more regularly thanks to feedback and playful exercises. Before recommending it, it should be clarified whether pain, recent surgery, unexplained bleeding, an infection, a pronounced prolapse or possibly overactive or tense pelvic floor musculature is present. In these situations a gynaecological or specialised physiotherapeutic assessment is indicated first. «More tension» is not the right therapy for every pelvic floor problem.

Beurer EM 50 Menstrual Relax in primary dysmenorrhoea

The Beurer EM 50 combines transcutaneous electrical nerve stimulation, TENS for short, with local heat. The rechargeable pad is attached to the lower abdomen and has several adjustable TENS intensity levels. The product is also distributed through Swiss pharmacies.[18]

The recommendation can rest on the evidence for the mode of action. Systematic reviews conclude that high- and low-frequency TENS can probably reduce menstrual pain compared with placebo or no treatment. Safety and tolerability are overall assessed as favourable, even if the quality and scope of the studies vary.[19]

The device is thus suitable as a non-pharmacological addition in known primary dysmenorrhoea, for example when heat alone is not enough or painkillers are not wanted or not well tolerated. It must not, however, lead to newly occurring or unusually severe pain being self-treated over a longer period. With increasing complaints, pain outside menstruation, pain during intercourse, fever, circulatory problems, unusual bleeding or suspected pregnancy, medical assessment is required. The manufacturer’s contraindications and warnings, for instance in connection with electronic implants or use during pregnancy, must also be observed.

Menstrual cups as «low-tech femtech»

Even though menstrual cups are not digital, they are frequently counted as part of the wider femtech field, since they address a health need specific to women through product innovation. A large systematic review concluded that menstrual cups, when used correctly, are in principle a safe and acceptable option for menstrual management. The available evidence points to comparable or lower leakage rates than other menstrual products, although a certain period of getting used to them may be required.[20]

Pharmacies can recommend established products made of medical-grade silicone such as the AllMatters Menstrual Cup or comparable cups from reputable suppliers. More important than the brand are a suitable size, comprehensible instructions for use, correct cleaning and a realistic expectation of the learning phase. Particular caution is required where an intrauterine device is used at the same time. A systematic review describes a possible connection between menstrual cups and IUD expulsion, although the data are still limited.[21] The cup should not be pulled out by the stem; rather, the suction must be released before removal. With an IUD, prior consultation with the gynaecologist is advisable.

What femtech means for pharmacy counselling

Femtech extends classic product counselling to include digital health literacy. In future it will not be enough to explain the use, price and technical functions of a device. Pharmacists must additionally assess what medical purpose a product pursues, whether it is regulated as a medical device, which data it collects and where the limits of its informative value lie.

In this the pharmacy can take on an important orientation function. Many customers discover femtech offerings through influencers, social media or personalised advertising. The pharmacy can translate marketing promises into medically comprehensible language: what does the product actually measure? What statement can be derived from that measurement? Was the specific product investigated, or merely the underlying principle? What consequences would a wrong result have?

Particularly relevant is the distinction between tracking, screening, diagnostics and therapy. An app that records symptoms does not make a diagnosis. A test with a conspicuous result does not replace a medical work-up. A digital pelvic floor trainer is not a universal remedy for all complaints in the pelvic area. A contraception app is not to be equated with an ordinary period calendar.

A short but structured quality check is advisable for counselling. It should examine the intended purpose, regulatory status, available clinical data, data protection, possible conflicts of interest and suitability for the specific user. Equally important is clear triage. Severe or suddenly changed pain, very heavy bleeding, bleeding after the menopause, unexplained intermenstrual bleeding, fever, conspicuous discharge, suspected pregnancy, palpable changes, recurrent urinary complaints or persistent incontinence do not belong in self-care alone.

From selling products to supported use

For pharmacies the potential lies not in selling a device alone. A sensible femtech service can consist of product selection, initial set-up, training in use and a later follow-up check. With a cycle app, customers could for example learn which symptoms are helpful for a medical conversation and how to produce a clear record. With a TENS device, correct placement and safe use can be explained. With a pelvic floor trainer, realistic training goals and criteria for referral to pelvic floor physiotherapy can be discussed.

This creates a new form of adherence support. Many digital products fail not because of their technical function but because they are no longer used after a few weeks. The pharmacy can put expectations in perspective, cushion initial difficulties and check whether the desired benefit is actually appearing.

Interprofessional collaboration also gains in importance. Cooperations with gynaecological practices, midwives, pelvic floor physiotherapists, sexual health counselling centres and specialised endometriosis centres could help to embed femtech products in comprehensible care pathways. The technology thereby becomes not a competitor to the professional but a tool between counselling, self-management and medical treatment.

Outlook: the pharmacy as an anchor of trust in the femtech market

Femtech will probably develop beyond cycle calendars and fitness devices. To be expected are more intelligent wearables, digital biomarkers, AI-supported symptom analyses, home diagnostics and personalised offerings for pregnancy, the menopause and chronic conditions. At the same time regulatory and ethical questions are increasing. The more strongly algorithms influence therapeutic or diagnostic decisions, the more important transparent data foundations, representative study populations and a review of possible biases become.[22]

For pharmacies there is an opportunity to establish quality standards early. What is advisable is not as many femtech products as possible, but a curated assortment with a clear intended purpose, comprehensible evidence, good data protection and defined limits to counselling. Clue can be useful as a structured cycle diary, Natural Cycles after thorough individual contraceptive counselling, Perifit as support for indicated pelvic floor training and the Beurer EM 50 as a non-pharmacological option in known menstrual pain.

Femtech can give women more knowledge, scope for action and access to support. This strength unfolds, however, only if technology is not confused with diagnosis and self-determination is not reinterpreted as sole self-responsibility. It is precisely here that the pharmacy can use its special position: as an easily reachable, professionally independent and trustworthy authority between digital innovation and medical care.