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The Fertile Area of Women’s Health

The Fertile Area of Women’s Health

11 Jun 18:00 by Julie McEwan

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My original intent when beginning research for this blog was to discuss women’s health as a whole and the patient use devices that play a part in empowering women to play a greater role in their own health and wellbeing. However, due to the massive surge in new technology in this area, it would be impossible to do the entire industry justice.

During my research I stumbled across a great deal of interesting articles surrounding MedTech advances in the area of fertility and pregnancy which I read with great interest. It stands to reason that women struggling with fertility issues would turn to technology, that they can use in their own home, to assist in this area, just as we have embraced wearables that allow us to be in greater control of our health, from fitness and sleep trackers to heartrate monitors.

In this series of  blogs I will discuss some of the devices on the market to assist not only in conception but also pregnancy avoidance, the reasons that this type of tech is becoming increasingly popular and the turnover it brings to the market, alongside the regulatory bodies approval process and when devices have not been embraced as hoped.  Also, the wearable technology and devices on offer for expectant mothers.

The growth in this particular market sector is hard to attribute to any one reason, but rather a cumulative effect, due to several factors. Some schools of thought include there being an increasing number of women in the technology sector and an obvious desire to address women’s issues and products in which is being called a much-needed revamp to women’s healthcare. It is also widely reported that women are waiting until later in their life to start families and as such fertility is a hotter topic for more women and one that is also more openly discussed on the back of this. Technological advances mean that wearables already play a bigger part in our day to day lives and consumers are more willing to take part in user research as it is less intrusive and largely takes place at home without much disruption to daily life.

Another huge factor is the increase in funding. With an ever-increasing interest in start-ups in this area, funding in 2018 was in excess of $500 million, with over 60% of this coming from first round seed or angel investors. The global assisted reproductive technology market is expected to exceed $31.4 billion by 2023. Fertility is becoming such a hot topic that some corporate companies are offering fertility services, through workplace benefits, alongside pensions and more standard healthcare.

So what devices are currently on the market to assist women with ovulation tracking and conception?

Many will be familiar with the more traditional urine strip testing Ovulation Predictor Kits (OPK) that detect and measure luteinizing hormones with a view to predicting ovulation and a fertile window of around 2 days, just before ovulation and the day of ovulation. With a 99% rate of efficiency, this is a cost-effective method but requires daily testing and in exchange for just a two day window. Some kits have built on this existing model to include the detection of oestrogen, which extends this to a 4-7 day fertility window each month. The overwhelming view on these types of tests are that they work very well for women with regular cycles, but unfortunately for those women that do not they are not such a success.

Period tracking have become more popular as information can be stored via a mobile phone application. Companies such as Clue and Flo produce apps that will collect a wide variety of data to collate a personal profile around a woman’s cycle. This includes emotions, cramps, bouts of PMS, sleep, pain and any other marker that the user attributes to coincide with her period, from headaches to skin outbreaks. These apps apply a machine learning algorithm in order to establish a unique pattern for prediction based on the information added by the user. Both companies, on their websites, report their products use by over 10 million and 8 million users respectively, but as with any information tool, predictions are only as good as the data added. The Flo website suggests the use of their free app in conjunction with other methods and that money can be saved by only using OPK test strips around the time it suggests ovulation rather than every day.

Readings from bodily fluids has prompted the birth (pardon the pun) of devices is this genre. Ovacue have developed a device which detects the presence of electrolytes in the user’s saliva and vaginal mucus during their cycle; providing more notice of upcoming ovulation. Other devices, such as the Ovatel Ovulation Monitor come equipped with a microscope that detects the crystallisation of saliva due to a higher oestrogen level, during ovulation. This device was cleared by the FDA in 2003 with a 98% accuracy and given CE marking in 2009 with a 95% accuracy rate.

Another, slightly more traditional method, and where new devices have focused to make improvements, is the measurement of body temperature. Many devices take an oral temperature reading, first thing in the morning just after waking. This is hoping to record Basal Body Temperature (BBT) or the lowest body temperature attained during rest. These thermometers generally work in conjunction with a mobile app where data is stored and a curve of results is produced to highlight an increase in BBT which is an indication of imminent ovulation, displaying a fertile window. Data is stored in the cloud so each month’s data can be compared by the user. The debate surrounding these oral temperatures is whether it is an accurate measurement of core BBT and if one temperature reading after sleep is enough to establish an 8 hour average.

New developments have focused on the same principle but in wearable devices that track temperature changes throughout the night in order to provide a more accurate average. The Himama fertility monitor is worn under the user’s armpit, stuck to the skin and throughout the night takes regular temperature readings. This data is downloaded each morning to a mobile app and the nightly average is used to chart a view during the users cycle to highlight a fertile window. It also records heart rate and sleep patterns to offer further insight into factors affecting fertility. The device offers 99% accuracy in detecting fertile days and is FDA registered as a Class I device, low risk device. Other devices that measure BBT from a skin adhered monitor are Ifertracker and a device manufactured by Cambridge Temperature Concepts, that boasts 99% accuracy and promises a full refund for any user who isn’t pregnant within 12 months of use. This device is pending its FDA approval.

The Ava bracelet is cleared by the FDA and has its CE marking for distribution in Europe. This device measures five physiological markers and uses an algorithm to predict fertility, with machine learning capability to evolve each month according to the data collected. These include skin temperature (taken at the wrist), resting pulse rate (this is higher during ovulation), breathing rate, sleep and prefusion (blood flow and rate of return to heart).

In a bid to record core BBT, some companies have produced internally worn temperature monitors. YONO have produced the world’s first in ear temperature monitor for fertility use. The ear bud takes regular measurements during the night and the information is downloaded to the accompanying app in the morning to chart an average BBT throughout the user’s cycle and interprets the data to display a fertility window each month. The ear bud is designed to be worn in the ear that is not pressed against the pillow and the website mentions factors to look out for regarding ear infections and irritations, which could be a reported side effect of this particular device.

Ovusense have taken this one step further and have developed a vaginal sensor that measures BBT during the night. This device has been clinically tested and reports accuracy across 50,000 cycles. It has been cleared by the FDA, CE marking for distribution in Europe and is also certified by the Canadian and Australian authorities. It provides an 8 day fertility window and offers an appointment with a fertility specialist if you have not conceived after four months of using the device. It seems the only possible down sides of this device is the comfort factor, although reports on the website from users state it is comfortable and easy to use. I can also see that it may not appeal to those hoping to achieve a natural conception as possible and although clinically approved as safe for use I can see some women shying away from internally worn sensors.

It is startling the number of different devices available and the breadth of the things that are being tested in order to predict ovulation and determine factors that affect fertility health. In this ever saturated market, it can be hard for women to invest time and money into devices that may or may not assist them in reaching their end goal of pregnancy. Normally in these circumstances I suspect that most would trend toward devices that have been tested and proved effective in a clinical setting, with positive testimonials from doctors and other healthcare professionals alongside previous users. Ordinarily I would personally lean towards a device that has been approved by the appropriate regulatory bodies, such as one approved by the FDA and with a CE mark.

As the next part of this blog will highlight though, this is not always as easy to rely on, as devices can be marked as certified, cleared and approved by the FDA and sometimes even those that are approved in this space, can prompt a backlash from users and healthcare professionals in this market sector, due to recent measures to accelerate medical product development and the potential holes in the process this creates.