Connected women – how medical devices are set to revolutionise women’s healthcare

In Issue 7 of Insight magazine, Ben Wicks considered the practicalities and realities of wearable sensing devices. In this article, we’ll take a look at how a range of connected biosensors will make a difference to women – in pregnancy, family planning and other aspects of women’s health.

The rhythm of life

The most established biosensor in women’s healthcare is perhaps the monitor which tracks ovulation, used to help a woman conceive or to prevent pregnancy. Understanding the rhythm of the ovulation cycle is a long-established method of fertility prediction and birth control, and biosensors make this technique easier to manage.

The simple design of the Priya, developed by Prima-Temp, is deceptive; inside the small white silicone ring is an array of sensitive temperature sensors capable of measuring temperature changes of 0.05°F.

Source: priyaring.com

Inserted into the vagina by the woman – a trip to the doctor is not needed – it monitors core body temperature in order to detect the 48-hour window each month, just before ovulation, when a woman is most likely to get pregnant. Once this ‘fertile window’ is detected, the sensors send an alert to the woman’s mobile phone.

DuoFertility™, developed by UK-based Cambridge Temperature Concepts, also uses basal temperature measurement to predict fertility. DuoFertility uses a small sensor, worn under the woman’s arm, to take a series of sensitive temperature measurements. A handheld reader allows the woman to add additional relevant information, and lights up to indicate periods of optimum fertility.

When connected to a PC, the handheld reader sends this information – together with user-provided medical details – to Cambridge Temperature Concepts’ servers, allowing a more personalised profile of a woman’s cycle to be built over time, so more accurate predictions can be made for those trying to conceive.

The advantage of sensor products like these is that they are available over-the-counter, and remove the need for a woman to take an early morning temperature reading as temperature data is collected automatically by the sensor.

Great expectations

The ‘Internet of Things’ even extends to some very early adopters – the unborn. Wearable sensor products are now available which continually monitor the foetus and provide pregnancy data to both healthcare professionals and parents.

Perhaps the greatest impact, and value, of remote, unobtrusive pregnancy monitoring will be in rural regions of developing countries where maternal and child mortality rates are still too high.

 

One example product is Ritmo Beats, developed by Israeli company Nuvo. Ritmo comprises both acoustic and ECG sensors within a light harness which is worn over and around the stomach. The wearable device allows a pregnant woman to listen to their developing baby’s heartbeat and movements at home, rather than just when visiting the hospital for a traditional ultrasound scan.

Like many wearable sensor technologies, Ritmo backhauls its data to the cloud where it is processed in near-real time and accessed by the user – via smartphone or website – on a pay-per-use basis. Nuvo is now planning to launch a new version of the device – PregSense – which will have more sensors and better accuracy, enabling healthcare professionals to remotely monitor women at high risk during pregnancy, helping them pick up early signs of potential complications.

This type of device does have some clear advantages compared with the current gold standard, the hospital or clinic based ultrasound. Like ultrasound it is safe to use, but provides easier to interpret data, and the ability to monitor continuously, away from the hospital or clinical setting.

Continual foetal monitoring devices compared with ultrasound

Conventional ultrasound

• Safe, well-understood, mature technology
• Confined to hospital/clinical setting
• Provides limited ‘image’ information
• Not suited to long-term use
• Needs an expert to interpret and relay the results

Continuous foetal monitoring device

• Safe technique
• Free from hospital-based observation
• Provides foetal heartbeat, motion and other feedback
• Supports continuous use and monitoring
• Provides data to both consumer and healthcare professional

Perhaps the greatest impact, and value, of remote, unobtrusive pregnancy monitoring will be in rural regions of developing countries where maternal and child mortality rates are still too high. A recent project in Yucatán, Mexico, used a wireless foetal monitoring kit (including pulse oximeter, glucometer, and blood pressure devices) to monitor high-risk pregnant women in remote areas. The project outcome showed that a greater percentage of women in the group trialling the wireless foetal monitor adhered to clinic appointments and recommended advice (94%), compared to the group offered standard care (45%).

Another continuous foetal monitoring device is the result of a collaboration between the Stanford India Biodesign Programme and the Government of India’s Ministry of Science and Technology. Developed for use by community health workers, the Brün device contains novel sensors which can record maternal uterine contractions, cervical dilation, blood pressure and both mother and foetal heart rate. Designed for easy use and easy data interpretation, it will be used to support labour in remote settings, providing the type of easily accessible and affordable technology that can help address pregnancy issues such as those faced by India, where there are around 330,000 stillbirths each year.

Taking the guesswork out of third trimester contractions – and avoiding mistimed panic trips to the hospital – is the focus of Bloom Technologies’ biosensor product. Their soon-to-be-launched wearable sensor uses ultra-low power electronics to keep it going throughout the third trimester without the need for recharging, and will measure and log the frequency, duration, and intensity of contractions. Future updates plan to distinguish between ‘mock’ Braxton-Hicks contractions and labour-inducing contractions, as well as tracking other maternal and foetal physiological parameters. In addition to helping women assess their labour status more accurately, Bloom hopes to use the product to build a comprehensive database of maternal health information for clinical research into pregnancy complications such as premature birth, gestational diabetes and pre-eclampsia.

Express delivery

The nursing mother’s breast-pump is, at first sight, an unusual candidate for the ‘connected’ treatment, but companies such as Medela, Kohana and Moxxly are developing ‘smart’ breast pumps with the ability to feedback potentially helpful information to the nursing mother.

As with other connected devices, there is also the longer-term opportunity to compile a central database of data used as the basis for tips and advice.

So what kind of data could a breast pump sensor capture? The consensus seems to be towards data which reduces uncertainty for mothers by measuring, for example, the volume of milk generated and from which breast, date and time, how long a pumping session has taken (so mothers can track variations over time), and perhaps even the fat content of milk at a particular time of day. Reassurance that things are working as they should would be helpful, and a better understanding of feeding patterns could also determine ideal times of day to pump, or for how long if data shows, for example, that 80% of the milk is produced in the first 15 minutes.

As with other connected devices, there is also the longer-term opportunity to compile a central database of data used as the basis for tips and advice. However, not all problems associated with pumps can be resolved by adding sensors. Practical solutions cited in a straw poll of mothers included the need for the pump to be integrated into clothing, silent and hands-free models, fewer component parts to sterilise and reassemble, and better milk storage systems.

Whose data is it anyway?

Data vulnerability in a connected device environment is a well-known issue, and policies and standards to reduce the risks of cyber-attack or compromise are being considered by regulators.

Professors Michael Barrett and Stefan Scholtes of the Judge Business School in Cambridge, UK, also point out a number of additional challenges: “You know the data is captured, but how do you go about accessing it?” they ask. “For a start, are we sure we know who owns it? The patient? The doctor? The hospital? The healthcare provider? What are the privacy and confidentiality issues around it?”

Wearable sensors are harnessing large amounts of potentially personal information which, anonymised and consolidated, could improve our understanding of pregnancy, child-birth, sexual health and breast-feeding trends and patterns. But despite the potential for new insights resulting from oceans of data collected at ‘point-of-source’, extracting digestible, meaningful information is the biggest challenge in the world of healthcare. The value is not in collecting ‘big data’, but in translating it into reliable, actionable information which allows women to make changes to their medicines, exercise, rest and diet, or to recognise when they need to seek medical help.

The shape of things to come?

Connected devices focusing on women’s health are still relative neophytes, and it is not yet clear what the future holds. My prediction (perhaps more of a hope) is that connected devices may help make ‘routine’ screening programmes for cervical cancer, chlamydia and HPV, for example, more robust.

Depending on your point of view, the prospect of smart sensors in women’s healthcare may be amazing and practical, or perhaps a little unnerving. Self-monitoring devices could be useful and reassuring but round-the-clock monitoring can also trigger unwarranted anxiety, with false alerts and failing batteries leading to stress, disengagement or even false reassurance. However, although there are many challenges to be met before wearable sensors gain a firm foothold in healthcare, truly wearable, unobtrusive biosensors which help women stay in control of their health, have clearly arrived.

---

References

1. Tapia-Conyer, R. et al, (2015) Improving perinatal care in rural regions worldwide by wireless enabled antepartum fetal monitoring: A demonstration project, International Journal of Telemedicine and Applications. Article ID 794180
2. BCIL, Brün – A Feto-Maternal Monitoring Device, www.bcil.nic.in
3. Barrett, M., Scholtes, S., (2015) Why big data comes with big headaches for the healthcare sector, Cambridge Judge Business School, insight.jbs.cam.ac.uk