Decades of stagnation in cardiotocographic innovation came to an end when Nemo Healthcare launched a non-invasive portable system for monitoring the unborn child during pregnancy and childbirth. This milestone was preceded by more than a decade of fundamental research. The Nemo Fetal Monitoring System (NFMS) itself was developed in just two and a half years. ‘Collaboration with Sioux Technologies was crucial’, says Will Ickenroth, VP Business Development at Nemo Healthcare.

A revolution in obstetrics is how Ickenroth rightly describes the NFMS. After all, not every birth passes off without complications. For example, the rate of Cesareans is still high in some European countries. During pregnancy and childbirth, monitoring – obtaining up-to-date information about heart rate and uterine activity – of mother and child is very important for early diagnosis and optimum intervention by gynaecologists and obstetricians.

Signal quality and infections

‘There are two ways of monitoring’, explains Ickenroth. ‘The non-invasive method uses Doppler ultrasound to measure the heart rate of the child and a toco-dynamometer to measure the contractions. However, the signal quality often leaves a lot to be desired, especially if the mother has a high BMI. The bands which are fitted tight around the belly feel uncomfortable and the measuring units have to be moved regularly as the child moves. The invasive method uses a scalp electrode for heart rate measurement and in some countries an intrauterine pressure catheter to record contractions. Although this approach is seen as the gold standard, it does involve risk, such as the risk of infection. The NFMS replaces both methods and the quality of the measurements is comparable with the best. The system is non-invasive, BMI-independent, and easy and comfortable to use. Moreover, it is wireless: you can walk around with it and even take a shower. We really are talking about a breakthrough in medical technology.

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‘The NFMS consists of several elements. The Nemo Patch that is applied to the abdomen contains six electrodes and a holder for one of the two Nemo Links. The latter sends the collected data to the Nemo Base that converts the data into relevant information in real-time. The NFMS actually measures all the electrophysiological signals. Its technological core is a smart algorithm that calculates the foetal and maternal heart rate and uterine activity from those signals. At the start of this century, the Maxima Medical Center and Eindhoven University of Technology began collaborating closely on fundamental research in the realm of electrophysiology. This collaboration resulted in Nemo Healthcare. The development of the NFMS began in 2016. Sioux provided the complete electronic, software and mechanical design and prototyping and is now manufacturing the system.

Stringent requirements

So the NFMS was brought to market in two and a half years’, emphasizes Koen Smits, senior account manager at Sioux Technologies. ‘That is remarkable in view of its complexity but also from the perspective of feasibility and cost. Moreover, the medical domain is subject to stringent requirements in terms of safety and reliability. Support during certification is always an important process. Sioux has all the necessary disciplines in-house. We can bring them together in an integrated medical solutions development process that meets the ISO-13485 requirements. Additionally, we can count on our ALLISON platform, which combines a number of high-quality electronic and software standard solutions and so contributes to achieving the required development speed and product quality.’

‘And don’t forget that working together as intensively as this depends on people’, adds Ickenroth. ‘There are always ups and downs. Transparency, perseverance, and talking things through at all levels are crucial. You need to literally and metaphorically be there for one another. To a large extent, daring to take risks together, having the feeling that “our success is their success” and wanting to contribute to a better world determine the result. I see those qualities very strongly at Sioux. This is also the foundation of our future. The NFMS is only a first step and offers opportunities for new applications. I want to pursue that path with Sioux.’ 

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