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Pregnant women testing wireless foetal monitor

Developers of the world’s first wireless foetal monitor win prestigious Academy Award

Thursday, 14 November 2019

A team of engineers and healthcare experts, led by the University of Nottingham, have been awarded by the Royal Academy of Engineering for the development of the Monica Novii ™ Wireless Patch System —  a wearable monitor that accurately and continuously monitors the baby’s heartbeat in labour.

The team, who started their research in the early 1990s, includes Professor Barrie Hayes-Gill and Professor John Crowe from the University of Nottingham; Terence Martin from Monica Healthcare; Kanwaljit Bhogal; and Dr Jean-Francois Pieri; and Dr Carl Barratt from GE Healthcare.

With early funding from Action Medical Research, in addition to EPSRC and Innovate UK, they collaborated to apply practical electronics and biomedical engineering to a real-world medical setting, to address the challenges of reliably and accurately measuring the heartbeat of a baby during labour.

The device overcomes heart rate confusion between mother and unborn child and is unaffected by high body mass index, unlike its ultrasound competitor. Its high sensitivity means that the data is more accurate — critical in enabling life-saving early interventions. The product allows mothers to move around freely while being monitored, which can help to shorten labour, reduce interventions and increase satisfaction with the mothers’ birthing experience.

The Colin Campbell Mitchell Award

The team received this year’s Colin Campbell Mitchell Award from the Royal Academy of Engineering at its annual Research Forum in London on 12 November. The award is given annually to an engineer or small team of engineers who have made an outstanding contribution to the advancement of any field of UK engineering. It is the second consecutive year a team from the University of Nottingham’s Faculty of Engineering has won the award. 

 

We are highly delighted to have won this prestigious RAE Colin Campbell Mitchell Award that recognises the achievement of the whole team.
Professor Barrie Hayes-Gill, Professor of Electronic Systems and Medical Devices at the University of Nottingham
It’s been a very long journey from the early funding of Action Medical Research, EPSRC and Innovate UK to the recent GEHC acquisition. To see our research of many years become a true commercial reality with devices now being sold around the world is a very proud moment for us all.
I am absolutely delighted to see the team from Nottingham recognised with the Colin Campbell Mitchell award for the wireless patch system. The development of the device is an outstanding example of how multi- and trans-disciplinary work leads to engineering innovation. It testifies the impact that engineering excellence has on healthcare and shows how engineering transcends traditional boundaries and affects our lives in a tangible way contributing to the societal wealth and well-being.
Professor Raffaella Ocone OBE FREng FRSE, Chair of the Royal Academy of Engineering Awards Committee

Professor Shearer West, President and Vice-Chancellor of the University of Nottingham, said: “Professor Hayes-Gill is an outstanding researcher and an inspirational figure. Throughout a distinguished career he has matched a commitment to discovery and flair for building partnerships with a passionate advocacy of our mission to translate world-class innovation into products and applications that change lives.”

Sarah Moss, Communications Director at Action Medical Research said: “This is great recognition for a highly skilled team of experts and highlights what can be achieved through collaboration and technological advances. Action Medical Research is very proud to have played a part in helping to develop this invaluable foetal heart rate monitor to help babies and mothers.”

From product to fully-fledged business

In the early 1990s, Professors Hayes-Gill and Crowe set themselves the challenge of separating the electrical signals produced by the unborn child’s heart from contaminating noise signals, including electrical signals from the mother’s heart, uterine activity such as contractions, and electronic interference from other medical devices used during labour.

By 1997, they had achieved a 45% success rate in detecting foetal heart-rate; and received a patent in 1999. The team had a champion in Professor David James, Dean of the Medical School at The Queen’s Medical Centre in Nottingham, where trials and modifications increased the monitor’s sensitivity and reliability. Here, a breakthrough came in the adoption of a three-channel sensor. If the foetus moves out of the range of one channel, it falls into range of another; this indicates movement – invaluable for monitoring foetal well-being – and this innovation secured another patent. Success rate was now 75% but the 85-90% success rate needed for a commercial product was still required.

Monica Healthcare was incorporated in 2005 by Professor Hayes-Gill and two of his PhD researchers – Drs Barratt and Pieri – in a University spin-out company. The company incorporated their intellectual property and know-how into a revolutionary wireless foetal monitoring device achieving CE approval in 2009 and US Food and Drug Administration approval in 2011. In these USA FDA regulatory trials the device demonstrated a success rate of 90%.

In 2017, Monica Healthcare was acquired by GE Healthcare, generating significant revenue for the University and has made the technology available to millions of women and unborn babies around the world.

Dr Carl Barratt, CEO of Monica Healthcare said at the time: “Joining GE Healthcare provides a fantastic opportunity to bring together Monica’s digital offerings with GE Healthcare’s global infrastructure to provide even stronger capabilities and solutions to customers around the world.”

Revolutionising labour and delivery foetal monitoring

For the past 40 years, foetal heart rate and contraction monitoring has been routine clinical practice during pregnancy and labour to evaluate the well-being of the unborn baby and mother. The traditional device involved two belts wrapped around the mother’s abdomen holding the transducers which are then in turn connected to a bedside monitor. Explaining the Monica device's unique elements, Professor Hayes-Gill said:

The device was developed with the patient in mind, which led to key developments such as: ambulatory allowing mum not to be tied to the bed; communicating via Bluetooth eliminating unnecessary wires; securing the sensors via adhesive PET patches; significantly reducing foetal and maternal heart rate confusion; and ensuring the device was waterproof.
Professor Hayes-Gill
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