A MULTIDISCIPLINARY team of engineers and healthcare experts – including an IPEM member – have won a prestigious award for developing the world’s first wireless foetal monitor.
Professor John Crowe, a Professor of Biomedical Engineering at the University of Nottingham, was part of the university’s engineering department who teamed up with colleagues from Monica Healthcare and GE Healthcare to address the challenges of reliably and accurately measuring the heartbeat of a baby during labour.
The team have now been presented with the Colin Campbell Mitchell Award from the Royal Academy of Engineering for developing the Monica Novii™ Wireless Patch System, a wearable monitor for women in labour that accurately and continuously monitors the baby’s heartbeat.
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.
Starting their research in the early 1990s, Professor Crowe and his colleague Professor Barrie Hayes-Gill 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 per cent success rate in detecting foetal heart rate and two years later a patent followed. The team had a champion in Professor David James, Dean of the Medical School at Queen’s Medical Centre, Nottingham, where trials and modifications increased the monitor’s sensitivity and reliability.
It was here that a breakthrough came in the adoption of a three-channel sensor, along with the careful design of electronics to reach the theoretical noise floor. 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.
Monica Healthcare was incorporated in 2005 by Professor Hayes-Gill and two of his PhD researchers in a university spinout. The company incorporated this intellectual property and know-how into a ground-breaking wireless foetal monitoring device, achieving CE approval in 2009 and US Food and Drug Administration (FDA) approval in 2011. In these USA FDA regulatory trials, the device demonstrated a success rate of 90 per cent with maternal heart rate confusion of only 0.4 per cent, compared to 10 per cent for its nearest competitor.
Foetal heart rate and contraction monitoring during pregnancy and labour has been routine clinical practice for the past 40 years to evaluate the well-being of the unborn baby and mother. However, the traditional device involves two belts wrapped around the mother’s abdomen holding transducers connected to a bedside monitor. The Monica device is belt-free and wireless, allowing the mother to walk freely around the delivery suite.
The sale of Monica Healthcare to GE Healthcare has made the technology available to millions of women and unborn babies around the world.
Professor Crowe said: 'Having been involved in our research on ambulatory antenatal trans-abdominal fetal ECG monitoring from the start in the early 1990s, it is very satisfying to receive this award. My colleague Barrie Hayes-Gill and our two former PhD students have done a remarkable job in taking our working prototype and developing it into a saleable FDA-approved product. Monica’s journey is an exemplar of the commercialisation of bio-medical engineering research.'
Professor Raffaella Ocone OBE FREng FRSE, Chair of the Royal Academy of Engineering Awards Committee, said: ‘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 to 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.’
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