A multidisciplinary team of engineers and healthcare experts from the University of Nottingham, Monica Healthcare and GE Healthcare are to receive this year’s 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 team will be presented with the award, which is made annually to an engineer or small team of engineers who have made an outstanding contribution to the advancement of any field of UK engineering, at the Academy’s annual Research Forum in London on 12 November.
Professor Barrie Hayes-Gill and Professor John Crowe from the University of Nottingham, Terence Martin from Monica Healthcare, and Kanwaljit Bhogal, Jean-Francois Pieri and Carl Barratt from GE Healthcare, 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.
Starting their research 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; in 1999 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. Here, 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. 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 in a University spinout – Drs Barratt and Pieri. 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% with maternal heart rate confusion of only 0.4% compared to 10% 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, and does not require any transducer repositioning by the attending team.
The sale of Monica Healthcare to GE Healthcare generated 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, comments:
“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.”
Professor Barrie Hayes-Gill, University of Nottingham, says:
“It’s been a very long journey but the device was developed with the patient in mind. Key developments include making it mobile, 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. 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.
“We are highly delighted to have won the prestigious Colin Campbell Mitchell Award that recognises the achievement of the whole team,”
adds Professor Hayes-Gill.
Professor Raffaella Ocone OBE FREng FRSE, Chair of the Royal Academy of Engineering Awards Committee, says:
“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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