Professor Shearer West, President and Vice-Chancellor, 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.”
Back in 1987, Professor Hayes-Gill and his colleague Professor John Crowe wondered whether ECG (electrocardiogram) monitoring could detect foetal heartbeats better than ultrasound, which detects heart movement.
A foetus’s heartbeat ECG “on a good day” via a mother’s abdomen is around 10 microvolts, whereas the mother’s heartbeat is between 1,000 and 5,000 microvolts (a microvolt is a millionth of a volt). Add electrical muscle and background electrical ‘noise’ and the isolation – and detection – of a tiny foetal signal was highly problematic.
It was a wonderful challenge for an academic engineer to play with.
Professor Barrie Hayes-Gill
Using an integrated-sensors patch placed on the woman’s abdomen, the team set about refining electronic signals and eliminating noise. By 1997, they hit a 45% success rate in detecting foetal heart-rate (FHR); in 1999 a patent followed.
The team had a champion in Professor David James, Dean of the Medical School at Queen’s Medical Centre, where trials and modifications increased the monitor’s sensitivity and reliability. But the 85-90% success rate needed for a commercial product was still distant.
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 on the sensor; this indicated movement – invaluable for monitoring foetal well-being – and secured a second patent. By 1999, the FHR success rate had reached 70%.
Professor Hayes-Gill spent the next four years securing funding, building a commercial team and developing a business plan. Monica Healthcare launched in 2005, with former PhD researchers Carl Barratt as Chief Executive, Jean Francois Pieri as Chief Technical Officer and Professor Hayes-Gill as Research Director. Dr Terry Martin, formerly of Oxford Medical, headed marketing; his connections with world-leading obstetricians secured the all-important US trials in 2009.
“We had fantastic results, our improved signal processing algorithm and shielded patch array now captured 85% of the FHR data compared to 72% from Doppler ultrasound,” said Professor Hayes-Gill.
US Food and Drug Administration (FDA) approval followed in 2011, and a North America deal in 2014 ensured further inroads into the US market. In March 2017, with an eye on soaring sales, GE Healthcare bought Monica Healthcare and the Novii Wireless Patch System.
It's been a very long journey.
Professor Barrie Hayes-Gill
“It’s been a very long journey,” said Professor Hayes-Gill. “We eventually had 12 patents, the spin-out, securing venture funding, deciphering the EU’s Medical Devices Directive and navigating entry into the US. Dr Susan Huxtable, as Director of Technology Transfer, and all of the Research and Innovation team have been brilliant and with us every step of the way.”
Professor Steve Morgan, who leads the University’s Centre for Healthcare Technologies, said: “Barrie has been at the forefront of technology transfer activity for many years. He is a mentor for PhD students and colleagues and has been a driving force in encouraging the translation of technological discoveries into commercial applications.”
Professor Barrie Hayes-Gill and Professor John Crowe begin investigating novel ways of electronically detecting foetal heartbeats
Foetal Heart Rate (FHR) detection around 45%
FHR detection reaches 70%
700 FHR subjects now recorded
Herobic Innovation Research Fund of £15,900 to commercialise technology
Secure £520,000 in venture capital, EU and private funding
Launch of spinout Monica Healthcare
EU CE mark awarded
Commercial product launched
Trials in New York hospitals
FHR detection 85%
FDA clearance opens up lucrative US market
4* REF impact case study
GE Healthcare becomes Monica’s excusive US distribution partner. Sales soar
Sale of Monica Healthcare to GE Healthcare
CE approval for spinout Surepulse Medical
Another such breakthrough technology by Professors Hayes-Gill and Crowe is Surepulse – a cap-like electronic device that measures a baby’s heart-rate during resuscitation – allowing doctors to be hands-free, speeding up interventions and reducing risks.
Professor Hayes-Gill remains part of the research team for Surepulse Medical, which became a spin-out in 2013. In June 2018, Surepulse was recognised as ‘Best Start-up’ by East Midlands Life Science Industry Association, Medilink.
Professor Hayes-Gill said: “My experiences as Research Director at Monica will be invaluable to the Surepulse Medical team as we aim to repeat the success of Monica in the years to come for the benefit of not just the University but for all newborns.”
The ability to detect acidosis – oxygene deprivation - during labour and delivery has the potential to dramatically reduce morbidity in newborn babies. Clinicians around the world commonly used Doppler ultrasound, sometimes complemented with an ECG clip attached to the baby’s head.
But ultrasound may struggle to isolate the foetal heartbeat and the ECG clip is invasive, risks infections and can only be applied in the later stages of labour.
The ECG system developed by Professors Hayes-Gill and Crowe delivers a much sharper heartbeat detection than ultrasound, is more informative for obstetricians and more comfortable for expectant mothers, representing a world first wearable labour and delivery foetal monitor.