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Issue 02

Winter 2018

A new beat generation

A world-leading breakthrough in wireless foetal heart-monitoring will help save lives in delivery suites across the globe

Vision Nottingham Inspires A new beat generation
Professor Barrie Hayes-Gill is an electronic engineer with a passion for connecting his research to applications in industry and healthcare. In his 30-year career at Nottingham, he has filed 16 patents and, with Optics and Photonics Research Group colleagues, has secured more than £20m funding and investment from commercial and public sector partners.

A career highlight is the development of a novel wireless foetal-monitoring device and the creation of a spin-out company, Monica Healthcare, to develop this ground-breaking technology. The spin-out’s sale, for an undisclosed sum, to the global giant GE Healthcare generated significant revenue for the University and has made the technology available to millions of women and unborn babies around the world.

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.”

 

Timeline

1987
Professor Barrie Hayes-Gill and Professor John Crowe begin investigating novel ways of electronically detecting foetal heartbeats

1990s
Foetal Heart Rate (FHR) detection around 45%

1997 
FHR detection reaches 70%

1999
First patent

2001
700 FHR subjects now recorded

2003
Second patent
Herobic Innovation Research Fund of £15,900 to commercialise technology

2005
Secure £520,000 in venture capital, EU and private funding
Launch of spinout Monica Healthcare

2007
EU CE mark awarded
Commercial product launched

2009-10
Trials in New York hospitals
FHR detection 85%

2011
FDA clearance opens up lucrative US market

2014
4* REF impact case study

2015
GE Healthcare becomes Monica’s excusive US distribution partner. Sales soar

2017
Sale of Monica Healthcare to GE Healthcare

2018
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.” 

Barrie Hayes-Gill

Barrie Hayes-Gill is Professor of Electronic Systems and Medical Devices in the Faculty of Engineering.

Facts

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.