Q&A: the challenge of foetal monitoring with Professor Barrie Hayes-Gill
Foetal and newborn heart-monitoring best practice can be the difference between life and death. But the current technology has several disadvantages. Natalie Healey speaks to Professor Barrie Hayes-Gill about designing devices to give expectant mothers and their healthcare professionals greater peace of mind.
arrie Hayes-Gill is professor of Electronic Systems and Medical Devices, Faculty of Engineering at the University of Nottingham. Over the last 30 years, he’s been helping to develop medical devices so doctors can more accurately monitor pregnant women, foetuses, and newborns.
We catch up with Hayes-Gill, the driving force behind two spin-out companies — Monica Healthcare and SurePulse Medical — to find out the magic formula for combining research and industry to improve patient safety.
How did you get involved in medical device research?
Professor Barrie Hayes-Gill
I actually never set out to work in this area. I'm an electrical engineer and worked in industry for many years for large semiconductor companies. But when my family wanted to move back to Nottingham, I went to work in academia.
Within a month of starting a role at Nottingham University, my wife — who had just given birth to our second child — was diagnosed with an aggressive cancer called adenocarcinoma. Tragically, she died after 12 months. It was horrendous but the university was fantastic, and told me to look after my family and put my research on hold for a bit. When I returned to work, I was understandably more interested in healthcare research and how electronics could help.
Nearly two years later, a colleague also died of cancer. He had been doing work on foetal monitoring. I went to see him in the hospital and he asked me to carry the work on with other colleagues. Two significant deaths in my life found me in this field.
What are some of the biggest challenges in foetal monitoring?
Foetal and maternal heart rate confusion is a big issue. Obviously, you get an electrocardiogram (ECG) reading on your chest. But you can also get a signal (albeit a much smaller one) if you measure down at the tummy from the maternal pulsing blood supply and the ECG itself. Clearly, this can be a problem with a pregnant woman when both her heart rate and foetal heart rate are present in the same place.
The standard Doppler ultrasound monitor has to be repositioned frequently to ensure it’s pointing at the foetal heart. Otherwise, you can get 30-40 minutes of the wrong heart rate. You can think everything's fine and then find the foetal heart rate has dropped down, putting the baby at risk and posing severe morbidity issues such as cerebral palsy.
So we developed an electrical method to detect both the maternal and foetal ECG. These signals have distinct signatures allowing separation with minimal confusion. We deployed three detection channels across the abdomen instead of one. That way, if the baby was lying to the left or right, we could get still get good detection.
Monitoring technology can be restrictive but our device is wireless so women can move freely during labour. Further, it is unaffected by high BMI, unlike the ultrasound, so it works for women of all sizes.
How did you commercialise the project?
We were lucky enough to win the Joint Research Councils Biosciences business plan competition in 2004 which made us more attractive to investors. We started the spin-out company Monica Healthcare in 2005. And by 2016, we had completed eight investment rounds with sales around the world. In March 2017, Monica was acquired by GE.
What did you have to do to get CE and FDA approval?
We got CE approval in 2007. We undertook two large trials. The first was in 2007, in the Netherlands. We were testing against the current gold standard, the Doppler ultrasound, on 100 pregnant women.
We soon realised it was difficult to sell to the NHS, so we set up a collaboration with obstetricians in the USA. We implemented a second trial for FDA purposes. They wanted to test our device against a foetal scalp electrode, — where you connect an electrode onto the baby's head — which is still carried out in some hospitals around the world. But the problem with this technology is it punctures the skin and hence risks infection of the baby's bloodstream.
We proved that Monica worked and we can avoid this infection problem, while preventing all the confusion the Doppler gives you with maternal heart rate, and allowing mum to be ambulatory in the early part of labour.
What were you trying to achieve with SurePulse Medical, your second spin out?
Believe it or not, around 10% of all babies born in the UK are in need of some form of resuscitation. Doctors check a newborn’s heart rate every 30 seconds with a stethoscope during this resuscitation. However, this can be subject to delays and human error. We designed a device which would support continuous resuscitation and remove the need for frequent pauses to check a baby’s heart rate.
We started the project in 2004 when we were looking into how technology could help monitor the workforce in risky environments, such as mines and other industrial settings. We put sensors into miner’s hard hats, so we could detect heart rate whilst also measuring the temperature and the humidity.
This project was presented to a group of doctors. A paediatrician in the audience asked: “could this hard hat project work for soft hats for a newborn baby?”. So we went from miners to minors – hence Surepulse Medical Ltd.
What’s your advice for a successful university spin out company?
A great model is to have a focused PhD researcher who has just finished their PhD and would like to become the CEO of a company! Partner with that person, set it up together with the university and then create your company.
The researcher is not encumbered with the rigours of academia and can truly focus on the job in hand whilst the academic opens the necessary university doors to get the technology out. Once the company is formed, it is essential that the academic stays the course within the spin out to achieve a successful technology transfer.
What are your future plans?
I'm 67 now! Am I getting tired? Yes, but I really do enjoy it. I've just taken on three new PhD students. And the next thing I predict is fibre optic sensors for a variety of medical applications, from digestive health to wound care. Fibre optic sensors have tremendous potential. I can see another spin out coming…
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