When it comes to motivation to innovate, there’s no greater incentive than a desire to solve one’s own problems. This goes double for medical innovations, in which the factor of concern for one’s own health and welfare provides an additional spur to invention.
This has certainly been the case for Oisín McGrath, a Master’s student at the National University of Ireland Galway, who in addressing a solution to his own medical issue, is developing something that could prove of benefit to millions worldwide.
He takes up the story: “My own personal background to it is that when I was much younger, I had my own issues with a heart abnormality that didn’t occur very often. This meant it was very hard for me to get a diagnosis at all. I had 11 different monitors and it took 13 years. I ended up having to go for a cardiac pacing procedure, which involves them putting catheters up the arteries in your legs and threading electrodes up to your heart. It’s a pretty extreme process to have to endure when a simple monitor could detect symptoms.”
Atrial fibrillation occurs when the electrical impulses that co-ordinate heartbeats don’t work properly, causing the heart to beat irregularly. Tens of millions of people globally suffer from this dangerous heart arrhythmia which often presents with infrequently occurring symptoms, making it challenging to detect with currently used monitors due to their short recording durations. Years of suffering and many lives themselves could be saved if a heart monitor were available which could be worn discreetly and unobtrusively for extended periods of time while continually capturing data.
A standard response for a clinician when a heart arrhythmia is suspected is to issue a 24-48-hour heart monitor in order to capture the symptoms. This would ideally allow for the diagnosis of the condition. As McGrath’s symptoms were often spaced out by a week or more, the short recording duration of these monitors failed to capture any symptoms, and the arrhythmia continued to go undiagnosed, causing great mental anguish, high financial costs, and a potential danger to his life. During that time 11 different heart monitors failed to capture anything.
Says McGrath: “Monitors just miss the symptoms entirely because they’re only prescribed for a day or two – maybe in rare cases for a week. However, the symptoms may only occur once a fortnight. So you’re relying on luck to catch the symptoms of a pathology that is extremely dangerous – and that’s not what you want,” he says.
Rather than just bemoan his lot, McGrath decided toaddress his situation directly, embarking on a path on which he remains today. He says: “I thought to myself: ‘Well there’s got to be a way of doing this’, which motivated me then to study biomechanical engineering, which I did here at the National University of Ireland at Galway. I did biomechanical engineering as a Master’s as well and then applied for funding from Enterprise Ireland. From them I was able to secure €500,000 for further development of Galenband, which is a simple, wrist-worn monitor that is designed to be able to be worn for periods up to 90 days and can continuously record your heart. This makes it the ideal device to record symptoms that occur infrequently.”
In addition to the funding from Enterprise Ireland, Galenband has won the Aerogen Zenith award and was the first Irish project chosen by Massachusetts Institute of Technology (MIT) to participate in its IDEA² Global program, and went on to win the Institute for Medical Engineering and Science (IMES) award for research in the field of medical engineering. Additionally, the project won the Technology category of the 2019 Universal Design Grand Challenge, organised by the Centre for Excellence in Universal Design at the National Disability Authority, and supported by Enterprise Ireland.
The work during his Master’s in Biomedical Engineering involved collaboration with students David Kerr, Belén Enguix, and Syed Kumail Jaffrey to investigate the logistical feasibility of the Galenband system ranging from a competitive landscape review to an overview of the regulatory pathway.
The extent of McGrath’s commitment to this project can be gauged by the fact that it began in 2010, when he was still at school. “I started originally developing it after I left hospital having had my cardiac pacing procedure,” he says. “I was in secondary school at the time and had lots of exams going on, so obviously wasn’t able to commit to it entirely. So it ticked over for the next few years until I was well settled in university and was able to orientate all of my projects and assignments to furthering this. So my undergraduate thesis was on the technologies related to Galenband and my Master’s was also on this. I was able to position all of my activities to further this. Initially I suppose you could say I was doing it because I had a problem – not realising, of course, that millions of others around the world also had a problem.”
The technical challenges of this process are considerable and the main obstacle is obviously the battery life, extending which is crucial to ensuring that the monitor is able to function for the period required to record an arrhythmic event. On this, McGrath says: “We’re looking at some novel power management systems to extend battery life for as long as possible.”
A large emphasis is placed on user compatibility and interaction – effectively making the device as simple to use as possible for both the wearer of the device, but also for the clinician using it. For that reason, the Galenband team has been working with cardiac clinicians to make sure that it meets their requirements and that there’s minimal learning curve there compared to existing devices.
“The other technical obstacle we’re having to overcome is noise cancellation,” says McGrath. “The sensor has to gain good data. There’s no point wearing it if just walking around is going to corrupt all the data if there’s jostling against the skin or what have you. So we’ve been developing noise cancellation methods that are software-based, physical and electrical as well. They’ll all hopefully come together to deliver a nice, stable system.”
Another – perhaps less predictable – challenge has been the need to record the patient data with the device while also ensuring that it remains secure.
McGrath is keen to emphasise that the project as a whole is testament to the quality of the teaching of the Master’s Degree course at NUI Galway. It was spurred on by that course because that
was orientated around the Stanford Bio-Design principles of ‘needs-led innovation’, in which the development process focuses primarily on what the issue is and less on the delivery method of that solution. “You focus on validating the problem and making sure that it’s a big enough problem to warrant all the effort of solving it,” he says.
Currently, the project is moving from the drawing board into the real world, with a clinical feasibility study being organised to create the most user-friendly design possible and the team working on securing the product’s intellectual property position.
This transition from the academic to the commercial is inevitably proving something of a culture shock for McGrath, whose entire focus until now has been on developing something that works rather than something commercially-viable.
“Looking at it as a product is something I’m still wrapping my head around,” he says. “Because I’ve been thinking of it as a project for so long and not as a company or something with business potential. That’s what I’m having to cope with now.”
Development is now taking place in conjunction with external partners in accordance with the rules of NUI Galway and in accordance with Irish public procurement policies (part of the deal with the funding with Enterprise Ireland).
Says McGrath: “We will be working with external companies on the prototyping and we’re likely to work through NUI Galway’s clinical research facility to organise the clinical feasibility study, but that’s probably about 18 months away yet.”
While progress is considerable, it is invariably – and understandably – slow in medical innovation, meaning the finished product is still some way off. “We’re looking at probably about two and a half years before it becomes a product,” says McGrath.
“We’re still a while away as there’s a lot of regulations to comply with, chief among which are gaining CE marking and FDA approval, which are predicate milestones to be hit with the clinical studies. Everything is ultimately moving towards that ultimate regulatory approval that then allow you to market and sell your product,” he continues.
Since he has spent nine years on the development of Galenband (11 by the time the product reaches the market), it might seem fair to assume that the completion of the project might leave a considerable hole in McGrath’s professional world. Not a bit of it, however. “I would see myself in the future involving myself if various aspects of technology – AI and VR in particular. I’ve a couple of notes on my phone for things I look at when I get the time,” he says.