What’s it like to commercialise a medtech innovation outside of the borders of Australia with the closest potential market an eight-hour flight away? Doris Retfalvi talks to Professor Malcolm Horne, founder of Australian startup Global Kinetics, about their efforts to introduce investors to the concept of a health wearable in a pre-mobile tech era, and why they decided on Europe as the next logical step in their road to the international market
It seems incredible now to imagine a world without smartphones or wearables, where patient monitoring was limited to a medical exam room with specialists operating bulky machines to record patients’ health. Such was the environment of Professor Malcolm Horne and Dr Rob Griffiths at the Florey Institute of Neuroscience and Mental Health in Melbourne, Australia, who in 1990 were trying to study the movements of Parkinson’s patients by using a monitoring device attached to the body via a cable. While inconvenient for the patient, the real challenge lay in trying to distinguish between normal and involuntary movements in relation to the medication dosage, all within a limited time frame. This sort of study required pattern recognition to establish certain tendencies in the patient’s movements in response to their levodopa treatment.
‘Because of the nature of the disturbances in Parkinson’s, patients are not often very aware of how their movements are changing,’ says Prof Horne. ‘That’s what we were trying to measure. We could tell whether someone was suffering from bradykinesia (slow movements) or dyskinesia (excess movements) but we couldn’t tell whether someone was busy pouring a glass of water or dyskinetic if we weren’t there to tell the difference between the two’.
So the two researchers decided to apply a measuring technique they had experimented with before – a method now known as machine learning – to the information received from patients’ neural networks to distinguish between the different symptoms of Parkinson’s disease, including bradykinesia, dyskinesia and essential tremor. All that was left was to develop a technology capable of logging all the data resulting from the measurements and report it in a way that was easy to interpret by specialists and patients alike. A tall order.
But the wheels were not set in motion until the early 2000s, when the two researchers felt they had an idea that was commercially viable. They envisioned a wearable device that would be worn by the patient for seven days, during which time it would log, assess and report data from their movements. The next step was to produce a business proposition around their concept that would attract investment. The only problem, however, was that this happened at the turn of the millennium when nobody had heard of a health wearable yet.
‘If you’re a scientist, often you’re not very good at explaining to people your vision of something new that no one else has ever seen before,’ Professor Horne continues. ‘We knew what the business proposition was but we were having trouble presenting it in a way that would get a VC excited.’ The focus of Australian venture capital investment didn’t help them either as more funds are usually directed towards biology and agriculture, rather than medtech and biotech. Investors also didn’t have a clear understanding of the difference between therapeutic and measurement devices at the time, Prof Horne believes.
‘We spent quite a lot of time trying to get grant money. We didn’t want to write a paper because we didn’t want to expose our IP so we decided to park it for a while. Then we met an Australian entrepreneur who helped us put a business case into business language, separate to what we scientists speak! That allowed us to get our first investment in 2009.’
The prototype for the first generation Parkinson’s KinetiGraph (PKG) system was developed shortly after. The algorithm-driven wrist-worn device recorded the different symptoms of Parkinson’s over a seven-day period and created data-driven reports that allowed the clinician to develop a more personalised treatment, based on the disease’s impact on each patient’s day-to-day life. The second generation PKG – which launched last year and has already received its CE-marking earlier this year – aims to help patients take more control of their condition through an attached vibrating alarm and LED light for medication reminders.
‘The main difference between the two generations,’ Prof Horne explains, ‘lies in the data logging system. But the algorithm – which operates to produce scores every two minutes – remains unchanged. That’s where the competitive advantage and the IP lies,’ he adds.
‘People ask us why we didn’t add the algorithm to an Apple Watch. We know we can, we’ve tried it, but the problem with it is that it has to be charged every day and that’s difficult for people with Parkinson’s. Plus it would also have trouble passing the regulatory approval because of security reasons and privacy reasons.’
When you come from an island-nation of 20 million people and your closest potential market is an eight-hour flight away, building a market for yourself is difficult unless you actually relocate to where the need is, Dr Horne believes. So in the case of Global Kinetics, the question was simple: do they go west to Europe or east to the US as their first step out?
They finally decided on the less popular choice of Europe, where the PKG was introduced in 2012. The watch is now being used in countries including Sweden, Finland, Germany, France, the Netherlands and UK. ‘Usually in Australia the decision is to go to the US first because the investment money is better there but the reason we went to Europe was because its key opinion leaders and fragmented markets were more to our advantage. It’s very hard to put your toe in the water in the US, you either have to go or not. We only recently moved to the US, about 18 months ago,’ Prof Horne explains.
The new generation PKG will be introduced to patients and clinicians in 12 leading European movement disorder clinics in the next two months, with a full rollout to follow thereafter. Global Kinetics is also involved in a Parkinson’s UK-funded project called PREDICT-PD. Run by UCL, the project aims to study 1,000 healthy people aged 60-80 with the help of the PKG to identify risk factors that could allow early detection of Parkinson’s disease.
‘We’re interested in measurement because, by the time someone has symptoms of Parkinson’s, they’ve lost in some parts of the brain up to 60 per cent of their nerve cells. If we manage to slow down the rate to half that over a 15-year period, the patient can be pre-symptomatic for another eight years. And that’s a really big saving,’ Prof Horne concludes.
Recommendations on how we should use AI, genomics and medtech in the NHS – click here for 98 pages to guide us to the future. ‘The greatest challenge is the culture shift in learning and innovation, with a willingness to embrace technology for system-wide improvement. An ambitious drive “towards the NHS becoming the world’s largest learning organisation”’.
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