Clinical trials are the last piece of the puzzle for Ireland’s medtech sector, says University of Galway’s John Kilmartin.
Did you know that Ireland produces 75pc of the world’s replacement knees? And 80pc of stents and a third of all contact lenses?
With 14 of the world’s top 15 medtech companies based here and more medtech professionals per capita than anywhere else in Europe, Ireland is well placed to become a world leader in medtech clinical trials.
This is according to John Kilmartin, adjunct professor in the Institute for Clinical Trials at the University of Galway.
Kilmartin is a medtech veteran, having worked in the industry for 30 years, including as VP of regulatory affairs at Medtronic, and now as a consultant supporting medtech companies in developing regulatory, clinical and market access strategies.
“I’ve probably seen more progress on the opportunity for medtech clinical trials in the last year, year and a half, than I had seen in the previous 15 years,” Kilmartin tells SiliconRepublic.com.
“So, there’s definitely a sea change, there’s definitely a different atmosphere.”
As far back as 2006, Kilmartin has been involved in writing reports for Irish Medtech, the Ibec business association for the industry, to identify barriers to and strategies for increasing the amount of medtech trials in Ireland.
“I was involved in a number of reports all saying the same thing, that Ireland seems to be a good location, a location of choice for clinical trials. Yet, we couldn’t seem to get our act together.”
And it’s not just medtech – compared to other countries of similar size, Ireland conducts far less clinical trials altogether, with a recent industry report finding that Ireland is 18th of 27 EU countries for the amount of pharma clinical trials it conducts per capita. Co-founder of clinical trials start-up Whyze Health, Prof Frank Sullivan is among those who have called for improvements to the process to increase trials here.
Kilmartin has joined the recently established Institute for Clinical Trials to help drive the uptake of medtech trials and he talks to us about the institute’s new Hypercare initiative.
What is Hypercare?
Hypercare is a pilot project to help streamline clinical trials in the medtech sector.
The aim is to act as a go-between, Kilmartin explains, supporting and guiding companies in their dealings with the National Research Ethics Committees (NREC) and the Health Products Regulatory Authority (HPRA).
So, if a company encounters a bump in the process, the Hypercare team can help navigate it. Examples Kilmartin gives include advising companies on the different processes, where to direct questions and if the questions are even valid.
“We weren’t changing anything. Those companies would still have to meet all the regulatory requirements etc,” he says, but this gives a level of comfort knowing that you have experts on your side.
Kilmartin wants to show that trials can be done predictably and efficiently, and that regulators are responsive to feedback and to process improvements.
Clinical trials are good for the industry and they’re good for the public, Kilmartin says.
And he’s confident Ireland has the capability to deliver trials. “We have the clinical research facilities, we have the academics and the physicians, and we have the likes of BioInnovate and the innovation hubs, and IDA and Enterprise Ireland all promoting it.
“But yet the proof’s in the pudding. The numbers tell the tale.”
There are about 10 medtech trials in Ireland each year, Kilmartin says. “That’s a small number relative to the scale and innovation in our ecosystem.”
Kilmartin wants to solve the puzzle as to why more trials aren’t held here and that’s why he joined the institute. “For me it was an opportunity to try and help put some of those pieces of the jigsaw together.”
One small step for medtech
Kilmartin believes that to gain momentum to achieve something you just need to start with one small action.
He often quotes his mother, he says, who would say “one good deed is better than 100 good intentions”.
His good deed-small action in this case was to call a meeting of stakeholders last April in the hopes of have an “open and honest conversation” about the challenges of conducting trials in Ireland.
This meeting was really the genesis of the idea for Hypercare, Kilmartin says. The interest was there for an initiative that would walk companies through the pathway to clinical trials and share lessons learned along the way.
They don’t have a set number of companies or set time period for the pilot – Kilmartin says they’ll know when they’ve learned enough.
Large multinational Medtronic and SME Intervene are the first two companies to get involved. Kilmartin says it’s important they get different types and sizes of companies with a range of devices for the pilot to see what different issues might arise.
At an event at the institute last month, Medtronic and Intervene gave feedback on the Hypercare project.
“It’s very easy for me or Prof Fidelma Dunne [institute director] to stand up and talk about the Hypercare initiative, but we decided to get two of the candidate companies to talk to the audience and share their experience and give feedback.”
Overall, the feedback was very positive, Kilmartin says. “I think they do feel that we helped smooth the bumps for them.”
‘Rewrite the narrative’
Last July, then Minister for Health Stephen Donnelly, TD, announced the establishment of a National Clinical Trials Oversight Group to make recommendations to increase the number of clinical trials taking place in Ireland.
Kilmartin is complimentary about the Group, describing it as diverse and “very action oriented”.
In an interim report released last October, the Group recommended a simplified contract process, cost standardisation and the development of national guidance for data protection, among other measures, to boost trial numbers. The Group’s final report is due in the next few weeks.
Kilmartin sees Hypercare as just one small example of ways to boost trial numbers.
He doesn’t want to “over-egg it”, he says, but he hopes the pilot will help “redress the narrative” on medtech trials.
“I’m very much a believer that if you talk negatively, you’ll get a negative outcome.
“I think we just need to talk more positively about our innovation in Ireland. And … device innovation is reliant on clinical research so it’s just offering a choice.”
He’d love to see a thriving ecosystem of medtech trials in Ireland in the near future. He sees it as the last piece of the puzzle to put in place for the sector.
“If we can create a culture where there are companies coming to Ireland who want to do clinical trials, all boats will rise on that tide.”
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