Clinical investigations in med tech: work in progress

17 Sep 2012

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We take a look at the scope for company-sponsored clinical investigations in the med-tech sector here in Ireland and ask how could we make Ireland an even better location for them.

"Much done, more to do" – that describes Ireland’s progress as a location of choice for clinical investigations in medical technology, according to Sharon Higgins. As director of the Irish Medical Devices Association, a business sector in IBEC, she has seen many improvements in the Irish landscape for company-sponsored clinical investigations, which see innovative technologies and devices being evaluated in patients. If the innovation proves safe and effective, the company can then apply for clearance to market.

But with Ireland hosting about five to 10 clinical investigations per year, Higgins comments that the numbers are still relatively low, and she wants to see them climb to the benefit of patients, clinicians and industry alike.

"We need those number to grow," she says. "As an industry in Ireland, we have moved quite significantly from being very focused on low-value products in the ’70s and ’80s and moving more towards R&D. And as we have increased the value of the type of product we are developing, we need to engage in clinical aspect of the business. More and more this will become central to business in Ireland."

Last week, the IMDA and the Irish Clinical Research Infrastructure Network hosted a symposium in Dublin on ‘Ireland – A Location of Choice for Medical Technology Clinical Investigations’ and Higgins describes how a huge amount has happened in recent years.

Not least, there has been a wide recognition of the importance of siting clinical investigations in the country.

"The key drivers of clinical investigations in Ireland, including the academic community, industry, development agencies and the clinical community recognise the value of that," she says.

Positive steps have included the establishment of Health Research Board-funded Clinical Research Facilities in Ireland, as well as the evolution of national networks of researchers, notes Higgins. Plus a company looking to sponsor a clinical investigation in Ireland can now have its applications to the competent authority (the Irish Medicines Board) and individual ethics committees processed in parallel, which can reduce waiting time.

But there’s still room for improvement, and Higgins highlights the need to centrally co-ordinate ethics committees at the various clinical sites around Ireland. "That would be a hugely beneficial advantage if it were to be put in place," she says.

Facilities on the doorstep

When Galway-based Marvao Medical went looking for a site to carry out a clinical investigation, it found facilities on its doorstep.

Marvao’s NextSite technology seeks to reduce infections in patients who have a catheter in place long term. It puts a scaffold around the catheter at the exit site that encourages the patient’s skin to grow into it and essentially form a protective barrier against infection.

The company employs six at the Galway-Mayo Institute of Technology Innovation in Business Centre and sub-contracts manufacturing to Harmac Medical Products in Castlerea.

In the US, the NextSite technology is considered ‘Class 2’ and because the company could demonstrate that it was similar to a product already on the US market, Marvao didn’t need to carry out a clinical investigation, explains Ann Marie Cannon, director of Quality and Regulatory Affairs at Marvao. They got FDA clearance within about six months of filing their ‘510k’ application.

In Europe though, the technology was classified as a ‘Class 3’ device and Marvao was advised that a clinical investigation was needed. The company set about looking for a site that had the appropriate clinical expertise and lab facilities, as well as nursing support to manage the patient follow-ups.

Luckily it was nearby: the clinical investigation is now ongoing at Galway University Hospitals, where Dr Gerry O’Sullivan is the principal investigator. Importantly, notes Cannon, the Health Research Board-funded clinical research facility in Galway is also involved, providing statistical and nursing support.

Before they could get going there was plenty of paperwork to get through, including approval from the Irish Medicines Board, insurance details and ethics approval. But the investigation is up and running now, and the hope is that when it is finished the company will file to a notified body in Europe and get a CE mark, which will allow it to market the product in the EU.

System enhancements?

So are there ways we could make the system more attractive for companies to run trials in Ireland? "I think having a hospital system that is more industry friendly for clinical [investigations] would be useful," says Cannon. "There are an awful lot of clinicians who are interested in getting involved – they are enthusiastic, they like research and evaluating new things – but I don’t know if the hospitals that are really engaging in research are getting enough kudos for it."

The establishment of Clinical Research Facilities in Ireland has been a major advance, but Cannon would like to see greater harmonisation across the system so patients can be more easily recruited across various sites, including private hospitals.

Another change that could make the system more attractive to industry would be electronic records that would give hospitals easy access to the statistics on patients.

"If we had an electronic system that meant the hospital could look up the numbers of patients of a certain age or with particular conditions it would give companies a pretty good indication of whether the site is suitable for their investigation," she says. "That type of database would be very useful for encouraging people to do clinical investigations here."

Siliconrepublic.com is hosting Med Tech Focus, an initiative which, over the coming months, will cover news, reports, interviews and videos, documenting Ireland’s leading role in one of the hottest sectors in technology.

Lab image via Shutterstock

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