Ireland must fight for devices industry

Greg Baxter spoke to Dr John O’Dwyer about how competition from other countries may threaten Ireland’s medical devices industry.
Ireland could lose irrevocable ground to Poland and the Czech Republic if it does not reduce bureaucracy in clinical trials for medical devices, Irish Medical Times has been told.

Dr John O’Dwyer, Medical Director, Medical Devices Division of the National Standards Authority of Ireland (NSAI), said that for all the health in Ireland’s medical devices industry – 13 of the top 25 global medical device companies have a presence here – the future is precarious.
‘Logically, Ireland should be attractive’ as a place to run clinical trials on medical devices, said Dr O’Dwyer.
There are talented bio-engineers and research and development staff. The sector has grown in size and technical ability, and the ‘indigenous talent’ here has demonstrated an ability to produce novel and high-tech products. “But it’s not,” he said.
“The European countries that are attractive for clinical trials of medical devices are Germany, Belgium and the Netherlands.” Additionally, EU Accession States, particularly Poland and the Czech Republic, have adopted models that allow clinical trials to be carried out swiftly and without red tape.
Medical device companies, most of which are US companies, have a natural attraction to European markets. “They want EU approval first, then Food and Drug Administration approval in the US. The European route is less bureaucratic, more predictable and more timely than the US system,” he said.
And companies that design and manufacture medical devices here want to get products to the market as quickly as possible. “The industry innovates every three years. Time to market is critical. Companies will look for the easiest route,” he said.
h4. Slow and complicated
Running clinical trials in Ireland, unlike elsewhere, is slow and complicated, which means that devices that are produced here are tested elsewhere, said Dr O’Dwyer. And the knock-on advantage to the local economy, and all the other advantages that go along with clinical trials, is lost to competing countries.
Those advantages include increasing knowledge base, rapid advances in technology and, importantly, long-term tie-ins between industry and third-level institutions, said Dr O’Dwyer, adding that links between industry and academic institutions make it far less likely that companies will abandon Ireland.
Likewise, if other countries take the lead in that area, it will be more difficult to lure companies back to Ireland. “We’ve got the language, the companies and the talented staff,” he said, but that’s not enough to compete. Companies, facing rapidly-increasing costs and an accelerating pace of innovation, need to get products on the market. If companies shift the clinical trials process to another country, it’s difficult to lure them back, said Dr O’Dwyer.
Much of the bureaucracy here is associated with Ireland’s messy ethics committee model. Whereas Poland and the Czech Republic – as well as Germany, Belgium and the Netherlands – have a single, centralised ethics committee for clinical trials, Ireland has more than 20.
Most major academic institutions have their own ethics committees, and approval in one means nothing to another, said Dr O’Dwyer. “The Mater Hospital will have different criteria than UCHG, St Vincent’s or CUH, for instance,” he said. “If you want to do a trial of a device, you have to go through all this red tape and bureaucracy. You have to go through all of these sites, deliver your protocol, then get the ethics committees to look at it. They may not like it.
“They are not well-informed about the technology. They have a conservative attitude towards the devices and the drug trials. There’s a public perception of risk, but they often do not understand the difference between risk and calculated risk.”
It is understood that work is under way to cut back on bureaucracy in Irish ethics committees, but Dr O’Dwyer said having a single committee is the goal.
In countries where a single ethics committee has been created, the members of the committee are generally very well informed about technology and risk.
Dr O’Dwyer said that while Ireland has a natural disadvantage in clinical trials for pharmacueticals – its small population – medical device trials require smaller numbers of patients. “Ireland can readily compete on patient population size.”
The National Standards Authority of Ireland is the notified body for medical devices, which means they approve CE marks – the declaration of comformity to European standards – for these devices.
Dr O’Dwyer spoke last week at the NSAI Information Day, where he discussed the implications of the revised Medical Devices Directive.
h4. Patient protection
The Directive sets out requirements to ensure that a medical device will not compromise the health and safety of the patient, user or any other person, and that any risks associated with the device are compatible with patient health and protection.
Regulation is trying to catch up with innovation, said Dr O’Dwyer. Under the revised Directive, there is a ‘demand for more clinical trials, and higher specified clinical trials’.
“Data has to be very specifically qualified to support the approval of such high-tech technology. The data has to be very convincing.” According to Dr O’Dwyer, companies will also have to perform significant post-market surveillance done at timely intervals.