Targeting regulatory processes could help protect med-tech innovation in Europe

17 Dec 2012

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Bill Doherty, vice-president EMEA, Cook Medical

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Bill Doherty from medical devices company Cook Medical became vice-chair of the Irish Medical Devices Association (IMDA) last week. We caught up with him at the Med Tech CEO Forum and sixth annual Medical Technology Industry Excellence Awards in Galway to ask him about his views on the changing landscape of medical-device regulation in Europe, Cook’s development in Ireland and the emergence of a med-tech ecosystem in the country.

In recent years, Europe has been seen as an attractive option for companies looking to develop new medical devices and technologies, explains Limerick-based Doherty, who is EMEA vice-president at Cook Medical.

"The regulatory regime we have had in Europe for the last 20 years has really benefited the med-tech sector in Europe," he says. "It has given us much faster approval times on devices – typically new technologies are available to patients in Europe two to three years ahead of when they are available in the US, and maybe four to five years ahead of Japan."

One of the key factors for innovators to the European market has been the relatively clear path to approval, he notes.

"Once you go into the process in Europe, you know pretty much how long it is going to take you to get there, and innovation in Europe really has grown on the back of that certainty."

But changes are afoot. The medical devices directive, which covers the approval of med tech in Europe, is under review. A proposal seeks to introduce a new scrutiny mechanism, and the concern is that it could introduce substantial delays into the approval timelines, according to Doherty.  

"There is no definition around [the scrutiny mechanism] yet and it still has to get through the legislative procedures," he says. "But the worry that industry has, and that I have, is that the scrutiny mechanism could turn out to be some form of pre-market approval system similar to the FDA [in the US]. That would ultimately mean that Europe would end up with a scrutiny system where you are [not] sure when the answers are going to come back."

Doherty would prefer to see the scrutiny mechanism being applied to the approval processes rather than the individual products and technologies going through the system.

"We would like to see much tighter control on the notified bodies, the organisations that examine the technical files and approve them," he says. "We know they are not all on the same level, we know some are more professional than others and we would really like to see those notified bodies being controlled more than they are at the moment. It’s a lesson we learned in manufacturing years ago – if you want to get good products out the door, you concentrate on the quality of the process."

Cook in Ireland

And Doherty has plenty of experience in manufacturing. He was literally first in the door at the Irish subsidiary of Cook Medical when the company was getting established in Limerick in the 1990s.

Initially the operation started with "basic manufacturing and R&D", he recalls. But, since then, the company has diversified and expanded activities.

Today, around 750 staff work at the Limerick site, says Doherty, where they develop and manufacture devices for minimally invasive surgery and run Cook’s European shared services centre.

"The decision in 2004 to put the shared services in Limerick was a very significant moment for us in terms of providing that service to the customer base across Europe," he recalls. "That gave us an insight into the business as opposed to purely manufacturing R&D, and it has allowed us to leverage into areas, such as strategic marketing."

And the signs are that there’s more to come: in January, the company announced a planned €16.5m research and development unit, and construction has already started on it, notes Doherty. "We are building new cleanroom manufacturing facilities and new R&D labs," he says.

Building the ecosystem

As well as his roles with Cook and now the IMDA, Doherty also chairs the advisory board of the Materials and Surface Science Institute (MSSI) at the University of Limerick (UL). Cook’s Limerick operation collaborates with MSSI, and Doherty sees it as a sensible option.  

"Over the years we have been trying to grow the ‘R’ part of R&D, but research is an expensive thing to do on your own," he says. "It makes sense to partner with universities such as UL to do that. The MSSI have some very good people, and they are working with us and with other companies in the med-tech space in a variety of areas."

On a wider level, he sees industry engagement with academic partners as an important part of the developing med-tech ecosystem in Ireland.

"One of the reasons the med-tech industry in Ireland is continually moving up the value chain is that there is much more increased interaction with the [higher education institutes]," he says. "And hopefully in the future as we also strengthen the relationship with the clinicians it will give us a really powerful ecosystem."

The sixth annual Medical Technology Industry Excellence Awards took place on 13 December in Galway’s Radisson Blu Hotel. The awards were jointly hosted by Enterprise Ireland, IDA Ireland and the Irish Medical Devices Association, a business sector within IBEC.

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