BBI Contributing Writer
GALWAY, Ireland – In late September, the fourth annual MedTec Ireland conference and trade show was held in the small but buzzing Irish city of Galway, sponsored by Canon Communications. This is one of the westernmost cities in Europe; in fact, the conference venue faced an inlet of the Atlantic ocean, and if you had traveled westward, your next landfall might be somewhere along the U.S. East Coast. So why hold a medical technology meeting here? Isn't Ireland a mainly rural spot, more accustomed to cows than catheters, and dungheaps than defibrillators?
Not any more. Dramatic things have been happening in Ireland lately, as Peter McHugh, PhD, chairman of one of the conference sessions, explains: "In the last 20 years there has been a very large government push to attract multinational industry to Ireland. This included a very favorable corporate tax regime that has proved attractive to large multinationals such as Boston Scientific (Natick, Massachusetts), Medtronic (Minneapolis) and Abbott (Abbott Park, Illinois). A large number of pharmaceutical companies have also come here, in addition to the electronic industry, of course. That led to a great amount of economic development here, resulting in a number of spin-off industries, service industries whose original role would have been to supply the multinationals with components and materials."
But things have evolved even further. "Now, as economies evolve, we are moving toward a more R&D type of environment here. A lot of manufacturing is moving to Eastern Europe and other locations and it is being replaced by research and development, developing new products and technologies," McHugh said. The multinationals are doing it, he said, and many of the indigenous industries that developed initially to service the multinationals are now doing R&D as well. "So you have a lot of product development and design activities going on here. In tandem with all of that, there has been a big government push toward the development of our academic infrastructure, with huge amounts of funding being allocated for the development of universities and research institutes in various areas, biomedical being one of the strongest areas. And undergraduate teaching programs have come along to help that."
The 2004 MedTec Ireland conference certainly reflected the dynamic status of this field in Ireland, to judge from the star quality of many of the speakers, including Les Weinstein, ombudsman at the FDA's Center for Devices and Radiological Health (CDRH), who gave an update of FDA/CDRH issues of interest to the medical device industry. He also discussed his role in resolving disputes between the FDA and device companies.
Another noteworthy contributor was Brian Griffin, MD, director of the cardiovascular training program at the Cleveland Clinic Foundation. His talk was on "Trials and Tribulations of Device Therapy in Cardiovascular Disease: News from the Front." He began with some scary statistics about the growing menace of cardiovascular disease. The lifetime risk of developing coronary disease is high, and the percentage of the U.S. population with at least two risk factors is growing. There are upward trends for the prevalence of obesity and diabetes, and the Framingham Heart Study shows the cumulative risk of developing congestive heart failure as a set of steep upward curves for both men and women.
Before discussing the current status of devices for the major categories of cardiovascular disease, Griffin compared the role of devices and drugs, declaring them to be "complementary rather than competitive. Devices solve mechanical problems and are well tolerated, but they are expensive at the outset, less widely applicable than drugs and require a skilled operator to install."
After describing the latest achievements in devices for coronary artery disease, congestive heart failure, arrhythmias and valve disease, Griffin summarized the global challenges to device therapy in this area. "The big one is cost. In the U.S., about 15% of the GNP is used for cardiovascular medical therapy. It's always hard to get new things paid for, even though they work; and devices are expensive. How do we get government, or insurance companies, to pay for them? In order to do this we need to define how they are valuable, and in order to do this we need to do clinical trials. Clinical trials are harder to do with devices than with drugs. It's hard to get a placebo effect; you can't do a sham operation and pretend that you're putting in a device. Medical ethics doesn't allow it."
Other challenges highlighted by Griffin are the scarcity of skilled operators; the durability of devices and their safety over time; and the difficulty of upgrading technology in the individual patient. But there are solutions, he said, and they depend on physicians and industry working together, for example to define the right device for the individual, to develop proper clinical trials, to share information and to work with, not against, regulatory bodies.
Alongside the three parallel tracks of the MedTec conference (research and development, regulation and manufacture) there was a commercial exhibition, billed as a "tabletop exposition," indicating the modest scale of the individual exhibits, although it was a busy and well-attended event with more than 90 company booths. Possibly because it was limited to tabletop-sized displays, the trade show was mainly populated by companies producing components. Perhaps the "big guns" of the medical device world – such as Boston Scientific and Medtronic – were holding their fire until the main European medical event of the calendar, the vast annual MEDICA exposition in Dusseldorf, Germany, due to take place less than two months after the Galway event.
A broader perspective
The importance of the med-tech industry in Ireland is considerably broader than might be expected from the above listing of component suppliers. According to IDA Ireland – an Irish government body charged with attracting industrial investment in the country – Ireland is home to 15 of the world's top 25 medical technology companies that have chosen Ireland as a base for developing, manufacturing and marketing a diverse range of products including disposable plastic and wound care products, precision metal implants including pacemakers, microelectronic devices, orthopedic implants, diagnostics, contact lenses and stents. Companies that have chosen Ireland as the location from which to service their worldwide markets include Abbott Laboratories; BD (Becton Dickinson and Co.; Murray Hill, New Jersey), Boston Scientific; Essilor (Charenton-Le-Pont, France); Guidant (Indianapolis), Johnson & Johnson (New Brunswick, New Jersey), Stryker (Kalamazoo, Michigan) and Tyco Healthcare (Mansfield, Massachusetts). These companies alone have 25 separate Irish manufacturing facilities. The Irish med-tech sector employs some 22,000 people with sales in excess of EUR 4 billion ($5 billion) annually and annual growth around 10%. As a result, this sector in Ireland has comparable scale to the largest clusters globally, including those in Minnesota and Massachusetts. And, echoing the comments by McHugh, more than half of all the med-tech companies in Ireland have dedicated R&D centers.
Among major sub-sectors of the sector in Ireland are:
Cardiovascular and cardiac rhythm management. Four of the top global companies – Abbott, Boston Scientific, Guidant and Medtronic – are present, with combined Irish manufacturing employment of more than 8,000 and 340 employed in R&D.
Orthopedics. Industry leaders J&J/DePuy (Warsaw, Indiana) and Stryker have manufacturing facilities in Ireland.
Diagnostics. Six of the top seven global diagnostics companies have manufacturing operations in Ireland.
Ophthalmic. This sector is well-developed, with industry leaders Alcon (Fort Worth, Texas), Bausch & Lomb (Rochester, New York), Essilor and Vistakon (Jacksonville, Florida).
Last word from the edge
At the beginning was the question: why hold a med-tech conference on the very edge of Europe? Peter McHugh again: "Galway has been referred to many times as the European capital of the medical device industry, because of the close concentration of med-tech companies here – originally large multinationals, but now with the growth of smaller ones as well. That has fueled other things, and one of them is that we now have, in our university, the national Center for Biomedical Engineering Science, which is a multidisciplinary research activity, with a teaching role as well. I am part of it, coming from the engineering side, and we have chemists, biologists and so on, working together on research but also in tandem with the industry."
"We have a teaching hospital here – there are a lot of joint appointments between the Western Health Board and the university. So many of the consultants in the hospital are professors and clinical lecturers in the university, and we work with them. A lot of these people, because of the development of the country, have been attracted back from the Mayo Clinic, from Duke University, and from various universities and hospitals in Britain and Europe as well. When they come to a country like this they have to do a lot of surgical work but they are piggybacking that with research, and thus helping us to do cutting-edge research here.
"This is one of the reasons why the MedTech conference comes here, because it can touch base with the industry, first of all, but we can also increase the R&D focus," McHugh said. "We have a very nice mix of industry people, academics and students. The conference may traditionally have been industry-focused, but you've got to have the students there – they are the industrialists of tomorrow."