Regulation is increasingly a topic of concern for the Irish economy. It is especially so in areas such as pharmaceuticals and medical manufacturing, or indeed any sector that has grown from and continues to rely on US and overseas investment.
The pace of change and the trend towards minimally-invasive surgery present challenges to a medical device and diagnostics industry that is currently one of the strongest sectors in the Irish economy. Directly employing almost 26,000 people, the sector produces export yields of €6 billion per annum, making up 7 per cent of the Republic's exports.
The man in charge of policing medical devices for the US Food and Drug Administration (FDA) says the medical device sector is the most "innovative and vibrant" part of the giant medical products business, and that younger companies in the Republic and elsewhere are leading the charge.
Dr Daniel Schultz is coming to Ireland next week to address the Irish Medical Devices Association (IMDA) annual conference, which this year is concentrating on the issue of regulation.
The event will feature sector regulators at the highest levels within the FDA and the EU, as well as internationally renowned experts on a range of subjects.
Dr Schultz, director of the Centre for Devices and Radiological Health at the FDA, and John Brennan, principal administrator at the medical devices section of the European Commission, will provide overviews on US and EU regulatory issues in the keynote addresses.
"What I'll be discussing in Galway is the theme which I'm constantly addressing at the moment: the need to ensure device regulation is carried out throughout the entire product life cycle," says Dr Schultz.
"We have to work with manufacturers from the very earliest development process to make sure that we have all the data we need, that we have a complete scientific basis to review the application, and we have to ensure that there is sufficient communication between the agency and the manufacturer during the review."
He continues: "Then when the product reaches the market, we need to make sure that we have the tools and the expertise and the abilities to monitor the device in the post-market. That way we can find any problems as quickly as possible, ascertain whether we do actually have a problem and see what action needs to be taken.
"So it's a case of following the process all the way through in the most efficient way possible."
The IMDA, the Ibec division lobbying on behalf of the sector, is looking to position the Republic as a "globally recognised centre of excellence" in medical devices and diagnostic technologies.
Indigenous companies and an increased spend on research and development (R&D) are widely seen as essential to avoid the "what if?" scenario of overseas companies pulling out or closing down en masse. And for R&D to develop into post-market products, regulation of the industry must be efficient.
The IMDA represents 78 medical technology companies across Ireland. It says the sector has comparable scale in Ireland to the largest clusters globally in Minnesota and Massachusetts.
Galway has established itself as the hub of the industry and is the location for the two-day IMDA Global Access 220506 Conference, taking place next week.
From his perspective at the FDA, Dr Schultz sees an organic trend in the medical-device industry. Research into surgical procedures and new theories drive the development of technologies and devices, which allows for further advances in the field, which demands new technologies, and so on.
"In the medical product sector, medical devices is the most vibrant and innovative part of that sector," he says. "The technology we're seeing and the research being done is changing the way medicine is being practised."
He explains: "Minimally invasive surgery, increased home care and improved diagnostics . . . create a demand for new devices, and we have the ability to design and manufacture products to fit those needs. For example, the introduction of drug-coated stents has changed the way we treat coronary artery disease. It's a much less invasive procedure that does the same thing as before."
Stents are manufactured in Ireland by Boston Scientific, one of the leading medical-device manufacturers in the world. Fifteen of the top 25 companies in this field have operations in Ireland, but the FDA is not necessarily concentrating on the major players.
The last few years have seen a mushrooming of new companies globally and in Ireland, and activity shows no sign of slowing down, keeping the FDA team very busy. Dr Schultz has been in his position for just over two years now but he says it "feels like 20".
Another emerging trend is the growing diversity of the industry, both in the US and abroad, according to Dr Schultz. "As well as your Boston Scientifics and your MedTronics, you have your smaller start-ups, and this where we see the most innovation and fresh ideas.
"Our task is to ensure that we work with all these different companies and help them develop their products," he says, adding: "Ireland has been a leader in this recent explosion of new companies and also in the location of established multinationals abroad."
He concludes: "I haven't yet been to Ireland, but from what I can see it's a major hub in the worldwide market, particularly the Galway area, and that's why I'm so excited about seeing it first-hand."
