State's medical technology sector needs R&D focus

Transforming the Irish medical technology industry from its current reliance on manufacturing toward research and development…

Transforming the Irish medical technology industry from its current reliance on manufacturing toward research and development (R&D) will require a major shift in culture, according to key international experts who spoke at a conference this week.

More than 300 delegates at the Irish Medical Devices Association (IDMA) conference heard that 22,000 people work in the industry and 11 of the top 12 medical technology firms have a presence in the Republic. But the vast majority of these people work in manufacturing rather than research-focused activities, which are a focus for the Government's development agencies.

Tom Fogarty, a professor of cardiovascular surgery at Stanford University and inventor of the ground-breaking balloon catheter, said the Republic faced big challenges in developing R&D.

He said the small size of hospitals in the Republic and a major lack of "physician interface" with industry would make it difficult for the development of innovative devices for new procedures.

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"We need to help the healthcare system get better. Unless we find a way for clinicians to have enough time to develop R&D, then there is no chance of generating intellectual property."

Mr Fogarty said that regulation in the US had failed to keep pace with technological change and was an enemy of innovation.

Michael O'Neill, chairman of the IDMA, said the regulatory authorities in the Republic had been seriously underfunded by the Government. Some money spent on the area of regulatory brainpower would help the State to develop an innovative sector.

But Mr O'Neill said the small scale of the Republic would make it very difficult to develop a vibrant R&D base in the area of medical devices. He said that more overseas links with physicians and universities would be required.

Mary Russell - senior vice-president and chief medical officer of Boston Scientific, which has several plants in the Republic employing 3,000 people - said the culture of entrepreneurship in the US was better suited to developing new products and devices.

However, she said Boston Scientific had located a lot of R&D capabilities at its Galway headquarters, which also manufactures drug-eluding stents (devices that are placed within the body to administer a drug locally).

"Our staff in Galway are working on technology development and concepts that may be applied to new or older products to extend their lifespan."

Mr Fogarty, an Irish-American with a wide sphere of interests from venture capital to inventions, said future innovation would follow a path similar to the previous decade, with inventors focusing on developing devices that could enable less invasive surgical procedures.

"People want to live longer, live better and we want medicine to be less invasive," he added.

Mr Fogarty's own contribution to medical device innovation, the Fogarty balloon embolectomy, has become an industry standard. The device allows a thin balloon to be inserted into a patient's artery and guided through an occlusion. It is then inflated and withdrawn along the blockage.

Famously, his device was once described by a pre-eminent US professor as "a dangerous instrument and an inappropriate procedure", who said that "only one so inexperienced and uninformed as a student would dare think of it".

Fogarty said inventors needed to count change as a natural ally and were willing to be unconventional. The best way to create the future is create it, he added.

At present, there are few indigenous Irish firms developing their own intellectual property. Some exceptions are Trinity Biotech, which develops diagnostic tests, and Heartsine Technologies, a firm based in Northern Ireland, which develops defibrillators - devices that deliver an electric charge to regularise heart beats.