Actions needed if we want to stay a global location of choice for the medtech sector

Ireland has established itself as a global location of choice for the medtech sector, but retaining that position will require action in a number of areas, including skills and training, rules governing investments, digitalisation, and innovation supports, according to Tom Clarke of West Pharma, who chairs the Irish Medtech Association, the business association within Ibec representing the medical technology sector.

Highlighting the importance of the life sciences sector, Clarke says its exports account for 32 per cent of Ireland’s GDP. “That’s a huge contribution and we need to be conscious of that today and in future,” he says.

Other statistics for the Irish medtech industry are no less impressive. “Eighty per cent of stents used worldwide are manufactured here; 50 per cent of ventilators used in acute hospitals are made in Ireland; and 25 per cent of injectable devices used by diabetes patients and others are produced here,” Clarke adds.

The Irish sector comprises 450 companies, four out of five of them SMEs. "Ireland is the largest per capita employer of medtech professionals in Europe with 40,000 people working in the industry here," he says.

And it has a long history.

"It goes back to 1935 when Johnson & Johnson set up here. They were followed by Abbott in 1926, Siemens in 1966, and a host of other world leaders including Boston Scientific and Medtronic in subsequent decades. West set up in 2005, and we now have a 1,000-strong team in our Waterford and Dublin facilities."

Personalised medicine

It is also constantly evolving. “Global healthcare has been moving towards personalised medicine,” says Clarke. “It is moving from disease management to preventative medicine. It is moving from a patient-centric to a human-centric model.

“We are seeing a convergence between the technology, medtech and pharma industries to create connected health and wellness solutions, and the Googles and the Apples are working with us on the development of the devices of the future.”

The Medtech Association will shortly publish its strategy to 2025 which is based on extensive research and interviews with companies and other participants in the top medtech innovation hubs around the world, including Boston, San Francisco, Asia, Israel, the UK, France and Switzerland.

“What we found is that best-in-class global innovation hubs are very well funded, both privately and publicly, and are driven by a strong collaborative culture with the universities and research incubators at the heart of their success,” says Clarke. “Innovation is and will continue to be the chief driver of sustainable economic growth for Ireland.”

He calls for the creation of a network of innovation districts throughout Ireland. "These will build on the deep research capacity of the anchor institutions and local enterprise to leverage synergies between business, academia, innovators and educators."

The start-ups and SMEs at the heart of medtech innovation in researching and developing unmet clinical needs and market opportunity need more resources.

"The Employment Investment Incentive Scheme needs to be replaced with a more workable and less complex scheme," says Clarke. "Losses on investment should be allowed against capital gains. Profits on the sale of shares should be taxed as capital gains not income.

"And the level of investment allowed needs to be increased to €2 million. Employee share option scheme rules also need to be simplified. These present real difficulties for small resource-constrained organisations."

New methods

Manufacturing enterprises generally should be incentivised to digitalise their operations, he adds. The Government should also provide upskilling programmes to ensure employees have a greater knowledge of new methods for analysing and adapting processes and to drive a digital implementation strategy.

Noting Ireland’s achievements in higher education, Clarke points to the impressive statistic that 47 per cent of people between 25 and 64 in this country have a third-level qualification. “But the global education and research sectors are powering ahead, and we need to keep pace.

“Under-investment in higher education is hampering our competitiveness. We need a sustainable long term funding model for higher education to provide a pipeline of talent for the medtech sector and the economy as a whole.”

The industry also faces regulatory challenges.

"The new EU Medical Device Regulations (MDR) represent the greatest change to the regulatory system in over 20 years," says Clarke "Although the transition period for MDR ended on May 26th, the new regulatory system is not ready to support the transition of tens of thousands of life-transforming technologies from the old regulatory regime to the new."

Among the key issues is the lack of notified body capacity. “New expert panels need to be established so that devices can gain MDR certification as soon as possible, and the European Commission should issue guidance documents as soon as possible to support industry implementation of MDR.”