John O’Brien
Chair of The Irish Medtech Association and S3 Connected Health CEO
Nessa Fennelly
Acting Irish Medtech Association Director
Ireland is one of the top locations for Medtech FDI investment in Europe and is, per capita, the greatest employer of Medtech professionals in Europe
The impacts of the changing EU regulations
Acting Irish Medtech Association Director, Nessa Fennelly, warns that changes in EU regulations could jeopardise this. “A high bar is set for manufacturers to demonstrate safety, efficacy and clinical benefit for Medtech products to get to market. This is strengthened under the EU Medical Devices Regulation. However, over the past two and a half years, while industry has been preparing for the biggest regulatory change in over two decades, policymakers have failed to ensure that the regulatory system is ready for tens of thousands of life transforming technologies to transition under the 26 May deadline.”
Fennelly adds: “The EU has historically been a location of choice for the launch of innovative medical technologies, with Ireland being chosen by many FDI multinationals as a gateway to the EU’s €115 billion market. Now, a lack of predictability under the EU regulations and increasingly favourable regulatory regimes in other markets, such as the United States, is undermining this position.
“The Irish Medtech Association is calling on the next government to work with the EU to conduct a ‘readiness check’ to identify and prioritise the main implementation challenges. Additionally, policymakers must work with the EU to maintain access to life transforming medical devices certified in the UK and avoid regulatory divergence after Brexit.”
The Government’s impact on the future of manufacturing
“Manufacturing is a vital part of the Irish economy, with major clusters in Galway, Limerick, Cork, Waterford, Sligo and Dublin. But, as we plan for the future, there is a serious gap in the Irish innovation ecosystem, which the government must address. We are calling on the government to invest ambitiously in an advanced, discrete manufacturing centre by adding €30 million to the IDA-led centre, with a well-coordinated governance structure that includes industry, to help companies take new technologies from proof of concept to commercialisation,” says John O’Brien, Chair of the Irish Medtech Association and S3 Connected Health CEO.
“For Irish manufacturers to compete, they need to embrace new technologies such as AI, data analytics and 3D printing. They must also provide access for professionals to these technologies to ensure that they are equipped to embrace industry 4.0. To help Irish people prepare for the jobs of the future, the government must foster lifelong learning by continuing to support the Irish Medtech Skillnet and ensuring the sustainability of the new manufacturing apprenticeships.”