The Irish Medtech Association, the Ibec group that represents the medtech industry, has launched its Budget 2022 submission in which it calls on Government to ensure the sector’s competitiveness capacity is supported.

Irish Medtech chair, Tom Clarke, senior director West: “Ireland is well positioned to build on its success and achieve new heights by gaining a greater share of the global medtech market which is forecast to grow 4.4% (CAGR) annually with sales expected to reach over €508 billion by 2023. However, to reach our potential we need to maintain our competitiveness and ensure we have the right business environment, which includes fostering collaboration between adjacent life sciences and technology industries.

“Blurring of traditional industry lines continues, with many healthcare solutions now arising from convergence across these healthtech industries. Given this trend, national ecosystem strategies are becoming common place in countries with big ambitions for healthtech innovation, such as France and the UK. For future competitive advantage we are asking Government to develop a national healthtech strategy and appoint appropriate resources within the Department of Enterprise, Trade and Employment to implement same.”

Irish Medtech Association director Sinead Keogh said: “Start-ups continue to be vital component of a thriving ecosystem and source of innovation within the medtech sector. Start-ups take on risk to drive radical innovation in the face of unmet clinical needs that represent significant commercial opportunities. However, to get these products to patients they need sufficient funding to get technologies through key stages including, prototyping and clinical investigations, to obtaining regulatory approval and to get products into the health system. To support start-ups the Irish Medtech Association believes Budget 2022 should:

• Increase in the threshold for the reduced rate of Capital Gains Tax from €1 million to €15 million to encourage risk taking and re-investment.
• Replace the EIIS scheme as it is currently unworkable with all the burden resting on the company for adherence. Its structure is such that investors seek indemnities from Revenue future actions
• Reform of the Key Employee Engagement Programme (KEEP), including an increase in the limit on market value of issue, but unexercised, shares under the scheme to €10 million to attract and retain talent.
• Reform of the Employment Investment Incentive Scheme (EIIS) including an increase in the limit on investments to €2 million to drive investment.
• Advance implementation of the new EU Medical Device Regulations (MDR) by urgently progressing Notified Body designation and rapidly establishing expert panels, so that devices depending on these panels can start going through MDR certification as soon as possible.

Keogh added: “As well as ensuring that start-ups are well funded, the progress around the implementation of the new EU Medical Device Regulations is very concerning, especially for start-ups, which represent 80% of the sector here. Although the transition period for MDR ended on 26 May 2021, there are several significant challenges today that prevent manufacturers and their devices from being (re-) certified against the new rules of the MDR among these the lack of Notified Body capacity.”

Ireland is also one of the top seven employers of medtech professionals in Europe as well as the greatest employer of medtech professionals, per capita, with more than 40,000 employed. The Irish Medtech Association Budget Submission 2022 makes several recommendations to Government across enterprise, innovation, education, and health to maintain competitiveness.