Policy

The Irish Medtech Association is the business association within Ibec representing the medtech sector. The Irish Medtech Association’s broad focus is to promote and support an environment that ensures the sustainable development and profitable growth of our multinational and small to medium size medtech companies. 
 
Along with a range of a business supports, we represent our members at a national and international level by engaging with stakeholders such as regulators, policy makers and government on key issues. 
 

Investment in an Advanced Manufacturing Centre 

•  What: Establish Advanced Manufacturing Centre of scale which offers discrete manufacturing businesses of all sizes and professionals access to a world-class equipment, expertise and collaborative opportunities. 

• Why: While Ireland is already a global leader in operational excellence with more Shingo Prizes, per capita, than any other country, the future of manufacturing is in advanced manufacturing. Competitor economies like the UK with the Catapult Centre, will steal a march if we do not embrace the latest technologies such as 3D printing, robotics and AI, or have the capacity to upskill Irish talent to work in this area. 
  
  

 Recommendations for nurturing entrepreneurship 

•  What: Nurturing entrepreneurship is one of the key priorities under the Irish Medtech 2020 strategy ‘The Global Medtech Hub’. Of the 450 medtech companies in Ireland, four out of five are SMEs or startups with 60% of these companies being homegrown. These companies are major drivers of innovation and vital part of the medtech ecosystem. 

• Why: Ireland is a good place to start a business, but many small companies struggle to make it big. More needs be done to foster entrepreneurship in education, and through business supports to make Ireland not only an attractive place to start a business, but also to grow a business. 
  
  

 Maximise opportunities and tackle challenges under Brexit

• What: Advocate Ireland’s medtech industry in Brexit negotiations by ensuring that the transition period allows enough time to grow the number of notified bodies in Europe to re-certify medical technology under the new EU Medical Devices and Invitro Diagnostic Regulation. As well as support the mutual recognition of CE marking certificates across EU and UK notified bodies until their expiration, and call for close cooperation to avoid regulatory divergence. 

• Why: As a leading hub for medtech in Europe and globally, Ireland is now well placed to attract further investment and talent to grow the sector. However, threats to the sale and release of medical technology will pose both a threat for businesses and affect patient access. To avoid this managing the new MD and IVD regulations smoothly across Europe and the UK will be key, along with reducing uncertainty in supply chains posed by the risk of tariffs or customs delays.

    
Advocating for appropriate methods for medtech HTA

• What: The Irish Medtech Association, MedTech Europe, and the industry supports the aim of assessing the value of medical technologies with the aim to foster timely access to innovation beneficial to patients and to ensure financially sustainable healthcare systems set out by the proposed European Commission Health Technology Assessment Regulation. But it is vital that the appropriate methods and tools are employed to reflect the medtech sector and its innovation model, which differs from the pharmaceutical sector where HTAs are more common. 

• Why: The current proposal would greatly affect businesses in the medtech sector in Ireland and patients’ access to medical technologies if it proceeds as is. To achieve its aims, we are calling on Irish representatives to advocate for European legislators to amend the European Commission Proposal in three key areas: the governance of HTA collaboration which should be done on a voluntary basis to address shared needs; the appropriate rules and methodologies which use reliable evidence to demonstrate the full value of technology; and the clear separation of the existing Medical Devices and IVD Regulation from the proposed HTA Regulation.

Ensuring medtech is ready for the application of the MD and IVD regulations

• What: The goals of the new EU the Medical Devices and Invitro Diagnostic Regulations are to increase patient safety, better protect public health and ensure both legal certainty in an innovation-friendly environment. Successful and timely implementation is a priority. In May 2017, the three years transition for medical devices and five years for IVDs began. Now, while the industry is ready, the system is not.  

• Why: A number of essential elements for manufacturers to comply with the dates of application remain outstanding notably: the Eudamed; numerous mandatory delegated and implementation acts; expert panels; reference laboratories; harmonised standards; common specifications; and critically, notified bodies designated. There is now critical concern that there will be too few notified bodies which will be available too late to adequately meet capacity. Subsequently, there’s a risk that there may be systematic discontinuation of medtech products which are essential to both our healthcare system and patients. This need to be redressed as a matter of urgency.
   

Ensure Ireland's workforce are equipped for the jobs of the future

• What: Review third level courses to ensure they prepare graduates for careers in medtech; tackle non-progression rates, particularly in engineering; continue to invest in upskilling as well as alternative career routes; and promote medtech careers along with a better understanding of this innovative industry. 

• Why: To sustain strong growth, continue to attract FDI investment and add jobs, we must continue to upskill and reskill people in the face of industry disruptors. While engineering and technology courses have been popular in recent years, the CAO has shown these courses may not remain as popular despite the opportunities they create. This highlights the importance of improving awareness about opportunities in hitech sectors like medtech. The detailed survey commissioned by the Irish Medtech Association and Skillnet, showed that nine out of ten responders found that it has gotten harder to recruit in the past five years. More needs to be done to address the skills gap and ensure our competitiveness as we look to the future.

Make Ireland a world leader for gender leadership in manufacturing and STEM

• What: The Irish Medtech Association has established a Gender Leadership Development Taskforce to tackle the lack of women in manufacturing leadership as a matter of priority. Key areas of focus identified by member companies in the group include: develop programmes for senior/middle managers to increase women in leadership; get commitment at CEO level to make gender leadership an industry priority; benchmark diversity in leadership in medtech; and identify best practices for those working manufacturing sector 

• Why: The recently released ‘Women in Management’ report, developed by Ibec, 30% Club, and DCU, reveals 6% of manufacturing firms have female CEOs. While this is below the national level, it is closer to the global standard of 6.4% of companies having a female CEO. While industry is taking steps to address this problem as a business issue, further collaboration between industry and political stakeholders is needed to address the gender imbalance in manufacturing, particularly at leadership level. Policy areas of focus include, make childcare more accessible by means testing child benefit and increasing the ratio of adult to children in line with other countries for childcare.