One of Ireland’s key strengths as a Medtech hub has been its exemplary regulatory environment and the level of collaboration that exists at all levels.

Irish Medtech companies have a proven track record in understanding the complexities of regulations facing the healthcare industry and continuously delivering compliance. This is because Irish companies have grown alongside multinationals, which have been boosting their presence in the country over the past 25 years.

Eighteen of the world’s top 25 Medtech companies are located in Ireland including Boston Scientific, Abbott and Johnson & Johnson and the country is the second-largest exporter of medical products in Europe with annual exports of €12.5bn.

The Irish Medtech sector has grown from fifty companies in the early 1990s to become one of the five global emerging hubs for Medtech with a cluster of 300 companies. Employing 38,000 people, Ireland is the highest employer of Medtech professionals in Europe per capita. The indigenous sector is an important component of this Medtech cluster with over 200 companies employing 6,500 people. Ireland now has world-class, highly innovative and dynamic indigenous Irish companies that are designing, developing, commercialising, manufacturing and marketing – delivering complex technologies, products and services throughout the world.

As foreign direct investment increased over the years, Irish sub-supply companies began to feed into multinationals. To a large extent, they were originally precision engineering companies which became more focused on the Medtech sector. They developed significant capability and became highly skilled in meeting demanding customer and regulatory requirements – particularly those imposed by the FDA in the US and the latest from the European Commission.

As well as their exemplary performance in regulatory compliance, Irish Medtech companies are also outstanding in terms of adhering to industry standards which are not mandatory, such as those of the European Respiratory Society.

This means Irish Medtech companies always stay on top of industry best practice.

This level of excellence in compliance and standards is particularly important in light of Brexit. It means Ireland can offer certainty and clarity for companies operating in the Eurozone’s remaining 27 member countries in terms of the device/drug approval process and the sale of products and materials. For example, they have the expertise to help customers to navigate the EU’s new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), which businesses must comply with by 2020 and 2022, respectively.

Active collaboration and knowledge-sharing have been a key driving force behind the success of Ireland’s globally recognised Medtech sector. Having evolved from being mainly manufacturing to being more complex and driven by R&D, it now involves intensive collaboration between a broad range of partners. These include higher education institutions, clinicians, manufacturing companies and government agencies.

In collaboration with third level researchers and the clinical community, Enterprise Ireland’s vision of realising a vibrant indigenous Medtech sector is driven by key initiatives and supports such as:

  • Market-focused technology centres in such areas as connected health and advanced manufacturing
  • Health Innovation Hub Ireland – a partnership of clinicians, academics, innovators and entrepreneurs from across Ireland working together to accelerate healthcare innovation and commercialisation
  • Technology gateways leveraging industry focused expertise within Institutions of Technology across the country, acting as open access points to deliver near-to-market solutions in areas such as design, medical engineering, and manufacturing and diagnostics
  • BioInnovate Ireland – a national medical technology innovation training programme in which academia, clinicians and industry members collaborate to develop novel medical technologies.

The way the ecosystem in Ireland is structured means that Irish companies are at the cutting edge of Medtech advances globally and it is easy to access key innovators in specialised areas across industry and academia.