Highlights from Global Access 2024

Attending Irish Medtech’s Global Access 2024 conference on October 23rd and 24th at the Galmont Hotel in Galway was an fantastic experience, as it, brought together international leaders for Ireland’s largest Medtech event. With over 250 attendees—including regulators, policymakers, and senior business leaders—the conference offered an in-depth look into the global regulatory landscape, featuring experts from Industry, Academia, Competent Authorities, Notified Bodies, the European Commission and global regulatory bodies who provided insights and fostered collaboration across the Irish Medtech sector.?

Ireland is a global leader in Medtech production, with over €16 billion of products exported to more than 100 countries. As Irish Medtech Director Eoghan ó Faoláin explained, the focus of Global Reach is to “ensure Ireland remains competitive and innovative, by offering industry insights into the latest trends such as, clinical investigations, sustainability and international harmonization”.? Regulatory burden is a key concern of the industry, as highlighted by Irish Medtech Senior Executive Emer Sherry who said ” The European Medtech sector is renowned for its constant innovation. However, the costs, the complexity and lack of predictability of the EU regulations are hindering patient access. That is why we are calling for EU regulatory reform.”

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The opening session expertly moderated by Amanda Maxwell l provided an interesting start to the conference with ideas including:

·???????? Opening up the recertification cycle

·???????? More transparency with clinical data

·???????? Enabling Notified Bodies to be more transparent with how and what they are doing

·???????? Improved resourcing at EU level to deal with MDR/IVDR implementation

·???????? More centralisation and harmonisation

·???????? Implementing a breakthrough device pathway

·???????? Utilisation of Electronic Instructions for Use?(eIFUs)

Health Products Regulatory Authority (HPRA) Niall MacAleenan stressed the importance of careful evaluation of options to support the MDR/IVDR with a focus on governance and patient safety.

波科 's Olga van Grol-Lawlor led a session on “The International Harmonisation Agenda” to delve into the progress made by the International Medical Device Regulators Forum (IMRDF) in harmonising global regulatory requirements for medical technologies, along with challenges and opportunities presented by greater regulatory convergence.

Stryker ’s Mairead Twomey chaired an insightful session on comparative regulatory approaches in jurisdictions other than the EU with a particular informative presentation by FDA ’s Kenneth J. Cavanaugh Jr. on their Early Feasibility Programme, Breakthrough Device Program, Total Product Lifecycle Advisory Program (TAP), Safer Technologies Program (STeP).

A highlight of the day for me was the Medtech Brew evening event co-hosted by BioInnovate Ireland and Irish Medtech which focused on the real-world experiences of young start-up companies under the session theme of “Choosing a Market to Launch”.? NUA SURGICAL , Spiorad Medical Limited , Veryan Medical shared their respective paths of identifying, engaging and penetrating their target markets in front of the capacity crowd.

A key takeaway for me from Day One is continuous improvement and transparency are key to moving forward under MDR/IVDR.

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Day Two– the inaugural session on the exploration of the global Clinical Investigations/Trials landscape with a focus on Ireland, Europe and the US- provided a key highlight for me.? Moderated by Robbie Walsh of AOTI , there were excellent insights by all speakers and discussants on exploring potential collaborative opportunities in Medtech clinical investigations here in Ireland. John Kilmartin , Adjunct Professor at the University of Galway - Institute for Clinical Trials highlighted that now is a “window of opportunity” and “there is a consensus by stakeholders to move into an action phase”. ?John outlined a proposed pilot to “Hypercare” a small number of studies to monitor the progress on speeding up the approval pathway and share lessons learned. Helen Scotch of CroiValve , an early-stage company, outlined key takeaways for conducting clinical investigations from their company experience. Tom Melvin of Trinity College Dublin provided important insights on the new Harmonised EU Early Feasibility Study (HEU EFS). Dr Donal O'Connor Health Products Regulatory Authority (HPRA) outlined HPRA priorities at EU level and future developments.

In summary, the programme sessions offered practical steps to stay aligned with the rapidly evolving landscape of medical devices and in vitro diagnostics. The conference underscored that the future of the Medtech sector lies in patient-centred innovation, ensuring global access to safe and effective medical devices. Moving forward under MDR/IVDR, collaboration and transparency remain essential.

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