There are over 160 medical technology companies in Ireland, exporting €6.8b worth of devices each year and employing 24,000 people. In order for this important industry to continue to flourish in Ireland, the sector requires a regulatory-friendly operating environment.
Professor Fergal McCaffery of Dundalk Institute of Technology and Professor Tomás Ward, director of Insight at DCU (pictured) are working together on a project entitked ‘Safe and Trustworthy Artificial Intelligence in Medical Devices – a Regulatory-Friendly Framework’. The project aims to address the challenges of using adaptive AI algorithms in medical devices, which are safety-critical systems, by enabling them to be used in a safe and regulated manner. This involves demonstrating to regulatory organisations that autonomous AI algorithms can be trustworthy and meet EU Trustworthy AI principles, developing a validated framework for the development of these systems and creating an assessment framework for assessing the trustworthiness of autonomous AI algorithms based on safety critical thresholds within each domain. The goal is to enable increasingly complex systems to be placed on the market and increase growth in the medical device industry in Ireland.