On 8–9 April 2025, the DeCODe consortium convened a focused workshop in Brussels, bringing together key stakeholders to advance the development of orphan medical devices. ERN eUROGEN was represented by former Coordinator Prof. Wout Feitz and Programme Manager Michelle Battye.
The workshop’s aim was to analyse the critical pathway for bringing orphan medical devices to market. Discussions explored the full lifecycle of development, from early-stage technology and clinical evidence generation to navigating the complex regulatory landscape, marketing strategies, and business planning. Five case studies were reviewed to highlight common challenges and opportunities in the field.
The insights gathered during the workshop will feed into the creation of a comprehensive “critical pathway” document. Once finalised, this guidance will be made publicly available to support innovators and developers working in the rare disease space.
In parallel, the DeCODe call for proposals closed on 31 March 2025. Nine applications were received and are currently under evaluation by the consortium. Up to five projects may be selected to receive tailored support through the DeCODe programme.
This initiative continues to support the development of much-needed medical devices for rare and complex conditions, in alignment with ERN eUROGEN’s mission to improve patient care across Europe.
