DeCODe Consortium Aims to Develop New Medical Devices for Children with Rare Diseases

The European Commission-backed DeCODe consortium, led by the University of Twente (UT), is set to drive innovation in healthcare by focusing on developing medical devices for children with rare diseases. Comprising clinicians, researchers, industry experts, and regulators, the group aims to create a platform for designing safe and effective paediatric and orphan medical devices, addressing a significant unmet need.

Few medical devices are tailored specifically for rare diseases or children, leaving gaps in care for both patients and their caregivers. DeCODe seeks to fill this gap through a two-step approach. First, the initiative will map key stakeholders and develop pathways for new paediatric and orphan technologies. In March 2025, DeCODe will launch grant applications to support five developers. The platform will track their progress, including device prototypes, clinical data collection, and regulatory approvals.

This initiative is expected to lead to the approval and implementation of 3-5 new medical devices for rare disease care, offering significant advancements in the field.

The DeCODe platform is open to developers across Europe, including patient-led groups, academics, and small-to-medium enterprises. Interested applicants can apply in Spring 2025, when the official website is launched.

The consortium is co-financed by the EU4Health program, with Dr. Anneliene Jonker of UT leading the project. It will collaborate with the US Alliance for Pediatric Device Innovation, a similar FDA-funded initiative in the United States.