Develop Child and Orphan Device Evaluation Support: DeCODe

Programme(s): EU4Health Programme (EU4H)

Project ID: 101160939

Topic(s): EU4H-2023-PJ-11

Type of action: EU4H Project Grants

Objective:
The DeCODe consortium represents a ground-breaking initiative aimed at catalysing innovation and addressing the unique healthcare needs of people living with a rare disease, specifically children. This collaborative group, comprising clinicians, researchers, industry experts, and regulatory authorities, will develop a pivotal platform for developing safe and effective paediatric and orphan medical devices. It will do so to accelerate the development of novel, innovative paediatric and orphan medical device solutions at all stages of the product lifecycle towards implementation. The platform’s methodology encompasses a multifaceted approach, beginning with mapping paediatric and orphan medical device stakeholders and initiatives and developing a critical pathway analysis for the optimal way of developing novel paediatric orphan medical technologies. The platform will be set up based on these elements and invites paediatric medical device stakeholders to apply for support for their use cases. Use cases are meticulously selected based on their medical significance, feasibility, and potential impact. Technical assistance is provided to use cases’ applicants, including guidance on device design, engineering, and regulatory compliance tailored to the paediatric population. A hallmark of the project is its commitment to fostering collaboration. Monitoring and evaluating selected use cases guarantees that devices are meticulously developed, tested, and refined. Successful output, the platform, and the advice given to developers are disseminated widely, contributing to the paediatric orphan medical community’s wealth of knowledge and fostering partnerships with industry stakeholders. By uniting diverse expertise, facilitating innovation, and surmounting regulatory challenges, DeCODe accelerates the development of essential medical devices that enhance the quality of care for our children living with rare diseases, ultimately transforming paediatric rare disease healthcare.