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. It will develop a pivotal platform for developing safe and effective paediatric and orphan medical devices, that will describe the 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.
In addition, the DeCODe consortium will provide support from a multidisciplinary perspective for different use cases of paediatric and orphan medical devices. Technical assistance is provided to use cases’ applicants, including guidance on device design, engineering, and regulatory compliance tailored to the paediatric population. 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.
DeCODe is co-funded by the European Commission.
DeCODe Work Packages
DeCODe has the following work packages that are aligned with its strategic objectives.
Work Package 1: Project management and communication
Work Package 2: Mapping of tools and stakeholders in paediatric medical orphan device development
Work Package 3: Creation of critical path for paediatric and orphan medical device development
Work Package 4: Set up of platform for innovation coaching for paediatric and orphan medical device development
Work Package 5: Regulatory support for paediatric and orphan medical device development