The paediatric and orphan medical devices sectors represent critical areas within healthcare, yet they remain underdeveloped compared to the broader medical device industry. Paediatric and orphan devices, designed specifically for the unique needs of children and rare disease patients, face distinct challenges in terms of research, development, regulation, and market access. Factors such as smaller patient populations, higher development costs, and the complexities of conducting clinical trials in vulnerable populations often lead to a lack of innovation and a scarcity of suitable products.  

The DeCODe project, co-funded by the European Commission EU4Health programme under grant agreement No 101160939, aims to address these challenges by accelerating the development of essential medical devices. The project aims to enhance the quality of care for children living with rare diseases, ultimately transforming paediatric rare disease healthcare. 

On 27 January 2025, DeCODe has launched a call for support for paediatric and orphan device developers. Successful applicants will benefit from the support of two dedicated innovation coaches to help achieve their development goals. Support will be available to a wide range of developers, including but not limited to academics and individual researchers, startups and industrial players, organizations from diverse settings, and patient-led developers, for both new device development and the adaptation of existing products for the orphan and paediatric populations. Assistance will be provided at various stages of the product lifecycle to ensure the success of these vital innovations. The type of support that qualify are, amongst others, business advice, funding advice, network building, technical advice, regulatory guidance, infrastructure for (pre-)clinical testing and/or a needs assessment.    

Information

Call open27 January 2025 
Deadline project submission 31 March 2025  
Expected duration of the project evaluation 4 weeks
Expected duration of support to the developer by the DeCODe consortium Minimum 6 months 
Language in which proposal should be submitted English

Application form

Please download the application form via the button below. Applications should be submitted to Anneliene Jonker via a.h.jonker@utwente.nl.

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