DeCODe Project Kick-Off: supporting Paediatric and Orphan Device Development

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The European commission co-funded DeCODe consortium held its kick-off meeting in Brussels on 9-10 September 2024. This two-year ground-breaking initiative aims to catalyse innovation and address the unique healthcare needs of people living with rare diseases (PLWRD), specifically children. This collaborative group, comprising clinicians, researchers, industry experts, and regulatory authorities, will develop a platform for developing safe and effective paediatric and orphan medical devices. 

There are very few medical devices specifically developed for children and rare diseases, the so-called paediatric and orphan devices. Many orphan devices provide essential functions for patients with rare diseases, their carers, and the healthcare professionals using them. At the same time, many patients and carers express a substantial unmet need for new paediatric devices for their conditions. As such, this initiative will support the development of paediatric and orphan devices via two steps.

The platform’s methodology encompasses a multifaceted approach, beginning with mapping paediatric and orphan stakeholders and initiatives and developing a critical pathway analysis to determine the optimal way to develop novel paediatric and orphan medical technologies.

As a next step, DeCODE will select five developers for support via grant applications that are expected to launch in March 2025.  For each of the successful developers, it will keep track of the paediatric orphan devices that are supported, the number of prototypes that each developer has developed, the business plans that are drafted, the number of clinical data collections that have been launched, and certificates that have been obtained throughout the support process. It is expected that 3-5 new medical devices will be approved and implemented in rare disease care due to this exciting new initiative.

The DeCODe platform will be available for any European developer (a patient-led group, academic, or small to medium enterprise).

So, if you have any great ideas for a new medical device for paediatric and orphan medical devices, please consider an application in the Spring of next year and visit the DeCODe website when it is launched!

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DeCODe is financed by the European Commission’s EU4Health programme (Grant Agreement ID: 101160939). Dr. Anneliene Jonker, from the University of Twente, will coordinate this project. This consortium is also linked to the US Alliance for Pediatric Device Innovation, an FDA-funded Pediatric Device Research Consortium, with whom it will collaborate throughout the project.

MetabERN, coordinated by Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), will actively participate in DeCODe project by providing input from clinicians perspective and will also provide expertise on implementing medical devices throughout expert centres in Europe. Dr. Annalisa Sechi (metabolic consultant) and Prof. Maurizio Scarpa (MetabERN Coordinator) will serve as contact persons for the project at ASUFC.