OrphaDev4Kids Project – Advancing paediatric medical devices for orphan disorders

The development of paediatric medical devices (MDs) is more complex and riskier for developers, and only a small number of approved MDs are available; a few are designed specifically for children and others readapted from adult applications.

The OrphaDev4Kids Project is a collaborative project, between eight European partners, all members of the European Paediatric Transnational Research Infrastructure (EPTRI), aimed at addressing the issue of Orphan MDs to be used in the paediatric population.

This Project is implementing a complex innovation ecosystem in the orphan and paediatric MDs field in order to maximise the value-for-patients of the research and development projects that will support academic bodies, scientific societies and device developers, in particular small and medium-sized enterprises (SMEs), and non-governmental organisations (NGOs) through all the development phases from the idea conceptualization to the market access.

This Project focuses on three specific orphan and paediatric case studies: two concerning the neonatal cardiology area, both referring to Cyanotic Congenital Cardiac Diseases, and one referring to paediatric diseases presenting with bone fragility.

Children with bone fragility often present with reduced bone mass, frequent fractures, and progressive skeletal deformities. These can affect the spine and long bones, but also critically impact the hip joint, leading to pain and instability, limited mobility and inability to sit.

The use of resorbable implants in this context provides a key advantage: it reduces the long-term presence of hardware in skeletally immature patients, potentially lowering the risk of implant-related complications and eliminating the need for subsequent removal procedures. This approach supports both immediate mechanical stabilisation and long-term biological integration as the child grows.

The OrphaDev4Kids Project will support the development of an absorbable biocompatible implant with a paediatric indication for the treatment of weakened, fragile and deformed pelvis. The proposed absorbable implant, made of materials of natural origin combining magnesium, zinc and calcium, will ensure support and a more natural ingrowth onto a weakened, fragile and fractured bone.

This case study benefits from the valuable insights and collaboration of Young Persons Advisory Groups (YPAGs), through EPTRI members, TEDDY Network and ANDO Portugal as part of the Project Patient Expert Committee and Clinical Expert Committee.

As the goal of the project is to help the development of orphan paediatric MDs, OrphaDev4kids invites academics and individual researchers, startups and industrial players, organisations from diverse settings, and patient-led developers, to request for supporting services both for new device development and for the adaptation of existing products for the orphan and paediatric populations.

Successful applicants will benefit from the support of dedicated experts to help achieve their project’s development goals.

More information about the application form is available here.