Launch of i4KIDS-4RARE: A European Initiative to Accelerate Paediatric Orphan Medical Devices

i4KIDS announces the launch of i4KIDS- 4RARE, a pioneering European project dedicated to the development of orphan medical devices for paediatric patients with rare diseases.  

This new project is born as a specific programme of i4KIDS, the Paediatric Innovation Hub coordinated by Sant Joan de Déu Barcelona Children’s Hospital and Fundació de Recerca Sant Joan de Déu.  
  

The need: Why is i4KIDS-4RARE relevant? 

Although children represent 25% of society, there remains a significant gap in medical innovation between adults and children. Barriers such as risk perception, market size, regulatory complexity and diffusion of paediatric knowledge have hindered investment in paediatric healthcare, leaving many opportunities unexploited. Rare diseases often affect a small percentage of the population, making it financially unattractive for mainstream medical device companies to invest in research and development.This population represents 8% of the world’s children. According to Eurordis, there are an estimated 7,000 to 8,000 rare diseases affecting an estimated 400 million people worldwide, including children. For this population, the current average time to diagnosis is 4.5 years and only 5% will have a specific treatment for their disease.  

The project: What are the objectives of i4KIDS-4RARE?  

 i4KIDS-4RARE aims to address these challenges through a coordinated, innovative approach to ensure that children, adolescents and mothers have access to the latest health innovations. 

Its main objective is to develop and execute a specialised accelerator programme dedicated to fostering the creation and advancement of innovative solutions specifically tailored for paediatric patients afflicted with rare diseases in areas characterised by unmet medical needs.  

The i4KIDS-4RARE accelerator aims to bridge the gap in paediatric healthcare by supporting the development of medical devices specifically designed for children.  

The programme: i4KIDS-4RARE Accelerator Programme 

The programme will focus on three critical areas:  

1. Paediatric Cardiology: Accelerating the development of a device to monitor patients during complex surgery for congenital heart disease.
2. Paediatric Rehabilitation: Development of a home rehabilitation platform for children with spinal muscular atrophy (SMA).
3. Paediatric Neurology: Launch of a challenge-based programme for rare paediatric epilepsy (Epicare).

The accelerator programme will provide a structured framework, essential resources, mentorship and financial support to innovators, researchers and healthcare professionals. By fostering a supportive ecosystem that encourages multidisciplinary collaboration, knowledge exchange and cross-sector partnerships, i4KIDS-4RARE will empower innovators to transform breakthrough ideas into tangible solutions. 

Through strategic partnerships with the European Reference Network (ERN), healthcare organisations and industry experts, i4KIDS-4RARE will facilitate collaborative research, development and validation of novel orphan medical devices. This initiative will address the medical, research and social needs of paediatric patients with rare diseases, ensuring that they receive accurate diagnoses and appropriate treatments.