Paediatric and Orphan Medical Devices: From Concept to Care—Transforming Innovation for Children's Health

The field of medical devices (MDs) has undergone substantial expansion in recent years, fostering advances in healthcare technology and enhancing patient outcomes. However, MD development predominantly focuses on adult populations, while paediatric applications often rely on the modification or repurposing of existing devices or is slow to gain traction in healthcare markets. This approach frequently overlooks critical physiological differences, including variations in disease presentation, developmental growth trajectories, and psychosocial maturation. Consequently, there remains a significant paucity of MDs explicitly designed, evaluated, and approved for paediatric use.
Additionally, the translational pathway from conceptual innovation to clinical implementation in paediatric MD development remains hindered by considerable barriers. These include the high financial burden associated with research, prototyping, and regulatory compliance, as well as the complex ethical and methodological challenges in conducting paediatric-specific trials. Addressing these gaps necessitates dedicated efforts toward paediatric-focused MD innovation, regulatory frameworks that facilitate safe and effective device approval for children, and interdisciplinary collaboration to optimize paediatric healthcare technology.

The development of medical devices (MDs) specifically tailored for paediatric populations presents a complex, multidisciplinary challenge, necessitating expertise across biomedical engineering, clinical research, regulatory sciences, commercialisation, human factors and paediatric healthcare. Given the substantial heterogeneity in disease and development in paediatric populations, MDs must be designed to accommodate physiological variation across developmental stages of childhood.
To ensure robust clinical evaluation, research protocols must strategically recruit and enrol a sufficiently diverse paediatric cohort, allowing for equitable representation across age groups. Maintaining an ongoing collaborative dialogue with patients and families—the primary end users—is imperative in the iterative refinement of MDs, enhancing their usability, safety, and efficacy in real-world applications.
Sustained investment and targeted funding for paediatric MD development projects, such as OrphaDev4Kids (coordinated by EPTRI[SB3.1]), DeCODe, NIHR , and i4KIDS-4RARE, are essential to fostering interdisciplinary collaboration and technology adoption. These projects serve as critical platforms for uniting key stakeholders, including clinicians, researchers, industry partners, and regulatory bodies, to advance innovation and accelerate the adoption of child health technologies to improve the health and heathcare of children and young people.

This Research Topic is introduced and supported by the European Pediatric Transnational Research Infrastructure (EPTRI), that aims to address the challenges faced today in pediatric medical device development, and focusses on:

• Digital technologies for mental health in children and young people
• Digital technologies for the delivery of paediatric medicines
• Digital technologies and medical devices for rare disorders
• Medical devices and technologies supporting long-term conditions in childhood
• Medical devices for transitions in paediatric healthcare systems
• Neonatal technologies and innovations
• Artificial Intelligence applications in paediatric health
• Access to and infrastructure for child health technology development
• Addressing digital poverty and health inequalities affecting children
• Health technology solutions for low and middle-income settings

The OrphaDev4Kids project has received funding from the EU4Health Programme (2021-2027) under Grant Agreement n. 101161377

Topic Editor Paul Dimitri has received consultancy and honoraria fees from Merck Pharmaceuticals and Rhythm Pharmaceuticals.

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• Brief Research Report
• Case Report
• Clinical Trial
• Community Case Study
• Conceptual Analysis
• Data Report
• Editorial
• FAIR² Data
• General Commentary
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Article types

This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:

• Brief Research Report
• Case Report
• Clinical Trial
• Community Case Study
• Conceptual Analysis
• Data Report
• Editorial
• FAIR² Data
• General Commentary
• Hypothesis and Theory
• Methods
• Mini Review
• Opinion
• Original Research
• Perspective
• Policy and Practice Reviews
• Policy Brief
• Review
• Study Protocol
• Systematic Review
• Technology and Code

Keywords: Paediatric medical devices, Digital health technologies, Rare diseases, Orphan medical devices, Device development, Child health technology

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