The field of medical devices is rapidly evolving, fostering significant advancements in healthcare technology and improving patient outcomes. Yet, the development of medical devices (MDs) has predominantly catered to adults, leaving a notable void in paediatric applications, which often rely on modified devices rather than those specifically designed for children. This approach fails to account for critical physiological differences, varying disease presentations, and developmental trajectories unique to children, resulting in a scarcity of MDs explicitly designed and evaluated for paediatric use. Furthermore, the journey from conceptual innovation to clinical implementation in paediatric MD development remains fraught with barriers, including high costs, stringent regulatory processes, and unique ethical challenges within paediatric trials.

This Research Topic aims to address these challenges by promoting dedicated efforts toward paediatric-focused MD innovation. It seeks to create regulatory frameworks that facilitate the safe and effective approval of devices for children, ensuring interdisciplinary collaboration to optimize paediatric healthcare technology. By emphasizing the importance of tailored MDs for the paediatric population's diverse physiological needs, this Research Topic endeavors to bring together expertise in biomedical engineering, clinical research, regulatory sciences, and pediatric healthcare to drive forward innovation in this critical area of health technology.

To gather further insights into the advancements and challenges in paediatric medical device development, we welcome articles addressing, but not limited to, the following themes:

• 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

We encourage contributions across a range of article types, ensuring a comprehensive exploration of innovations and solutions in this emerging field.

Topic Editor Paul Dimitri has received consultancy and honoraria fees from Merck Pharmaceuticals and Rhythm Pharmaceuticals. The other Topic Editors declare no conflicts of interest.

Are you interested in contributing a manuscript to this Research Topic?

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