Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities

Paul Dimitri, Valeria Pignataro, Mariangela Lupo, Donato Bonifazi, Maria Henke, Umberto Musazzi, Floris Ernst, Paola Minghetti, Davide Redaelli, Sophia Antimisiaris, Giovanni Migliaccio, Fedele Bonifazi, Luca Marciani, Aaron Courtenay, Nunzio Denora, Angela Lopedota

Research output: Contribution to journalReview articlepeer-review

7 Citations (Scopus)
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Development of specific medical devices (MDs) is required to meet the healthcare needs of children and young people (CYP). In this context, MD development should address changes in growth and psychosocial maturation, physiology, and pathophysiology, and avoid inappropriate repurposing of adult technologies. Underpinning the development of MD for CYP is the need to ensure MD safety and effectiveness through pediatric MD-specific regulations. Contrary to current perceptions of limited market potential, the global pediatric healthcare market is expected to generate around USD 15,984 million by 2025. There are 1.8 billion young people in the world today; 40% of the global population is under 24, creating significant future healthcare market opportunities. This review highlights a number of technology areas that have led to successful pediatric MD, including 3D printing, advanced materials, drug delivery, and diagnostic imaging. To ensure the targeted development of MD for CYP, collaboration across multiple professional disciplines is required, facilitated by a platform to foster collaboration and drive innovation. The European Pediatric Translational Research Infrastructure (EPTRI) will be established as the European platform to support collaboration, including the life sciences industrial sector, to identify unmet needs in child health and support the development, adoption, and commercialization of pediatric MDs
Original languageEnglish
Article number2178
Pages (from-to)1-17
Number of pages17
Issue number12
Publication statusPublished (in print/issue) - 17 Dec 2021

Bibliographical note

Funding Information:
Acknowledgments: We acknowledge the European Pediatric Translational Research Infrastructure (EPTRI project) funded by the European Union’s Horizon 2020 program under grant agreement no. 777554.

Funding Information:
Funding: This work is partially funded by the National Institute for Health Research (NIHR) MedTech and In-vitro Diagnostic Cooperative Programme (NIHR Children and Young People MedTech Cooperative). The views expressed are those of the author and not necessarily those of the NIHR or the Department of Health and Social Care.

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.


  • medical devices
  • pediatrics
  • 3D printing
  • diagnostic imaging
  • delivery device
  • patient involvement


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