Medical device development for children and young people—reviewing the challenges and opportunities

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

Abstract

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.

• Journal Article Type: Article
• Acceptance Date: Dec 2, 2021
• Online Publication Date: Dec 17, 2021
• Publication Date: Dec 1, 2021
• Deposit Date: Jan 18, 2022
• Publicly Available Date: Jan 20, 2022
• Journal: Pharmaceutics
• Electronic ISSN: 1999-4923
• Publisher: MDPI AG
• Peer Reviewed: Peer Reviewed
• Volume: 13
• Issue: 12
• Article Number: 2178
• DOI: https://doi.org/10.3390/pharmaceutics13122178
• Keywords: Pharmaceutical Science
• Public URL: https://nottingham-repository.worktribe.com/output/7277019
• Publisher URL: https://www.mdpi.com/1999-4923/13/12/2178