TY - JOUR
T1 - Medical Device Development for Children and Young People - Reviewing the Challenges and Opportunities
AU - Dimitri, Paul
AU - Pignataro, Valeria
AU - Lupo, Mariangela
AU - Bonifazi, Donato
AU - Henke, Maria
AU - Musazzi, Umberto Maria
AU - Ernst, Floris
AU - Minghetti, Paola
AU - REDAELLI, DAVIDE FELICE
AU - Antimisiaris, Sophia
AU - Migliaccio, Giovanni
AU - Bonifazi, Fedele
AU - Marciani, Luca
AU - Courtenay, Aaron
AU - DENORA, Nunzio
AU - Lopedota, Angela
PY - 2021/12/17
Y1 - 2021/12/17
N2 - 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
AB - 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
KW - medical devices
KW - pediatrics
KW - 3D printing
KW - diagnostic imaging
KW - delivery device
KW - patient involvement
UR - https://www.mdpi.com/1999-4923/13/12/2178
UR - http://www.scopus.com/inward/record.url?scp=85121454793&partnerID=8YFLogxK
U2 - 10.3390/pharmaceutics13122178
DO - 10.3390/pharmaceutics13122178
M3 - Review article
C2 - 34959459
SN - 1999-4923
VL - 13
SP - 1
EP - 17
JO - Pharmaceutics
JF - Pharmaceutics
IS - 12
M1 - 2178
ER -
