Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities
Paul Dimitri,
Valeria Pignataro,
Mariangela Lupo,
Donato Bonifazi,
Maria Henke,
Umberto M. Musazzi,
Floris Ernst,
Paola Minghetti,
Davide F. Redaelli,
Sophia G. Antimisiaris,
Giovanni Migliaccio,
Fedele Bonifazi,
Luca Marciani,
Aaron J. Courtenay,
Nunzio Denora,
Angela Lopedota
Affiliations
Paul Dimitri
Department of Pediatric Endocrinology, Sheffield Children’s NHS Foundation Trust & Sheffield Hallam University, Shefeld S10 2TH, UK
Valeria Pignataro
Consorzio per Valutazioni Biologiche e Farmacologiche, Via N. Putignani 178, 70122 Bari, Italy
Mariangela Lupo
TEDDY European Network of Excellence for Paediatric Research, Via Luigi Porta 14, 27100 Pavia, Italy
Donato Bonifazi
Consorzio per Valutazioni Biologiche e Farmacologiche, Via N. Putignani 178, 70122 Bari, Italy
Maria Henke
Institute for Robotics and Cognitive Systems, University of Luebeck, Ratzeburger Allee 160, 23562 Luebeck, Germany
Umberto M. Musazzi
Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo, 20133 Milan, Italy
Floris Ernst
Institute for Robotics and Cognitive Systems, University of Luebeck, Ratzeburger Allee 160, 23562 Luebeck, Germany
Paola Minghetti
Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo, 20133 Milan, Italy
Davide F. Redaelli
Scientific Institute IRCCS E. Medea, Bosisio Parini, 23843 Lecco, Italy
Sophia G. Antimisiaris
Department of Pharmacy, University of Patras, Rio Campus, 26504 Rio Patras, Greece
Giovanni Migliaccio
Consorzio per Valutazioni Biologiche e Farmacologiche, Via N. Putignani 178, 70122 Bari, Italy
Fedele Bonifazi
Fondazione per la ricerca farmacologica Gianni Benzionlus, Via Abate Eustasio, 30, 70010 Valenzano, Italy
Luca Marciani
Translational Medical Sciences, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Derby Road, Nottingham NG7 2UH, UK
Aaron J. Courtenay
School of Pharmacy and Pharmaceutical Sciences, Coleraine Campus, Ulster University, Cromore Road, Coleraine, Co. Londonderry, Northern Ireland BT52 1SA, UK
Nunzio Denora
Department of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, Via E. Orabona 4, 70125 Bari, Italy
Angela Lopedota
Department of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, Via E. Orabona 4, 70125 Bari, Italy
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.
