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.
Highlights
There has been an exponential rise in the development of medical devices with a concomitant rise in the number of companies working in the life sciences sector
Despite the rapidly increasing growth predicted in the medical device market, this sector has been dominated by the development of devices for adult healthcare with paucity in the development of medical devices for pediatric healthcare [3,4]
Device Development In Europe, several legislative initiatives exist for pediatric medicines [100], but none have been developed for pediatric medical devices (MDs)
Summary
There has been an exponential rise in the development of medical devices with a concomitant rise in the number of companies working in the life sciences sector. 14–26 lenges in assessing large, stratified populations of children to appropriately power studies Clinicalinevaluation of these may require stratification by age,should posingplay chal-an integral part in addressing the needs of the pediatric population. In this respect, technology lenges in assessing large, stratified populations of children to appropriately power studapproaches such as 3D body or facial scanning andin. There has been a significant shift in attitude to the delivery of healthcare, with a move away from a hospital-centric approach towards community or home settings with the support and integration of medical devices and a greater emphasis on self-management This will inevitably improve the quality of life for children with longterm conditions, leaving them with more time for education and social integration, whilst reducing the number of workdays missed by parents. The situational context of healthcare delivery for children, young people, and their families must be factored into the development of novel MDs to minimize disruption to their lives and limit the number of hospital attendances
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