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

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.

PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development

“…Despite the increase in the medical device market size, the sector is still dominated by adult medical devices [5]. The limited devices for pediatric health care delivery are attributed to fewer pediatric disease population, difficulty in clinical trial enrollment, parental consenting, and liability concerns [15].…”

“…To compensate for this gap, adult devices are often adapted or configured to address unmet needs in children, even when there is a lack of safety data in children. Despite new regulatory and legislative initiatives, the percentage of novel approved devices is still stagnant [5]. The lack of devices designed, evaluated, and approved for pediatrics not only limits access to potentially beneficial novel devices but also leads to off-label use of adult devices, potentially altering the risk-benefit profile [6,7].…”

Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study

“…Furthermore, numerous devices fail to scale up [3]. For the development of medical devices for infants and children, the challenges are even larger [4,5].…”

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters

“…[12][13][14] Considering children, in turn, medical device development has been described to simply "gravitate […] towards the repurposing of adult's applications, on the basis of the incorrect assumption that devices can simply be made smaller in line with a child's size, with little consideration for changes in anatomy and physiology through growth and development" (p. 17). 15 Critically, the development of tVNS devices, even though commercially available devices show no restrictions of application to exclusively adult populations, currently does not intend specific stimulation systems for children and young people. 16 This also might seem reminiscent of a past situation in which, alongside clinical practice experience in children and adolescents, the administration of psychotropic drugs in pediatric patients was usually guided by evidence extrapolated from adults, leading to substantial off-label use.…”

“…[21][22][23][24] The development and application of medical devices should address changes in growth and psychosocial maturation, physiology, and pathophysiology and avoid inappropriate repurposing of adult technologies. 15 Regarding the development and application of treatment systems for auricular tVNS in pediatric patients, critical aspects include, among others, ear-anatomical changes in development (ie, electrode fit and engineering), increased needs for independence, especially during puberty (compliance and compliance monitoring), and the assessment of physical symptoms and mental distress, which might be hampered by an inability to communicate such symptoms in specific pediatric subpopulations (ie, affecting the assessment of adverse effects and adverse events). Addressing these aspects should not only be considered in the development of tVNS devices and systems but also should present a key priority in research studies producing relevant data on the clinical application of tVNS in pediatric populations-if really contributing to achieving good clinical benefit presents a primary aim in these studies.…”