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

Paul Dimitri1, Valeria Pignataro2, Mariangela Lupo3

  • 1Department of Pediatric Endocrinology, Sheffield Children's NHS Foundation Trust & Sheffield Hallam University, Shefeld S10 2TH, UK.

Pharmaceutics
|December 28, 2021
PubMed

Insights

Developing specialized medical devices (MDs) for children and young people (CYP) requires tailored regulations and innovative technologies. The European Pediatric Translational Research Infrastructure (EPTRI) aims to foster collaboration for pediatric MD innovation.

Area of Science:

  • Biomedical Engineering
  • Pediatric Healthcare Innovation
  • Regulatory Science

Background:

  • Children and young people (CYP) have unique healthcare needs distinct from adults, necessitating specialized medical devices (MDs).
  • Current MD development often involves repurposing adult technologies, potentially compromising safety and efficacy for pediatric populations.
  • The global pediatric healthcare market presents significant growth opportunities, projected to reach USD 15,984 million by 2025.

Purpose of the Study:

  • To review successful technologies in pediatric MD development.
  • To highlight the importance of pediatric-specific regulations for MD safety and effectiveness.
  • To advocate for collaborative platforms to drive innovation in pediatric MDs.

Main Methods:

  • Literature review of successful pediatric MD technologies.
  • Analysis of market trends and opportunities in pediatric healthcare.
  • Discussion of regulatory frameworks for pediatric medical devices.

Main Results:

  • Successful pediatric MD development has been driven by technologies such as 3D printing, advanced materials, drug delivery systems, and diagnostic imaging.
  • There is a substantial and growing global market for pediatric healthcare solutions.
  • Collaboration across disciplines and the establishment of platforms like EPTRI are crucial for advancing pediatric MDs.

Conclusions:

  • Tailored development and regulation of MDs for CYP are essential.
  • Technological advancements offer promising avenues for pediatric MD innovation.
  • Multidisciplinary collaboration and dedicated infrastructure are key to meeting unmet needs in child health and commercializing pediatric MDs.

Keywords:
3D printingdelivery devicediagnostic imagingmedical devicespatient involvementpediatrics

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