Medical device development for children and young people—reviewing the challenges and opportunities

Tools

DIMITRI, Paul, PIGNATARO, Valeria, LUPO, Mariangela, BONIFAZI, Donato, HENKE, Maria, MUSAZZI, Umberto M., ERNST, Floris, MINGHETTI, Paola, REDAELLI, Davide F., ANTIMISIARIS, Sophia G., MIGLIACCIO, Giovanni, BONIFAZI, Fedele, MARCIANI, Luca, COURTENAY, Aaron J., DENORA, Nunzio and LOPEDOTA, Angela (2021). Medical device development for children and young people—reviewing the challenges and opportunities. Pharmaceutics, 13 (12). [Article]

Documents
29464:597463
[thumbnail of pharmaceutics-13-02178.pdf]
Preview
PDF
pharmaceutics-13-02178.pdf - Published Version
Available under License Creative Commons Attribution.

Download (1MB) | Preview
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.
More Information
Official URL:
https://www.mdpi.com/1999-4923/13/12/2178
Open Access URL:
https://www.mdpi.com/1999-4923/13/12/2178/pdf
Open Access Version:
Published version
Additional Information:
** From MDPI via Jisc Publications Router ** Licence for this article: https://creativecommons.org/licenses/by/4.0/ **Journal IDs: eissn 1999-4923 **History: published 17-12-2021; accepted 02-12-2021
Uncontrolled Keywords:
medical devices, pediatrics, 3D printing, diagnostic imaging, delivery device, patient involvement

Identifiers

Identification Number:
10.3390/pharmaceutics13122178
ORCID for Donato Bonifazi: ORCID iD orcid.org/0000-0003-2636-9159
ORCID for Umberto M. Musazzi: ORCID iD orcid.org/0000-0002-7049-4152
ORCID for Floris Ernst: ORCID iD orcid.org/0000-0002-0474-6673
ORCID for Davide F. Redaelli: ORCID iD orcid.org/0000-0002-8513-8222
ORCID for Sophia G. Antimisiaris: ORCID iD orcid.org/0000-0002-2312-5848
ORCID for Fedele Bonifazi: ORCID iD orcid.org/0000-0003-4935-5702
ORCID for Luca Marciani: ORCID iD orcid.org/0000-0001-9092-4300
ORCID for Aaron J. Courtenay: ORCID iD orcid.org/0000-0002-2651-7839
ORCID for Nunzio Denora: ORCID iD orcid.org/0000-0002-7756-7828

Library

Item Type:
Article
SWORD Depositor:
Colin Knott
Depositing User:
Colin Knott
Date Deposited:
20 Dec 2021 16:17
Last Modified:
18 Dec 2024 19:49
Date of first compliant deposit:
20 December 2021
Date of first compliant Open Access:
20 December 2021
Version of first compliant deposit:
Version of Record
URI:
https://shura.shu.ac.uk/id/eprint/29464
Statistics

Downloads

Downloads per month over past year

View more statistics

Metrics

Altmetric Badge

Dimensions Badge

Share
Add to AnyAdd to TwitterAdd to FacebookAdd to LinkedinAdd to PinterestAdd to Email

Actions (login required)

View Item View Item

SHURA supports OAI 2.0 with a base URL of https://shura.shu.ac.uk/cgi/oai2