References
CDRH. Report to Congress annual report premarket approval of pediatric uses of devices FY 2017 submitted pursuant to Section 515A of the Federal Food, Drug, and Cosmetic Act Food and Drug Administration. 2017. Available from: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089734.p. Accessed 20 Apr 2023.
Takahashi S, Iwasaki K, Shirato H, Ho M, Umezu M. Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States. J Artif Organs. 2021;24(1):90–101. https://doi.org/10.1007/s10047-020-01216-6.
Dimitri P, Pignataro V, Lupo M, et al. Medical device development for children and young people-reviewing the challenges and opportunities. Pharmaceutics. 2021;13(12):2178. https://doi.org/10.3390/pharmaceutics13122178.
National Institute for Health and Care Excellence. NICE’S equality objectives and equality programme 2020–2024. Available from: https://www.nice.org.uk/Media/Default/About/Who-we-are/Policies-and-procedures/Equality%20objectives%20and%20equality%20programme%202020%20-%202024.docx. Accessed 20 Apr 2023.
Campbell B, Campbell M. NICE medical technologies guidance: a novel and rigorous methodology to address a new health technology assessment challenge. Appl Health Econ Health Policy. 2012;10(5):295–7. https://doi.org/10.2165/11640550-000000000-00000.
Crispi F, Naci H, Barkauskaite E, et al. Assessment of devices, diagnostics and digital technologies: a review of NICE medical technologies guidance. Appl Health Econ Health Policy. 2019;17(2):189–211. https://doi.org/10.1007/s40258-018-0438-y.
NICE. Guidance, NICE advice and quality standards. Available from: https://www.nice.org.uk/guidance/published?ngt=Medical%20technologies%20guidance&ndt=Guidance. Accessed 23 Sept 2022.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Funding
This research received no specific funding.
Conflict of interest
Sarah Greasley and James Wall have no conflicts of interest that are directly relevant to the content of this article. Mark Campbell was employed by NICE between August 2010 and March 2019 as the Associate Director for the Medical Technologies Evaluation Programme.
Ethics approval
Not applicable.
Consent to participate
Not applicable.
Consent for publication
Not applicable.
Availability of data and material
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
Code availability
Not applicable.
Authors’ contribution
SG carried out the initial data collection and analysis on the MTGs with input from JW. All authors were involved in interpretation of the analysis. SG wrote the manuscript with multiple manuscript revisions contributed by JW and MC.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Greasley, S., Campbell, M. & Wall, J. Health technology assessment – an important opportunity to inform the use of medical devices in the paediatric population: an analysis of NICE Medical Technology Guidance. Appl Health Econ Health Policy 21, 533–535 (2023). https://doi.org/10.1007/s40258-023-00805-9
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40258-023-00805-9