IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

202237 citationsJournal Articlegreen Open Access

Authors

Hani J. Marcus · University College London

Amy Bennett · Orthox (United Kingdom)

Ajai Chari · University College London

Toni Day · OrganOx (United Kingdom)

Allison Hirst · University of Oxford

Archie Hughes‐Hallett · Charing Cross Hospital

Angelos G. Kolias ·

Abstract

The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.

Topics & Keywords

Biomedical and Engineering Education Biomedical Ethics and Regulation Health Systems, Economic Evaluations, Quality of Life

UN Sustainable Development Goals

Industry, innovation and infrastructure

Publication Details

Published in: PubMed

Volume 275, Issue 1, pp. 73-79

DOI: 10.1097/sla.0000000000004907