Affiliation:
1. School of Biomedical Engineering and Imaging Sciences, King’s College London, London, UK
Abstract
The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.
Funder
Engineering and Physical Sciences Research Council
Wellcome Trust
Subject
Mechanical Engineering,General Medicine
Reference48 articles.
1. From computer-assisted intervention research to clinical impact: The need for a holistic approach
2. Spinning Out of Control? How Academic Spinoff Formation Overlooks Medical Device Regulations
3. Lack of Support in Medical Device Regulation within Academia
4. RSM PACEC LTD. Gov UK. A report for the Department for Business, Energy, and Industrial Strategy (BEIS) - Research into issues around the commercialisation of university IP, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/699441/university-ip-commercialisation-research.pdf (2018, accessed 8 January 2023).
5. MSk Accelerator. Faculty of Engineering, Imperial College London, https://www.imperial.ac.uk/bioengineering/about/innovation-and-translation/msk-accelerator/ (accessed 1 August 2023).