Evidence map›Paper›PMID 37840272›Full record

ArticleProceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine2023

Medical device regulatory challenges in the UK are affecting innovation and its potential benefits.

Jacqueline Beddoe-Rosendo, Clare L Heaysman, Joseph V Hajnal, Sebastien Ourselin, Anne Vanhoestenberghe

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Jacqueline Beddoe-RosendoSchool of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Clare L HeaysmanSchool of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Joseph V HajnalSchool of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Sebastien OurselinSchool of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.
Anne VanhoestenbergheSchool of Biomedical Engineering and Imaging Sciences, King's College London, London, UK.ORCID 0000-0002-7244-5864
King's College London · GB

Funding

Wellcome Trust
6 · The paper itself

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.

Indexed as

Equipment and SuppliesMedical Device LegislationInventionsUnited Kingdomapproved body capacityinnovationMedical device regulationMHRAUKCA marking

Identifiers

PMID37840272
PMCPMC10685680
OpenAlexW4387661481

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.