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Cited by 203Usability and User Interface DesignMental Health and Patient InvolvementErgonomics and Human Factors

The DOI matches its Crossref record; 44 of the 45 references it cites were found in a registry or an index.

The role of the user within the medical device design and development process: medical device manufacturers' perspectives

Open access
Money, Arthur G, Barnett, Julie, Kuljis, Jasna, Craven, Michael P, Martin, Jennifer L, Young, Terry·2011·BMC Medical Informatics and Decision Making
DOI 10.1186/1472-6947-11-15PMC PMC3058010
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Abstract

BACKGROUND: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. METHODS: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. RESULTS: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. CONCLUSIONS: Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised.

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Figure 1 Medical device development lifecycle adapted from [5].
Figure 1 Medical device development lifecycle adapted from [5].CC BY · PubMed Central
Figure 2 Process of thematic analysis.
Figure 2 Process of thematic analysis.CC BY · PubMed Central

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Show all 45 references

Research works printed but not linked: 6

  1. Martin JL: Design for patient safety: User testing in the development of medical devices. 2010, National Patient Safety Agency, London, UK
  2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities. 1993, L169:
  3. Sawyer D: Do it by design: an introduction to human factors in medical devices. US Department of Health and Human Services Food and Drud Administration. 1996
  4. Cooper RG: The invisible success factors in product innovation. Journal of Product Innovation Management. 1999, 16: 115-133. 10.1016/S0737-6782(98)00061-7. · DOI
  5. Steen M, Kuijt-Evers L, Klok J: Early user involvement in research and design projects - A review of methods and practices. 2007
  6. Steen M, de Koning N, Takahashi I: Innovating together with users - Taking the organizational context into account. 2009

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Metadata

Authors
Money, A. G., Barnett, J., Kuljis, J., Craven, M. P., Martin, J. L., & Young, T.
Affiliations
  • University of Bedfordshire (GB)
  • Brunel University of London (GB)
  • University of Nottingham (GB)
Corresponding author
Money, Arthur G
ORCID
Venue
BMC Medical Informatics and Decision Making
Publisher
Springer Science and Business Media LLC
Published
2011-02-28
Volume
11
Issue
1
Pages
15-15
ISSN
1472-6947 (ISSN-L)
DOI
10.1186/1472-6947-11-15
PMC
PMC3058010
OpenAlex
W2128506806
Cited by
203
References
45
Citations by year
2026: 12 · 2025: 8 · 2024: 11 · 2023: 19 · 2022: 13 · 2021: 19 · 2020: 21 · 2019: 22 · 2018: 12 · 2017: 12 · 2016: 14 · 2015: 10 · 2014: 11 · 2013: 10 · 2012: 8
FWCI
16.95
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Medical Informatics and Decision Making (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Brunel University Research Archive (BURA) (Brunel University London) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Nottingham ePrints (University of Nottingham) (submittedVersion, cc-by)
  • Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
  • Repository@Nottingham (University of Nottingham) (submittedVersion, other-oa)
Funders
Engineering and Physical Sciences Research Council (GR/S29874/01, EP/F063822/1)
Topics
  • Physical Sciences › Computer Science › Human-Computer Interaction › Usability and User Interface Design
  • Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
  • Social Sciences › Human Factors and Ergonomics › Ergonomics and Human Factors
Keywords
user participation, human factors engineering, medical device manufacturers, clinical champions, patient involvement, usability, research ethics approval
MeSH terms
Community Participation, Equipment Design, Humans, Safety, Technology Assessment, Biomedical

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