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 accessAbstract
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].](/paper-figures/a12e63d83c8c49ba8f07daaedb52c9e3/the-role-of-the-user-within-the-medical-device-design-and-development-process-figure-1.jpg)
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“To remain competitive within a fast-moving market, it is important to develop quickly [31].”
From Lessons Learned From a Living Lab on the Broad Adoption of eHealth in Primary Health Care (2018) · cites this paper as [31]
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Zidaru, T., Morrow, E. M., & Stockley, R. (2021) · Health Expectations · doi:10.1111/hex.13299 · Cited by 143
Vincent, C., Li, Y., & BLANDFORD, A. E. (2013) · Applied Ergonomics · doi:10.1016/j.apergo.2013.05.009 · Cited by 107
Pecchia, L., Martin, J. L., Ragozzino, A., Vanzanella, C., Scognamiglio, A., Mirarchi, L., & Morgan, S. P. (2013) · BMC Medical Informatics and Decision Making · doi:10.1186/1472-6947-13-2 · Cited by 104
Self-citationLessons Learned From a Living Lab on the Broad Adoption of eHealth in Primary Health Care
Swinkels, I. C. S., Huygens, M. W. J., Schoenmakers, T. M., Oude Nijeweme-D'Hollosy, W., van Velsen, L., Vermeulen, J., Schoone-Harmsen, M., Jansen, Y. J., van Schayck, O. C., Friele, R., et al. (2018) · Journal of Medical Internet Research · doi:10.2196/jmir.9110 · Cited by 90
“To remain competitive within a fast-moving market, it is important to develop quickly [31].”
BackgroundAssistive Technology for the Upper Extremities After Stroke: Systematic Review of Users’ Needs
van Ommeren, A. L., Smulders, L. C., Prange-Lasonder, G. B., Buurke, J. H., Veltink, P. H., & Rietman, J. S. (2018) · JMIR Rehabilitation and Assistive Technologies · doi:10.2196/10510 · Cited by 89
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
- Venue
- BMC Medical Informatics and Decision Making
- Published
- 2011-02-28
- Volume
- 11
- Issue
- 1
- Pages
- 15-15
- ISSN
- 1472-6947 (ISSN-L)
- 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
- gold
- doi.org
- 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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