Skip to main content

Research Repository

See what's under the surface

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

Money, Arthur G.; Barnett, Julie; Kuljis, Jasna; Craven, Michael P.; Martin, Jennifer L.; Young, Terry

Authors

Arthur G. Money arthur.money@brunel.ac.uk

Julie Barnett julie.barnett@brunel.ac.uk

Jasna Kuljis jasna.kuljis@brunel.ac.uk

Michael P. Craven michael.craven@nottingham.ac.uk

Jennifer L. Martin jennifer.martin@nottingham.ac.uk

Terry Young terry.young@nottingham.ac.uk



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.

Journal Article Type Article
Publication Date Feb 28, 2011
Journal BMC Medical Informatics and Decision Making
Electronic ISSN 1472-6947
Publisher Humana Press
Peer Reviewed Peer Reviewed
Volume 11
Issue 15
Institution Citation Money, A. G., Barnett, J., Kuljis, J., Craven, M. P., Martin, J. L., & Young, T. (2011). The role of the user within the medical device design and development process: medical device manufacturers' perspectives. BMC Medical Informatics and Decision Making, 11(15), doi:10.1186/1472-6947-11-15
DOI https://doi.org/10.1186/1472-6947-11-15
Keywords user requirements, medical devices, human factors, regulation, industry, interviews
Publisher URL http://www.biomedcentral.com/1472-6947/11/15
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

Files

1472-6947-11-15.pdf (488 Kb)
PDF

Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





Downloadable Citations