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Human factors in the design of medical devices – approaches to meeting international standards in the European Union and USA

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journal contribution
posted on 07.10.2016 by Mary Privitera, Mark Evans, Darren Southee
This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analysed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the attitude of clinical users directly impacting on the device developer's invitation to participate in the development processes. The barriers presented in this research have the potential to be resolved but only with greater commitment by both medical device users and developers.

History

School

  • Design

Published in

Applied Ergonomics: human factors in technology and society

Volume

59 Part A

Pages

251 - 263

Citation

PRIVITERA, M.B., EVANS, M.A. and SOUTHEE, D.J., 2017. Human factors in the design of medical devices – approaches to meeting international standards in the European Union and USA. Applied Ergonomics, 59, Part A, pp. 251-263.

Publisher

© Elsevier

Version

AM (Accepted Manuscript)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence. Full details of this licence are available at: https://creativecommons.org/licenses/by-nc-nd/4.0/

Acceptance date

29/08/2016

Publication date

2017

Notes

This paper was published in the journal Applied Ergonomics and the definitive published version is available at http://dx.doi.org/10.1016/j.apergo.2016.08.034.

ISSN

0003-6870

Language

en

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