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.
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.
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.