PAGE, T., 2015. A study into the use of tolerance analysis in the mechanical design of medical devices. International Journal of Design Engineering, 6(2), pp.116-139.
The medical device industry is fast becoming the most regulated design sector, despite this
evidence; the employment of tolerance analysis is scarce. Research conducted into tolerance analysis in
the medical device industry and the barriers affecting its use would provide methodology to increase the
use of tolerance analysis, consequently improving product quality, reliability, cost-effectiveness and patient
care. Telephone interviews and questionnaires were used to collect both qualitative and quantitative
research from industry professions. Three industries provided detailed qualitative responses highlighting
that complexity and lack guidance were the industry specific factors deterring the use of the tolerance
analysis. Research indicated that the primary barrier deterring the wide spread adoption of tolerance
analysis was the confusion caused from a lack of guidance. This encouraged the development of a
procedure workflow checklist to aid designers through the often misunderstood process of performing a
tolerance analysis study.
This paper was accepted for publication in the journal International Journal of Design Engineering and the definitive published version is available at http://dx.doi.org/10.1504/IJDE.2015.076376