A study into the use of tolerance analysis in the mechanical design of medical devices

Tom Page
2015 International Journal of Design Engineering  
Citation: PAGE, T., 2015. A study into the use of tolerance analysis in the mechanical design of medical devices. Abstract 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,
more » ... ty, 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.
doi:10.1504/ijde.2015.076376 fatcat:cyj5t2uqkvfyla4jfeuu4rfxli