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, 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.

Statistical Tolerance Analysis—A Survey on Awareness, Use and Need in German Industry

“…PAGE investigates in [48] the use of tools in tolerancing in the medical device industry, and companies from the aviation industry were also included in the survey. An online survey, which followed several telephone interviews, found that statistical tolerance analyses were rarely applied among engineering design departments in the medical sector.…”