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

Authors: Tom Page

Addresses: Loughborough University, LE11 3TU, UK

Abstract: The medical device industry has become the most regulated design sector and despite this, the adoption of tolerance analysis is scarce. The objective of his research was to identify barriers to the adoption of tolerance analysis in the medical device industry. This was done with a view to establishing a methodology to increase the use of tolerance analysis, consequently improving product quality, reliability, cost-effectiveness and patient care. The methods used here, comprised telephone interviews and questionnaires to collect qualitative and quantitative data from industry professionals. Findings were obtained from three companies that provided detailed qualitative responses highlighting that complexity and lack guidance were the industry specific factors deterring the use of the tolerance analysis. This work concludes that the primary barrier deterring the widespread adoption of tolerance analysis was the confusion caused from a lack of guidance in is adoption. An application of this research is the development of a procedure workflow checklist to aid designers through the often misunderstood process of performing a tolerance analysis study.

Keywords: medical device design; tolerance analysis; mechanical design; medical devices; barriers; procedure workflow checklist; design process.

DOI: 10.1504/IJDE.2015.076376

International Journal of Design Engineering, 2015 Vol.6 No.2, pp.116 - 139

Received: 15 Nov 2014
Accepted: 24 Sep 2015
Published online: 05 May 2016 *

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