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Journal cover: The TQM Journal

The TQM Journal

ISSN: 1754-2731
Previously published as: The TQM Magazine

Online from: 2008

Subject Area: Managing Quality

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Quality and continuous improvement in medical device manufacturing

Document Information:
Title:Quality and continuous improvement in medical device manufacturing
Author(s):Alan Brown, (Northern Ireland Bioengineering Centre (NIBEC), University of Ulster, Newtownabbey, UK), Julie Eatock, (School of Information Systems, Computing and Mathematics, Brunel University, Uxbridge, UK), Dorian Dixon, (Northern Ireland Bioengineering Centre (NIBEC), University of Ulster, Newtownabbey, UK), Brian J. Meenan, (Northern Ireland Bioengineering Centre (NIBEC), University of Ulster, Newtownabbey, UK), John Anderson, (Northern Ireland Bioengineering Centre (NIBEC), University of Ulster, Newtownabbey, UK)
Citation:Alan Brown, Julie Eatock, Dorian Dixon, Brian J. Meenan, John Anderson, (2008) "Quality and continuous improvement in medical device manufacturing", The TQM Journal, Vol. 20 Iss: 6, pp.541 - 555
Keywords:Leadership, Lean production, Medical appliances, Six sigma, Total quality management
Article type:Research paper
DOI:10.1108/17542730810909329 (Permanent URL)
Publisher:Emerald Group Publishing Limited
Acknowledgements:The authors acknowledge Dr Michael Craven at the University of Nottingham who designed the in-depth interview instrument and all MATCH colleagues who conducted interviews. The authors acknowledge support of this work through the UK MATCH Programme (EPSRC Grant GR/S29874/01), although the views expressed are entirely their own.

Purpose – The purpose of this paper is to compare a range of quality and continuous improvement strategies and to investigate whether there is a best choice of strategy for use within the medical devices sector.

Design/methodology/approach – A brief literature-based review of a number of continuous improvement strategies. Comparison of these strategies and a subsequent discussion of the rationale that guides the choice of strategy based on the prevailing conditions. An overview of this process in the context of the medical devices sector is provided.

Findings – Quality and continuous improvement strategies can be differentiated in terms of their cultural or process focus. Moreover, the favoured leadership style of an organisation may play a part in determining which strategies are likely to be most appropriate. From the medical device and healthcare product perspective, regulatory and purchasing considerations will have a role in determining the strategy adopted.

Practical implications – For managers seeking to implement a strategy for continuous improvement, a review of organisational leadership styles may help the decision–making process. For the medical devices sector, in particular, the need to align the strategy adopted with regulatory requirements is perhaps self-evident. However, only by a detailed understanding of the issues involved in continuous improvement, can all of the attendant benefits be gained.

Originality/value – The paper proposes a link between a given organisation's favoured leadership style and the applicability of a particular continuous improvement strategy. The implications for the medical device and healthcare technologies sector are specifically addressed.

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