Quality and continuous improvement in medical device manufacturing

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.

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.

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.

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.

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.