Abstract:

Traditional quality management (QM) methodologies used by medical device (MD) companies have been criticized for hindering radical innovation, as they tend to prioritize risk aversion over fostering innovation. Scholarly research suggests that process-centric approaches result in only incremental innovations, increased bureaucracy, and a disconnect between various processes. As a result, MD companies often face product recalls due to design flaws, manufacturing defects, software malfunctions, and inadequate traceability from requirements to testing, all of which can negatively impact patients. In contrast, Quality 4.0 (Q4.0) concepts and technologies representing radical innovation could potentially improve conventional QM practices within MD companies. Researchers argue that exploration practices can help organizations tackle future challenges, such as adopting Q4.0, while exploitation practices ensure compliance and the maintenance of current operations. However, balancing exploitation and exploration within a QM system designed for incremental innovation or exploitation is challenging for MD companies aiming to adopt Q4.0. This challenge stems from the competition for resources between exploitation and exploration activities, which typically require different mindsets, management styles, and strategies. Consequently, failing to manage the tension between these activities can undermine an organization's change initiatives. Yet the academic literature on Q4.0 has not addressed this paradox and remains largely silent on the issue. Therefore, this study explores how Danish MD companies are balancing exploitation activities in their current operations while moving towards Q4.0 readiness. The research plans to conduct semi-structured interviews with quality practitioners within Danish MD companies.

Please choose your submission type: Developmental Paper

Primary Track: Organisational Transformation, Change and Development

Keywords: Change Management

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Mr. Stanley Mauro Jensen

Biography