Corporate Requirement Culture in Development of a Large Scale Medical System: A Case Study

Abstract

This case study explores requirements evolution of a medical device system. The study focuses on the analysis of requirements via interviews and document analysis. The mechanical, software, and systems engineering directors were interviewed regarding eight revisions to the design specifications (>1000 total design requirements). Findings suggest 1) change in requirements leadership, 2) market strategy, and 3) requirements writing may lead to requirements change. From analysis, a requirements culture emerged highlighting a need for greater understanding of company requirements cultures in situ.

Part Change Management: A Case Study on Automotive Engineering and Production; Domestic and International Perspectives

“…The views and perceptions of participants within the process are critical for understanding the rationale associated with any process deviations. This approach has been used for understanding other aspects of engineering design, such as the research culture [44,45], change management in automation and manufacturing [34,46], and capstone design effectiveness [47,48]. Alternative approaches in case study research in engineering design are more generally focused on document analysis, focusing on the objectivity of analyzing existing information rather than seeking to extract potential explanations or perceptions.…”