CORPORATE REQUIREMENT CULTURE IN DEVELOPMENT OF A LARGE SCALE MEDICAL SYSTEM: A CASE STUDY

DS 92: Proceedings of the DESIGN 2018 15th International Design Conference

Year: 2018
Editor: Marjanović D., Štorga M., Škec S., Bojčetić N., Pavković N.
Author: DelSpina, Brandon; Gilliam, Sarah; Summers, Joshua; Morkos, Beshoy
Series: DESIGN
Section: SOCIOTECHNICAL ISSUES IN DESIGN
Page(s): 2621-2632
DOI number: https://doi.org/10.21278/idc.2018.0521

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.

Keywords: engineering change, requirements management, engineering design

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