Date of Award
Master of Science (MS)
Joshua D. Summers, Committee Chair
Mary Elizabeth Kurz
This case study explores requirements evolution of a multimillion-dollar medical device under development for cancer therapy. The study focuses on the analysis of requirements across a twelve month window via interviews with involved parties and document analysis of the company's design requirements. Three engineering directors (mechanical, software, and systems) were interviewed contemporaneously with the analysis of eight revisions to the design functional specifications, consisting of over 1,000 total design requirements. Significant requirement change was observed and associated with 1) change in requirements leadership, 2) market strategy including scope towards regulatory approval, and 3) requirement learning curve with respect to writing testable requirements. From analysis of the interview transcripts and company requirement evolution, a requirements culture emerged highlighting a need for greater understanding of company requirements cultures in situ. Further, analysis of the company's biomedical requirement behavior align with those found in the avionics and automobile industries suggesting requirements evolution, and therefore problem understanding, occur similarly irrespective of domain or problem size.
DelSpina, Brandon Matthew, "Requirement Culture at a Large Scale Medical Device Developer: A Case Study" (2017). All Theses. 2617.