The nonfunctional requirement focus in medical device software: a systematic mapping study and taxonomy

This paper describes the results and analysis of a systematic mapping study of research focusing on the nonfunctional requirements in software intensive medical devices. The review covered 238 journal papers from five digital libraries. The 55 papers that met the review inclusion criteria focused on 22 NFRs, each describing a unique system behavior quality. The most dominant of these NFRs were interoperability,usability,performance,security, privacy, safety, and accuracy. A noticeable NFR gap is the notion of caring. It is not readily apparent how a medical device that monitors a patient or delivers medications or anesthetics can “care about” the sufferings, feelings and emotional needs of a patient; however, in the healthcare arena these are valid concerns. A second theme found in the papers reviewed focused on software standards/process improvement when developing software intensive medical devices. This research also provides an analysis of the software architecture tactics those researchers utilized to implement the NFRs in the medical devices.