Modeling requirements: The customer communication

This paper describes the results of six years of experience in eighteen real-world projects in two companies of using models, primarily Unified Modeling Language-based models, to gather, review, record and communicate product definition solution requirements for customers in the medical device industry. The motivation for this approach was a response to ineffective projects that documented requirements in the traditional text format of “The system shall...”. In an attempt to both increase the quality of communication and fit with the rapid cycles of an agile-based project structure, a primarily graphical-based technique was used. The use of multiple models for the business requirements versus a single text document made communication across many business groups easier and decreased review time dramatically. The ISO RM-ODP standard was used to keep the focus of the business requirements models at the Enterprise, Information and Computation viewpoints. The use of multiple graphical models emulates the techniques of architects as they extract, document and present a building´s requirements. The graphical modeling-based formats and agile-based project techniques of this approach produced successful in-production solutions, which have been validated to FDA compliance standards.