Bioanalytical Device Design With Model-Based Systems Engineering Tools

Development of bioanalytical devices requires a multidisciplinary team working together. In the current article, the model-based systems engineering (MBSE) methodology is applied for the design of a bioanalytical device, in order to create a unique system model with consistency of model elements and relations. This allows a multidisciplinary team to work together in order to define and develop the overall system, from bio/chemical processes to software, hardware, and mechanics; for example, scientists may express bio/chemical events in the system model in a way that the design engineers understand the process and requirements, learn the constraints, and develop the system accordingly. In the article, a tailored version of the object-oriented systems engineering method modeling method was used together with systems modeling language. The major steps of the modeling method utilized include define problem, define context level, define technical requirements, define logical level, and define physical level. The modeling method developed for the article may be used as a base for the development of bioanalytical devices. There is a market push to develop new bioanalytical devices, such as point of care sensors. It is believed that the transformation of the product lifecycle process from document centric to MBSE will provide a competitive advantage to the life sciences industry.