Nowadays, the development of new products implies the interaction of different engineering and non-engineering disciplines in order to fulfill the amount of requirements and specification. Each discipline has its own language and methods. Therefore, Systems Engineering (SE) has become an important discipline to technically coordinate these kind of complex projects and to assure the success of the projects. This presentation will describe the methodology of Model Based Systems Engineering (MBSE) for medical devices based on the V-Model. For each phase the methods are described that are required to successfully drive a project. The main focus hereby is on the functional modeling and physical modeling of a medical device. Using the example of an insulin delivery system the presentation will illustrate the advantages of MBSE with respect to time schedule and cost reduction, changes of specification or the implementation of algorithms for diagnostics purpose.

Thomas M. Rudolf is Visitant Professor in the Department of Industrial & Operations Engineering at ITAM. Thomas is a mechanical engineer from the University of Darmstadt and specializes in Mechatronics. He focuses his studies on dynamic behavior of mechatronic systems, control theory and identification of systems. He graduated in May 2005 as Master in Mechanical and Process Engineering. During the following six years, he worked as a research assistant and project manager at the Laboratory of Machine Tools and Process Engineering, at RWTH University Aachen. During this time he developed his doctoral investigation. Later in 2011, he continued his professional carrier at Roche Diagnostics as a Systems Engineer with focus on simulation and calculation.