Optimizing the innovation and development process of medical devices - a study based on angiographic equipment

Cardiovascular diseases are the leading cause of death. The gold standard for their diagnosis and treatment are angiographic procedures, which require specialized equipment. The speed of their continued development is important as better technology enables progress in clinical outcomes. This article proposes a new process model for the innovation and development and shows how to optimize it such that it takes minimal time. The conducted literature research identifies this closed loop process model as being unique in comparison to the well-established models proposed by Brockhoff, Cooper, Crawford, Durfee, Ebert, Eppinger, Hughes, Pleschak, Thom, Ulrich, Vahs and Witt. During a long-term observation of the innovation and development process of angiographic systems 672 data sets on 302 topics were collected over 47 months to validate this process model. The data collected is equivalent to efforts worth 30 man-years. This input was used to calculate key process parameters, analyse key process roles, evaluate the use of problem-solving methods and identify key technologies. We recommend to apply a continuous loop process in the context of innovation and development of medical devices. In the analysed datasets a potential of an up to 20% shorter process time was identified. Our results can be used for an Activity Based Costing Approach or be applied to bring new or upgraded angiography systems faster to market benefitting patient outcome due to improved diagnosis and treatment. According to the best knowledge of the authors no comparable data collection relating to angiography systems has been performed and presented anywhere else yet.