Integrative Technology and Inspection Planning of Medical Devices

Medical devices show great promise for future medicare. Due to strict legal requirements to ensure the functionality of high-risk medical devices, both manufacturing costs and quality costs contribute significantly to total production costs. Thus, quality costs have to be taken into consideration during the stage of technology planning. Due to the high variety of potential interactions between individual component properties as well as between component properties and manufacturing processes, the analysis of the influence of the manufacturing history on an efficient design of inspection processes is extremely complex. Furthermore, the effects of test strategies and quality costs on the planning of manufacturing process sequences can not be modeled to date. As a consequence, manufacturing and testing processes are designed separately and thus a high cost reduction potential remains untapped.In this paper an approach for an integrative technology and inspection planning is presented. At first, existing approaches with regard to technology and inspection planning are reviewed. Afterwards, a model to depict the manufacturing history including alternative inspection pro-cesses will be introduced. On the basis of this descriptive model a mathematical model to determine the expected production costs of alternative technology and test sequences will be developed. Thus, the complex causalities between technology planning, manufacturing history and inspection planning are systematically explained by analytical models enabling a cost-effective, integrative technology and inspection planning.