Integration of technology and inspection planning for cost-optimized production processes of medical devices

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Changing legal requirements and shorter product life cycles are increasingly forcing companies to adapt their products and their production. The increasing number of adaptations poses a particular challenge for medical technology, as both products as well as manufacturing and inspection processes have to be recertified after adaptations. For the planning of manufacturing and inspection, this means that criteria and efforts for a successful certification must be integrated into the planning process in order to make adaptions economical. As a result, there is a need for systematic methods to support technology and inspection planning in medical technology. The relevance of the challenge described is emphasized by the strong growth of the medical technology industry. However, there are no methodologies supporting technology and inspection planners in adapting the production regarding future certifications of medical devices so far. Another special feature of medical technology is the high proportion of inspection costs in production costs. This results from the legal obligation of a complete proof of functionality. In order to use cost optimization potentials it is necessary to plan the use ofmanufacturing and inspection technologies in an integrative manner. Therefore, all methods to be developed in the planned research project will have an integrative character. In addition, cost saving potentials result from the use of process data based prognosis models for predicting component characteristics. These offer the potential to substitute inspections in order to reduce production costs. However, for the use of prognosis models in medical technology, there is a lack of methodological principles on how to design and implement them to meet the requirements of certification. The firstobjective of the research project is the development of a methodology for the systematic adaptation of manufacturing and inspection sequences in response to a component adaption. The methodology to be developed comprises the derivation of adaptation alternatives for the existing manufacturing and inspection sequence, the analysis ofchange propagation within these and the economic evaluation of the analyzed adaptation alternatives. The methodology thus forms an important part for the cost-optimized production of medical technology components. The second objective of the research project is the development of a methodology for the design and application of prognosis models in manufacturing and inspection sequences for medical devices. Using this methodology, technology and inspection planners are supported in designing prognosis models so that they are potentially suitable for substituting expensive inspection processes in the future and can thus reduce the production costs for medical technology components.