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

不断变化的法律的要求和更短的产品生命周期正日益迫使公司调整其产品和生产。越来越多的调整对医疗技术提出了特别的挑战，因为产品以及制造和检查过程都必须在调整后重新认证。对于制造和检验的规划，这意味着成功认证的标准和努力必须整合到规划过程中，以使适应经济。因此，需要系统的方法来支持医疗技术中的技术和检查规划。医疗技术行业的强劲增长强调了所述挑战的相关性。然而，到目前为止，还没有方法支持技术和检查计划人员适应医疗器械未来认证的生产。医疗技术的另一个特点是检查费用在生产成本中所占的比例很高。这是由功能完整证明的法律的义务所导致的。为了利用成本优化潜力，有必要以综合的方式规划制造和检测技术的使用.因此，在计划的研究项目中开发的所有方法都将具有综合性。此外，成本节约的潜力来自于使用基于过程数据的预测模型来预测部件特性。这些提供了替代检查的可能性，以降低生产成本。然而，对于预后模型在医疗技术中的使用，如何设计和实施以满足认证要求，缺乏方法论原则。该研究项目的第一个目标是开发一种方法，用于系统地适应制造和检测序列，以响应组件的适应。待开发的方法包括现有的制造和检验序列的适应替代品的推导，这些和分析的适应替代品的经济评价的变化传播的分析。因此，该方法是医疗技术组件成本优化生产的重要组成部分。该研究项目的第二个目标是开发一种方法，用于设计和应用医疗器械制造和检查序列中的预后模型。使用这种方法，技术和检查规划人员在设计预后模型时得到支持，以便它们可能适合在未来替代昂贵的检查过程，从而降低医疗技术组件的生产成本。

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.