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

集成技术和检验计划，实现医疗器械成本优化的生产流程

• 批准号: 323577145
• 负责人: Professor Dr.-Ing. Thomas Bergs
• 金额: --
• 依托单位: Werkzeugmaschinenlabor - WZL
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2019-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/323577145?language=en
• 关键词: Integration; technology; inspection; planning; cost

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.

不断变化的法律要求和更短的产品生命周期正越来越多地迫使公司调整其产品和生产。不断增加的改装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改装后重新认证。对于制造和检验的规划，这意味着必须将成功认证的标准和努力纳入规划过程，以便使适应变得经济。因此，需要有系统的方法来支持医疗技术中的技术和检查计划。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，还没有方法来支持技术和检验规划者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成本在生产成本中所占比例很高。这是由完整的功能证明的法律义务造成的。为了利用成本优化潜力，有必要对制造和检验技术的使用进行综合规划。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，由于使用基于过程数据的预测模型来预测部件特性，因此具有节省成本的潜力。这些措施提供了替代检查以降低生产成本的潜力。然而，对于预测模型在医学技术中的应用，如何设计和实施预测模型以满足认证要求，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，以系统地适应制造和检验序列，以响应部件适应。将制定的方法包括为现有的制造和检查程序推导适应替代方案，分析这些方案中的变化传播，以及对分析的适应替代方案进行经济评估。因此，该方法构成了医疗技术部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，用于在医疗器械的制造和检验序列中设计和应用预测模型。使用这种方法，技术和检查规划者在设计预测模型时得到支持，因此它们可能适合于在未来取代昂贵的检查过程，从而可以降低医疗技术部件的生产成本。