Integrative Technology and Inspection Planning of Medical Devices

Klocke, Fritz; Müller, Johannes; Mattfeld, Patrick; Kukulies, Jan; Stauder, Jens

doi:10.1016/j.procir.2016.05.097

Cited by 5 publications

(1 citation statement)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although this represents a systematic procedure, the effort involved in generating completely new process chains to identify alternative MCs is excessively high. Validation efforts are not taken into account [17]. Similar approaches with a different focus but the same deficits for the identification of alternative MCs for safety-critical components were developed by Müller [18] and Schindler [19].…”

Section: State Of Research Regarding the Identification Of Alternativmentioning

confidence: 99%

Methodology for the identification of alternative manufacturing changes for safety–critical components

Bergs

Hermann

Rey

et al. 2020

Prod. Eng. Res. Devel.

View full text Add to dashboard Cite

A variety of factors are forcing companies to change their products and the components these products are composed of. Examples of current factors are changing customer requirements, product optimizations or ever-shorter product lifecycles. These component changes, particularly in safety-critical components in the medical and aerospace industry, pose great challenges and are limited in scope. The challenges and limitations arise from the high costs and the amount of time involved in component recertification as required by law, as well as revalidations of the manufacturing after a change has been implemented. Some component changes are even mandatory. In this case there are no options for reducing recertification efforts by choosing between different design changes. In contrast, there are alternative manufacturing options with which to implement the prescribed component changes that can reduce the amount of revalidation required on the manufacturing side. Due to the fact that changes to the manufacture of safety-critical components require validation, the existence of alternative manufacturing changes offers the potential to save time and money by selecting the best-suited alternative. In order to be able to select the best-suited alternative, all alternative manufacturing changes must be known, which poses a challenge for technology planners dealing with the complex manufacture of safety-critical components. Therefore, a methodology is introduced to support technology planners in identify alternative manufacturing changes with which to implement scope-restricted changes to safety-critical components. The methodology is validated by applying it to a case study from the medical industry.

show abstract

Section: State Of Research Regarding the Identification Of Alternativmentioning

confidence: 99%

Methodology for the identification of alternative manufacturing changes for safety–critical components

Bergs

Hermann

Rey

et al. 2020

Prod. Eng. Res. Devel.

View full text Add to dashboard Cite

show abstract

Robust technology chain design: considering undesired interactions within the technology chain

Klocke

Mattfeld

Stauder

et al. 2017

Prod. Eng. Res. Devel.

View full text Add to dashboard Cite

Integrative Technology and Inspection Planning—A Case Study in Medical Industry

Klocke

Müller

Mattfeld

et al. 2018

Journal of Manufacturing Science and Engineering

View full text Add to dashboard Cite

In most trendsetting industries like the aerospace, automotive and medical industry functionally critical parts are of highest importance. Due to strict legal requirements regarding the securing of the functionality of high-risk parts, both production costs and quality costs contribute significantly to the manufacturing costs. Thus, both types of 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 and inspection strategies is extremely complex. Furthermore, the effects of inspection strategies and quality costs on the planning of manufacturing process sequences cannot be modeled to date. As a consequence, manufacturing and inspection processes are designed separately and thus a high cost reduction potential remains untapped. In this paper, a new approach for an integrative technology and inspection planning is presented and applied to a case study in medical industry. At first, existing approaches with regard to technology and inspection planning are reviewed. After a definition of relevant terms, the case study is introduced. Following, an approach for an integrative technology and inspection planning is presented and applied to the case study. In the presented approach, the complex causalities between technology planning, manufacturing history, and inspection planning are considered to enable a cost-effective production process and inspection sequence design.

show abstract

Integrative Technology and Inspection Planning of Medical Devices

Cited by 5 publications

References 17 publications

Methodology for the identification of alternative manufacturing changes for safety–critical components

Methodology for the identification of alternative manufacturing changes for safety–critical components

Robust technology chain design: considering undesired interactions within the technology chain

Integrative Technology and Inspection Planning—A Case Study in Medical Industry

Contact Info

Product

Resources

About