Physikingenieurwesen (PHY)
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- Conference Proceeding (4) (remove)
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- 3d-printing (1)
- CMS (1)
- V&V 40 (1)
- biomedical sensing application (1)
- computational modeling and simulation (1)
- laser powder bed fusion (1)
- material extrusion (1)
- metal additive manufacturing (1)
- model credibility (1)
- validation (1)
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This study presents a comprehensive evaluation of force sensors manufactured through conventional CNC machining, laser powder bed fusion (LPBF), and material extrusion (MEX) 3D printing methods. The study utilized a combination of finite element method (FEM) simulations, functional testing, durability assessments, and ultimate strength testing in order to assess the viability of additive manufacturing for sensing technology applications. The FEM simulations provided a preliminary framework for predictive analysis, closely aligning with experimental outcomes for LPBF and conventionally manufactured sensors. Nevertheless, discrepancies were observed in the performance of MEX-printed sensors during ultimate strength testing, necessitating the implementation of more comprehensive modeling approaches that take into account the distinctive material characteristics and failure mechanisms. Functional testing confirmed the operational capability of all sensors, thereby demonstrating their suitability for the intended application. Moreover, all sensors exhibited resilience during 50,000 cycles of cyclic testing, indicating reliability, durability, and satisfactory fatigue life performance. Notably, sensors produced via LPBF exhibited a significant increase in strength, nearly three times that of conventionally manufactured sensors. These findings suggest the potential for innovative sensor design and the expansion of their use into higher-loaded applications. Overall, while both LPBF and conventional methods demonstrated reliability and closely matched simulation predictions, further research is necessary to refine modeling approaches for MEX-printed sensors and fully unlock their potential in sensing technology applications. These findings indicate that additive manufacturing of metals may be a viable alternative for the fabrication of biomedical sensors.
Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.
The use of computational modeling and simulation (CMS) as a tool for gaining insight into the technical performance and safety of medical devices has emerged continuously over the past years. However, to rely on information and decisions derived from model predictions, it is essential to establish model credibility for the specific context of use. Limited regulatory requirements and lack of consensus on the level of verification and validation activities required result in rare use of CMS as a source of evidence in the medical device approval process. The American Society of Mechanical Engineers (ASME) developed a risk-informed framework to establish appropriate credibility requirements of a computational model: the ASME V&V 40?2018 standard. This paper aims to outline the concepts of this standard and to demonstrate its application using an example from the orthotics field. The necessary steps to establish model credibility for a custom?made 3D printed wrist hand orthosis (WHO) are presented. It is shown that the credibility requirements of each verification and validation activity depend on model risk by applying two different contexts of use to the same computational model.