Verification of Integrated Computational Material Engineering for Virtual Life Management® of Medical Devices S. Kulkarni*, R. Tryon#, K. Merdan*, G. Krishnan# ASTM Third Symposium on Fatigue and Fracture Metallic Medical Materials and Devices
• Computation methods are available to determine blue line (loads) • Red line (capacity) is traditionally determined with lots and lots of testing • ICME determines red line using computational methods and less testing
MP35N Lead VT Objective Demonstrate VLM Technology • Ability to predict product durability under varying conditions • Provide understanding of technology and the benefits of VT Simulators
Specifically….. • Simulate fatigue buckling test under 2 load conditions • Conduct Sensitivity Studies around principal durability drivers • Provide opportunity to compare predicted trends against known trends
Condition 2: B” Von Mises Stress; Max Stress=YY ksi
MP35N Coil Simulation Set-up • • • •
Define geometry and stress with FEA Define microstructure with metallography Run Simulation Calibrate to residual stress profile with experimental data
– Residual Stress – 10% improvement yields 60% improvement in mean total life – Inclusion Size – 50% smaller inclusion size yields 25% improvement in mean total life – Inclusion Density- 50% lower inclusion density; No significant impact – Trade-off threshold exists between residual stress and inclusion size
Global Perspective and Summary •
Able to Characterize MP35N lead design • Material Microstructure (grain size, inclusion size and density) • Residual Stress
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Developed Insights • Concept or design alternatives • Material substitution or vendor management
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Potential application of VLM • Sensitivity analysis • Design trade studies • Supplier controls • Design optimization • Next Steps – new materials and new designs