Transforming Medical Device Development Using Simulation
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The document outlines Vias' expertise in medical device product development, emphasizing the advantages of realistic simulation using Simulia to reduce costs and improve design accuracy. It details various simulation capabilities and case studies, including knee implants and heart valve optimization, showcasing the efficacy of simulation in accelerating the development process. Vias aims to enhance the safety and effectiveness of medical devices through advanced modeling and simulation techniques.
Transforming Medical Device Development Using Simulation
- 1. TRANSFORMING MEDICAL DEVICE PRODUCT DEVELOPMENT – VIAS EXPERIENCE September 2017 1400 Broadfield Blvd. Suite 325, Houston TX 77084 Phone : +1 (832) 301-0881 www.viascorp.com 1 Arindam Chakraborty, Ph.D., P.E. VP- Advanced Engineering, VIAS
- 2. Outline © 2017 Virtual Integrated Analytics Solutions Inc. 2 • VIAS Overview • Realistic Simulation with SIMULIA ▪ What is Realistic Simulation ▪ What can Simulation Convey? ▪ Simulation vs Physical Testing ▪ SIMULIA Capabilities for Life Sciences • Medical Device Development with Simulation ▪ Abaqus Knee Simulator (AKS) • Case Studies ▪ Knee Implant Simulation using AKS ▪ Simulation of Joint Forces due to Exoskeleton Structure ▪ Simulation of Device Collapse under Pressure ▪ Heart Valve- Weld Parameter Optimization • Conclusion
- 3. VIAS Overview Engineering Consultancy Training Automation & Customization Software © 2017 Virtual Integrated Analytics Solutions Inc. • Multiple Industry Experience • Presence in Houston, Chicago, Cincinnati, San Francisco, Detroit • Team consists of Ph.D. and Masters in Solid Mechanics, Fluid Mechanics, Materials and Corrosion, Numerical Analysis, Statistics; Optimization and Reliability • Solution partner of Dassault Systèmes SIMULIA products – Abaqus, Isight, fe-safe, Tosca • Provides Virtual Design Experience through Collaboration and Data Analytics – Provides Automation and Customization • Provide 3D Printing and AM Simulation Services 3
- 4. Our Technical Capabilities © 2017 Virtual Integrated Analytics Solutions Inc. Design Analysis and Virtual Testing using Simulation Fatigue / Fracture / Damage Optimization and Reliability Multi-physics Simulations (CFD, EMAG, FSI) Composite and Elastomer Modelling Additive Manufacturing Simulation Simulation Automation Patient Specific Simulation 4
- 5. REALISTIC SIMULATION WITH SIMULIA 5
- 6. © 2017 Virtual Integrated Analytics Solutions Inc. “Realistic Simulation” is a simulation that is physically realistic and “life like” in every way 6 What is Realistic Simulation • Reduces Physical Testing • Save Time and Money • Improve Quality
- 7. © 2017 Virtual Integrated Analytics Solutions Inc. Know your products and processes… and improve them! Is my product safe? How long will my product last? How can I make it last longer? Will my product work as I intended it to? Will it break if I drop if from 1m? From 2m? From 10m? How can I make it lighter without sacrificing performance? Is my development process efficient? How can I accelerate the process and get to market faster? Can I use a different material and still get good results? What type of packaging will work best for my device? 7 What can Realistic Simulation Convey?
- 8. © 2017 Virtual Integrated Analytics Solutions Inc. Physical Testing • Very expensive (often $100Ks/test) • Time consuming (weeks or months) • Can only be done in an expensive lab • Requires sophisticated equipment • Can only be done at certain times • Says what happened (“pass/fail”), but not why Realistic Simulation • Cheap • Quick (minutes or hours) • Can be done anywhere • Uses only a computer and software • Can be done 24/7/365 • Says what happened AND why Realistic simulation allows validation of products and processes that simply can’t be tested physically! 8 Realistic Simulation vs Physical Testing
- 9. © 2017 Virtual Integrated Analytics Solutions Inc. 9 SIMULIA Capabilities
- 10. © 2017 Virtual Integrated Analytics Solutions Inc. Simulation Process and Data Management Predict and Analyze Product Life • Fatigue Analysis • Durability Prediction fe-safe Process Automation & Design Optimization Isight • Design/Runtime Gateway • Application Components • Process Drivers Continued Technology Leadership & Innovation More Physics, Open Co-Simulation Abaqus • Abaqus/CAE • Abaqus/Standard • Abaqus/Explicit • Abaqus/CFD • CEL, FSI, SPH, EMAG Non-parametric Design Optimization Tosca • Structural & Fluid Flow Optimization • Conceptual & Detailed Design • Topology, Sizing, Shape, Bead Optimization 10 SIMULIA Portfolio for Life Sciences
- 11. © 2017 Virtual Integrated Analytics Solutions Inc. 11 SIMULIA for Life Science Industry Design Exploration Material Choices and Geometries Manufacturing Tolerances Fatigue and Failure Stress Concentration Cyclic loading Patient Specific Realistic Patient Geometries Realistic Loading Conditions Understand Device Effectiveness Device Safety Predict Device Durability, Reliability and Potential Failure Mitigate Reduce Risk of Device Failure in Patients Why?What?How? Realistic Simulation and Durability Evaluation Optimize Device Effectiveness and Safety RoleofRealisticSimulation Faster Better Cheaper
- 12. MEDICAL DEVICE DEVELOPMENT WITH SIMULATION 12
- 13. © 2017 Virtual Integrated Analytics Solutions Inc. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm Current usage of modeling and simulation 13 Medical Device Development Process
- 14. © 2017 Virtual Integrated Analytics Solutions Inc. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm Where modeling and simulation will eventually be used 14 Medical Device Development Process
- 15. © 2017 Virtual Integrated Analytics Solutions Inc. 15 Developing Medical Devices and Processes with Simulation Devices and Processes Joint Replacements and Implants (Knee, Dental, Eye) Stents and Catheters Heart Valves and Pacemakers Surgical Planning Simulation Value Realistic and virtual model development and analysis using ▪ Advanced Material Models ▪ Non-linear large deformations ▪ Robust contact algorithms ▪ Wear Analysis ▪ Fracture and failure analysis
- 16. © 2017 Virtual Integrated Analytics Solutions Inc. Virtual implant testing with patient-specific bone geometry from scan data Patient-specific load data considering personal activity level Forecasting patient-specific long-term behavior (bone remodeling) 16 Simulation of Personalized Implants
- 17. © 2017 Virtual Integrated Analytics Solutions Inc. Abaqus Knee Simulator (AKS) Automated modeling tool to easily build advanced knee implant simulations Based on well-known implant evaluation workflows 17
- 18. © 2017 Virtual Integrated Analytics Solutions Inc. Abaqus Knee Simulator (AKS) 18 Designer Analyst Switch between the two modes
- 19. © 2017 Virtual Integrated Analytics Solutions Inc. AKS Workflows Contact Mechanics Implant Constraint Tibiofemoral Constraint Wear Simulator Basic TKR Loading AKS accepted by FDA as Non-clinical Assessment Model (NAM) for Implant Design Analysis 19
- 20. © 2017 Virtual Integrated Analytics Solutions Inc. Why Now? 20 Technology Regulatory Support Market forces Patient Specific simulations Automation, optimization, and variational studies Greater fidelity HPC Imaging to Simulation
- 21. CASE STUDIES 21
- 22. © 2017 Virtual Integrated Analytics Solutions Inc. Knee Implant Simulation using AKS 22 Motion Capture Data Kinematics Inverse Dynamic Model Joint forces Patient- specific load data considering personal activity level
- 23. © 2017 Virtual Integrated Analytics Solutions Inc. Knee Implant Simulation - Material Modelling 23 • Bone modelled as isotropic and linear elastic material • Cartilage generally modelled as isotropic, hyper-elastic material • Shear modulus/Young’s modulus generally obtained from empirical relationships • Soft-tissue material properties depend on factors, such as synovial fluid, age and level of activity, and vary among individuals • Neo-Hookean hyper-elastic material properties are generally used to represent ligaments • Muscles/ soft tissue generally modeled as a homogenous, isotropic, quasi-incompressible or hyper- elastic material
- 24. © 2017 Virtual Integrated Analytics Solutions Inc. Knee Implant Simulation using AKS- Simulation Results 24 • Stresses induced within the knee implants • Joint Contact Area and Contact forces for daily activities like • Gait • Deep Squat • Step-Down
- 25. Simulation of Joint Forces Due to Exoskeleton Structure © 2017 Virtual Integrated Analytics Solutions Inc. • FE model of entire limb developed with simplified axial connectors (simulates muscles / muscle contractions) and detailed bone geometry. • Knee joint simulated as a modified hinge joint with 3 DOFs. • Ligaments modelled as 3D structures that allows wrapping over bone surfaces. • Exoskeleton structure modeled around knee joint. • Musculoskeletal kinematics applied to the entire model. • Stresses induced at knee joint as a result studied and exoskeleton knee device design modified to fit patient specific requirements. Upper Brace Lower Brace Flexible Linking Structure
- 26. Collapse under Pressure - Design using Virtual Test © 2017 Virtual Integrated Analytics Solutions Inc. 26 • Simulate collapsing of the device using non- linear FEA simulation due to elevated external pressure. • From FEA results, determine the required pressure to collapse the device. • Validate FEA model with observed pressures in testing. • Use validated model to optimize the geometry of the device to allow closure at different external pressure values. • Minimize prototype testing.
- 27. Heart Valve – Weld Parameter Optimization © 2017 Virtual Integrated Analytics Solutions Inc. 27 • Simulate laser welding process of the impeller cap welds that subsequently distorts the impeller within the HVAD heart pump. • Analyze • Heat distribution due to welding process • Residual stress field within welds • Validate model and predicted results with actual physical data. • Numerical exploration of various welding process parameters to minimize the distortions at the critical regions of the impeller. Residual Stresses
- 28. Heart Valve – Weld Parameter Optimization © 2017 Virtual Integrated Analytics Solutions Inc. 28 • Stress and strain field at the end of cooling after completion of welding gives an idea of distortion within the impeller geometry. • Welding parameters controlled to minimize residual stresses and thereby distortion. The parameters include: ▪ Energy input per pulse ▪ Pulse frequency ▪ Duration of single pulse ▪ Torch speed ▪ Weld spot diameter ▪ Pulse shape ▪ Cooling rate
- 29. IN CONCLUSION 29
- 30. © 2017 Virtual Integrated Analytics Solutions Inc. Accelerate innovation Design and develop more effective products – better performing and more durable Improved comfort levels for users or patients – more than would be otherwise possible Evaluate scenarios that would be difficult if not impossible to assess Accelerate progress towards personalized solutions 30 Why Simulate Product-Life Interactions?
- 31. © 2017 Virtual Integrated Analytics Solutions Inc. How can we help you? 31
- 32. © 2017 Virtual Integrated Analytics Solutions Inc. Thank you 32