Life Sciences & Medical Devices Simulation Services
Computer Modeling and Simulation (CM&S) plays a key role in accelerating medical device development by reducing reliance on physical testing and shortening time to market. Regulatory bodies such as the FDA and EMA increasingly recognize simulation as an essential component of the development process, alongside bench testing, in vitro studies, and in vivo validation.
At 12Simulate, we deliver advanced multi-physics simulation solutions that support every stage of medical device development, from early concept evaluation to verification, validation, and in silico clinical studies.
Core Life Sciences Capabilities
Structural Mechanical Analyses: Simulation of mechanical behavior in medical devices and biological systems, including deformation, stress distribution, and performance under realistic loading conditions.
Computational Fluid Dynamics (CFD): Analysis of fluid flow behavior within medical devices and biological environments, enabling the study of pressure distribution, flow patterns, and device-fluid interaction.
Fluid-Structure Interaction (FSI): Coupled simulations that capture the interaction between fluid flow and deformable structures, commonly used in cardiovascular and implant device modelling.
Heat Transfer Analyses: Evaluation of thermal behaviour in devices and surrounding biological tissues, including conduction, convection, and thermal regulation.
Coupled Heat-Stress Analyses: Integrated simulations that assess the combined effects of thermal loads and mechanical stress on medical device performance.
Electromagnetic Analyses: Simulation of electromagnetic fields and their interaction with medical devices and biological environments, supporting applications such as imaging, sensing, and therapeutic devices.
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Simulation Driven Design Exploration
Simulation driven design enables engineers to explore design concepts early in development and better understand performance limits. By systematically evaluating design parameters and performance conditions, engineers can identify key design drivers, assess potential risks, and develop optimized and robust solutions that perform reliably throughout the product lifecycle.
Automation and Optimization Capabilities
Parametric Modeling and Structural Analysis Systematic evaluation of design parameters to understand their influence on device performance and structural behavior.
Early Performance and Fatigue Assessment: Prediction of device durability and mechanical performance during the early stages of development.
Design Sensitivity Analysis / Design of Experiments (DoE): Identification of key parameters influencing device behavior and performance.
Statistical and Six Sigma Analysis: Evaluation of design robustness and variability using statistical engineering methods.
Parametric and Non-Parametric Design Optimization: Optimization of device geometry and parameters to improve performance and reliability.
Robust Design Optimization: Development of designs that maintain performance despite manufacturing tolerances or operational variations.
Video courtesy of 4RealSim.
Virtual Device Testing
12Simulate provides high fidelity simulation support for verification, validation, and reliability assessment of medical devices throughout the development process. Using high-fidelity computational models, simulations allow engineers to evaluate device performance under realistic physiological and operational conditions. These analyses help identify potential design risks early, reduce the need for extensive physical testing, and support regulatory submissions through robust and traceable computational evidence.
Core Measurement Support
Stress-Strain Analyses: Evaluation of mechanical stress and strain behavior in medical device components.
Fatigue Analyses: Prediction of long-term device durability under cyclic loading conditions.
Damage Tolerance Analysis: Assessment of device behavior in the presence of defects or material damage.
Crack Growth Analysis: Simulation of crack propagation and fracture behavior under operational conditions.
Manufacturing Process Analysis: Evaluation of manufacturing effects such as forming, expansion, or material processing on device performance.
Drop Test and Vibration Analysis: Simulation of device behavior under impact or vibration loading conditions.
Impact Analyses: Assessment of device performance under sudden loading scenarios.
Worst-Case Identification: Identification of critical design scenarios and limiting conditions.
Uncertainty Analysis and Propagation: Evaluation of uncertainties in model parameters and their influence on simulation results.
Reliability Analysis: Statistical evaluation of device reliability and expected lifetime.
Tissue Damage Analysis: Simulation of interactions between medical devices and biological tissues.
Video courtesy of 4RealSim.
ASTM and ISO Compliant Simulation Services
12Simulate delivers simulation services aligned with internationally recognized standards and regulatory frameworks.
Examples of applicable standards include:
ASTM Standards
ASTM F2477: Pulsatile durability testing of vascular stents
ASTM F2514: Finite element analysis of metallic vascular stents under radial loading
ASTM F2942: Axial, bending, and torsional durability testing of vascular stents
ASTM F3067: Radial loading of balloon expandable and self-expanding vascular stent simulation of crack propagation and fracture behavior under operational conditions.
ASTM F2079: Elastic recoil of balloon-expandable stents
ASTM F3211: Fatigue-to-fracture methodology for cardiovascular devices
ISO Standards
ISO 25539-1 / ISO 25539-2: Cardiovascular implants and endovascular devices
ISO 5840-1 / ISO 5840-2 / ISO 5840-3: Cardiac valve prostheses
ISO 14242-1: Wear of total hip-joint prostheses
ISO 7206-4 / ISO 7206-6 / ISO 7206-10: Hip joint prosthesis evaluation
Video courtesy of 4RealSim.
Virtual Clinical Studies – In-silico Medicine
12Simulate contributes to the advancement of in silico methodologies capable of supporting in-silico clinical studies. These efforts aim to establish credible computational evidence that can support regulatory submissions and medical device certification.
Key Focus Areas Include
Development of validated computational models representing medical devices and physiological environments.
Integration of simulation workflows to support virtual clinical studies and patient-specific analyses.
Collaboration in international research initiatives advancing regulatory acceptance of in-silico methods.
Contribution to frameworks that establish credibility, verification, validation, and uncertainty quantification for simulation-based evidence.
Video courtesy of 4RealSim.
Simulation Credibility and Compliance
Simulation services at 12Simulate follow established verification, validation, and uncertainty quantification practices to ensure reliable and regulatory compliant computational models.
Relevant guidance and frameworks include
FDA Guidance: Reporting of Computational Modeling Studies in Medical Device Submissions
ASME V&V 10-2019: Verification and Validation in Computational Solid Mechanics
ASME V&V 20-2016: Verification and Validation in Computational Fluid Dynamics and Heat Transfer
ASTM F3067: Radial loading of balloon expandable and self-expanding vascular stent simulation of crack propagation and fracture behavior under operational conditions.
ASME V&V 40-2018: Assessing Credibility of Computational Modeling for Medical Devices