Comprehensive Cardiovascular Device Simulation Data and Process Management

1. Comprehensive Cardiovascular Device Simulation Data and Process Management c METHODS c c INTRODUCTION BENEFITS • Medical Device manufacturers must comply with the revised good manufacturing practices established by the FDA for managing and tracking all aspects of data related to the design of products. FDA submissions require a comprehensive audit trail which includes: • Record of all simulation data • Revision management and control • Correlation with physical test results • Proven repeatable methods • Software version tracking. • SimManager automatically stores all simulation, data files, input data and results, thereby providing a full history of how medical product simulations are performed. This capability instills management oversight into the simulation process and ensures the information provided is realistic, reliable, and traceable. • MSC SimManager incorporates comprehensive data and process management tools for: • Workflow and task status • Design Variants • Publishing of analysis/computational data • Audit trail and pedigree information • Work requests • SimManager is vendor-neutral and can incorporate any analysis software or reporting tools such as spreadsheets or documents, and complements existing PDM software. Cardiovascular related simulations such as nonlinear finite-element analysis and computational fluid dynamics (CFD) generate very large data sets of results. This data needs to be tracked and managed, especially when multiple mesh refinements and material changes are performed on each model such as the stent shown in Figure 1. If alternate designs need to be explored, then it results in many sets of files generated during simulation. Design modifications and parametric studies magnify the volume of data as new simulation data are either used or generated for each computation. Simulation data may include design models, model configurations, geometryfiles (CAD), FEM model files, results, design requirements, input & output documents, design validation documents, material properties, load cases, and test data. It may even include non-CAE type files such as documents, spreadsheets, Mathcad* or MATLAB* calculations, MS Outlook* message files, as well as any type of method or template file that generated the content for a computation (see the illustration in Figure 2). If this huge volume of simulation data and the associated design history files are not tracked and managed effectively, then it results in unmanaged information chaos, resulting in poor knowledge sharing, inability to access and reuse prior results, ineffective communication, and process inefficiency within the company. *All trademarks belong to their respective owners. • A simulation management system provides benefits such as: • Improved R&D efficiency, quality, and risk reduction • Regulatory and approval process improvements; potential for use of a limited portal to facilitate review, comment, and response from regulatory staff on submissions • Traceability and audit trail for design basis, material and loads data, and experimental validation • Dashboard for validation and verification of computational methods • Implementation of best practices • The implementation of a simulation management system can begin with simulation data and work in process applications. It can be expanded in a logical manner to include the simulation process, test results, and final regulatory submission results. Figure 1: Stent Model CONCLUSION Create a Project in SimManager Store Simulation Data in SimManager Revise Model In SimXpert Publish Revised Files to SimManager Keep track of all changes & versions Models Material Properties Documents SOLUTION STEPS Templates Session Files Macros, Scripts Spreadsheets This figure shows specific sets of results and ways that they can be summarized and reviewed. SimManager dashboards or portals can be configured to provide specific views for project management and limited views for regulatory review and communication. There is tremendous potential for streamlining the regulatory submission and review process, resulting in significant time savings. Output Files Curves,Values, Animations, Plots Publish the modified model as a new version Create a ‘Stent’ Project in web-based SimManager Client Import model data or publish files from SimXpert session Open file from SimManager and modify design Design verification, validation, history Reports Input Files CONTACTS Figure 2: ”Unmanaged Chaos”