Comprehensive Cardiovascular Device Simulation Data and Process Management INTRODUCTION METHODS BENEFITS Cardiovascular related simulations such as nonlinear finite-element analysis Medical Device manufacturers must comply with the revised good manufacturing practices established by the FDA for A simulation management system provides benefits such as: and computational fluid dynamics (CFD) generate very large data sets of results. managing and tracking all aspects of data related to the design of products. FDA submissions require a comprehensive • Improved R&D efficiency, quality, and risk reduction This data needs to be tracked and managed, especially when multiple mesh audit trail which includes: • Regulatory and approval process improvements; potential for use of refinements and material changes are performed on each model such as the • Record of all simulation data a limited portal to facilitate review, comment, and response from stent shown in Figure 1. • Revision management and control regulatory staff on submissions • Correlation with physical test results • Traceability and audit trail for design basis, material If alternate designs need to be explored, • Proven repeatable methods and loads data, and experimental validation then it results in many sets of files • Software version tracking. • Dashboard for validation and verification of computational methods generated during simulation. Design • Implementation of best practices modifications and parametric studies SimManager automatically stores all simulation, data files, input data and results, thereby providing a full history of how magnify the volume of data as new medical product simulations are performed. This capability instills management oversight into the simulation process and The implementation of a simulation management system can begin with simulation data are either used or ensures the information provided is realistic, reliable, and traceable. simulation data and work in process applications. It can be expanded in a generated for each computation. logical manner to include the simulation process, test results, and final Figure 1: Stent Model MSC SimManager incorporates comprehensive data and process management tools for: regulatory submission results. Simulation data may include design models, model configurations, geometry • Workflow and task status files (CAD), FEM model files, results, design requirements, input & output • Design Variants CONCLUSION documents, design validation documents, material properties, load cases, • Publishing of analysis/computational data and test data. It may even include non-CAE type files such as documents, • Audit trail and pedigree information spreadsheets, Mathcad* or MATLAB* calculations, MS Outlook* message files, • Work requests as well as any type of method or template file that generated the content for a c computation (see the illustration in Figure 2). c SimManager is vendor-neutral and can incorporate any analysis software or reporting tools such as spreadsheets or c documents, and complements existing PDM software. SOLUTION STEPS Models Material Properties le doMputeS strop puSeta erC stnia rt snoC ylppA Documents sdaoL ylppA n art saNtrop xE sr iaPDI RG Create a Project Store Simulation Revise Model Publish Revised Keep track of all tro peR etar eneG Templates Session Files in SimManager Data in SimManager In SimXpert Files to SimManager changes & versions Spreadsheets Macros, Scripts 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 Create a ‘Stent’ Import model data or publish files Open file from Publish the modified Design verification, views for regulatory review and communication. There is tremendous Output Files Project in web- Curves,Values, Animations, based SimManager from SimXpert SimManager and model as a new validation, history potential for streamlining the regulatory submission and review process, Plots Client session modify design version resulting in significant time savings. Reports Input Files CONTACTS Figure 2: ”Unmanaged Chaos” MSC.Software Corporation 2, McArthur Place, Santa Ana, CA 92707 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 Marketing: Technical: Tel: 1.714.540.8900 chaos, resulting in poor knowledge sharing, inability to access and reuse prior Leslie Rickey Kim Parnell, PhD,PE Fax: 1.714.784.4056 Baskar Rajagopalan Mike Grossen Toll-Fee: 1.800.345.2078 results, ineffective communication, and process inefficiency within the company. Burcin Ekener www.mscsoftware.com *All trademarks belong to their respective owners.
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