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									                                                                                                                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
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
                                                                                                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

                                                                                                                 Session Files                    in SimManager                    Data in SimManager                      In SimXpert                   Files to SimManager      changes & versions
                                                                                                                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-
                                                                                                              Animations,                       based SimManager                      from SimXpert                      SimManager and                      model as a new          validation, history   potential for streamlining the regulatory submission and review process,
                                                                                                                                                      Client                              session                         modify design                          version                                   resulting in significant time savings.
                                                                                          Input Files
                                                                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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