Simulation Data & Process Management for FDA

download report

Transcript Simulation Data & Process Management for FDA

Comprehensive Cardiovascular Device Simulation Data and Process Management
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.
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
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.
Figure 1: Stent Model
Simulation data may include design models, model configurations, geometry
files (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
c 2).
computation (see the illustration in Figure
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.
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
c tools such as spreadsheets or
SimManager is vendor-neutral and can incorporate any analysis software or reporting
documents, and complements existing PDM software.
le doMputeS
strop puSeta erC
stnia rt snoC ylppA
sdaoL ylppA
n art saNtrop xE
sr iaPDI RG
tro peR etar eneG
Session Files
Macros, Scripts
Output Files
Input Files
Figure 2: ”Unmanaged Chaos”
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.
Create a Project
in SimManager
Create a ‘Stent’
Project in webbased SimManager
Store Simulation
Data in SimManager
Import model data
or publish files
from SimXpert
Revise Model
In SimXpert
Open file from
SimManager and
modify design
Publish Revised
Files to SimManager
Publish the modified
model as a new
Keep track of all
changes & versions
Design verification,
validation, history
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.
MSC.Software Corporation
2, McArthur Place, Santa Ana, CA 92707
Leslie Rickey
Kim Parnell, PhD,PE
Baskar Rajagopalan Mike Grossen
Burcin Ekener
Toll-Fee: 1.800.345.2078