Medical Devices
MSC has been a trusted engineering simulation and analysis partner to the medical device industry for over 15 years. Our consulting services and solutions are used by medical device companies during the design process to predict mechanical performance, durability, stress, and fatigue of medical products using computational modeling and analysis methods.
The FDA’s Center for Devices and Radiological Health (CDRH) is now recommending computer aided engineering analysis results in support of the approval process for medical devices. These computer modeling and analysis methods are helping device manufacturers enter clinical trials and experimental testing stages with more confidence.
By optimizing design, biomedical engineers can reduce time to market and increase product reliability while meeting budgetary and regulatory requirements.
Benefits of utilizing FEA for medical design include:
- Shorter development cycles
- Reduced risk
- Faster FDA and CE approval
- Enhanced patent protection
- Improved quality management
- Increased performance and mechanical reliability
- Increased product life and durability
- Improved patient effectiveness
"The simulation study led to a redesign that saved $125,000 in tooling costs, saved 12 weeks hard tooling design & production, and met time-to-market requirements"- Svenn Borgersen
BIOSIMulations, LLC
The distribution of axial stress in the rat tibia at the peak of the four-point bending loading cycle.
Example of a PATRAN-based adaptation simulation using the axial bending stress as the driving stimulus.
von Mises stress of ulnar bushing
Contact us today to help you:
- Optimize your designs within a reliable timeframe
- Improve product development while still following regulatory processes that maintain safety and reliability
MSC Software is used for many types of medical related simulations:
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Biomedical Engineers use MSC Software for simulating:
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Simulate Complex Interactions
Get Approval Faster
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The FDA’s Center for Devices and Radiological Health (CDRH) is now recommending computer aided engineering analysis results in support of the approval process for medical devices. These computer modeling and analysis methods are helping device manufacturers enter clinical trials and experimental testing stages with more confidence. |
Maintain Design and Simulation Traceability
Ensure Audit Trail and Process Automation |
Managing and tracking the simulation process is just as important as the simulation process itself. Medical device manufacturers must comply with Good Manufacturing Practice when managing and tracking product development data. FDA submissions require a comprehensive audit trail which includes:
To ensure confidence in the simulation and reliability of the analysis results, medical device manufacturers must ensure that the CAE analyst is using the most current CAD geometry, specify the correct material properties, and apply the appropriate environmental loading conditions. They must also create the proper mesh type and size, record the version of the analysis software, and correlate results with physical test data. These criteria must be preserved and managed for FDA compliance purposes and for the benefit of enhanced enterprise productivity. |
Establish Best Practices for Simulation
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User-Friendly Desktop Simulation MSC delivers a powerful, easy-to-use simulation workspace environment with capabilities to capture and automate complex processes. Our customers can cost effectively build customized virtual medical device test solutions which allow the user to focus on the products to test instead of specifics of how to run a simulation. Rapid Virtual Testing with Integrated Workspaces Fully integrated simulation workspaces provide a range of built-in multidisciplinary capabilities for medical device modeling and simulation including linear and nonlinear structures, motion, thermal conditions, drop testing, and more. By using common data models across workspaces within a customizable user interface, medical product designers can perform tightly coupled simulations for total flexibility and faster results. |
