Finite element analysis and Digital Twin for Orthopedics, Dental and Medical Device Industry
FEA & CFD Based Simulation Design Analysis Virtual prototyping MultiObjective Optimization
Enteknograte has expertise in finite element (FE) analysis of biomaterials, containers and closures, drug delivery systems including injectors, implantable and patch pumps, medical device components. We specialize in developing and validating detailed computational models for due diligence, ideation, concept selection, requirements identification and generation, design evaluation and optimization, generating design output elements for verification. We assist clients solve a variety of challenges associated with device design, design optimization, and interaction with calcified and soft tissues.
FDA submissions require a comprehensive audit trail which includes:
- Records of all simulation data
- Revision management and control
- Correlation with physical test results
- Proven repeatable methods
- Software version tracking
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.
Realization: Great ideas are nice, but ideas have little value until they can be transformed them into “realized” manufactured devices with high quality, and high confidence in their ability to perform safely and effectively in the healthcare delivery value chain. Simulation: Digital Twins predict and optimize the operating performance of your devices, as well as manufacturing and service operations. Work out quality and volume production ramp-up issues early, digitally, and avoid expensive rework driven by late stage non-conformances and complaints.