Medical & Health care Applications:
Medical products function in many environments that interact with one another simultaneously, not sequentially. Using Sigmund enables engineers to simulate these different non-intuitive interactions/conditions using a single model environment to ensure results with higher accuracy while increasing the efficiency of the virtual product build process.
Some of the Medical applications addressed using variation simulation includes:
Cardiovascular: stents, pacemakers, defibrillators, heart valve replacements, catheters
Orthopedic: knee replacement, hip implants, cartilage and joint replacement, human modeling and virtual biomechanics
Physical Medicine: laparoscopic, endovascular, spinal, cervical etc
Dental: implants, general devices • Optical: intra-ocular lens implants, general devices
Medical Electronics: radiology, imaging devices, monitors
Ensuring Design & Simulation Traceability
Managing and tracking the simulation process is just as important as the simulation methods themselves. Medical device manufacturers must comply with Good Manufacturing Practices for managing and tracking all aspects of data related to the design of products, whether Class I, II, or III. FDA submissions require a comprehensive audit trail which includes:
Record of all variation simulation data.
Statistical Quality/Process Control data.
Meet build quality performance requirements.
Revision management and control.
Correlation with physical test results.
Proven repeatable methods.
Software version tracking.
Building a Simulation Knowledge Base
Sigmund automatically stores all simulation, data files, input data, quality metrics, capability database, and results, thereby providing a full history of why medical product simulations are performed. This capability instills management oversight into the simulation process and ensures the information provided is realistic, reliable, and traceable.