Medical

medicalMedical and Biomechanics
Helping medical device manufacturers adopt virtual test and simulation methods successfully

How can a medical device corporation successfully accomplish and balance both of the following critical business objectives:

- Reduce Time to Market
- Increase Product Reliability

While staying within cost targets and meeting regulatory requirements?

MSC.Software is helping medical device manufacturers adopt virtual test and simulation methods successfully within their engineering process. Until now, companies have had to use point analysis tools which never fully provided the level of sophistication or integration needed to study the range of complexities associated with the design of medical applications.

Through MSC SimEnterprise solutions, medical companies now have access to a suite of integrated engineering productivity solutions and techniques for managing the entire simulation process while establishing best practices and standards for virtual testing across the enterprise.


Value to Medical Device Product Development
MSC SimEnterprise is an enterprise business strategy and suite of solutions that help medical device companies address the five key success factors. SimEnterprise solutions allow companies to complete more virtual testing throughout the design process, capture and reuse the experts' best practices and methods, and control the resulting simulation data, processes, methods and knowledge across engineering teams.

The suite of SimEnterprise solutions which improve medical product testing include:

  • MD (Multidiscipline) Solver Solutions
  • MSC SimXpert
  • MSC SimManager
  • MSC SimDesigner

Medical / Biomechanics Benefits

Why Simulation is Important to Medical Product Engineering
In order to understand product performance attributes, eliminate design problems, and make informed product development decisions, engineers in the medical device field are leveraging simulation or computer aided engineering (CAE) methods. In addition to the product design improvements gained from CAE, the ability to capture and manage the associated engineering knowledge and use it for competitive advantage is also extremely valuable.

By evaluating multiple variations of virtual prototypes, manufacturers gain a greater quantity of high-quality data with which to make product development and manufacturing decisions, ensure efficacy, and increase robustness before the product is submitted for regulatory approval.

Simulation is accelerating the way medical device companies are moving products through different phases of development. Virtual prototypes play a critical role in design verification and validation. Through the virtual prototype, the design can be verified against the required customer specifications. Additionally, the design’s compliance can be validated against relevant regulatory standards. The final result is a highly reliable, cost-effective design developed and validated in less time.


Medical / Biomechanics Applications

Multidisciplinary (MD) Simulation of Medical Products
Medical products function in many environments that interact with one another simultaneously, not sequentially. Using MD solvers enables engineers to simulate these conditions using a single solver environment to ensure results with higher accuracy while increasing the efficiency of the virtual testing process.

MSC offers a range of MD analysis solutions for medical product testing. Analysis disciplines that are important for studying medical product performance include:
  • Structural
  • Thermal
  • Fluid Structures Interaction
  • Motion-Structure-Fatigue
  • Advanced Nonlinear-Materials
  • Motion-Structures Interaction
  • Mechanisms
  • Drop Testing and packaging analysis
  • Fatigue and Durability

Rapid Medical Product Simulation with Integrated Workspaces
The fully integrated simulation workspaces within SimXpert provide a range of built-in multidisciplinary (MD) capabilities for medical product testing including structural linear and nonlinear structures, motion, thermal, drop testing, and more.

Medical applications addressed using simulation include:
  • Cardiovascular: stents, pacemakers, defibrillators, heart valve replacements, catheters
  • Orthopedic: knee replacement, hip implants, cartilage and joint replacement, human modeling and virtual biomechanics, biocompatible materials analysis
  • Physical Medicine: artificial limbs, prostheses, human gait analysis, rehabilitation
  • Dental: implants, general devices
  • Optical/Ophthalmology: intra-ocular lens implants, general devices
  • Medical Electronics: radiology, imaging devices, monitors

Creating Repeatable Simulation Methods
Creating best practices for simulation will enable medical companies to improve accuracy and develop standards for doing virtual testing.

A comprehensive template authoring and execution tool is available within SimXpert to enable medical product manufacturers to create best practices or templates in-house for virtual testing of medical devices. These templates can take advantage of a single workspace or string together an entire process that uses multiple analysis disciplines within SimXpert for simulating medical product performance characteristics.


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 simulation data.
  • Revision management and control.
  • Correlation with physical test results.
  • Proven repeatable methods.
  • Software version tracking.

Building a Simulation Knowledge Base
MSC 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.