Finite Element Analysis, FEA, Computational Modeling, Computer Simulation…what is it and how can you use it to improve medical device product development?

All of these terms refer to the creation and use of computer models to analyze performance of a design. For orthopedic medical devices, these methods could help in predicting failure loads and locations, comparing performance of several design options, determining mechanical performance ranges within a product family, comparing performance of one device to a competitive (predicate) device, and more. Several examples of these applications are shown below.

ASTM/ISO Mechanical Testing

Any orthopedic device submitted for FDA 510(k) must undergo some kind of mechanical testing, usually according to an applicable ASTM or ISO test standard. FEA can be used to simulate the tests and get a preview of performance and results, before time and money has been spent on prototypes and lab testing. The simulation can also be applied to a competitor’s design as a preview of mechanical equivalence testing, or even used in lieu of mechanical testing when test specimens are limited or unavailable.

Design Family Analysis

Many medical devices contain various sizes in a product family, but it’s impractical to prototype, evaluate and test every variation. FEA can be used to quickly analyze the whole family to determine the range of performance, and which versions should be used for physical testing.

Design Optimization

Design features and tolerances certainly affect device function and performance in different ways. Computer simulation offers a quick and efficient way to analyze design options to determine the advantages and disadvantages of each on various aspects of the device. Ultimately, the results allow designers to optimize the design and performance, leading to a superior product.


The use of computer simulation during product development can save months on the timeline and tens of thousands of dollars in the budget. Contact Engineering & Quality Solutions, Inc. today to find out how our experts can help your project with customized computer simulation. We are experienced in simulation testing for orthopedic devices according to ASTM F382, F543, F564, ASTM F1800, F2996, F3161, and spinal devices according to ASTM F1717 and F2077, and in the use of computer simulation for design optimization, family performance analysis and worst case device determination. We have also completed many custom analysis projects.

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