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Meeting FDA Expectations with Finite Element Analysis

Meeting FDA Expectations with Finite Element AnalysisSpeed to market is a significant consideration for medical device manufacturers. Not only is it helpful for gaining a competitive advantage, it usually means the regulatory review and approval process went smoothly - which can be a challenge, with increasingly stringent requirements established by the U.S. Food and Drug Administration (FDA).

Bringing a product from concept to market quickly is usually the result of a highly efficient design and production process that wastes little time on unnecessary steps or rework. The key is coming up with a design that is easy to manufacture and uses validated processes and techniques that meet FDA expectations.

A tool that helps achieve this goal (and inspires confidence with the FDA regarding your approach to design) is a process called finite element analysis, or FEA.

Eliminate flaws before they happen

Finite element analysis is increasingly being used for the design of complex medical devices, especially those made from plastic or rubber. FEA is a sophisticated computer modeling program that shows a visual simulation of how materials for a proposed product might perform during the proposed use, utilizing on-screen virtual environments. Material performance over a range of conditions is tested to see if the product will perform as expected, or if the design needs to be adjusted. FEA can be repeated as many times as needed to fine-tune the design and make the final product as strong, functional and reliable as possible.

This process is completed before any prototyping, mold design or production is undertaken, greatly reducing the possibility of errors or redesign issues occurring later. FEA is also essential for assuring the safe performance of a medical device. Proper use of FEA can greatly improve both the speed and the quality of product design, reducing overall cost.

To learn more about FEA, download Parker Medical System Division’s “Practical Use of FEA for Medical Rubber Components

Impact on the FDA approval process

Meeting FDA Expectations with Finite Element AnalysisPerhaps the most important benefit of finite element analysis is that it speeds up the timeline toward FDA approval. The use of FEA quickly shows regulators that the best science was used to design, test and manufacture the product, demonstrating validated materials and processes. This streamlines the 510(k) submission process, eliminating the risk of having submissions returned for insufficient data or additional testing and validation.

FEA is a great way to help customers decide what direction to take with a new product, based on modeling results for various materials and configurations. As great as it is, however, FEA is still a modeling program - full validation testing must be performed on the medical device by the equipment manufacturer.



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