Although computation modeling may appear to be a novel tool to some medical device makers, it is definitely not new to the FDA and other standard development agencies. Seeing so many device makers using simulation results as part of their submission packages, the agencies have realized the importance of computational tools like Finite Element Analysis (FEA), and have taken the initiative to develop standards and guidelines that include or be dedicated to instructions on how to use computational modeling for device submission.
In April 2010, the FDA issued its latest revision of the guidance document, “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.” In section IV-B-8 of this document, the agency made the following recommendation:
“…We recommend that you determine the stress-strain response, endurance limit, and post-processing mechanical properties through physical experiments or computational models that simulate stent material properties, manufacturing, and deployment processes…”
Then in the next section, the agency went into much more details regarding what should be reported for Finite Element Analysis (FEA) including the following recommendation on stress /Strain report:
“…We recommend that you identify the critical locations of stress or strain on the stent using finite element analysis and address the effect of dimensional variation within allowable tolerances on the results…”
FDA also recognizes “ASTM F 2514-08, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial.(Cardiovascular),” which is a standard dedicated to FEA analysis of cardiovascular stents.
In addition to standard and guidance development, FDA together with NHLBI and NSF has been hosting an annual workshop on computer methods for cardiovascular devices since 2008. The latest workshop was held on “June 10-11, 2010 where Nuno Rebelo from SIMULIA gave a presentation entitled “On modeling assumptions of Finite Element Analysis of stents.”
At SIMULIA, we understand the importance of following FDA guidance for our customers, we have developed training material and best practices for stent analysis using Abaqus to help new customers quickly learn the best options for their finite element analysis that will both save them time and money for product development and satisfy FDA’s requirements at the same time.