“TriMech’s services were an excellent match for the testing we needed to complete for FDA clearance. Working with their team was smooth and we are very happy with the process and professionalism.” – Trey Robbins – Alevio Spine, Inc – Quality/Engineering
TriMech’s client, Alevio Spine, is a medical device company that specializes in developing titanium implants that are used in sacroiliac (SI) joint fusion surgeries. Alevio reached out to TriMech’s Project Engineering Group to help them simulate various lengths of implants to ensure they met ASTM testing standards required by the FDA. The task at hand was to replicate physical test conditions in SOLIDWORKS using FEA analysis, before conducting costly, real-life tests such as destructive testing.
The goal of the project was to understand the behavior that the implants would exhibit based on two ASTM testing standards. After researching options and comparing costs, Alevio decided to outsource the project to TriMech because it was less expensive than performing multiple physical tests. By virtually simulating the physical test conditions under which the implants would be certified, any areas of potential failure can be identified and re-designed before the costly destructive testing. Project engineer Alain Bucio’s challenge was to set up the implants in SOLIDWORKS simulation software the same way they would be fixtured in the test apparatus. To do so, Alain researched ASTM testing standards required of the implant before setting up the tests.
Preliminary analyses included two tests to place the screws in worst case scenarios to understand weak points. After the screws passed the ASTM standards in each test, Alain went further to identify an optimal product design.
The complex topology of the implant was challenging to master, but Alain was able to complete the FEA simulations to test the implants. As the test results exceeded the ASTM standards, Alevio was left with increased confidence in their design and a completed engineering portion for the approval process of their spine implants. By choosing TriMech, Alevio was able to complete the physical testing faster and at a lower cost.
Interested in learning more about how TriMech’s Project Engineering Group can help your company with virtual simulations and testing? Contact us today to discuss your project needs and get started on improving your product design and development process. Our team of experts has the knowledge and experience to deliver high-quality results efficiently and cost-effectively.
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