Finite element analysis is an excellent technology to apply to medical device development. It can reduce the amount of expensive prototype construction and testing cycles necessary for a complete product development cycle ready for certification and manufacturing. And it does not stop there. FEA tools are also used for manufacturing to assist with perfecting assembly and quality control methods along with follow-up debugging, packaging, transportation analysis, drop test simulation, continuation and product extensions. Its a tool that has applications throughout the product’s entire life cycle.
A blog article here goes into much more detail.
As a case in point, during a recent catheter development program, FEA was suggested as an alternate/addition to the typical design/build/test cycle typically taken by this manufacturer. The suggestion was not taken. Over 4 months of design, parts build and testing went into the first cycle. The desired information gleaned from the testing was rather basic – flex and torsion characteristics for a catheter sheath made up of hypo tube modified with micro cuts in the tube (see screenshot at right). Several cut patterns were tested. The CAD models for the parts were used in a FEA simulation that took 2 days to complete.
The FEA results agreed closely with the tests.
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