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tn58 replied to the topic Discussion Topic: The critical path in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
In designing a hip stem implant and running finite element analysis on it last semester. After creating the part file which took hours, and applying constraints and loads on the hip stem implant. After running 20 analysis to predict where our implant will fail, a very critical detail was left out. The threshold of a software and bugs in a software. The stem implant passed all of the analysis such as flexion, tension, axial loading test but it our results were never looked at from a real point of view. Yes the software and computational analysis turned out great. However, when the stem analysis were looked at by an expeirenced engineer he point out that there was a 20% chance that this stem design will fail and result in a fracture because the software is not able to predict real life scenarios. The stresses on the stem in real life can be very rare and the stresses and concentration the software predicts are limited. First off, the computer on which the software is installed does not have the capacity and speed to run fast and real life results. The software contains bugs and adds to limits to meshing tools. Giving inaccurate predictions. So the very small detail of environmental effects and comparative analysis which does not matter in the research phase, can be the most essential in the practical field. The stem was great but when compared to real life situations and materials added on the stem, our results had too much percent error to manufacture such a stem. The cost and time do not justify the computational results. So even though, these software are excellent, but the very small errors which we ignore and press ignore can lead to voiding a project or product.