Medical Design Technology Magazine asked Cyth Systems' Francis Toglia to submit an expert response to an industry opinion question.
Question: Has design software reached the point where it can serve as an acceptable replacement for physical prototypes in medical device manufacturing?
Answer: Design software cannot yet replace physical prototypes in medical device manufacturing because they are often complex systems interacting with delicate parts and substances. The software model is not optimized for testing materials or the fitting and interaction of materials and parts. Some materials may expand or change with temperature, while others may change size or strength when contacted with fluids. Surface friction is a frequent issue with interacting parts that design software would not often be able to detect. Tolerance is not free and the design software may give a false preview of the final costs of the medical device. Depending on how fine and polished a prototype needs to be, the surface finish and tolerances between each part cannot be accurately depicted by design software.
More importantly, humans interact differently with each medical device. In order to test these products with humans, prototypes must be tangible. There are design errors that engineers can make in the software that would not be possible when building the physical model. There are some simple designs that may get by without needing to build a prototype, but design software cannot acceptably replace a physical prototype at this point.