When a mechanical engineer and a material scientist were asked for the root cause of an in-vivo fracture. Mechanical engineer pointed to the loading and the material scientist pointed to the processing. While they both are correct, they both also missed the real ROOT cause, the design.

It is very common that medical device design engineers are so focused on the device functionality that often the very basic mechanics is overlooked. Lack of knowledge on the in-vivo environment (Design Requirements) is another subject to blame. However, it is common that even technology driven companies have gaps between design department and duarability deparment. Up front design engineers do not necessarily keep up with the fast paces of material advances. On the other hand, downstram subject matter experts, device tesing teams or often the R&D departments are not informed of design changes before the design is fixed. The problem is worse often in industrial leaders than in start-ups, but the sympton is the same, problem found in animal studies and/or clinical trials before they reached industrial subject matter experts.