Stage 1: Explore
Because the manufacturing process is rather new we started with a process risk analysis, something which is usually performed in the Engineer stage. Cleaning and sterilization where identified as the two main issues that should be addressed early in the project. We also decided to develop a “general worst case” product that will represent all type of cages within a specific dimension range.
We started to define a new cleaning and sterilization process for a “general” worst case mesh structure. We also defined a method for overall mechanical validation partly based on FEM calculations combined with mechanical tests. The reason for this approach is that a general mechanical validation combined with a general cleaning and sterilization validation gives our customer much freedom to bring cages in various shapes on the market. Having a general validation available, it is even possible to offer customized cages for specific users. In this stage some initial tests where performed to find out if the proposed processes will indeed show sufficient results.