Design validation is an important factor in project management as it will determine the needed deliverable to ensure that the correct product with the aimed solutions will be delivered to the customers’ needs. In the medical devices industry, in particular, ignoring the importance of the validation stage means that a company did not design the right device that a patient would need to use, which means a waste of time, effort, money, etc.
Per the Greenlight website, “Design Validation means the medical devices used for validation have to be built in the production environment, using drawings, specifications, etc. (i.e. Design Outputs) by production personnel. This means that the end-user(s) should be involved and the device should be tested either under simulated use or actual use.”
The importance of validation is caused by the consequence that would occur if this step was ignored such as a negative effect on public health.