I was talking to a Medical Device colleague recently who complained to me that his project was a disaster because the final Design of the product did not match the original Design Input Spec. How could this happen? It appears that the design drifted and the team did not revisit the Design Input Spec.
Many, many design teams are guilty of this.
Design Input Specs are a starting point for a project. The Spec should be endorsed by the ENTIRE project team. The Spec should be written in a detailed and quantitative. Many technical types tend to equate the “exacting” detail in the Design Spec to the performance of the design. This is not the case. The Design Input Spec is a living document that should be revisited at every major design iteration during a project….after each prototype round, after each testing round, after each customer evaluation.
For God’s sake! Go back and change the Spec if necessary.
