Design in the Absence of Standards

Design in the absence of standards creates both opportunities and challenges. When working with regulators and reviewers, conformance to established guidance can expedite the review process by reducing the need to justify each decision. Accordingly, the adoption of standards and guidelines offers efficiencies in the formulation of direction and in the review process. In instances where the guidance available is unsuitable, bespoke guidance can be developed from first principles. This is particularly useful for very specific cases. Furthermore, it could be argued that innovative approaches to research and analysis are more likely to result from more innovative outputs. For most cases, some combination of prescribed and adopted guidance is expected along with elements of guidance derived from first principles.