Validation of design methods: lessons from medicine

This paper discusses the validation of design methods. The challenges and opportunities in validation are illustrated by drawing an analogy to medical research and development. Specific validation practices such as clinical studies and use of models of human disease are discussed, including specific ways to adapt them to engineering design. The implications are explored for three active areas of design research: robust design, axiomatic design, and design decision making. It is argued that medical research and development has highly-developed, well-documented validation methods and that many specific practices such as natural experiments and model-based evaluations can profitably be adapted for use in engineering design research.