Patterns in the Public Square: Reference Models for Regulatory Science

Science and engineering involve discovery, representation, explanation, and exploitation of recurrent patterns, observed as phenomena. Model-based representations describe not only natural phenomena and engineered products, but also the socio-technical systems of systems that carry out scientific study, product engineering, medical practice, public health, commerce, and regulation. The term “Regulatory Science” invites us to represent and understand innovation, regulation and their intended and actual consequences as observable system phenomena in their own right, using scientific and engineering principles, tools, and insights. This article summarizes three classes of model-based reference patterns central to representing, understanding, communicating, and enhancing systems of innovation, regulation, and improvement over life cycles. In order of increasing scale, these pattern classes are (1) the domain-independent pattern of model-based representation of system phenomena (the S*Metamodel) in the sciences and engineering disciplines, underlying all modeling and simulation; (2) domain-specific patterns representing families of natural systems and engineered products in their life cycle contexts; and (3) the large-scale Innovation Ecosystem Pattern, in which science, engineering, commerce, medicine, and regulation are performed, planned, and advanced—including sharing of managed models and data across ecosystems. All three are applied by the Model-Based Patterns Working Group of the International Council on Systems Engineering (INCOSE).