Healthcare Domains
Also known as: Domains, The 4 Domains
The four parallel dimensions tracked at every Innovation Maturity Level: Clinical/Workflow, Market/Business, Regulatory, and Technical/Science.
Full Definition
Clinical/Workflow covers the clinical evidence, workflow integration, and care pathway development needed at each level. Market/Business covers commercial validation, stakeholder mapping, and business model development. Regulatory covers regulatory strategy, submissions, and approvals across the relevant jurisdictions. Technical/Science covers the science, engineering, pre-clinical, and product development work.
All four domains should advance together to reduce risk and to increase the chance that strong technology becomes a commercial success. Market/Business is the domain most often under-developed relative to technical progress. On the GAITS carousel, the domains appear as four concentric bands labeled Clinical, Market/Bus, Regulatory, and Technology.
A diagnostics team reviews its carousel and finds no progress in its Regulatory band beyond IML 2. It creates a Work Package to define its regulatory pathway before it starts validation studies.