FIGURE 3.

Workflow for generating evidence computational patient models during development of a physiological closed-loop controlled medical device using. The process begins with considering the question of interest (Box 1) that the computational patient model will be used to address. Next are the design of the computational test setup (Box 2) as well as establishment of the computational patient model credibility goals (Box 3). These are used to determine the evidence needed to support the use of the computational patient model (Box 4) for the particular question of interest. The evidence supporting the computational patient model credibility can be used to interpret the evidence from the computational device testing.