4.5.1 Stages and gates

Stages are key areas of activity that define a functional area or focus. Moving from one stage to the next also generally correlates to major steps along the value chain (see Chapter 1). Gates are the decision-making evaluation points for the results of that stage. Each stage could have several evaluation criteria within a gate. If the outcome from that stage does not meet pre-defined parameters, then the project does not move on to the next stage of activity. For example, if a diagnostic test cannot demonstrate specificity to a certain pre-set level, then it cannot move on to clinical testing (Figure 4.6). An example gate for a drug would be the demonstration of efficacy in an animal model of the disease or the demonstration of adequate stability in formulation; without showing which the drug will not be allowed to move onto formal pre-clinical toxicity testing studies.

Figure 4.6: Stage and gate detail.

Cooper, in his original paper (1988), defined six stages of activity in a product development process and it is conceptually useful to see those original six stages and screening gates as shown in Figure 4.7.

Figure 4.7: Stage-gate process as described by Robert Cooper (adapted from Cooper, 1988). Reproduced by permission of Westburn Publishers, Ltd.

4.5.2 How to configure a stage-gate process plan for my biomedical product

Each stage should be focused on one key functional area with the gates defined by key risk-reducing results of that stage. Within each...