Decision: Trial Strategy

Almost all new products merit some form of market trials prior to full-scale launch to the masses.  These may be clinical trials in the case of medical devices or new drugs; they may be alpha or beta releases in the case of software.  The product design decision pattern within the Decision Driven® Solutions Framework (DDSF) includes a Trial Strategy branch under the product Life Cycle decision.

Trial Strategy decisions – tree view

Trial Strategy decisions – tree view

Trial Strategy decisions - table view

Trial Strategy decisions – table view

The overall Trial Strategy is driven by the need to satisfy regulatory requirements, discover and remove defects and gain additional understanding of user needs and priorities.  The trial may vary in its usage scenarios (scope of the product exercised, situation/context of its use), trial methodology and its execution team.  These may be fairly simple decisions driven by SOP (Standard Operating Procedure) or they may call for creative thinking on how to maximize the knowledge gained from the trial in the face of tough regulatory, time or cost constraints. The following criteria should be considered when evaluating various trial schemes:

Trial Strategy decision - Criteria

Trial Strategy decision – Criteria

The Trial Strategy decision is framed with the assumption that a set or series of trials may be conducted before the product is ready for prime-time.   If multiple trials are planned based on this decision, then the model fans-outs at this point into a set of N Trial Concept branches (1 for each trial envisioned) as each trial may vary in its participants and recruiting methods.

Plan your trial strategy with the decision/criteria patterns within the Decision Driven® Solutions Framework (DDSF). Please contact the Decision Driven® Solutions team at trial@decisiondriven.com or solutions@decisiondriven.com to start your free trial of DDSF.

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