The purpose of Phase 2 – Proof of Concept is to demonstrate that critical design features of one or more of the selected design concepts perform as intended. Prototypes of critical design features will be fabricated to explore and address design challenges. Where a design concept relies on one or more critical manufacturing processes, these too will be proven. A further outcome of the Proof of Concept phase is to finalize the design requirements drafted in Phase 1.
Prototype critical design features
Prototype critical manufacturing processes
Develop preliminary product test methods
Procure or design preliminary test equipment
Perform focus groups if required
Conduct design reviews as required
Initiate development of a risk management plan
Determine regulatory strategy
Identify packaging and labeling requirements
Identify sterility method and requirements
Phase Review – Final concept selection
Completed Design Requirements Document (DRD)
Prototypes of critical design areas or processes
Preliminary test methods
Draft risk management plan
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