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


  • Proven concepts

  • Completed Design Requirements Document (DRD)

  • Prototypes of critical design areas or processes

  • Preliminary test methods

  • Draft risk management plan

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