In the context of GCMI’s phase-gated product development process the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase (called “Phase 1” at GCMI). At the completion of project planning, innovators have determined what work is required to take the technology from prototype to product. The Design and Development phase is all about the meat of the design work: digging in to complete the design tasks, and ensuring that the device is ready for manufacturing and customer use.


Editor’s note: GCMI’s design and development process moves through in series from our Phase Zero to Phase 5. Innovators can jump in at any point in the process, though many actually discover that “backing up” to earlier stages may be advantageous in the long-run. We encourage all medtech innovators to talk to us wherever you may be in your project path.


What is the Goal of the Design and Development Phase?  

The ultimate milestone of the design and development process is called “design freeze.”   At the exit of Phase 2, a device should include all of the features required for function and safety, and the project team should have confidence that the device will meet all of the input requirements. The marketing team should also approve the look and feel of the device for the intended customers.     


Phase 2 continues the formal design control process: like Phase 1, the activities during this phase are documented and included in the Design History File. During Phase 2, designers work not only to improve on the form, materials and function of the device, but also to generate final drawings, specifications and manufacturing procedures describing every detail of every component and assembly. These details are critical to product quality – ensuring that the product can consistently be manufactured in the same way every time.  


On the way to this end goal, the project team uses an iterative approach that includes the following steps in each design cycle:  

  • Confirm design input requirements
  • Identify device design and user risks
  • Make design changes to form, fit, function and/or to allow for a manufacturing method
  • Build samples using expected manufacturing methods
  • Test device samples against the input requirements


By the exit of Phase 2, “design freeze,” the product has its final design features, all specifications and manufacturing processes have been documented, and the project team is confident that the device can be a sellable product that can enter initial (pilot) manufacturing and pass its verification testing.


What makes GCMI unique in this phase

Our team plans for significant effort during the design and development phase because we know the hurdles involved in ensuring that the design meets the needs of its users.  Clear requirements definition and risk mitigation, plus an emphasis on sufficient testing during the design and development phase de-risks the process and product. GCMI serves as your comprehensive project planning, research and development team, taking an integrated view of product design and manufacturing process development. Our phased approach gives promising technologies the best chance to achieve commercialization in a cost efficient manner.

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