A design review is typically held at the beginning and end of the Design & Development phase to review all work done to date, including design inputs and findings from the research phases. We will use design inputs to drive the design work, which will be generated based on user needs, usability and ergonomic studies, and risk management activities. We will create a requirements specification that clearly defines the device's purpose, functionality, features, and behavior.

We will generate a development plan describing tasks and the development schedule with key milestones and resources. The development plan will describe all work and begin the process of generating design inputs and summarizing the inputs in a traceability matrix. An essential part of the plan is a mutually agreed-upon responsibility matrix.

We will develop a practical and successful device design during the Design & Development Phase. We may perform industrial design and human factors studies to help drive the device's look and feel and to develop usability requirements. We may create several iterations to refine the design. The design may use solid computer models, electronic designs, and software, as appropriate. A software development plan for designs incorporating software or embedded firmware will be created. 

During the Design & Development phase, design prototypes will be created to assess function, gather user feedback, and begin developing the preliminary manufacturing processes. Prototypes will be produced using rapid prototyping techniques and tested using preliminary test methods. In some cases, tooling, such as short-run aluminum molds, may be created to produce prototype parts.

Final prototypes will be fabricated using the preliminary manufacturing processes. Pre-verification testing will be performed to the draft protocols to assess the design and identify any issues with the protocols. The testing results will be summarized in one or more reports, and adjustments will be made to the design and the protocols as needed.

Although our team at Build by Boyd provides manufacturing services, our design and development team’s responsibility is to design the best device and identify the most appropriate manufacturing solution. Sometimes, that requires a third-party manufacturing partner.  

In either case, we will leverage our manufacturing expertise to perform a DFM in order to optimize manufacturability and reduce cost. We will create a complete bill of materials, component-level drawings, specifications, and inspection forms. We will also develop appropriate packaging, labeling, and instructions for use (IFUs). Our team will develop and fabricate all assembly fixtures, tooling, assembly procedures, routers, and other documentation. We will generate a verification and validation plan, including protocols, test methods, and appropriate sterilization methods.

During the Design & Development phase, we will generate a risk plan and an initial hazard analysis to identify risk inputs early in the development process. A phase-end design review will be held to show that the plan was met, risk management activities have been completed, and the design is ready for verification and validation.

We will control all documentation in a project file or a design history file, depending on the quality system used to control development. A phase-end design review will be held with the client to review all tasks against the development plan and ultimately release all documentation into the quality system.