Through our 17 years of experience, Key Tech has developed and refined a Product Development Process which allows us to efficiently and effectively bring a product from an idea to a production-ready reality. Key Tech utilizes a multiphase, stage-gated approach, which creates both a clear set of near-term objectives and a holistic, long-term perspective on the project’s entire development path. Despite this structured and well-defined project architecture, Key Tech’s process is also adaptable and can be modified to meet the specific needs of each project.
As part of the initial phase of a project, our experienced project managers work with our clients from the start to create a structure that is best suited for the particular engagement. Using the project proposal as the cornerstone, Key Tech gathers inputs from a variety of sources to create the Design and Development Plan, which serves as the foundation and central planning document for the project. Because Key Tech knows that project details often change over the course on an engagement, our Design and Development Plans are living documents that are regularly updated as the project progresses.
Next, Key Tech proceeds into the proof-of-concept phase, wherein we demonstrate that the core features of the product can be attained with the established constraints. This is generally accomplished with benchtop hardware to prove functionality and “looks-like” mockups to demonstrate form, layout, and workflow. During this phase, the Product Requirements Document (PRD) is updated and expanded as product understanding grows. Additional documentation, such as the Risk Management Plan and Software Development Plan, is created during this phase. The updated product requirements and other design inputs are agreed upon by the team before the project continues to the Alpha and Beta designs.
From experience, Key Tech knows that product design is best undertaken as an iterative process, and structures its Product Development Process to reflect that model. The Alpha design of the product typically achieves most of the performance and usability objectives set forth in the PRD. Often, parts from rapid prototype and quick-turn vendors are used to minimize lead time and cost during this phase. This allows for multiple iterations within the alpha design if needed. While the alpha devices generally resemble the intended final form of the product, lessons learned from these prototypes often drive design changes in the subsequent phase.
The Beta design represents a more refined prototype, informed by the alpha design and more representative of the final device. Often, fewer components are made using quick-turn processes, and instead are fabricated in a manner more scalable to production quantities. Remaining performance and usability questions are answered during this phase.
Verification and Validation is a critical part of the product design process. Using devices that are representative of (or identical to) production units, the requirements set forth in the PRD are confirmed. Key Tech has vast experience in conducting verification testing, including confirmation of adherence to design standards such as 60601.
After Verification and Validation, Key Tech transfers the final design to the customer and/or manufacturing partner. Although Key Tech does not manufacture devices in-house, we are adept at working with manufacturers to ensure that the final product meets the requirements and lives up to our high standard of design.