At the clinical validation stage, we establish that the device specifications conform to user needs and intended uses. We also conduct production readiness builds and finalize the risk management plan and production process documents.
High-level outputs
At the design qualification stage, we provide needed data points and information to verify and validate the component. The component should work like, look like and be made like a production component, as well as meet your original design intent (incorporating all requirements and inputs). The component we build for design qualification uses representative production parts.
High-level outputs
At the feasibility stage, we create working engineering-level prototypes and obtain initial evidence supporting design feasibility. If approved, we freeze the design.
High-level outputs
At the proof of concept stage, we work with you to transform your idea, thought, or sketch into a design with a working and functioning prototype that mimics the intended component and prospective use in a device.
High-level outputs
We eliminate the known pain points that can occur at every phase of component development. It’s critically important to ensure that your design will be able to be manufactured as intended. At both the concept and feasibility phases, the design goes through a development and prototype process to ensure the component is manufacturable as intended.
Our proactive DFM has these benefits
We have developed and refined our component design approach over the past 25+ years of working with our customers. Our phase-gate approach divides the component design process into five phases:
