July 2, 2024
Formalized Steps Ensure Projects Meet Timelines and Objectives.
Norman Noble has established a New Product Implementation (NPI) team of engineers to put a phase gate process into effect to more efficiently develop, qualify, and manufacture customer-designed medical implants and devices.
Phase 1: Initial Development or Characterization – Norman Noble engineers collaborate directly with customers on the design for manufacturing new customer designs. For existing commercialized products, the NPI team characterizes the current product against existing specifications and functional performance, even when these items are not fully defined.
Phase 2: Optimization – Norman Noble manufacturing process optimization activities involve developing nominal process parameters, process controls, and robust inspection methods. This stage focuses on improving Norman Noble manufacturing process efficiencies and product yield to meet both drawing standards and customer cost targets.
Phase 3: Validation – Norman Noble engineers conduct validation to meet regulatory requirements and ensure Norman Noble’s commitment to delivering compliant, repeatable products to customers.
Phase 4: Production Ramp – The validated process is scaled to meet customer needs in terms of product launch and volume.
“Norman Noble’s NPI process provides our customers with complete transparency into each stage of their product’s development,” said Sarah Pickens, Norman Noble Engineering Manager. “Throughout each stage of the NPI process, our customers can be confident that their product is being manufactured to their drawing specifications while developing processes that ensure quality and maximum efficiency for long-term commercial success.”
Click here to download a PDF of the Phase Gates Press Release.