Norman Noble expands engineering department to support Phase Gates

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.

“We have introduced a phased approach to our manufacturing development process, which enhances our ability to deliver high-quality customer designs with improved time to market. This approach begins with initial process development, followed by process optimization, validation, and finally, production ramp,” says Eric Lehuta, Norman Noble director of engineering. “By breaking down the development into these distinct phases, we ensure better planning, more rigorous testing, and faster implementation. Moreover, this phased approach fosters closer collaboration with our customers, providing them with valuable insight into our activities and ensuring their needs are met at every stage. Ultimately, this type of continuous improvement leads to greater customer satisfaction through product quality and on time delivery.”

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,” says 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.”