A large, successful American medical instrumentation company was experiencing increasing difficulty competing with Japanese and German offerings. The company enjoyed a proprietary technology. However, the competitors were gaining market share with lower cost, more reliable products.
The company engaged ASI Consulting Group to help improve their Product Development Process. Enhancements to the Product Development Process included intense interactions between engineers and customers, Quality Function Deployment, Pugh Concept Generation and Selection, and a disciplined Verification and Validation Process which met FDA requirements. Verification and Validation are associated with Prototype and Pilot Fix Cycles respectively. Earlier development programs needed several Prototype Cycles to achieve performance goals and meet FDA regulatory requirements. The new process called for a single Prototype Cycle with the intent to drive completion of product and process design prior to undertaking the manufacturing intent Prototype Cycle.
The next new product development programs far exceeded expectations. The development schedule was cut in half and the early introduction of the new, superior offerings helped the company to regain market share.