Faced with increasing demands from the market and regulatory agencies, manufacturers must establish a robust product-development process that incorporates sound engineering. A systematic approach, one that is logical and scientific, leads to cost reduction, reduced time to market, prevention of premature failures, and minimal rework loops. This presentation focuses on traditional vs. systematic approaches to product design and development, concurrent engineering practices, and 12 critical steps to follow to minimize cost overruns and project delays. The discussion centers on basic part design, material selection, structural analysis, mold-flow analysis, importance of rapid prototyping, design reviews, single-cavity prototyping, tolerance analysis, establishing tooling protocols, navigating through the mold-construction phase, mold sampling and pilot runs, DOE/CPK studies, establishing process parameters, and final part evaluation and acceptance.