Managing Design Excellence Tools During the Development of New Orthopaedic Implants

Design excellence (DEX) tools have been widely used for years in some industries for their potential to facilitate new product development. The medical sector, targeted by cost pressures, has therefore started adopting them. Numerous tools are available; however only appropriate deployment during the new product development stages can optimize the overall process. The primary study objectives were to describe generic tools and illustrate their implementation and management during the development of new orthopaedic implants, and compile a reference package. Secondary objectives were to present the DEX tool investment costs and savings, since the method can require significant resources for which companies must carefully plan. The publicly available DEX method "Define Measure Analyze Design Verify Validate" was adopted and implemented during the development of a new spinal implant. Several tools proved most successful at developing the correct product, addressing clinical needs, and increasing market penetration potential, while reducing design iterations and manufacturing validations. Cost analysis and Pugh Matrix coupled with multi generation planning enabled developing a strong rationale to activate the project, set the vision and goals. improved risk management and product map established a robust technical verification-validation program. Design of experiments and process quantification facilitated design for manufacturing of critical features, as early as the concept phase. Biomechanical testing with analysis of variance provided a validation model with a recognized statistical performance baseline. Within those tools, only certain ones required minimum resources (i.e., business case, multi generational plan, project value proposition, Pugh Matrix, critical To quality process validation techniques), while others required significant investments (i.e., voice of customer, product usage map, improved risk management, design of experiments, biomechanical testing techniques). All used techniques provided savings exceeding investment costs. Some other tools were considered and found less relevant. A matrix summarized the investment costs and generated estimated savings. Globally, all companies can benefit from using DEX by smartly selecting and estimating those tools with best return on investment at the start of the project. For this, a good understanding of the available company resources, background and development strategy are needed. In conclusion, it w