ABSTRACT
Measuring the effectiveness of Six Sigma in product design and development has been one of the key topics of discussion in recent Six Sigma conferences. There is no clear consensus among Six Sigma practitioners on any one set of measures. This is because, unlike for Six Sigma-based improvement opportunities using DMAIC methodologies, measures used in the design and development efforts are not as straightforward. For example, it is easier to measure the level of improvement in cost, quality, and time using the DMAIC approach since there are established baselines. Further, measures in new product development are traditionally more focused on cycle time (time to market). Especially in the medical device business, this cycle time measure is crucial due to severe competition, changing regulations, and customer preferences. When FDA’s Design Control was introduced as a requirement, most of the product development professionals feared that this metric would be negatively impacted due to increased documentation. Our observations indicate that there seems to be little to no negative impact over the past 5 years to this measure due to Design Control.
