Quality engineer Justiniano and Gopalaswamy, an executive director in a large company, explain how managers engaged in launching a medical device with distinctive features or innovations can use Design for Six Sigma as a management philosophy, and use it to link the US Food and Drug Administration's Design Control requirements of the Quality System Regulations and ISO 13485 with contemporary competitive global business scenarios. They cover regulation, business, and Six Sigma; the design control roadmap; the Six Sigma roadmap for product and process development; design control and Six Sigma roadmap linkages; measuring design for Six Sigma effectiveness; and leadership's role in ensuring success.