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True to our Mission, everything we do is consistent with delivering the best possible care for patients. By actively managing product quality and safety through product development, manufacturing, supplier quality assessments, clinical trials, post-market surveillance activities, and customer satisfaction surveys, we are providing safe, high-quality therapies and solutions to patients around the world.
The third tenet of Medtronic’s mission is: “We strive without reserve for the greatest possible reliability and quality in our products: to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.”
Three programs are key to our product quality: Design, Reliability, Manufacturability (DRM), Medtronic Operating System (MOS), and supplier quality.
We use proven DRM methodologies to “design in” quality during the product development process. For example, we test for long-term product reliability using real-world simulation and examination of how healthcare professionals use and implant our products.
We also drive quality improvements in our manufacturing operations using the MOS framework, which applies Lean Sigma tools to achieve continuous improvements. In addition, we plan to achieve and maintain International Standards Organization (ISO) 13485 certification, a standard that provides a basis for quality management systems that satisfy international medical device regulations at our manufacturing facilities worldwide.
Our supplier quality efforts also ensure that the therapies and solutions we source are developed and manufactured for safety and quality. We work closely with our supply chain—from our planners, to suppliers, manufacturers, and logistics teams—to achieve our Mission and develop and deliver our life-sustaining and lifesaving therapies and solutions.
“Our customers and patients rely on the quality and reliability of what we do every day. We are proud that every three seconds somebody in the world relies on Medtronic. Patients trust Medtronic. And quality is key to earning and keeping that trust,” says Luann Pendy, Medtronic senior vice president, Global Quality.
Other key components of our approach to product quality include:
Whenever necessary, we initiate communications—called field corrective actions—with customers to share new information on the appropriate use of our products.