More than a million times each year in hospitals all around the world, a device called the heart-lung machine keeps patients alive while surgeons repair damaged hearts in an unobstructed "dry environment." Those who benefit range from tiny babies with congenital defects to adults suffering from arterial blockage. For many years, Richard Griewski has led the design efforts on the 3M Sarns brand of heart-lung pumping systems, one of the oldest and most respected names in this life-sustaining technology. Griewski has played a particularly important role in pioneering the first computer-aided centralized monitoring systems for heart-lung machines. In the process, he has had to learn the fundamentals of cardiac surgery to address the human factors needs of the perfusionists who operate this equipment during critical moments. His engineering expertise also includes: pumping systems, cell biology, display systems, electronics, software, and electromagnetic compatibility. One veteran perfusionist at the famed Texas Heart Institute calls the Sarns devices the "Coca Cola" of the field, based on the machines' long track record for reliability, as well as such innovations as automatic battery backup, integrated gas mixer, and "splash-proof" design.
As manufacturers add new technologies to their products, designing for compliance becomes more difficult. Prepare for the certification testing process. Otherwise, you increase the risk of discovering a safety issue after a product leaves the assembly line. That will cause significant time-to-market delays, be much costlier to fix, and damage your brand in the eyes of customers.
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