Facing the Challenges of Increased Regulatory Demands

Managing the environmental and regulatory performance of products is an increasingly complicated challenge for medical device manufacturers who face a myriad of requirements from regulators, consumers, and customers to control and report on the toxicity, safety, and overall environmental impact of their products. Today’s medical device products are more complex—both technically and commercially. They have more variants than ever before and are designed to support global markets. Along with complex products, many medical device manufacturers have evolved to become less vertically integrated, relying more and more on multitier, global partnerships for design and manufacturing. At the same time, the sluggish global economy and pressure from developing markets have forced manufacturers to adopt aggressive cost targets, continuously look for ways to reduce cost, and try to manage unpredictable cost drivers, such as wildly fluctuating commodity prices.