ABSTRACT
The medical device and diagnostics industry isn’t as much fun as it used to be. Products are aging and increasingly more difficult to differentiate. Market success has attracted more competitors, many from outside the United States. Changing regulatory requirements in the United States and across the globe have resulted in increasing costs and time to develop new products. What’s more, regulatory agencies around the world are requiring postmarket data about the long-term safety and efficacy of products, especially when they are used by broader patient populations in real-world settings.
