Incremental Innovation

Transformative innovations—the ones that use new technologies to disrupt the world—command our attention. But most new products are the result of a more mundane process of incremental iterative innovation, evolving through a long series of small modifications of existing technologies. Although both kinds of innovation can result in improved safety and utility, both can also create new dangers. We tend to be more aware of this in trans- formative innovations (as current worries over artificial intelligence show); by contrast, dangers created by incremental iterative innovation often go unrecognized, because the process itself is easy to overlook. Policymakers and regulators need to be aware of both kinds of innovation and to consider different approaches to each if we are to reap their benefits and avoid their dangers. Unfortunately, incremental iterative innovation has often been neglected, sometimes with devastating consequences. This is particularly true in the field of FDA-regulated medical devices, which have caused hundreds of thousands of injuries and deaths. Critics have attributed the harms caused by one particular set of devices to incremental iterative innovation, but they have failed to appreciate the full scope of this process, leading them to over- look the dangers posed by many other devices. This Article is the first to identify the full scope of incremental iterative innovation in the medical device field. It develops a nuanced understanding of where this process is taking place and where it is creating dangers, and suggests regulatory reforms designed both to ensure safety and to support innovation. Using the device field as a case study, the Article also helps to expand our understanding of how incremental iterative innovation and regulation intersect in other contexts.