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The Judges' Book

Abstract

Transformative medical innovations—the ones that disrupt the world—command the lion’s share of attention. But the vast majority of innovations are incremental—the result of small modifications made to existing products. The process of incremental innovation tends to be highly iterative, with products being modified again and again. Over time, dozens or hundreds of small changes can accumulate to the point where contemporary technology bears little resemblance to the technology of years or decades before.

In the field of medical devices regulated by the Food and Drug Administration (FDA), incremental innovation accounts for roughly 99% of new devices. On the upside, incremental innovation can, just like transformative innovations, radically alter technologies and disrupt the fields in which they are used, albeit at a slower pace. On the downside, the dangers created by incremental innovation often go unrecognized because of the gradual rate of change involved. Indeed, incrementally innovative devices have inflicted harm on more U.S. patients than transformative innovations.

This Chapter sheds light on the dangers of incremental innovation in medical devices, argues that the regulatory pathways for FDA approval of incrementally innovated devices are insufficient for mitigating those dangers, and offers a regulatory reorientation for making incremental innovation safer. In short, understanding the innovative processes through which medical-device technologies and applications are developed is critical to optimal regulation of incremental innovation.

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