LAUSR

> The road is long > > With many a winding turn > > That leads us to who knows where > > Who knows where > > —“He Ain’t Heavy, He’s My Brother,” by Bob Russell and Bobby Scott The pitch begins like this: “Patients with #NameYourDisease represent a large market with a significant unmet medical need.” It goes on: “Our #NameYourTechnology is currently in development and promises to improve patient outcomes.” Then without fail, a Gantt chart shows the (best-case) plans for development, preclinical testing, and clinical trials. All of which leads to the pot of gold at the end of the bar chart rainbow: approval by the US Food and Drug Administration (FDA). For many years, this strategy was all it took to make a new therapy successful. All we in industry had to do was to build it—and provide reasonable assurance that it was safe and effective for use in the United States—and patients and providers would come. Like superannuated generals always preparing to fight the last war, many in medical technology continue viewing FDA approval as the end goal of medical research and development efforts. Since leaving academia and joining industry ≈8 years ago, I have found that the world is more complicated than that. Today, FDA approval is just 1 waypoint on a long, winding, and …