Medical Progress, Please

Holman Jenkins, writing in The Wall Street Journal, succinctly and perfectly describes the brilliance and, sometimes, serendipity involved in breakthrough entrepreneurship.  From Medical Progress, Please:

How does a device like MelaFind come into the world? It begins when a small defense contractor specializing in computer vision is approached by pharmaceutical giants seeking objective ways to evaluate unguents for hair growth, wrinkle reduction or wound healing. An adviser to the small company, a world-famous dermatologist, pipes up: “Wound healing is cool, but if you really want to do something for humanity, help us detect melanomas.”

America having great capital markets, it’s possible to raise $130 million for a speculative venture.

In addition to extolling the wizardry of American medicine and the strength of our capital markets, Mr. Jenkins recounts some of the challenges faced during FDA approval by the current “wave of devices bringing artificial intelligence to bear on medical diagnosis.”  The details Mr. Jenkins reports are a clear example of what our friend Rhys Williams has argued before Congress:  in addition to streamlining its approval process the FDA needs to switch from the “zero defect” to the ”calculated risk” model.