In “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Joseph Gulfo tells the tumultuous history of MELA Sciences, the company that invented MelaFind. When Dr. Gulfo joined the firm as president and CEO in 2004, the company’s brilliant team of scientists had spent many years and tens of millions of dollars to develop MelaFind, a “camera with a brain”—optical technology that would scan potential melanomas in multiple spectra and then, using sophisticated algorithms and large datasets, diagnose which were most likely to be cancerous.
The company’s scientists had done successful research for the Department of Defense, but they had little experience in navigating the FDA, running a clinical trial or bringing a product to market. Dr. Gulfo, an MD with an MBA and a history of successful FDA-approved products to his name, had all the right skills to lead the company. And MelaFind had a lot going for it. It was noninvasive technology, the first of its kind. It promised a crucial opportunity for earlier detection: If left untreated, melanoma often spreads and kills, but it is highly curable when caught early. Read Full Book Review