Medicine Is Going Digital. The FDA Is Racing to Catch Up

When Bakul Patel started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware--your pacemakers and your IUDs--it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well. But as computer code took on more complex tasks, like spotting specious moles and quantifying blood flow, their duties began to accelerate. Software developers needed months, not years, to make it to the market.