Songwriter Tom Petty observed that “The waiting is the hardest part.” For those who have lived through the past few years in the medical device industry, Petty is truly preaching to the choir. The theme of last year’s annual review of the device industry was change; medtech was in a state of transition, almost as if waiting for the other shoe to drop, on a number of fronts. We optimistically suggested that 2011 would see one or more of those shoes finally fall, bringing some resolution, most notably in the regulatory area. However, one year later, just about the only thing we can comfortably predict is that we’re going to be living with uncertainty for the foreseeable future.
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