Cyberonics' Two-Front War
Executive Summary
Most medical device executives are reluctant to say anything that could in any way be construed as critical of the FDA or the agencies that determine reimbursement coverage decision. But not Robert "Skip" Cummins, president and CEO of neurostimulation pioneer Cyberonics. For the past two years, Cummins has been waging what has been a virtual one-man war with the FDA and major payers to make sure that psychiatrists and their patients have access to the only FDA-approved treatment for severe treatment resistant depression.