On January 10, PricewaterhouseCoopers, the California Healthcare Institute, and BayBio released early results of the California Biomedical Industry 2012 Report, which surveyed biomedical industry CEOs.
Speaking at the announcement was a panel of three CEOs including Alex Lukianov, CEO of Nuvasive; Rick Winningham, CEO of Theravance; and Stephen Cary, PhD, CEO of Omniox.
When asked what the broader trends were in terms of FDA, Lukianov cited the much-talked about slow down in device approvals at the Center for Devices and Radiological Health's Office of Device Evaluation. Nuvasive, which is just over a decade old, has grown rapidly from a start up to a company with more than 1000 employees. "And I think the success we have enjoyed has been predicated upon innovation and the rapid release of new products," Lukianov says. "We have released, historically, about 10 new products per year over the last six years or so," he said. "That number last year was cut in half."
Lukianov explained that his firm continues to see ongoing challenges with regard to FDA and the release of products, citing moving regulatory goal posts and frequent requests for additional information. "From a broader perspective, there have been just really significant delays, to the point where last year, we estimated that the delays cost our company about $70 million in terms of last revenue in 2011 and pouring over into 2012," he said. He explained that the firm has been forced to reduce our headcount growth plans. "We didn’t have to make any cuts but we did have to reduce our headcount growth plans," he said. "And that is because of all of the products that were backed up at FDA."