Meet Early. Meet Often.

PTV Senior Regulatory Advisor Tony Blank on the consumerization of the FDA

Austin, Texas – June 29, 2017 – We are excited to announce the release of the next podcast in our TOP Talks series. The podcast features PTV Senior Regulatory Advisor Tony Blank as he joins PTV to discuss the consumerization of the FDA.

In the podcast Blank and PTV Senior Associate Clay Samford discuss the macro view of the current regulatory environment and what potential impact recent changes and new product categories might have on safety and efficacy standards. In particular Blank discusses how we might improve the pace of innovation and how health entrepreneurs can give themselves the best chance for success.

On the whole, Blank’s outlook is encouraging for healthcare entrepreneurs and investors alike. “I would have to say I’m pretty bullish on the way FDA is responding to particularly young entrepreneurial companies that are coming forward with substantial technologies. That’s not to say it’s easy; the process can be time consuming, it can be expensive. But the FDA would encourage you and I would encourage you, as I do my clients, to meet early and to meet often with the agency to help get through the process with as little upset as possible, recognizing that scientific development is an inherently risky business.”

Tony Blank, a regulatory consultant focused on medical devices, previously spent twelve years at Boston Scientific in both corporate and business regulatory leadership roles.  While at Boston, he led their CRV regulatory teams in obtaining numerous regulatory approvals for Class II & III medical devices and combination products. Tony also represented the medical device industry and regulatory professionals on numerous policy issues through work with AdvaMed working groups including pediatric devices, advertising and promotion, and reprocessing.

Tony is involved in developing and delivering meaningful educational programs in the field of regulatory affairs, including co-facilitating the recent inaugural Global Regulatory Strategy Summit (sponsored by Medical Device Summit). He continues to actively participate as a faculty member for the AdvaMed IDE and PMA submissions workshops.  In addition to his time at Boston Scientific, Tony has worked within the cardiopulmonary, surgical, ophthalmic, vascular access and critical care industries.
Tony recieved his B.S. from Colorado State in Chemical Engineering, with additional graduate studies from the University of California, Berkley.

TOP Talks, PTV’s podcast series, features conversations between PTV and various industry thought leaders as they discuss the changing landscape of the healthcare industry and what that means for healthcare entrepreneurs. Previous episodes can be found on PTV’s website.