Burden of Opportunity:
Hurdling the Regulatory Process
PTV Senior Advisor Bob O’Holla sits down with Managing Director Rick Anderson to discuss navigating today’s regulatory environment
Austin, Texas – February 11, 2015 – We are excited to announce the release of the next podcast in our TOP Talks series. The podcast features PTV Managing Director Rick Anderson and PTV Senior Advisor Bob O’Holla as they discuss navigating today’s regulatory environment and the opportunity it presents for healthcare entrepreneurs.
In the podcast O’Holla addresses the so-called hurdles of the regulatory environment, the longer approval times, and the increasing burden of proof on medical devices for more clinical data. “Certainly if you’re not involved and engaged in the industry, you can see them as a negative looking from the outside, but on the inside they are all opportunities,” he says. “Look at the face of healthcare, it’s changing. Bigger regulatory requirements, reimbursement issues are changing, but we’re looking at new development paradigms as well as new medical care paradigms, and today the environment is ripe for rewarding those healthcare investments that help move that changing paradigm forward. It’s the most exciting time I’ve seen in my career.”
The key to success, O’Holla stresses, is that entrepreneurs understand the regulatory environment and the specific regulatory requirements their product will face. When asked what advice he would give his younger self, O’Holla laughs and says the big thing is patience. “Have patience and remember when you’re negotiating it’s got to be a win-win, otherwise you can’t get anywhere – including with regulatory bodies. There has to be a win on both sides.”
O’Holla is a health products executive and the former Worldwide Vice President of Regulatory Affairs at Johnson & Johnson. He has over thirty years experience, including research and development, quality and compliance, regulatory affairs, policy development, and product sterilization. O’Holla has also written several publications regarding health products.
TOP Talks, PTV’s podcast series, features conversations between PTV Managing Director Rick Anderson 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.