Premier Research
Premier Research has hired three new medical device and diagnostics specialists.
John Pappan (image left) who joins Premier Research from a global regulatory compliance consultancy, has been named director of regulatory affairs, medical device, and business strategy.
He has held positions at DePuy Synthes (Johnson & Johnson), the Long Island University College of Pharmacy, Integra LifeSciences Corporation, ConMed Corporation, and mdi Consultants Inc.
"What our team aims to achieve is the appropriate regulatory pathway for our clients,” Pappan told us. "Many times we will be able to simply pursue the Traditional 510(k) pathway. But because FDA published an updated guidance back in December and also had announced changes to their 510(k) paradigm, that may lead more companies choosing the Breakthrough Device Program (BDP), particularly those companies with breakthrough technology."
"To that point, the device you intend to bring into the market must provide a more effective treatment or diagnosis of the life-threatening or irreversibly debilitating disease or condition. In many cases, the device will fall under a premarket approval application, or PMA, which is a more costly (not to mention much more lengthy) pathway for the sponsor to pursue," added Vicki Gashwiler (image right), who, with nearly 20 years in health care, has been named the executive director of medical device and diagnostics. She is licensed and has served as a registered nurse in critical and cardiovascular care.
Sundeep Shrivastava (not pictured) has held leadership positions at Iqvia and Abbott Vascular and in his new role will be executive director of clinical development services, medical device, and diagnostics.
The company last month named a new COO, Dr. Mike Wilkinson.