Justin Ballotta is an accomplished senior executive with more than 20 years of success in the medical device sector. As the chief operating officer of Cardiva, Ballotta is responsible for product development, quality assurance, clinical, regulatory affairs, manufacturing and customer operations. Under Ballotta’s leadership, Cardiva has successfully completed two randomized, multi-center U.S. pivotal clinical trials leading to the approval of two premarket approval (PMA) devices; built a manufacturing facility offshore from the ground-up; improved gross margin by 250% and in 2018, won the Shingo prize for manufacturing excellence.
Prior to Cardiva, Ballotta was senior director of Global Business Assessments & Strategic Marketing at Johnson & Johnson (Cordis) responsible for next generation structural heart and drug-eluting stent programs. He held various leadership positions in new product development and program management and was the general program manager for the Cardiovascular Technologies business unit, where he was responsible for product development in both the U.S. and Europe, commercializing eight PMA and 510(k) medical devices. Preceding this leadership role, Ballotta spent three years in the Netherlands leading research and development for coronary stent delivery systems and PTCA catheters.
Ballotta co-founded Bio-Trainers, LLC, a company that focused on scanning technology of human cadavers for the development of surgical training tools.
Ballotta holds dual M.B.A. in Corporate Finance from Columbia University, Columbia Business School and an M.B.A. in Entrepreneurship from the University of California, Berkeley, Walter A. Haas School of Business; a Masters of Engineering Management from Florida International University, and a B.S. in Biomedical and Mechanical Engineering from the University of Miami.