Craig Straley Joins Fogarty Institute as Director of Clinical and Regulatory Affairs

As the Fogarty Institute continues to strengthen services to its companies-in-residence in areas critical to their growth and success, Craig Straley has joined as the director of clinical and regulatory affairs, bringing more than 20 years of experience in conducting clinical research with a number of successful startups.

Expertise fueled by a number of career moves

Craig’s passion for healthcare began when he was studying biomedical and electrical engineering at Duke University and one of his professors encouraged him to pursue a master’s degree related to his interest in cardiovascular dynamics. That led him to work with both the cardiology and cardiac surgery department, solidifying his interest in pursuing a career in this specialty.

While looking for his first job in the medical device industry, he discovered the field of clinical research, which he found appealed to his background in engineering and desire to work closely with physicians and clinicians to execute the trials.

His first job was with Telectronics Pacing Systems in Denver, where he first met Andrew Cleeland and worked for three years before relocating to Silicon Valley to work with Prograft/Gore & Associates. There he assisted with the clinical trials of the abdominal aortic aneurysm (AAA) stent graft they were developing, work he found to be extremely rewarding as he saw immediate results in patients suffering from abdominal aortic aneurysms.

Craig later joined Andrew at Radial Medical, managing feasibility studies, international multi-center pivotal studies and U.S. investigational device exemption (IDEs). He then moved to Ardian, where he was responsible for building and leading the clinical program and evaluating the first-of-its-kind device for renal denervation to treat hypertension. After Ardian’s acquisition by Medtronic, he helped manage the clinical program’s transition and initiated the pivotal trial in the U.S.

Ultimately, he returned to his roots in startups, joining Twelve, where he developed and executed the early clinical studies for its Transcatheter Mitral Valve program, subsequently assisting Medtronic with continuing clinical trials, following its acquisition of Twelve.

Joining the Fogarty Institute

Joining the Fogarty Institute was a natural next step, given his passion for the industry and the startup space, combined with his deep appreciation for the leadership team.

“What I have always loved about my job is the challenge of working within guidelines to find the most efficient and effective way to conduct trials and working with product development and clinical research teams at hospitals around the world, with the ultimate goal of bringing forth innovative devices to improve patients’ lives,” said Craig. “It’s exciting to see the advances being made every day through the companies-in-residence at the Institute, and I look forward to lending my expertise to help them hone their skills.”

In his spare time, Craig likes to golf, ski and travel with his two kids and wife. In fact, you may see him at Lincoln Park in San Francisco hitting birdies.

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