Vice President, Regulatory, Quality & Clinical
Mike serves as Vice President, Regulatory, Quality & Clinical. In addition to his work with InCube, Mike is CEO of Experien Group, a clinical and regulatory consulting firm, which he co-founded in 2003. His entire 35+ year professional career has been involved with regulatory affairs, quality systems, clinical research, and general management for medical device companies. Mike has secured regulatory approval for hundreds of medical device products across the U.S., Europe, Canada, Central and South America, and Asia. He has been involved with a variety of product areas, including sterile disposable products, electronic instruments, robotics, combination products, and devices for regenerative medicine. Mike has particular expertise in the interventional cardiology and cardiac surgery areas.
Mike entered the device industry in 1973 at Medtronic, setting up the company's first microbiology laboratory in Minneapolis. He transitioned to regulatory affairs at Medtronic as a Project Regulatory Manager at the time that the U.S. Medical Device Amendments of 1976 were finalized. Mike went on to work for a number of other large companies and public corporations, including Syntex, Oximetrix, Abbott and Guidant. Mike spent the majority of his time in the industry in senior management for start-ups, holding executive-level positions for 20 years at companies such as CardioThoracic Systems, Cardiometrics, Converge Medical, and Timi3 Systems. In these early stage companies, Mike oversaw the regulatory, clinical and quality teams and provided strategic direction for product development and marketing. As a vice president of several companies and the former President and CEO of Timi3 Systems, Mike provided overall leadership for strategic business affairs and company growth. He was instrumental with substantial fundraising, multiple successful IPOs, and company sales/corporate acquisitions from both seller and buyer positions.
Mike earned his BS degree in Microbiology from the University of Minnesota.
Chairman & CEO
Research & Development
Director of Manufacturing
Sr. Director of Intellectual Property
DVM, Preclinical Sciences