Michael J. Billig is CEO of Experien Group, a clinical and regulatory consulting firm, which he co-founded with his wife, Darlene Crockett-Billig, in 2003. His entire 45-plus 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 in a variety of product areas, including sterile disposable products, electronic instruments, robotics, combination products, mobile health, and devices for regenerative medicine, and more recently, devices incorporating artificial intelligence (AI). Mike has particular expertise in the interventional cardiology and cardiac surgery areas, although Experien Group has engaged in virtually every medical device area over the past 15 years.
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 being 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 over 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 CEO and President of Timi3 Systems, Mike provided overall leadership for strategic business affairs and company growth. He was instrumental in substantial fundraising, with multiple successful IPOs, and with company sales/corporate acquisitions from both seller and buyer positions. Mike earned his Bachelor of Science degree in Microbiology from the University of Minnesota.