| |
Mike co-founded Experien Group in 2003 with Darlene Crockett-Billig. 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.
At Experien Group, Mike’s primary role for client companies is to provide strategic regulatory and clinical support, including virtual staff executive leadership. For several clients, Mike functions as the Acting Vice President of Regulatory, Quality and Clinical, representing the companies in Board of Directors meetings, sales meetings, industry symposia, investors meetings, regulatory agency interface, and more. Mike assists small start-ups, mid-sized companies and major public corporations alike, providing advisory and tactical direction for:
- Complex U.S. and international regulatory and clinical strategies
- Communications and interface with U.S. and international regulatory agencies
- U.S. and international regulatory submissions
- Clinical trial designs
- Venture presentations and facilitation of strategic corporate partnerships
- FDA and international compliance activities (e.g., MDRs, Vigilance Reporting, and field actions)
- Product labeling and promotional materials
PAST COMPANIES AND EXPERIENCE
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.
EDUCATION
Mike earned his BS degree in Microbiology from the University of Minnesota. |
