Fred Colen, MSEE

Fredericus (Fred) A. Colen is a global medical device executive and innovator, currently serving as Chairman of the Board of Xeltis AG, a leader in restorative cardiovascular devices. Based in Ponte Vedra Beach, Florida, Fred has more than four decades of experience leading early-stage ventures, mid-sized enterprises, and multi-billion-dollar global medical device businesses. He is widely recognized for building strong organizations that develop and commercialize breakthrough medical technologies while maintaining a steadfast focus on patient safety, business ethics, quality, compliance, manufacturability, and innovation. His career reflects a dedication to improving the quality of life for patients worldwide while driving sustainable business success.

Fred served as President and CEO of Neovasc Inc. from 2018 to 2023, where he led a cross-functional team to grow international sales of the Reducer device from zero to $8 million annually, secured reimbursement approvals in key markets including the U.S., France, the UK, and Germany, and strengthened the company’s clinical and market presence. During his tenure, Neovasc successfully raised $100 million in capital and initiated a U.S. FDA-approved IDE study, culminating in the company’s acquisition by Shockwave. Previously, he led BeneChill, Inc., developing innovative non-invasive brain cooling technologies and positioning the company for acquisition by a Swedish brain cooling company.

Earlier in his career, Fred held numerous senior executive roles at Boston Scientific Corporation, including Corporate Executive Vice President, Chief Technology Officer, and President of the $2.5 billion Cardiac Rhythm Management Group. He was instrumental in restoring revenue growth, increasing operating margins, and establishing the Taxus drug-eluting stent platforms as global market leaders. His leadership included overseeing global R&D, regulatory approvals, and commercial launches while fostering a culture of patient safety, manufacturability, and meaningful innovation.

Fred also contributed to the growth of St. Jude Medical and Lewicki Microelectronic GmbH, managing international operations, R&D, and manufacturing while integrating acquisitions and improving operational efficiency. He began his career at Cardiac Pacemakers Inc. and the University-Clinic of Aachen, Germany, where he worked on implantable pacemakers and diagnostic tools for cardiac care. He holds a Master’s degree in Electrical Engineering, specialized in Biomedical Engineering, from RWTH Aachen University, Germany, and a Bachelor’s degree in Electrical Engineering from the Technical University of Eindhoven, the Netherlands. Fred is fluent in English and Dutch, and proficient in German, with basic knowledge of French and Swedish.

Beyond executive leadership, Fred serves on several boards and advisory roles, including Xeltis AG, Onward Medical, Mölnlycke Healthcare, and Middle Peak Medical, contributing his expertise to innovative medical technologies worldwide. He is a vocal advocate for meaningful innovation in the medical device industry, emphasizing the need for both high-risk, high-reward development and long-term investment in solutions for unmet medical needs. Throughout his career, Fred has combined technical expertise, strategic vision, and ethical leadership to advance patient care and shape the future of medical technology.

• Master’s in Electrical Engineering (Biomedical Engineering specialization), RWTH Aachen University, Germany, 1977
• Bachelor’s in Electrical Engineering, Technical University Eindhoven, The Netherlands, 1974

• Corporate Executive Leadership and Board Roles in Medical Device Industry

• Recognition for successful global product launches, clinical innovation, and leadership in the medical device sector

• Vice President & Chairman, MedTech Europe
• Board Member, Xeltis AG, Onward Medical, Mölnlycke Healthcare, Middle Peak Medical

• Advocate for advancing cardiovascular and spinal injury solutions
• Mentoring in medical technology innovation