Co-Founder, Chief Executive Officer
Koa Accel
Dr. Francis G. Duhay stands as one of the most influential leaders in modern medical device innovation, distinguished by a career that bridges world-class clinical practice, pioneering research, and transformative corporate leadership. From his early days as an Assistant Professor of Cardiothoracic Surgery at Duke University to his tenure as Chief Medical Officer at Edwards Lifesciences, he has consistently demonstrated a rare ability to translate complex medical challenges into breakthrough technologies that reshape patient care on a global scale. His personal mission – to advance medical innovation that improves human health – has guided every chapter of his professional journey.
Trained in the highly rigorous surgical programs at UC San Francisco and Duke University, Dr. Duhay cultivated a deep appreciation for both clinical excellence and the scientific curiosity that drives medical advancement. At Duke, he contributed to foundational research in cardiothoracic surgery and physiology, playing an early role in what is now known as Minimally Invasive Cardiac Surgery – work that ultimately led to more than 30 U.S. and international patents underpinning several widely adopted cardiovascular technologies. His academic contributions include 45 peer-reviewed publications, multiple book chapters, and over 200 scientific abstracts and invited lectures, reflecting a sustained commitment to advancing knowledge across the medical community.
His transition from academia to clinical leadership was a natural progression for a physician driven by large-scale impact. As Chief of Cardiothoracic Surgery across major health systems – including Kaiser Permanente, Medical Center Hospital in Texas, and St. Luke’s Hospital in Pennsylvania – he built and led high-performance teams, elevated standards of care, and improved patient outcomes across diverse populations. These experiences shaped his core leadership philosophy: that meaningful innovation must be clinically relevant, operationally scalable, and grounded in the realities that physicians face every day.
This philosophy would ultimately place him at the forefront of one of the most significant medical breakthroughs of the 21st century. Joining Edwards Lifesciences during the formative era of Transcatheter Aortic Valve Replacement (TAVR), Dr. Duhay played a central role in shepherding the technology from early clinical exploration to global adoption. Serving as Vice President, General Manager, and eventually Chief Medical Officer, he oversaw clinical, regulatory, medical affairs, and health economics & reimbursement programs that helped transform TAVR into a multi-billion-dollar therapy and one of the most successful cardiovascular innovations in history. His strategic leadership not only advanced the IDE pivotal trials, which supported PMA approval, but also helped establish the reimbursement and market adoption frameworks essential for real-world patient access – enabling millions to benefit from a life-saving therapy once thought impossible.
Beyond Edwards, Dr. Duhay has repeatedly demonstrated his ability to scale early-stage innovation into commercial reality. As CEO and Co-Founder of multiple venture-backed startups – including Koa Accel, Makani Science, Kino Discovery, and Kahala Biosciences – he has built teams, secured funding, navigated regulatory environments, and launched disruptive technologies across in vitro diagnostics, respiratory monitoring, microfluidics, and biotech. Notably, during the COVID-19 pandemic he led Kahala Biosciences in commercializing one of the earliest FDA-authorized RT-PCR detection assays, enabling testing for millions of Americans at a time of critical national need. As Senior Vice President of Medical and Clinical Affairs at Olympus Corporation, he further broadened his clinical and business expertise beyond cardiovascular medicine into gastroenterology, urology, pulmonology, obstetrics, ENT, and general surgery.
Today, as Senior Vice President of Clinical, Regulatory, Medical Affairs, Health Economics & Reimbursement, and Business Development at EnCompass Technologies, Dr. Duhay continues to shape the future of cardiac interventions. There, he led the development and First-in-Human clinical execution of the F2 cerebral embolic protection system for TAVR, achieving IDE approvals for both early feasibility and pivotal studies. The device’s performance – demonstrating 94% improvement over the market-leading comparator – underscores his continued ability to elevate standards of care and advance the field of structural heart disease.
Dr. Duhay’s influence extends internationally, with work spanning Europe, Asia, and North America, and direct engagement with regulatory bodies including the FDA, CMS, PMDA, TGA, and Health Canada. His contributions to the ISO 5840 standards for cardiac valve prostheses reflect a deep commitment to shaping the ethical and scientific frameworks that guide device safety and performance worldwide. Fluent in conversational Japanese and experienced across global markets, he brings a cross-cultural perspective essential to modern healthcare leadership.
Despite his extensive credentials, Dr. Duhay remains grounded in the values that shaped his career: intellectual rigor, ethical leadership, and service to others. A lifelong learner, his MBA coursework strengthened his strategic and operational insight, complementing his medical training. Outside of his executive roles, he finds balance through surfing, reading, and a deep appreciation for classical and jazz music – pursuits that speak to his curiosity and reflective nature.
He now seeks to channel his experience into advisory and board leadership roles, particularly within small to mid-sized medical device companies where his clinical intuition, regulatory expertise, and commercialization skill can meaningfully accelerate growth. His career reflects not only a commitment to medical science, but a genuine desire to elevate the next generation of innovators who will continue transforming patient outcomes.
In every role he has held, Dr. Francis Duhay has embodied the belief that advancing medical innovation is both a responsibility and a privilege. His legacy is marked by life-saving technologies, high-performing teams, and a forward-looking vision that continues to shape the trajectory of cardiovascular and medical device development.
Character:
Dr. Duhay brings unwavering integrity in every decision, consistently placing patient welfare and clinical excellence at the center of his work. He leads with humility, earning trust and respect across multidisciplinary teams and is driven by a deep sense of responsibility to advance healthcare in ways that genuinely improve human lives.
Knowledge:
His expertise spans clinical operations, regulatory affairs, medical affairs, and business operations, making him a rare executive who combines scientific depth with commercial acumen. He remains current with evolving technologies and global regulatory standards, ensuring his guidance is both innovative and compliant. Decades of research, patents, and publications reflect a lifelong commitment to expanding the boundaries of medical knowledge.
Strategic:
Dr. Duhay applies long-term, systems-level thinking to every initiative, aligning clinical evidence, regulatory pathways, and business strategy to achieve sustainable outcomes. He consistently identifies emerging opportunities and translates them into actionable plans with measurable impact. His ability to anticipate market shifts and guide organizations through complex challenges marks him as a highly effective strategic leader.
Communication:
Whether addressing physicians, investors, regulators, or early-career innovators, Dr. Duhay communicates with clarity, precision, and authenticity. His scientific and clinical background enables him to translate complex concepts into compelling narratives that resonate across diverse audiences. Through hundreds of presentations and leadership roles, he has established himself as a trusted and influential voice in the medical device industry.
https://koaaccel.com/leadership/
