The Medical 21 team is led by Manny Villafaña.  Manny has a substantial track record starting companies that develop and deliver successful products to the market.

• Cardiac Pacemakers, Inc. (CPI) revolutionized the pacemaker industry by introducing a long-life lithium iodine pacemaker, a technology still used today by 100% of the pacemaker/defibrillator market.  CPI is now owned by Boston Scientific.

• St. Jude Medical developed an innovative, mechanical, bi-leaflet heart valve that dramatically reduced the frequency of blood clots.  St. Jude is now part of Abbott Medical.

• ATS Medical further evolved the mechanical heart valve, introducing an open-pivot design and capturing a strong share of the market.  ATS is now owned by Medtronic.

As a result, Manny has received numerous awards of recognition, including:

• The "Living Legend of Medicine" award from the World Society of CardioThoracic Surgeons.

• MDEA Lifetime Achievement Award.  (https://www.mddionline.com/manny-villafa%C3%B1a-relentless-risk-taker-and-enduring-entrepreneur)

• Inductee of the Minnesota Business Journal Hall of Fame and the Minnesota Science and Technology Hall of Fame.

• Research at the University of Iowa:

       - Medical Devices

       - Cardiovascular Biomechanics

       - Biomaterial Development

       - Mechanical Assessment of Soft Tissues

• Former Process Engineer at 3M.

• Ph.D., Biomedical Engineering, University of Iowa.

• Expert in the pre-clinical development of bypass grafts.

• Accomplished pre-clinical surgeon.

• Extensive experience in the application of Good Laboratory Practices (GLP) quality controls and methodologies.

• Served as Associate Director of cardiovascular research laboratory (ESS) at the University of Minnesota.

• Medical device experience with roles in:

       - Manufacturing

       - Operations

       - Process Development

       - R&D

       - Quality

• Deep medical/technical experience with nitinol support systems.

• B.S., Mechanical Engineering, University of North Dakota.

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• 30 years of leadership across all sectors of life sciences, with a focus on medical technology

• Served as President of a publicly traded medical technology company with Manny Villafaña.

• Frequent lecturer and guest speaker at prominent life sciences conferences such as The Medtech Strategist, The Medtech Conference (AdvaMed) and The BIO Conference

• Medical Director, Cardiovascular Surgery, St. Joseph’s Hospital, St.Paul, MN

• Boston Children’s Hospital

• Initial research work on St. Jude Heart Valve

• Co-Founder & First President of Int’l Society of Minimally Invasive Cardiac Surgery

• Member: American Association for Thoracic Surgery and Society of Thoracic Surgeons

• Associate Professor, Cardiac Surgery, Medical College of Wisconsin, Milwaukee

• Former Professor, Mayo Clinic

• Member: Int’l  Society for Heart and Lung Transplant, Society of Thoracic Surgeons, and American College of Surgeons

• MBA, University of Chicago

• Harvard Medical School

• Resident, Johns Hopkins

• Fellowship, Stanford University

• Principal at Florida Inst. for Angiography & Gene E. Myers Cardiac/Vascular Consultants

• Completed 20,000+ coronary/peripheral procedures

• Medical device & EMR patents

• Discovered Cervicoprecordial angina disease

• University of Pennsylvania medical school

• Cardiology fellow, Duke & Georgetown (Nat’l Inst of Health, Children’s Nat’l Medical Center)

• U.S. Navy, Lieutenant Commander

• Cardiologist, Norfolk Regional Medical Center/East VA Med School

• Section Chief, Adult Cardiac Surgery, Medical College of Wisconsin, Milwaukee

• Co-surgeon on first permanent implant of the Jarvik 7 total artificial heart

• First to implant a total artificial heart in a woman and a child

• Former positions at the Mayo Clinic, University of Minnesota, and the Minneapolis Heart Institute

• Fulbright Distinguished Chair

• Fellow, American Institute of Medical & Biological Engineering

• 25 years experience in cardiopulmonary biomechanics and device design, critical care therapies, soft tissue mechanics, and computational modeling

• Ph.D. in Bioengineering, University of Pittsburgh