Dr. Manny Villafaña has led the industry in cardiac device advancements for the last 50 years. So impactful are his contributions, that he has been named “The Living Legend of Medicine” by the World Society of Cardiothoracic Surgeons. As a serial entrepreneur and medtech innovator, the companies he started have reshaped the landscape of cardiac medical devices time and time again.
The Definition of The American Dream
Manny was raised in the South Bronx by Puerto Rican immigrant parents. His is a story of perseverance, hard work, and the embodiment of The American Dream. Living in poverty and navigating the daily difficulties of a life in the South Bronx was no easy feat. After the early passing of his father and brothers, Manny was raised solely by his mother. He started working at the Kips Bay Boys’ & Girls’ Club at the age of 9, with all his earnings going to helping his mother pay for their home and his school. The Kips Bay Boys Club proved to be an invaluable safe haven for Villafaña, helping him stay off the streets while developing his love for learning; books, science clubs, and lessons learned from positive male role models kept him on a healthy path. Manny continues to pay forward the great opportunities the Club provided him through his many charitable donations.
So how did a “latchkey kid” from the South Bronx with nothing but a high school diploma and a spitfire work ethic become a world-renowned entrepreneur and medtech game-changer? Let’s find out.
The Path to Greatness
In 1964, Manny answered a small square ad in the daily paper for a Spanish-speaking sales position at Picker International — a medical device exporter and x-ray manufacturer. Starting out in sales, he quickly rose to a customer service role for high-profile accounts like Medtronic.
In March of 1967, Medtronic hired him as its first international sales administrator for the cardiac pacemaker. Manny was in the room with surgeons who implanted pacemakers for the first time, teaching doctors and surgeons about the pacemaker technology, and, after moving to Argentina a few years later, expanded Medtronic’s market size substantially.
But as much as Manny loved, lived, and breathed the pacemaker, he knew it needed improvements. The pacemakers at the time would only last around 12–18 months before needing replacement. Manny knew there had to be a way to have them last much longer: at least 10 years. Medtronic told him it was impossible to do. But, as we’ll come to see, Manny thrives on doing the impossible.
An Unstoppable Force — 7 IPOs and Millions of Lives Touched
“The greatest hazard in life is a person who does not take risks. If you don’t take any risk, nothing is going to happen.” — Manny Villafaña, Ph.D.Sc.
Cardiac Pacemakers Inc.
In 1972, after leaving Medtronic, Dr. Villafaña founded Cardiac Pacemakers, Inc. (CPI) in Minnesota. He had an ambitious goal: to develop a small, lightweight pacemaker that would last 10 years instead of 18 months. Manny and his team developed the first long-life, lithium-powered pacemakers and defibrillators. This new technology didn’t only meet their goal; it surpassed it. The CPI pacemakers lasted 30–40 years instead of the intended 10 years. The technology they developed is incorporated into virtually every single pacemaker and defibrillator around the world. What was referred to as impossible became the cornerstone of the pacemaker industry.
CPI was bought by Boston Scientific for $27 billion.
St. Jude Medical, Inc.
Having seen how he could transform inefficient technology into a remarkable advancement, surgeons approached Manny and asked if he could do the same to artificial heart valves. Thus, St. Jude Medical, Inc. was born.
In 1976, Manny founded St. Jude Medical and co-developed the St. Jude heart valve: a bi-leaflet artificial heart valve made of pyrolytic carbon. This next-generation advancement became the “gold standard” of heart valves due to its durability and the material’s biocompatibility and thromboresistance.
The St. Jude heart valve was such a profound leap forward in cardiac device technology that it is still the most commonly used prosthesis in the world. There are approximately five million patients with this implant.
Abbott Medical of Chicago recently paid $30 billion for St. Jude Medical, Inc.
In 1987, Dr. Villafaña founded ATS Medical, where he and his team developed the next-generation heart valve. The ATS heart valve is still used in cardiac surgeries over 30 years later.
Medtronic purchased the publicly traded ATS Medical in 2010 for $400 million — which would be $1 billion in today’s dollars.
Dr. Villafaña has founded, developed, taken public, and sold several other companies as well, with notable successes and contributions to the industry along the way. Without his advancements in cardiac devices, the procedures and medical solutions would surely not be where they are today. Manny has done seven IPOs, raising capital for his companies and charities over 45 different times.
Honoring a Game-Changer: Awards and Achievements
While accepting his most recent award, LSI’s 2022 Lifetime Achievement Award in Medical Devices, Manny humbly remarked,
“Some people think that I’ve done this alone but … none of the things that we’ve accomplished are ever accomplished without first your family, the members of the staff — that are usually the smartest people around — and by the investors who have taken hard-earned money and said, ‘Manny, we’re going to take a risk with you.’ But at the end of the day, it’s due to the bravery of a lot of doctors and patients who have trusted us to be able to implant and develop a product that will hopefully be able to bring better patient care, better survival, and a better life. Thank you for this moment.”
1985 Cardinal Hayes High School Hall of Fame, Bronx, New York
1990 National Master Entrepreneur of the Year, Ernst & Young LLP
1991 Top 100 Hispanics in the USA
1993 Boys and Girls Club of America Hall of Fame (Kips Bay Boys & Girls Club)
1998 Grand Prize Recipient — Mediterranean Institute of Cardiology
2003 Minnesota Business Hall of Fame
2006 Ellis Island Medal of Honor
2006 Living Legend of Medicine Award from the World Society of Cardiothoracic Surgeons
2010 Induction into the Minnesota Science and Technology Hall of Fame
2011 Patrick Cardinal Hayes Man of the Year
2014 Honorary Doctor of Science degree in Biomedical Engineering from the University of Iowa
2016 Medical Design Excellence Awards (MDEA) Lifetime Achievement Award
2016 Minnesota Business Lifetime Achievement Award
2016 In Minnesota, October 27th is now “Manny Villafaña Day”
2017 Bronx Walk of Fame — honored by his hometown by having a street named “Dr. Manny Villafaña Street”
2022 LSI Lifetime Achievement Award for Medical Devices, Dana Point, CA
Manny has taught/lectured at Harvard, Universities of Minnesota, Iowa, Notre Dame, Miami of Ohio, Stanford, Brown, St. Olaf, and others.
An Even Brighter Road Ahead
Of all his remarkable achievements, the serial entrepreneur describes his latest venture as “the most exciting one yet,” and with good reason. Founded in 2016 in Minneapolis, Medical 21 is a next-generation medtech company whose goal is to revolutionize the future of the cardiac bypass surgery procedure.
The Medical 21 team is developing an artificial artery that is designed to replace the need for blood vessel harvesting in cardiac bypass surgery patients. Although others continue to pursue its development, the groundbreaking MAVERICS graft system is something that has never been done before — just the type of adventure Manny lives for.
The graft is a flexible, strong, and biocompatible device unlike any other. The company’s goal to eliminate blood vessel harvesting may bring a host of benefits for patients, surgeons, and the healthcare system alike. Without the need for the grueling process of removing blood vessels from the arms, legs, or chest to use as coronary artery grafts, patients may experience less pain and disfigurement along with fewer complications and a shortened recovery time. Surgeons could spend less time performing the procedure, allowing more patients to receive life-saving heart bypass surgery. A door could open for previously unsuitable patients to receive the surgery — patients with amputations, severe diabetes, varicose veins, and other health conditions that make their saphenous veins unusable. By eliminating this step, patients could also spend at least one less day in the ICU.
“In 2021, the company blew past its $10 million funding goal, allowing it to set up human trials in Europe. Those trials will begin in 2022. Villafaña also plans to add $30 million to $40 million in additional funding via a Regulation A+ financing.”
Medical 21 has filed a Regulation A+ offering, opening up investment opportunities to the general public with a minimum investment of $116. Manny’s passion for improving and saving lives, and his exceptional track record in founding companies that advance medtech, are positioning Medical 21 as a leader in the advancement of the cardiac bypass surgery procedure.
Manny Villafaña, Ph.D.Sc., has led a long, successful career thus far — one that has greatly contributed to advancing cardiac medical devices and procedures and positively impacting millions of lives. For Manny, heart disease is a deeply personal topic. Having lost his mother, father, and brothers to the disease, he is passionate about saving as many lives as he can and reshaping the future of heart surgery.
To learn more about Manny, his team, Medical 21, and how to invest in reshaping a life-saving procedure, go to our homepage.