Dr. Manny Villafaña has led an extraordinary career, spanning over five decades of groundbreaking contributions to the medical device industry. His inventions and innovations in the field have created lasting change and touched the lives of millions of people around the world.
A Medtech Game-Changer
His most notable contributions include founding Cardiac Pacemaker, Inc. (CPI)/Guidant, where he co-invented the first lithium-powered pacemakers and defibrillators that lasted 30–40 years when pacemakers at the time only lasted 18 months. The technology he developed is used in virtually every pacemaker and defibrillator today.
Dr. Villafaña founded St. Jude Medical, Inc. shortly after, which led to the remarkable advancements in artificial heart valves. He co-developed the St. Jude heart valve which quickly became the “gold standard” in heart valves and brought much-needed change to a challenging procedure. Approximately 5 million patients have the implant.
To learn more about the history of cardiac bypass surgery and Manny’s significant contributions to the advancement of the procedure, read our blog post.
An Industry Leader
Villafaña presented for Medical 21, Inc. at the LSI Emerging Medtech Summit on March 16, 2022. The summit brought together the leading investors, innovators, and strategists in the medtech industry. Villafaña has presented at the LSI Summit for the last two years, including the featured fireside chat interview in 2020.
During the 2022 LSI Emerging Medtech Summit in Dana Point, California, Villafaña was honored with the Lifetime Achievement Award in Medical Devices. Scott Pantel, President and CEO of LSI, introduced Dr. Villafaña, sharing his notable achievements in the industry:
Manny has invented medical devices that truly have saved and touched the lives of hundreds of millions of people, and that includes over 5 million heart valves and 10 million pacemaker implants.”
While accepting the award, Dr. Villafaña expressed gratitude for the honor and for the people who have played a pivotal role in his success and ability to impact the lives of so many people over the course of his illustrious career,
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, 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.
Christopher J. Velis, Founder and Executive Chairman of Miraki Innovation, opened the conversation with Dr. Villafaña by saying, “That is an incredible accomplishment, and we thank you for what you’ve done. To set out on an endeavor to create technology that is on the cutting edge, alone, is a scary thing to do. I’ve often watched doctors who deserve tremendous credit for all the time and effort and energy that they’ve put in, getting praised. I’ve seen researchers get the highest awards, but often the work of entrepreneurs like you who take that research and translate it and innovate it into a form that makes it into our bodies, into our brothers, our sisters, our mothers, our fathers, well … it’s quite an accomplishment, sir, thank you.”
From humble beginnings in the South Bronx to founding some of the most successful medical device companies, Dr. Villafaña has repeatedly revolutionized the industry through his determination, risk, and brilliance. With seven IPOs under his belt, his latest venture, Medical 21, Inc., is the one he’s most excited about.
Continuing His Mission to Advance Cardiac Devices
Medical 21, Inc. is a developmental stage medical device company founded by Manny Villafaña, Ph.D.Sc. Medical 21 is developing and intends to commercialize and market a biocompatible artificial graft to bypass blockages in the heart. It is designed to eliminate the need for blood vessel harvesting in cardiac bypass surgery patients, with the goal of making the procedure and recovery safer, less painful, and cost-effective.
This revolutionary device is supported by a team that collectively possesses decades of experience in the successful development, manufacturing, sales, and marketing of medical products to the domestic and international healthcare markets. The Medical 21 artificial graft is not yet FDA approved or cleared. For investigational use only. Not yet available for commercial sale.
To learn more about Dr. Villafaña and the Medical 21, Inc. graft, visit Medical21.com.