How has he transformed the scene?
Like the revolutionary pacemakers he introduced to the world, Manny Villafana is renowned for his start-ups, and he just doesn't stop. A serial entrepreneur and innovator, Villafana is a leader among leaders in the international arena of technology for cardiac care. Over the past four decades, he has launched and led seven publicly held med-tech corporations in Minnesota—including block-busters St. Jude Medical and Cardiac Pacemakers Inc.—and has been the driving force behind such standard-setting devices as the lithium battery-powered pacemaker, the St. Jude bi-leaflet heart valve, and the ATS open-pivot heart valve. An estimated 250,000 patients each year receive a medical device produced by a company that Manny Villafana founded.
Heads' Up!
"The epitome of an entrepreneur."
Lida Estela Ruano, in the Puerto Rico Herald, 2000
His instincts about next-generation technology are informed by personal experience in all aspects of this specialized medical device industry, from concept to marketplace, and from the boardroom to the operating room. There is perhaps no greater testament to his contributions than his 2006 designation as a "Living Legend of Medicine" by the International Association of Cardiothoracic Surgeons—an honor typically reserved for doctors.
He's come a long way—literally and figuratively—from where he began. Manny Angel Villafana was born in South Bronx on August 30, 1940. His parents were native to Puerto Rico and moved to New York in the 1920s. Like many, they had come seeking opportunity, but the life they found was not an easy one. Villafana describes his family as being very poor. His mother was a seamstress in a sweatshop and his father, who worked as a janitor, died when Manny was just ten years old. By then, his three brothers—who were older than he by more than a decade—had left home. Young Manny was largely on his own outside of school hours while his mother worked, a "latch-key kid" left to fend for himself in the tough neighborhood as best he could.
Fortunately, in the year before his father died, a tip from a friend had led him to the local Kips Bay Boys Club, which Villafana credits with keeping him "off the street, out of jail, and probably, alive." To get the 4+ miles from his family's apartment on 139th St. to the Club on 52nd, he walked or took his chances sneaking onto the subway, lacking the money for the fare. The trip was worth whatever effort it took, for at the Club he found caring mentors and a world of opportunity. Villafana participated in activities ranging from athletics to science clubs to summer camp. There were books to read, a chance to improve his skills in English—Spanish having been his primary language—and to develop his character in the company of men who came to serve not only as positive role models but as surrogate fathers. Recognizing his family's dire financial circumstances, the Club offered him regular work helping out with equipment and other tasks. At age 9, it was his first job. Any money he earned went for necessities as home.
Villafana has never forgotten the difference that Kips Bay Boys Club made for him, nor the people who made it both a good and safe place for a boy who needed exactly that. In the years since, through his charitable giving, he's made sure that other children have been able to find such a haven in the Boys and Girls Clubs of America.
High school for Villafana was New York's highly regarded Cardinal Hayes, where he received rigorous academic training. It had to serve him well, since cost put college out of reach. As Villafana headed for the working world, his job experience was limited to the work at the Club and selling magazines door-to-door in Queens for Cardinal Hayes. But his life experiences had provided young Villafana with a unique set of resources and perspectives that would prove invaluable.
Shortly after his 1958 graduation from Cardinal Hayes, Villafana found a job in the print shop at Radio Engineering Labs, a Long Island-based electronic firm that made equipment for the Ballistic Missile Early Warning System. He was an avid reader who read the materials he printed with great interest and an uncanny ability to absorb what he read. He also made a regular practice of asking if there were openings in other departments. Supervisors took note of the young man's ambition, offering him a chance to work as an aid testing products for the engineers, and sending him for technical training in electronics through night classes at RCA Institute.
Moving on from Radio Engineering Labs, Villafana worked briefly as a business assistant at a testing lab of the Ethyl Corporation in Yonkers, then in 1964—without realizing it—took his first real step toward a corporate career in the med-tech field. He answered a "help wanted" ad for a NYC-based company seeking a salesman who could speak Spanish. At the interview, he learned that the company, Picker International, manufactured X-ray and nuclear resonance equipment for hospitals. It also served as an export agent for a number of clients, including the then-fledgling Minnesota-based Medtronic. Picker's CEO liked what he saw in Villafana, and hired him to work as its customer service rep handling these accounts. Three years later—similarly impressed—Medtronic lured Villafana away from Picker with a job offer of their own. Medtronic was ready to develop and manage its own international market, and wanted Manny Villafana to help make it happen. Villafana said "yes" before he even knew the full terms of the offer. It was a chance to get out of the Bronx.
He re-located to Minnesota in 1967, where he was trained in the features, functions, and implantation of Medtronic's flagship product—the cardiac pacemaker. A full grasp of the technology was essential, as he would be responsible for passing the information to doctors and surgeons in the markets he developed as the company's first and only international representative in all of Latin America.
Villafana was breaking new ground, not only for Medtronic, but for patient access to life-saving cardiac pacing. He was routinely called upon to be in the operating room as devices were implanted, attending many "firsts" of surgical implantations of pacemakers in hospitals and in countries where the technology had not yet been tried. After commuting from Minnesota to Latin America on frequent business trips throughout 1967-68, Villafana moved to Argentina to set up a Medtronic sales facility in 1969. Working from this base of operations, Villafana steadily expanded the market, largely by developing close relationships with doctors.
Along the way, he was learning as well as teaching, gaining an increasing understanding of the medical issues associated with cardiac care, the standards of treatment and the practical challenges facing doctors. For Villafana, this period in his career also offered experiences with the patients themselves—especially children—that taught him something else: a passion for pacemakers that would drive him for years to come. Recalls Villafana, "Once you get into pacemakers, you're sold. You can't leave. You end up eating, drinking, living, loving pacemakers. You love it because it's a therapy in which, the moment you flip the switch, the moment you connect the pacemaker, the heart responds instantaneously." In the operating room with doctors, a child with blue pallor and heart rate of 20-30 beats per minute could be brought instantly to vibrant life, with color rising in their cheeks and a steady heartbeat of 70 beats per minute. "Now, you tell me that all this does not get inside you? That's great stuff. That's really great stuff."
Villafana parted ways with Medtronic in 1971. By February of 1972 he was opening the doors on Cardiac Pacemaker, Inc. (CPI). It was the first of seven corporations that he would found and lead, each based on a single product exemplifying a revolutionary concept. Steeped in a lifelong love of baseball—in particular, mindful of Mickey Mantle of his original hometown Yankees—every time Villafana stepped to the plate he was swinging for the seats. To date, he has hit a remarkable number of home runs. On the rare occasion of a strike-out—an unsuccessful bid to introduce an effective artificial coronary artery bypass graft with a company called CABG—Villafana startled and pleased shareholders by refunding $30 million of their investments. In the medical device industry—as in all research-based endeavors—such trial and error are a necessary part of advancement. But for Villafana, CABG was the exception rather than the rule. From 1972 to the present, a list of Villafana's most successful enterprises reads like an evolutionary chart of advancements in technology for cardiac care:
1972
Cardiac Pacemakers Inc. (CPI) introduced the first lithium iodine battery-powered pacemaker. Hermetically sealed, it was smaller, lighter, and longer-lived than any pacemakers then on the market. CPI swept the market with a 6-year guaranteed life expectancy on the pacers, as contrasted with the 12-18 month life expectancy of then-standard pacemakers powered with mercury/zinc batteries. In fact, CPI pacemakers would later be shown to last more than 30 years: an astounding leap.
1976
St. Jude Medical brought the introduction of the first bi-leaflet mechanical heart valve, the St. Jude heart valve. The revolutionary valve dramatically reduced the incidence of blood clots and resulting strokes associated with valves then on the market. Made of tough pyrolitic carbon (with a hardness of diamonds), it had the added advantage of being quieter.
1982
GV Medical explored the efficacy of laser angioplasty somewhat ahead of its time. Modestly successful as a business venture, it laid important groundwork for the device and technique that would later become an important tool used by doctors in conjunction with stent implantation.
1987
With Advancing the Standard (ATS) Medical Inc., Villafana pulled together the same team that had developed the St. Jude heart valve to create "next generation" heart valves featuring an open-pivot design that did indeed become the new industry standard. In 2010, ATS Medical was acquired by Medtronic.
2007
Villafana says his most recent start-up, Kips Bay Medical Inc., is a project that he is "110% involved with" and sincerely feels has a chance to be "the biggest one of them all." Named as a tribute to the boy's club so important to Villafana in his early years, the company produces a mesh sleeve made of nitinol (nickel/titanium) wire designed to fit on the outside of veins used for coronary artery by-pass grafts. The mesh reinforces the vein and prevents its expansion. It's a mechanical fix for a common problem that can lead to graft failure: the rupture and scarring of tissues in the vein lining that occurs in the transition from a low-pressure environment in the leg to a high-pressure environment in the heart. The device has been introduced on a small scale in Europe, where early results are promising, and is awaiting FDA approval in the U.S.
Currently, Villafana divides him time between serving as Board Chair and CEO of Kips Bay Medical, lecturing internationally on entrepreneurship, engagement in a host of philanthropic causes, and family. If his past is prologue, there will be some future day when this inveterate entrepreneur will hand over the reins of Kips Bay Medical to capable leaders within the company. But he makes it a personal policy never to move on until he is confident that he and his team have built what he calls "all four legs on the chair" of a corporation, including: 1) a proven technology, 2) a strong sales, marketing, and distribution team, 3) financial stability, and 4) construction of a new/expanded facility to enable increased production.
When he takes the time to look back, he's gratified to have had a role in improving the health and lives of so many people around the world, but quick to give credit to those who have been on his team throughout the years and helped to make it happen. Of course, he's not the sort to spend much time looking back. As he enthused in a 2011 interview, "The technology we're working on now is so new that people don't even know how to ask the questions about it; but when we explain it, they understand it, and they say, 'Let's go.' "
With Manny Villafana, they'll know there's no need to say it twice.
