Manny Villafaña is one of the founders of Minnesota's medical device hub. He started some of its major companies and worked with some of the industry's greatest early innovators. Here are some important lessons he's learned along the way.
Manny Villafaña was a key figure in the era of heart device derring-do, in which medical device wonders blossomed amid Minnesota's "frozen tundra" and the state's Medical Alley became a hub of innovation.
During the 1970s, Villafaña founded two businesses that remain industry pillars in the Twin Cities: Cardiac Pacemakers Inc., which is now part of Boston Scientific's Guidant business, and St. Jude Medical. (He also invested in a first-rate downtown Minneapolis steakhouse that's named after him.)
Now in his 70s, Villafaña is as active as ever: He's started a new company, Medical 21, that seeks to develop and commercialize the first artificial grafts for heart surgery, doing away with the need to substitute blood vessels from the legs and other parts of the body.
"It's, 'Manny, it can't be done.' And that's what I like to do," Villafaña told a few hundred medical device enthusiasts during a Wednesday lunchtime keynote at the Design of Medical Devices Conference at the University of Minnesota in Minneapolis. (See Villafaña accept the 2016 MDEA Lifetime Achievement Award at MD&M East, June 14-16 in New York City.)
Doing things that supposedly couldn't be done--Villafaña saw it first hand during his formative years. Here are four important lessons he learned along the way:
1. Persistence Is Important
Villafaña recalled that F. John Lewis, MD, performed the first successful open heart operation at the University of Minnesota in September 1952. Lewis used hyperthermia. "They took a child and would put him literally in a big huge water pail ... fill it with ice and try to work on a child," Villafaña said.
"Could you imagine being a surgeon and losing a few patients, a few kids here, before you got to lunch?"
Clarence Dennis, MD, at the University of Minnesota invented a heart-lung machine and sought to use cardiopulmonary bypass in surgeries to treat children with congenital heart disease. The first 17 patients died, 11 in the operating room. Dennis stopped performing the surgeries for the remainder of his time in Minnesota. Villafaña couldn't blame him. "I don't know about you. I don't think I could have done it."
Ditto for Philadelphia surgeon John Gibbon, MD, who had the first successful use of cardiopulmonary bypass, but couldn't repeat his success and also eventually stopped the surgeries. He died about 20 years later of a heart attack while playing tennis.
Luckily, enough innovators in those early years kept up the fight. "Some of our early pioneers didn't have many of the tools, kept at it."
2. The Medical Device Business Needs Risk Takers
Perhaps the gutsiest risk-taker of them all was a man Villafaña counted as a mentor, collaborator, and "great friend": the Univeresity of Minnesota cardiac surgeon C. Walton Lillehei.
On March 25, 1954, Lillehei went to his boss Owen Wangensteen, MD, and made a radical proposal: using a milk pump acquired from a Wisconsin dairy farm to pump blood from a boy through the kid's father do that the dad's heart and lungs could keep the child alive while Lillehei operated. "Dear Walt -- By all means go ahead!" Wangensteen wrote in a note back.
The child operated on the next day, 13-month-old Gregory Glidden, died 11 days later of suspected pneumonia, but 32 of the next 44 patients survived, according to Wikipedia.
Lillehei once quoted the inspirational writer William Arthur Ward to Villafaña: "But risks must be taken, because the greatest hazard in life is to risk nothing. The person who risks nothing, does nothing, has nothing, and is nothing."
From Villafaña's point of view, nothing can be accomplished in medtech with out risk-taking: "If you're not a risk taker, if you're not that kind of person, the ideas are not going to happen."
3. You Can't Do It Alone
Villafaña, who started out in the 1960s drumming up international business for Medtronic, took a risk himself in leaving to start CPI. He sought and eventually accomplished something that many thought impossible: a pacemaker that lasted more than a few years. In fact, CPI made pacemakers that lasted for decades, including in Villafaña's own mother.
Villafaña was very clear, though: He needed a lot of help, especially from mentors including Lillehei; Wilson Greatbatch, who helped invent the first totally implantable pacemaker; and many others.
One friend and mentor, Demetre Nicoloff, MD, at the University of Minneapolis, persuaded Villafaña to kick his addiction to pacemakers. "Nicoloff came up to me and said, 'Why don't you do a heart valve, because we've done the pacemaker,'" Villafaña said.
Villafaña's business partners at CPI didn't think the company had the bandwidth to branch into valves. So Villafaña went off in 1976 and started St. Jude Medical and its bi-leaflet artificial heart valves.
4. You Have to Think Outside the Box
St. Jude Medical's foundations were not only in risk-taking, but thinking outside the box--especially because most artificial heart valves failed in the early 1970s. It was a daunting proposition for Villafaña. He recalled what a big deal it was, the first time he saw a valve cut out, the hole, and the realization that his device had to plug that hole.
"You invented a product... And you were going to put it into that hole. And if that failed, for sure you had a problem," Villafaña said.
There were many risks taken in the devolopment of the St. Jude valve. Industry insiders warned that pivots in the design would be too prone to failure. "We didn't have a pivot. We didn't have two pivots. We had four pivots," Villafaña said. He recalled an academic paper about the device that had the title: "It will never work."
"You have to think out of the box. You have to think ahead. You have to take risks."
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