Be Still, My Heart: Behind the Scenes in the Cardiac Collections

We crowded together in the narrow passageway at the rear of the Medicine and Science collections storage area. Curator Judy Chelnick slowly opened a drawer in one of the gray metal cabinets and special guest Manny Villafaña’s eyes lit up. He exclaimed: “It’s like being a kid in a candy store!” Before him lay a group of small archival boxes nestled together, each holding a cardiac pacemaker or valve. Judy picked up items one by one for Manny to get a closer peek. She also showed him related objects in glass-fronted storage cabinets around the room. This was a highlight of Manny’s visit to the National Museum of American History in late March. He came to town in part to learn more about the Museum’s collections and why, how, and where we care for both three-dimensional objects and archival documents.

Inventor Manny Villafana with curator Judy Chelnick in storage looking at heart valves.

As he oohed and aahed about the array of medical collections, my colleague Chris Gauthier captured Manny’s expert commentary on video while I snapped photographs. Not only does Manny have great familiarity with these objects from his life-long career as an inventor and entrepreneur in the medical-device industry, but also he knows many of their inventors. For example, he had professional connections with the inventors behind two key artifacts for the Places of Invention exhibition’s “Medical Alley” story: a Medtronic 5800 externally wearable cardiac pacemaker and a Chardack-Greatbatch implantable pacemaker model.

Manny Villafana examines a pacemaker.

Manny talked knowingly about the 5800, which was originally invented by Medtronic, Inc. co-founder Earl Bakken in 1957 and sold commercially starting in 1958 (thus the model number). Manny worked for Earl at Medtronic as its first international sales administrator before starting his first rival company, Cardiac Pacemakers Inc. At the latter, Manny worked closely with engineer Wilson Greatbatch, the inventor of the first successful implantable cardiac pacemaker named for him and surgeon William Chardack. The Chardack-Greatbatch pacemaker model dating from about 1961 has been in the Museum’s care for a long time. Medtronic recently donated the 5800 model dating from about 1972, along with two other recent cardiac pacemakers to help expand the medical sciences collections.

An early pacemaker.

A Chardack-Greatbatch pacemaker.

As part of Manny’s behind-the-scenes tour, archivist Alison Oswald welcomed him to the Museum’s vault to show him a range of archival materials. She explained why we save certain items and how we care for them, from inventors’ notebooks to paper prototypes to marketing brochures. He was surprised about the Archives Center’s interest in collecting ephemera, which the Society of American Archivists defines as “Materials, usually printed documents, created for a specific, limited purpose, and generally designed to be discarded after use….Examples of ephemera include advertisements, tickets, brochures, and receipts.” It got him thinking about how seemingly unimportant papers he has squirreled away might be worth saving. Alison gave him a copy of our Modern Inventors Documentation (MIND) Program brochure to take home for further consideration.

Archivist Alison Oswald shows Manny Villafana archival documents.

While he was here, we filmed Manny as he shared great stories about his personal collection of pacemakers and heart valves, including some objects he brought along in his jacket pockets. He pulled out a real gem, St. Jude Medical bileaflet mechanical heart valve serial number 1—“the industry’s gold standard”—that he co-invented. (Be sure to watch the full video to see a later set of ATS heart valves, which he co-invented, used as cuff links!) Manny founded St. Jude Medical, Inc. in the 1970s and ATS Medical in the 1980s, and is now the CEO of his seventh company, Kips Bay Medical, Inc. In addition to the video footage of him discussing the Museum’s collections with Judy and talking about his own, I conducted a short video interview with Manny in the Lemelson Center. I asked him questions about his childhood and career, the history of the medical-device industry in Minnesota, and his relationships with some of the key Medical Alley pioneers like Bakken and Dr. C. Walton Lillehei, “the father of open-heart surgery.” Manny’s visit provided a wonderful opportunity to create video documentation to complement the Museum’s medical-device object and archival collections. We also look forward to featuring clips in the Places of Invention exhibition!

Manny’s Medical Alley

Recently I traveled to Minnesota to conduct additional research for the Places of Invention exhibition about the early days of the region’s medical-device industry now known as “Medical Alley.” This wasn’t just any research trip, though. Thanks to a personal introduction from David Rhees of the Bakken Museum, I had the special opportunity to meet one of the region’s pioneers, Manuel (“Manny”) Villafaña. You may not know his name, but you’ve probably heard of at least one of the seven medical-device companies he has founded in Minneapolis, including Cardiac Pacemakers Inc. (CPI) and St. Jude Medical.

Manny and I first chatted briefly on the phone in early June, while he was waiting for a business flight to Rome and I was in my office in D.C. I had read a number of articles and transcripts of oral history interviews with him and many of his fellow Medical Alley pioneers. Still, there is nothing like meeting with inventors and innovators in person, hearing their anecdotes and getting to know them better. I always leave these conversations feeling inspired.

On June 25, I hurried from the airport to Manny’s Steakhouse in downtown Minneapolis to join him for dinner. (Yes, the restaurant is named for him!)  Manny greeted me warmly from his booth, where he was waiting for me patiently with customary glass of milk in hand. Over Caesar salads, a huge shared NY strip steak, and even bigger “Manny’s brownie” for dessert, we discussed highlights from his fascinating life and career.

Manny Villafaña at St. Jude Medical, June 27, 2013

Manny Villafaña at St. Jude Medical, June 27, 2013

Born in 1940 to Puerto Rican parents, Manny grew up in a tough South Bronx, New York, neighborhood. A high-school graduate, Manny quickly showed his skills as a salesman. By his early 20s, Manny worked for Picker International selling medical products on behalf of many companies, including Minneapolis-based Medtronic Inc. In 1967 Medtronic co-founder Earl Bakken and colleague Charlie Cuddihy flew out to New York and lured him away to help expand international distribution of Medtronic implantable cardiac pacemakers. Manny told me he’ll never forget the day he and his wife arrived in Minnesota for his new job. It was March 8 and he recalls the weatherman announcing the temperature as “15 degrees below zero with a negative 43 degree wind chill.” Welcome to Minneapolis!

Manny and Elizabeth Villafaña at his childhood home (undated). Courtesy of Manny Villafaña.

Manny and Elizabeth Villafaña at his childhood home (undated). Courtesy of Manny Villafaña.

Two days after our delicious steakhouse dinner, details about Manny’s early career in Medical Alley emerged during a great driving tour he gave me. He wanted to chronologically illustrate his career and show both the growth and proximity of his various companies. So we started by driving to the small former Medtronic site where Manny first worked in 1967. At that point the company had moved from the original garage headquarters where it was founded by Bakken and Palmer Hermundslie in 1949 to a building that was about 7,500 square-feet.

In 1971, Manny left Medtronic and founded CPI to develop a cardiac pacemaker he co-invented using a new lithium battery developed by engineer Wilson Greatbatch. Greatbatch, who I met in 1996, is best known for inventing the first commercially successful implantable pacemaker in 1958. Named after him and collaborating surgeon William Chardack, the Chardack-Greatbatch implantable pacemaker was licensed by Medtronic in 1960 and became the driving force behind that company’s success. About a decade later, Greatbatch’s latest battery invention became the basis for the success of Manny’s rival company CPI. As we sat in the parking lot by the 5,000 square-feet building where it was originally located, Manny told me that CPI’s first lithium battery-powered pacemaker is still running today—41 years later.

Once again as his company expanded, Manny decided to leave and start another venture, St. Jude Medical, in 1976. This time he focused on developing a mechanical heart valve, which became the industry’s gold standard. His new company moved into the old CPI office space after it moved across the highway to a bigger building. CPI (now owned by Boston Scientific) and St. Jude Medical remain Medtronic’s biggest competitors in the medical-device industry. Manny drove me to CPI’s and then St. Jude Medical’s headquarters, which are near each other today and dwarf the 5,000 square-feet industrial park buildings where they began.

We ran out of time that afternoon to drive by the sites of his other Minneapolis companies in intervening years—GV Medical, Helix Bio-Core, ATS Medical, and CABG Medical. However, he invited me and my colleague Kari Fantasia to meet him the following day at his newest venture, Kips Bay Medical. So we duly drove to the company’s 5,000 square-feet headquarters in an office park. [Notice a trend? He thinks that size is optimal for medical-device start-ups.]

Kari Fantasia, Monica Smith, and Manny Villafaña at Kips Bay Medical, June 28, 2013

Kari Fantasia, Monica Smith, and Manny Villafaña at Kips Bay Medical, June 28, 2013

Manny gave us a brief overview of technologies he has been involved in, from the Chardack-Greatbatch pacemaker he sold for Medtronic to the St. Jude Medical heart valve he co-invented to today’s Kips Bay’s eSVS® Mesh that he believes will revolutionize coronary bypass surgery. Interestingly, his current company is named for the Kips Bay Boys Club in New York where he spent a lot of time as a kid and that he credits in part for his later success.

When I asked Manny “Why Minnesota?” for all of his companies, he answered: Where else are there 10,000 engineers all in one place with such medical device expertise? It’s a highly skilled, tight-knit, hard-working community and he clearly wouldn’t consider founding his companies anywhere else. Manny is very proud of his special relationships over the decades with other key Medical Alley pioneers, including his friend and mentor Dr. C. Walton Lillehei. Medical Alley has a long history of being a collaborative, inventive community indeed.

1985 photo of four cardiac pioneers who trained or worked in Medical Alley (left to right): Dr. Nazih Zudhi, Manny Villafaña, Dr. C. Walton Lillehei, and Dr. Christiaan Barnard. Courtesy of Manny Villafaña.

1985 photo of four cardiac pioneers who trained or worked in Medical Alley (left to right): Dr. Nazih Zudhi, Manny Villafaña, Dr. C. Walton Lillehei, and Dr. Christiaan Barnard. Courtesy of Manny Villafaña.