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David Rhees, Kirk Jeffrey* On a brilliant August morning in 1994, a large crowd of officers, employees, and stockholders of the medical device firm Medtronic, Inc., gathered outside the company headquarters in a northern suburb of Minneapolis, Minnesota, U.S.A., for an important ceremony. The occasion was the retirement from the board of directors of Earl E. Bakken, who in 1949 had cofounded the company and had helped make it into the world’s leading manufacturer of cardiac pacemakers.1 There were many speeches that morning, but the highlight of the ceremony was the unveiling of a full-sized statue of Bakken that stood facing the main door of the company headquarters building. Partially encircling the statue was a low stone wall engraved with the mission statement that Bakken had written in the early 1960s, which was still in force more than three decades later. While the words spelled out the values for which the company had become famous in the medical community, the visual symbol of Medtronic’s corporate culture was held in the statue’s outstretched right hand. There, forged in bronze, was a replica of the device that Bakken had invented during the winter of 1957–58—the world’s first wearable transistorized cardiac pacemaker.2 The bronze replica in the statue’s hand represents the crude prototype that Bakken made at the request of a renowned heart surgeon at the University of Minnesota. This prototype, housed in aluminum and containing only two transistors, had been intended for tests with dogs but was used on human patients within days of its invention. Soon afterward, Bakken and his employees introduced a more refined version of the transistor pacemaker in a black plastic shell; about ten of these went into clinical use at the University. Later in 1958, Medtronic began manufacturing a commercial version in white plastic—the ‘5800.’ All three versions were essentially identical in circuitry and other interior features. The white production model was best known to doctors in the U.S. and abroad, but it is the earliest model that seems to hold the most meaning for Earl Bakken and others at his company.3 For Medtronic, this first pacemaker has come to embody the firm’s creation myth. (We use myth in the sense of a story that gives meaning to the collective experience of a particular group.) During Medtronic’s first decade, the company had led a precarious existence as a repair service for hospital electrical equipment and a regional distributor for a manufacturer of electrocardiographs. Medtronic also customized [75]‡ standard instruments and built new ones to order for laboratory and clinical researchers at the University of Minnesota and a few other sites in the upper Midwest. Bakken’s transistorized pacemaker, made at Dr. C. Walton Lillehei’s request to treat an unusual complication of openheart surgery, seemed at first to be just another one of these special orders. This order, however, opened up what would prove to be an enormous new market in medical electronics, positioning Medtronic to become the world’s leading manufacturer of invasive electrotherapeutic devices. In retrospect, Earl Bakken’s invention of the transistorized wearable pacemaker in 1957–58 marked a new beginning for the company. For Bakken and many others at Medtronic, the pacemaker also symbolizes their shared belief in medical progress through technology. So it is not surprising that Medtronic would permanently enshrine the event in bronze.
Earl Bakken’s retirement ceremony evokes an important theme of this paper, that people often impute powerful cultural meanings to made things. Numerous scientific and technological artifacts have achieved such iconic standing: one thinks of Lavoisier’s chemical equipment at the Conservatoire des Arts et Métiers in Paris, the apparatus in the Galileo Room at the Deutsches Museum, the Newcomen and Watt steam engines at the Science Museum in London, and the John Bull locomotive at the Smithsonian Institution. However, we know relatively little about how such objects have acquired their cultural meaning. On one point there seems general agreement: various groups will understand the core [76] significance of an object in somewhat different ways. In his recent study of scientific symbols and cultural meanings in American life, sociologist Christopher P. Tourney argues persuasively that symbols are ‘polysemic,’ meaning that ‘they are capable of conveying multiple different meanings so that the same image means different things to different people.’ Social groups may also attribute a variety of meanings to artifacts. It is this process of endowing technological objects with cultural meanings that most intrigued us as we explored the history of the Medtronic 5800 pacemaker.4 This essay asks how the construction of meaning occurred in the case of Earl Bakken’s transistor pacemaker, not only within Medtronic’s corporate culture but also among various other social groups that encountered the artifact. Other studies have elucidated the meanings of generic technologies to various social groups; Pinch and Bijker’s study of the bicycle and Bettyann Holtzmann Kevles’s recent history of medical imaging technologies come to mind.5 We focus as much as possible on the meanings of a specific artifact, or rather its three physical embodiments. We also seek to include as broad a spectrum of relevant audiences as our sources permit: the inventor and his company, the surgeon and his university, other physicians who used these devices, some of the early patients, and the broader public. Melvin Kranzberg pointed out in 1986 that the history of technology is a very human activity’; by implication, historians of technology also constitute a relevant social group.6 Thus empowered, we suggest some meanings not apparent to the other audiences for Bakken’s pacemaker. Business historians Louis Galambos and Jane Eliot Sewell have shown how basic scientific advances in bacteriology, virology, and genetic engineering have repeatedly sparked cycles of innovation that in some cases have lasted for decades.7 Bakken’s pacemaker, as one of the first successful applications of transistor technology to medical devices, helped launch a new innovation cycle in the field then called ‘medical electronics.’ The invention represented a transition from the previous generation of vacuum-tube, tabletop equipment connected to the electrical power system to a new generation of solid-state, battery-powered devices that could be attached to the human body and very soon fully implanted within it. This remarkably fruitful cycle of innovation, driven in part by physicians’ repeated discoveries of new diseases in new patient populations, continues to the present day.8
The practice of cardiac pacing to treat bradycardias (disorders of heart rhythm in which the heart beats too slowly) eased itself into American medicine between the early 1950s and the mid-1970s. During these years, the first pacemaker implantations took place and cardiac pacing grew from an unusual and daring procedure reported in national newspapers and magazines to a reliable and routine treatment for many heart rhythm disorders. By the 1980s, the implanted cardiac pacemaker had become a commonplace medical device in the United States, Canada, [77] western Europe, Israel, Australia, and most other developed countries, though implantation rates continue to vary greatly from country to country. No comprehensive registry of implantations exists, but we estimate that roughly two million people in the world carry pacemakers in their bodies today. The expanding demand for cardiac pacemaker therapy has made possible a thriving industry with current worldwide sales of more than $2.5 billion. The Twin Cities of Minneapolis and St. Paul, Minnesota, constitute the leading center for the industry. Medtronic, the leader in implantable pacemaker sales from 1961 to the present, has given rise to more than thirty new medical technology companies staffed by former Medtronic employees. Two of these companies, St. Jude Medical and Cardiac Pacemakers, Inc., the latter a division of Guidant Corp., are Medtronic’s chief competitors today in the world pacemaker industry.9 Medtronic and the many ‘baby Medtronics’ have contributed to the emergence of the Twin Cities’ reputation as ‘Medical Alley,’ a world-class center for research and manufacturing in medical technology. The Medtronic 5800 pacemaker thus led to big things a few years after its invention. Because of its ubiquity, Americans and western Europeans are today perhaps inclined to take for granted the pacemaker and even the implantable defibrillator or ICD (an invention of the 1980s). They might be surprised to learn that in the entire history of medicine before 1957, there had never been a partly or completely implantable electrical device. In the development of cardiac pacing as a medical field, the [78] invention of a transistorized external pulse generator in 1958 was an important step that few remember today. But to Earl Bakken, the people at his company, and many doctors and patients, the encounter with electrostimulation was immensely important; it remains vivid and significant to them four decades later. Clinical Background: Open-heart Surgery at the University of Minnesota In 1952, as medical scientists and clinicians were beginning to embrace this new set of technological marvels, a cardiologist in Boston named Paul M. Zoll invented a tabletop pacemaker with chest electrodes and successfully used it to resuscitate people from standstill of the heart in the hospital. The proximate origins of cardiac pacing as a medical field and an industry lie in Zoll’s work.11 The Medtronic 5800, however, was invented a few years later to deal with an unexpected side-effect of open-heart surgery. At the University of Minnesota, under the driven leadership of Dr. Owen Wangensteen, the surgical faculty and their trainees had transformed the Department of Surgery into an invention factory of international significance. After World War II, the university trustees and private groups had contributed $1.5 million to build a special hospital dedicated to the treatment of acute heart disease. This facility, the first of its kind in the United States, opened in 1951. As chief of surgery, Wangensteen insisted that every member of the surgical faculty pursue some program of research and that every surgical resident contribute as an apprentice investigator. Generous funding for surgical research was [79] available throughout the 1950s from private sources (the American Heart Association) and public (the National Heart Institute within the National Institutes of Health).12 Surgeons at Minnesota developed or improved numerous techniques for entering the living human heart and correcting congenital defects; these efforts culminated in 1954–55 with the first successful surgery for total correction of tetralogy of Fallot, a set of four defects that weakened and stunted children (these were the famous ‘blue babies’), then usually killed them in adolescence.13 In order to perform the lengthy and complex corrective operation, it was necessary to stop the heart from beating; this meant devising some temporary means to provide a circulation of oxygenated blood to the patient. The surgical research program at Minnesota developed not one but three new technologies that enabled surgeons to work for many minutes within the heart.14 The third of these, a true heart-lung machine known as a bubble oxygenator, was ready for use with human beings in May 1955.15 The leading heart surgeon at Minnesota, C. Walton Lillehei, was an intense, charismatic figure who had attained international fame by the mid-1950s.16 By 1957, as Leonard Wilson vividly recounts in Medical Revolution in Minnesota, Lillehei and his assistants had carried out 305 open-heart operations on young adults and children. However, even when he successfully repaired a defect, about one patient in ten developed complete heart block as a consequence of the surgery itself. In heart block, the electrical impulse that begins high in the right atrium of the heart fails to reach the main pumping chambers, the ventricles. Deprived of their normal signal, the ventricles may beat slowly on their own, but their rate gradually falls. Eventually the heart fails to provide an adequate circulation of oxygenated blood to the brain and the body and the patient dies. The surgeons concluded that they were occasionally causing damage to the heart’s conduction pathways while carrying out their surgical repairs. But they believed that if they could keep patients alive for two to three weeks with artificial support for the heartbeat, patients’ conduction systems would heal and normally conducted beats would resume. Zoll’s external pacemaker was clearly inappropriate because it delivered impulses at 50 to 150 volts through electrodes strapped to the patient’s chest. For children, ‘it was way too traumatic,’ Earl Bakken recalled. ‘They’d be bouncing on the table each time the pacemaker fired.’17 The Myocardial Wire Around the summer of 1956, Lillehei and his associates decided to try pacing the children’s hearts through an electrode that would actually touch the surface of the heart. By delivering the electrical stimuli directly to the excitable tissue rather than firing them through the body from outside, this arrangement might capture the heartbeat at a much lower voltage. Vincent L. Gott, one of Lillehei’s trainees, borrowed a laboratory physiological stimulator and took it to the dog lab. Using a standard surgical technique he created heart block in a dog. He inserted a wire into the heart wall (the myocardium), connected it to the external stimulator, and found that ‘it picked the rate right up.’19 Lillehei wondered whether the heart tissue would develop a rejection reaction to the metal electrode or the wire cause a serious lesion as it moved around with the beating heart, but he went ahead anyway because ‘we were desperate.’ On January 30, 1957, he implanted a multistranded, braided stainless steel wire in a Teflon sleeve into the ventricular myocardium in a three-year-old girl when she developed symptoms of heart block during open-heart surgery. He brought the other end out through the surgical wound, attached it to an external stimulator, and buried an indifferent electrode under the child’s skin to complete the circuit. The little girl survived.20 Lillehei soon came to rely on the myocardial wire whenever a patient showed signs of heart block at the end of an open-heart operation. By delivering the electrical pulses directly to the excitable tissue of the heart, this arrangement permitted effective pacing at around 1.5 volts. Days later, when the heart’s own conduction fibers had healed, the surgeon could tug gently on the wires and pull them out of the child’s body. But maintaining a heartbeat through a myocardial wire had problems of its own, the most important being that the pulse generator was still a bulky tabletop stimulator plugged into an electrical socket. Lillehei wished to get the children out of bed and was concerned because their hearts were potentially exposed to power failures and surges in the hospital electrical system and short circuits in the pulse generator. On 31 October 1957, an equipment failure at a large Twin Cities power plant caused an outage in Minneapolis that lasted more than two hours.21 The University hospitals had auxiliary power, but Lillehei viewed the event as a warning. Even before the power failure, he had asked a graduate student in physics at the university to make a pulse generator powered by a battery. When the student failed to produce a device after repeated prodding, the surgeon turned to Earl Bakken, the electrical engineer who repaired and calibrated electronic equipment for the Department of Surgery.22 [81] The Inventor: Earl Bakken and Medtronic Bakken found that researchers at the University of Minnesota Medical School and the nearby campus of the College of Agriculture. Investigators often ‘wanted special attachments or special amplifiers’ added to some of the standard recording and measuring equipment. ‘So we began to manufacture special components to go with the recording equipment. And that led us into just doing specials of many kinds. For the farm campus, for the X-ray department, we developed many, many instruments: animal respirators, semen impedance meters for the farm campus, just a whole spectrum of devices.’ Usually Bakken’s company would sell just a few of these items. Medtronic by 1957 had four or five employees and was located in a remodeled three-car garage that stood behind Hermundslie’s parents’ house in north Minneapolis. ‘It was a desperate struggle all the time to meet the next payroll,’ Bakken has said. ‘We would make these specials for people, and they’d always end up costing us much more to make than we had bid. Everything we did, we lost money on ... . We just seemed to go further and further downhill and borrowed more and more money.24 When Bakken accepted Lillehei’s assignment in December 1957, it seemed to the engineer just another special order. His first thought was to set up a cart that would hold equipment to run a conventional AC-powered pacemaker: a six-volt DC automobile battery, a battery charger, and an inverter. But then he realized that he could build a heart stimulator using transistors, a few other components, and a small battery. He borrowed a circuit design for a metronome that had appeared a the year before in an electronics magazine for hobbyists.25 He used a ‘powerful miniature [9-volt] mercury battery,’ housed the assemblage in an aluminum circuit box, and provided an on-off switch and control knobs for stimulus rate and amplitude.26 Bakken assumed that the surgeons would test the device by pacing laboratory dogs—his company had no animal testing facility. They did ‘a few dogs,’ then Lillehei put the pacemaker into clinical use. When Bakken next visited [82] the university, he was surprised to find that his crude prototype was managing the heartbeat of a child recovering from open-heart surgery.27
Readying the Pacemaker for
the Market The housing of the 5800 ‘was a kind of carvable Bakelite paneling that was available at the time. It was layered, white inside, black on the back, and then it was carved’ to bring out the white lettering. Sometime in the [83] spring of 1958, Bakken ordered an important design change in the product: by reversing the Bakelite housing, he changed its color from black to white. ‘It appeared to me that white was more appropriate with the whiteness and cleanliness of a hospital,’ Bakken later commented. He also joked that ‘the black didn’t work out all that well because you could always see it; and if it was pinned to the laundry or to the sheet of a child’s bed, before they threw the laundry in the chute to have it cleaned, the pacemaker always got removed. So when you make it white, then it isn’t so visible—so they throw them away and have to buy more—so that was an advantage.’29 The surgical program at Minnesota in effect marketed the 5800: scores if not hundreds of surgeons visited Minneapolis to observe Lillehei’s team at work, and each year surgical residents who had trained under him fanned out to positions at leading hospitals and medical schools. A few hospitals in the United States and western Europe that were setting up programs in openheart surgery sent in orders for the pacemaker, which was known as the 5800 ‘because we made it in 1958.’ In 1960, Lillehei and others at the University, together with Bakken, published a paper in the Journal of the American Medical Association that described the device and discussed its clinical uses. Two illustrations showed the 5800 and the Medtronic name up close; one of them pointed out nine important features of the pacemaker such as its handles, neon flasher, control knobs that ‘cannot be accidentally changed,’ and white case that ‘allow[s] for damp scrubbing with alcohol.’ No ad agency could have prepared a more effective advertisement for the invention.30 Medtronic probably sold only a few hundred of the 5800 pulse generators between 1958 and 1964. The reason was that the device was not implanted but could be re-used to assist many patients over a year or two, whereas implantable pacers (introduced late in 1960) were used only once. Heart surgeons sometimes resisted postsurgical cardiac pacing; Lillehei has suggested that some were probably reluctant to admit that they were creating heart block when putting stitches into the ventricular septum, and many clearly didn’t like the idea of having to manage the myocardial wire and the external pulse generator, even for a few days. Bakken remembers sitting in the Medtronic booth at a medical convention and noticing that heart doctors would walk on the opposite side of the aisle to avoid having to talk to him. He thinks that they didn’t want to reveal their ignorance of electronics and their dependence on an engineer to enlighten them. In later years, doctors swallowed their pride: today company technicians attend and assist at most pacemaker implantations in the U.S. Even in 1958, it seems, the pacemaker with its two transistors heralded an era when physicians would come to rely on various kinds of experts to invent and manage the technologies of cardiovascular medicine.31 [84] The 5800, the Heart, and Medical Progress Many organs of the body are necessary to sustain life, but European and American cultures have imbued the heart with special cultural meanings. For centuries, we have imagined the heart as the seat of the human emotions, particularly humane feelings toward others, and of the soul itself. This mystique long antedates Harvey’s discovery that the heart pumps blood throughout the body. Even today the English language retains scores of metaphorical expressions of the ancient belief that the heart is the mysterious center of our emotional natures, our very identities. Prescientific and romantic notions about the heart have not disappeared but linger in modern culture at the end of the twentieth century. For example, men and women scheduled for heart transplants often ask if their new hearts will cause changes in their personalities, particularly if the donor was of the other sex or a different ethnic origin.32 Whether they continued to believe in traditional verities or not, Americans readily accepted open-heart surgery, heart transplants, and machine substitutes for the heart. Indeed, perhaps their belief that the heart was a sacred part of the body helps explain why many Americans developed an attitude approaching reverence for the God-like physicians who cut it open. But at the same time, advances in heart care since 1945 were founded on a mechanistic understanding of the heart and a more aggressive, manipulative approach toward it. Behind them all lies the belief that the heart is nothing but a pump, a machine within the body. This shift in medical thinking had begun in the age of Descartes and Harvey; it had made possible the laboratory studies of the heartbeat as an electrical phenomenon and the invention of the electrocardiograph at the end of the nineteenth century.33 Heart surgery and the other new treatments of the postwar period did not inspire but rather built upon this understanding of the heart as a piece of machinery. Thinking of the heart as a pump leads on to the possibility that we can open it up and repair it when it breaks down, perhaps by replacing worn-out parts of the machinery. Despite its apparent simplicity, Earl Bakken’s transistorized pacemaker of 1958 embodied a set of attitudes about the heart that still inform the cardiovascular technology industry and the practice of cardiovascular medicine.34 [85] In a rapidly changing field like cardiac pacing that has brought wealth and renown to many and ‘full life’ to many more, all participants and most observers will understandably tend to view the history of the field as a case study in technological progress.35 From this premise, it is easy to move on to the belief that each technological innovation has represented an inevitable step toward ever more advanced, sophisticated, and subtle cardiac pacing devices. Our own belief is that impersonal explanatory concepts such as ‘medical progress’ or ‘the advance of technology’ offer little insight into why some inventions won general acceptance while others were rejected and soon forgotten; and by invoking powerful ‘forces’ apparently unrelated to human choice, such explanations imply that the role of human beings has consisted of conforming themselves to the inevitable.36 We believe that people working in specific cultural situations, after all, invented pacemakers, and that each new feature or new device had to satisfy other people—physicians, above all—whose reasons for accepting or rejecting new medical devices often went beyond narrowly technical factors.37 The progressive view of steady and inevitable technological progress in cardiac pacing also takes for granted that inventors and the social groups for whom they worked always and consistently shared a common goal, a stable vision of what the pacemaker was for and how it ought to develop. But this has clearly not been the case: research into heart rhythm problems has repeatedly led to the framing of new disorders for which some form of cardiac pacing seemed the appropriate treatment. At first these disorders all involved unduly slow heart rates; more recently, some pacemakers can detect and halt heart rates that are too fast (tachycardias). Again and again, heart specialists have revised their ideas about what pacing was for. Consider the key social group in 1958, the cardiothoracic surgeons who pioneered openheart surgery in children. While many were cautious about the new device and some perhaps avoided the Medtronic booth at medical conventions, most eventually accepted the need for postsurgical pacing sooner or later. The technical advantages of the transistorized pacemaker for managing the heartbeats of children recovering from open-heart surgery seemed obvious compared with alternative treatments or no treatment at all. Lillehei spoke of his first use of the myocardial wire as ‘a revelation’—that a simple piece of wire ‘could drive the ventricles very accurately ... . It was great!’ Others too spoke of ‘driving’ the heart. By reducing the daunting complexity and uncertainty that surgeons faced, it helped free the surgeon to focus on other aspects of open-heart procedures and the care of his patients. But the 5800 was appealing for other reasons as well. These men (they were all men) enjoyed national acclaim, at that time; they had the image of being quintessentially modern and high-tech, and the Medtronic external pacemaker had modernity written all over it. It was small, white, transistorized, a technologically satisfying solution; and [86] it was associated with a radically new practice, management of a physiological function over a period of time through electrostimulation via a wire left in the heart.38 The context within which the 5800 constituted a step in medical ‘progress’ was actually more complex than the foregoing suggests: at the very time that the device came into use, a debate was underway among clinical researchers over whether the future of cardiac pacing lay within the hospital for short-term stimulation or whether, on the other hand, patients might someday be able to leave the hospital and lead ‘normal’ lives while relying on pacemakers to manage their heartbeats. Invented for short-term pacing in the hospital, the 5800 was soon redefined as a device for longterm heart stimulation outside the hospital. By finding new uses for the device, its users redefined cardiac pacing itself.39 The 5800 as an Example of Innovation in Medical Devices Second, Annetine Gelijns and Nathan Rosenberg have pointed out that with medical devices, the distinction between a stage of research and development (R&D) and a stage of adoption often breaks down in practice: ‘It is a serious misperception,’ they write, ‘to think that all important uncertainties have been ironed out by the time a new technology has finally been introduced into clinical practice. In fact, much uncertainty associated with a new technology can be resolved only after extensive use in practice.’42 Bakken’s transistor pulse generator made a nearly overnight transition from bench testing to clinical use, this set a pattern in the cardiac pacing industry. For the next decade at least, it would be a common practice to put new devices, including fully implantable ones, into clinical use and then iron out the imperfections [87] based on the accumulation of clinical experience. This practice developed because most of the early patients were close to death, no other treatment existed, and American medical culture rewarded physicians for using bold new strategies.43 A third pattern of broader application was apparent in Minneapolis during the late 1950s. This was mutual dependence between device manufacturing firms and their clients. The clients were not the patients kept alive on products like pacemakers but the physicians who decided whether to embrace a new technology such as cardiac pacing, and then which specific pacemaker brands and models to use. Cooperation between innovative physicians and device manufacturers was founded on mutual dependence; it was present in embryonic form in the relationship between Earl Bakken and Walt Lillehei in 1957–58. Lillehei was a famous surgeon, Bakken an unknown who tinkered with electronic equipment and repaired things. However, surgeons could not invent electronic medical devices themselves, so they had to rely on the people who could. Bakken’s company, Medtronic, stood out from a myriad of small electronics repair shops because of its association with one of the most famous surgical establishments in the world.44 Bakken had begun attending surgical procedures at the university even before 1957 and had a personal locker in the surgeons’ locker room. He carefully nurtured the friendships he formed at the university. He has observed that ‘many of the residents, interns, that were working for Lillehei at the time, went on to become heads of surgery around the world.’ He ‘kept in good touch with physicians around the world; but it kept me traveling at a great rate, a good deal of the time.’ For the next decade, Medtronic’s reputation and sales—its very survival—would depend heavily on public associations between the company and distinguished surgeons and engineers who served as consultants, and on Bakken’s personal acquaintance with leading surgeons. These connections gave Medtronic a kind of instant credibility in the world of cardiovascular medicine....
* David Rhees is Executive Director of the Bakken Library and Museum in Minneapolis. His current research concerns the development of therapeutic medical technologies, for which he is conducting oral histories with some of the pioneers of the medical device industry in Minnesota. Kirk Jeffrey is a Professor of History at Carleton College, Minnesota. His book on the invention of the cardiac pacemaker and the implantable defibrillator, and the subsequent growth of the rhythm management industry will be published in 2001. † From Exposing Electronics, ed. Bernard Finn (Australia:
Harwood Academic Publishers, 2000) Notes 2 This was not, of course, a working replica of the pacemaker but a sculpted shape that evoked the general appearance of the artifact. 3 Earl E. Bakken, interview by David J. Rhees, 10 January 1997, transcript in interviewer’s possession. The surgeon, C. Walton Lillehei, called this early prototype the ‘dog model,’ and the name has stuck. 4 Christopher P. Tourney, Conjuring Science: Scientific Symbols and Cultural Meanings in American Life (New Brunswick, N.J.: Rutgers Univ. Press, 1996): 48–49 et passim. Tourney’s leading example, having to do with meanings imputed to nuclear power, involves a technological system. 5 Trevor J. Pinch and Wiebe E. Bijker, ‘The Social Construction of Facts and Artifacts: or how the Sociology of Science and the Sociology of Technology might Benefit each other,’ in The Social Construction of Technological Systems, ed. Bijker, Thomas P. Hughes, and Pinch (Cambridge, MA, 1987): 17–50; Bettyann Holtzmann Kevles, Naked to the Bone: Medical Imaging in the Twentieth Century (New Brunswick, 1996). 6 Melvin Kranzberg, ‘Technology and History: “Kranzberg’s Laws”,’ Technology & Culture 27 (July 1986): 544–560. 7 Louis Galambos with Jane Eliot Sewell, Networks of Innovation: Vaccine Development at Merck, Sharp& Dohme, and Mulford, 1895–1995 (Cambridge, Eng., 1996). 8 Charles E. Rosenberg and Janet Golden, eds., Framing Disease: Studies in Cultural History, ed. Rosenberg and Janet Golden (New Brunswick, 1992), especially the essays by Steven J. Peitzman and Christopher Lawrence. For physicians’ framing of new heart rhythm disorders treatable with the pacemaker, see Kirk Jeffrey, ‘Pacing the Heart: Growth and Redefinition of a Medical Technology, 1952–1975,’ Technology & Culture 36 (July 1995): 583–624. 9 ‘Pacemaker Market shows Slight Growth,’ Cardiovascular Network News 4 (November 1997): 7; confidential industry sources. The figure $2.5 billion in sales covers pacemaker equipment only and does not include implantable defibrillators. A pacemaker speeds the heartrate when the rate is too slow to maintain an adequate circulation of blood to the body’s organs, while a defibrillator terminates episodes of ventricular fibrillation, random electrical activity in the ventricles that prevents any organized heartbeat. A pacemaker works by firing tiny electrical impulses into the right atrium and/or right ventricle of the heart at an appropriate rate; a defibrillator gives the heart a high-energy shock that terminates all electrical activity and permits an organized heartbeat to resume. In 1996, physicians implanted about 142,000 pacemakers in the U.S., 170,000 in Europe, and 75,000 elsewhere, counting first-time and replacement implants. The three Twin Cities firms held about 80% of the world market for pacemakers and virtually the entire world market for implantable defibrillators. 10 ‘Electronics Boom Spreads to medicine,’ Medical World News 2 (18 August 1961): 15–17; Charles K. Friedberg, Medical Electronics in Cardiovascular Disease (New York: Grune & Stratton, 1963); Lawrence Lessing, ‘The Transistorized M.D.,’ Fortune 68 (September 1963): 131+; ‘Electronics helps to heal the sick,’ Business Week, 19 September 1964: 75–78; Hughes Day, ‘An intensive coronary care area,’ Diseases of the Chest 44 (October 1963): 423–427; Paul M. Zoll, ‘The cardiac monitoring system’ [interview], Medical World News 186 (2 November 1963): 33–36; W. Bruce Fye, American Cardiology: The History of a Specialty and Its College (Baltimore, 1996), pp. 176–181, 250–254. 11 Paul M. Zoll, ‘Resuscitation of the Heart in Ventricular Standstill by External Electric Stimulation,’ New England Journal of Medicine 247 (13 November 1952): 768–771; Kirk Jeffrey, ‘The Invention and Reinvention of Cardiac Pacing,’ Cardiology Clinics 10 (November 1992): 561–571. 12 Leonard G. Wilson, Medical Revolution in Minnesota: A History of the University of Minnesota Medical School (St. Paul, 1989): chapter 20. 13 Tetralogy of Fallot is a congenital malformation of the heart named for the French physician who had first described the condition in 1888: William F. Friedman, ‘Congenital Heart Disease in Infancy and Childhood,’ in Heart Disease: A Textbook of Cardiovascular Medicine, ed. Eugene Braunwald (4th edn.; Philadelphia, 1992): 935. 14 The three technologies were controlled hypothermia or lowering the body temperature so as to slow the metabolism and reduce the body’s need for oxygenated blood, thereby giving the surgeon a few minutes to work in the slowly beating heart; cross-circulation, in which an artery and a vein from the surgical patient were connected to the circulatory system of a parent, whose heart then pumped blood for both bodies during surgery; and the bubble oxygenator, the first practical and reliable heart-lung machine. A group in Toronto had conceived of the hypothermia technique in 1950 and it was under study in several surgical programs besides the one at Minnesota: Wilfred A. Bigelow, John C. Callaghan, and John A. Hopps, ‘General Hypothermia for Experimental Intracardiac Surgery,’ Annals of Surgery 132 (September 1950): 531–539. Surgeons at Minnesota were, however, the first to use hypothermia clinically in open-heart operations (September 1952). Cross-circulation had been tried with laboratory animals in England but was first used clinically at Minnesota. See Vincent L. Gott, ‘C. Walton Lillehei and Total Correction of Tetralogy of Fallot,’ Annals of Thoracic Surgery 49 (February 1990): 328–332; Wilson, Medical Revolution in Minnesota, pp. 488– 517; C. Walton Lillehei and Leonard Engel, ‘Open-Heart Surgery,’ Scientific American 202 (February 1960): 76–90; and Stephen L. Johnson, The History of Cardiac Surgery, 1896-1955 (Baltimore, Md.: Johns Hopkins Univ. Press, 1970), 113–119. Many surgeons believed that cross circulation was too risky for everyday use; one visitor told C. Walton Lillehei that he was the first surgeon who had ever devised an operation with a potential for a 200% mortality rate: C. Walton Lillehei, interview by Kirk Jeffrey, 25 July 1990, NASPE [North American Society of Pacing and Electrophysiology] Oral History Archive, Natick, MA. 15 C. Walton Lillehei, Herbert L. Warden, Richard E. DeWall, et al., ‘Cardiopulmonary By-pass in Surgical Treatment of Congenital or Acquired Heart Cardiac Disease,’ Archives of Surgery 75 (December 1957): 928– 945; Wilson, Medical Revolution in Minnesota, pp. 508–516. As Wilson shows, an improved oxygenator known as a sheet oxygenator (also pioneered at Minnesota) supplanted the bubble oxygenator within a few years. 16 For popular worship of heart surgeons see, e.g., ‘Stopped Heart Operation,’ Reader’s Digest 69 (August 1956): 29–33; ‘Rare, Revealing Look into a Beating Heart,’ Life 41 (3 December 1956): 127–128; ‘Inside the Heart: Newest Advances in Surgery,’ Time 69 (25 March 1957): 66–77. 17 Earl E. Bakken, interview by William Swanson, 22 December 1992, transcript at The Bakken Library and Museum, Minneapolis, Minn. Lillehei said, ‘50 to 75 volts was intolerable ... . It takes that much to stimulate the heart through the chest. Getting a shock like that fifty, sixty times a minute is torture. With some of the infants, we were able to restrain them so they wouldn’t tear [the chest electrodes] off, but they would develop blisters and ulcers [beneath the electrodes] in four to five days. So that was totally inadequate’: Lillehei interview by Jeffrey; C. Walton Lillehei, Morris J. Levy, Raymond C. Bonnabeau, et al., ‘Direct Wire Electrical Stimulation for Acute Postsurgical and Postinfarction Complete Heart Block,’ Annals of the New York Academy of Sciences 111 (11 June 1964): 938–949. 18 Herbert E. Warden, ‘C. Walton Lillehei: Pioneer Cardiac Surgeon,’ Journal of Thoracic and Cardiovascular Surgery 98 (November 1989): 33–45; C. Walton Lillehei, videotaped conversation with Earl E. Bakken, 10 June 1977, ‘Pioneers in Pacing’ videotape series, The Bakken Library and Museum. 19 It will be recalled that the heart in dogs and human beings has two small upper chambers, the atria, and two main pumping chambers, the ventricles. The right ventricle pumps blood to the lungs while the left ventricle pumps oxygenated blood to the body. The myocardial wire was attached to the outer surface of one of the ventricles. Warden, ‘C. Walton Lillehei’; Vincent L. Gott, interview by Kirk Jeffrey, 2 May 1997, transcript in interviewer’s possession. Lillehei recalled, ‘They created some heart block, put the wire in the heart, and lo and behold, one or two volts, five to ten milliamps ... drove the heart beautifully! Any rate that you’d set. And obviously, one to two volts was totally imperceptible to the animal. And there was no FDA [Food and Drug Administration] in those days. We ran some animals—I don’t know, ten, fifteen—and it just worked beautifully’: Lillehei interview by Jeffrey. 20 Ibid.; Wilson, Medical Revolution in Minnesota, pp. 517–519. 21 [Northern States Power Co.,] ‘Report on October 31, 1957 Major Disturbance,’ typescript, copy courtesy of Ronald T. Hagenson. 22 C. Walton Lillehei in Lillehei and Earl E. Bakken, videotaped interview by David J. Rhees, 9 September 1997, Pioneers in Minnesota Medical Device Industry Oral History Series (Minnesota Historical Society, St. Paul, Minn.). 23 Medtronic went public in the 1960s. Palmer Hermundslie, a diabetic, remained actively involved in managing the company but died in 1970 at age 51. 24 Bakken interview by Swanson. 25 Earl E. Bakken, interview by Kirk Jeffrey, 23 May 1990, transcript in interviewer’s possession; Bakken interview by Swanson; Art Detman, ‘The Reluctant Millionaire,’ Dun’s Review 103 (March 1974): 12–19 at 13–14; Lillehei conversation with Bakken, 1977, ‘Pioneers in Pacing’ Series; Louis E. Garner, ‘Five New Jobs for Two Transistors,’ Popular Electronics 4 (April 1956): 54–59. 26 The Medtronic 5800 was first formally described in print in 1960: C. Walton Lillehei, Vincent L. Gott, Paul C. Hodges, Jr., et al., ‘Transistor Pacemaker for Treatment of Complete Atrioventricular Dissociation,’ Journal of the American Medical Association 172 (30 April 1960): 2007. See also the comments in an early company history, ‘Medtronic: a Look Back’ (Minneapolis, Minn.: Medtronic, Inc., 1970): 6–7; copy in Medtronic Information Resources Center, Fridley, Minn. 27 Bakken interview by Rhees, 9 September 1997. At the Karolinska Institute in Stockholm, surgeon Ake Senning and engineer Rune Elmqvist built an external pacemaker of similar design around 1958. Senning had visited Minnesota to study Lillehei’s surgical techniques and had observed the use of the myocardial pacing wire, but this was in 1957 before Bakken had invented the Medtronic 5800. The Swedish external pacemaker was commercialized in 1960 by Elmqvist’s employer, the Swedish firm Elema-Schönander: Elmqvist et al.,‘ Artificial Pacemaker for Treatment of Adams-Stokes Syndrome and Slow Heart Rate,’ American Heart Journal 65 (June 1963): 731–733; Senning, ‘Cardiac pacing in retrospect,’ American Journal of Surgery 145 (June 1983): 734. 28 Lillehei interview by Jeffrey, 1990; Bakken interview by Rhees, 10 January 1997. 29 Bakken interview by Rhees, 10 January 1997. 30 Wilson, Medical Revolution in Minnesota, 523; Vincent Gott, ‘C. Walton Lillehei and his Trainees: One Man’s Legacy to Cardiothoracic Surgery,’ Journal of Thoracic and Cardiovascular Surgery 98 (November 1989): 846–851; Lillehei et al., ‘Transistor Pacemaker.’ See also ‘Heart Timer: Minnesota Reports on Use of Electronic Pacemaker,’ New York Times, 1 May 1960. 31 Earl E. Bakken, interview by David J. Rhees, 1 February 1998, Pioneers in Minnesota Medical Device Industry Oral History Series, Alan D. Bernstein and Victor Parsonnet, ‘Survey of Cardiac Pacing and Defibrillation in the United States in 1993,’ American Journal of Cardiology 78 (15 July 1996): 195. 32 Howard Bird, ‘An Affair of the Heart,’ New England Journal of Medicine 326 (13 February 1992): 487–488; Mary Moore Free, ‘The Heart of the Matters of the Heart,’ American Journal of Cardiology 78 (15 July 1996): 217–218; Lynn Payer, Medicine and Culture: Varieties of Treatment in the United States, England, West Germany, and France (New York, 1988), pp. 74–75, 79–85. Two recent mass-market books have reasserted some of the older notions about the heart: Paul Pearsall, The Heart’s Code: Tapping the Wisdom and Power of Our Heart Energy (New York, 1998) and Claire Sylvia, A Change of Heart: A Memoir (New York, 1998). 33 See, e.g., Gerald Geison, Michael Foster and the Cambridge School of Physiology (Princeton, 1978); Robert G. Frank, Jr., ‘The Telltale Heart: Physiological Instruments, Graphic Methods, and Clinical Hopes 1854– 1914,’ in The Investigative Enterprise: Experimental Physiology in Nineteenth-Century Medicine, ed. William Coleman and Frederic L. Holmes (Berkeley and Los Angeles, 1988), pp. 211–290; W. Bruce Eye, ‘A History of Cardiac Arrhythmias,’ in Arrhythmias, ed. John A. Kastor (Philadelphia, 1994): 1–24. 34 For comments on the interventionist attitude toward the human heart in American medical culture, see, inter alia, Payer, Medicine and Culture, pp. 23–34, 124–131, 149–149–152; Bruce F. Wailer, “Crackers, Breakers, Stretchers, Drillers, Scrapers, Shavers, Burners, Welders and MeLters”—The Future Treatment of Atherosclerotic Coronary Artery Disease? A Clinical-Morphologic Assessment,’ in An Era in Cardiovascular Medicine, ed. Suzanne B. Knoebel and Simon Dack (New York: Elsevier, 1991), pp. 177–194; and Fye, American Cardiology. 35 The Medtronic company motto is ‘Toward Full Life.’ For an example of a history of cardiac pacing that implicitly uses the concept of progress, see Robert D. Gold, ‘Cardiac Pacing—From Then to Now,’ Medical Instrumentation 18 (January–February 1984): 15–21. 36 For a recent discussion of the doctrine of technological determinism, see Does Technology Drive History? The Dilemma of Technological Determinism, ed. Merritt Roe Smith and Leo Marx (Cambridge, MA, 1994), particularly the introductory essay by Smith, ‘Technological Determinism in American Culture.’ For applications to medical technology, see Fye, American Cardiology, and Stuart S. Blume, Insight and Industry: On the Dynamics of Technological Change in Medicine (Cambridge, MA, 1992). 37 The importance of non-technical factors is evident in the way pacemakers are marketed to physicians and hospitals; for example, manufacturers give their pacemakers distinctive model names—CyberLith, Dash, Activitrax, Vigor—and publish multi-page advertisements that feature pictures of the devices. The advertising has the effect of turning them into objects of desire while downplaying their functional characteristics. 38 Lillehei interview by Rhees, 9 September 1997. We speculate further that for some heart surgeons, the transistorized pacemaker with an implantable wire pointed the way toward artificial organs. The Society for Artificial Internal Organs began to publish its annual Transactions in 1955; Willem Kolff and Tetsuze Akatsu inaugurated their experimental work toward an artificial heart at the Cleveland Clinic in 1957. See Thomas A. Preston,‘ The Artificial Heart,’ in Diana B. Dutton, Worse than the Disease: Pitfalls of Medical Progress (Cambridge, Eng., 1988), pp. 91-126. 39 Kirk Jeffrey, ‘The Next Step in Cardiac Pacing: The View from 1958,’ PACE 15 (June 1992): 961–967. 40 In May 1976, Congress passed and President Gerald Ford signed into law the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, the legislation that created the Food and Drug Administration. Under the terms of the new law, cardiac pacemakers, as life-sustaining technologies, became subject to‘ premarket approval’ from the FDA. For a brief introduction see Michael S. Baram, ‘Medical Device Legislation and the Development and Diffusion of Health Technology,’ in Technology and the Quality of Health Care, ed. Richard H. Egdahl and Paul M. Gertman (Germantown, Md.: Aspen Systems Corp., 1978), 191–197. As Earl Bakken and C. Walton Lillehei are well aware, their technology for postsurgical pacing would have been subjected to months, perhaps years of animal and clinical trials before commercial release had they invented it after 1976 instead of in 1957–58. 41 Gold, ‘Cardiac Pacing’; Wilson Greatbatch to Kirk Jeffrey, 2 March 1990; Bakken interview by Jeffrey. 42 Annetine Gelijns and Nathan Rosenberg, ‘The Dynamics of Technological Change in Medicine,’ Health Affairs 13 (Summer 1994): 31. 43 Kenneth E. Warner, ‘A “Desperation-Reaction” Model of Medical Diffusion,’ Health Services Research 10 (Winter 1975): 369-383; Payer, Medicine and Culture, pp. 124–131. 44 Bakken recalls that the Medtronic booth at a cardiology convention prominently featured the photograph from the Saturday Evening Post showing Lillehei and a surgical patient who was wearing a 5800 pacemaker (see Figure 9): Bakken interview by Rhees, 1 February 1998. |
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