LIVER TRANSPLANTATION 20:E6–E8, 2014

ILTS COURSE SYLLABUS

Creating an Environment That Supports Innovation Michael Abecassis Division of Transplant Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL Received October 8, 2014; accepted October 9, 2014. Entrepreneurship and innovation in transplantation originally stemmed from the fact that no other viable alternatives to end-stage organ failure existed. The first successful kidney transplant was performed at a time when dialysis was so primitive as to be considered ineffective. The first liver, heart, and lung transplants were also performed at a time when no alternatives existed. As transplantation has evolved, the entrepreneurial spirit that marked its birth and growth have been tempered by the fact that transplantation is now well accepted as definitive therapy, so the threshold for taking risk has decreased. In parallel with this development, the administrative structures of academic institutions and the regulatory environment have also evolved. Academic institutions have become increasingly risk averse, adopting a more corporate culture engrained in manuals of operations and procedures designed to implement reliability and compliance. Moreover, funding agencies and study sections currently assimilate and amalgamate transplantation research with other disciplines, whether systems based or anchored to particular organs, resulting in funding thresholds that have become increasingly difficult to cross, especially for high-risk/high-reward research. As a result, although in the early phase of transplantation investigative teams enjoyed strong support from academic leadership and from peerreviewed funding agencies and were typically viewed and considered with vibrant enthusiasm and passion, this has now given way to indifference or, at best, benevolent curiosity. Therefore, the challenge for investigators now consists of galvanizing and

maintaining the innovative energy that fuels discovery while accepting and dealing with the realities of becoming part of a corporate structure. The successful transplant research enterprise will adapt to the requirements of this corporate culture while remaining at the margins of discovery. This means that transplant leaders must leverage the benefits of a highly reliable organization (HRO) while fueling the engine that drives innovation in order to provide an environment that supports innovation.

EVOLUTION OF ENTREPRENEURSHIP AND INNOVATION IN TRANSPLANTATION Entrepreneurship is a process by which a new idea or invention is converted into a successful, and typically profitable, innovation. Although the term has traditionally referred to business initiatives, it has taken on broader applications, extending into academic innovation. Innovations, in academic settings, are more likely to represent incremental improvements rather than quantum discoveries. Although in the business world entrepreneurs may bear risk, putting their financial security or careers on the line in the name of an idea, demonstrating initiative in the face of uncertainty, academia provides some protection from this risk. Successful entrepreneurship is rewarded by academic advancement and national reputation for both the individual and the institution. As transplants have evolved from the investigational realm to become a widely accepted therapy,

Abbreviations: HRO, highly reliable organization.. Potential conflict of interest: Nothing to report. Address reprint requests to Michael Abecassis, M.D., Division of Transplant Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, 676 N. St. Clair St., Suite 1900, Chicago, IL 60611. E-mail: [email protected] DOI 10.1002/lt.24018 View this article online at wileyonlinelibrary.com. LIVER TRANSPLANTATION.DOI 10.1002/lt. Published on behalf of the American Association for the Study of Liver Diseases

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transplantation research finds itself transitioning toward a culture less enamored with innovative risktaking and more in line with a corporate culture. This “process culture,” as defined in the Deal and Kennedy framework,1 is marked by bureaucracy, safety, and corporate culture. The affinity of large health care organizations for self-protection is sensible, given both financial and reputational liabilities. The lure of innovation is foreshadowed by the realities of corporate responsibility and accountability. As a result, institutional bureaucracy and policies and procedures designed to contain risk and increase predictability will trump any entrepreneurial desire to assume risk, especially when high-profile fiascoes are even remotely possible. Thus, there is a tendency for academic institutions and medical schools in particular to avoid risk. There is certainly merit to the standardization of processes and improvement of outcome measures espoused by both corporate structures and regulations; it is well established that standardized processes are a key element in increasing reliability and decreasing the risk of error. However, these principles include not only structured processes and roles but a “preoccupation with failure,” defined as constant vigilance for sources of error and accident and the operational sensitivity to manage the unexpected successfully. The highly reliable organizational (HRO) culture dictates that established therapies be delivered safely and consistently, with efforts to reduce the risk and consequences of individual human failures. These principles, originally developed to prevent clinical errors, can also be successful in mitigating financial and legal risk. HRO principles have been shown to help in managing the evolution of proven procedures into highly reliable services, and they require administrative oversight by professionals familiar with the business principles that make large organizations reliable, efficient, and adaptable as well as with the many complexities and nuances of business operations and compliance. As a result, this culture is becoming more common in, and is being embraced by, academic centers. The widespread risk taking typically exhibited by those faced with few, if any, viable treatment alternatives for their desperate patients, which was accepted in the earlier days of transplantation, can no longer be tolerated. The culture of “never events” dominates in deliberations about health care delivery and may lead to a clash of cultures between the more entrepreneurial spirit of the innovator and the more risk-averse corporate administrative leadership. Although everyone desires the avoidance of risk, most would agree that the only way to avoid risk is not to innovate, and risk aversion may curb the freedom to innovate. Therefore, through the application of HRO principles, it is essential that the academic leadership not allow itself blindly to adopt a risk-averse culture but rather embrace the opportunity to learn from both failure and success. Preoccupation with failure should not be allowed to stifle entrepreneurial innovation, and all involved should fully understand and accept the risks of inno-

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vation and work together to mitigate them to the greatest extent possible.

INTRAPRENEURSHIP: BALANCING THE ENTREPRENEURIAL SPIRIT WITH THE CORPORATE CULTURE The challenge for transplant leaders is to leverage successfully the strengths of corporate cultures while preserving the entrepreneurial spirit. In Great by choice, Collins and Hansen2 proposed that the most successful companies (10Xers) combine creativity and discipline: “The great task, rarely achieved, is to blend creative intensity with relentless discipline so as to amplify the creativity rather than destroy it. When you marry operating excellence with innovation, you multiply the value of your creativity.” Many businesses have addressed the problem of maintaining an entrepreneurial spirit within a corporate culture, dubbed intrapreneurship, and these models may be instructive for transplant centers. The terms intrapreneur and intrapreneurship, first described in late 1978 by Gifford and Pinchot,3 were popularized in 1982 by Macrae.4 The terms were first used in the popular media in 1985 by Time magazine in an article entitled “Here come the intrapreneurs”5 and in the same year, in a quote from Steve Jobs, then Apple’s Chairman, in Newsweek. In that article, Jobs was quoted as saying “The Macintosh team was what is commonly known as intrapreneurship, only a few years before the term was coined—a group of people going, in essence, back to the garage, but in a large company.”6 In 1992, the American Heritage Dictionary acknowledged the word intrapreneur.7 Intrapreneurs are encouraged to behave as entrepreneurs within the context of the resources, capabilities, and security of a larger organization, which allows for the dynamic and energetic nature of entrepreneurship while providing protection against the risks and accountability normally associated with entrepreneurial failure. Thus, intrapreneurship combines the ability of individuals to transform an idea into a profitable finished product through assertive risk taking and innovation with the protection and backing of a large corporation, allowing for the application of corporate management practice within “minifirms.” Scott Anthony8 describes 4 eras in the history and evolution of innovation. The first era was the lone inventor; the second era “corporate labs,” less stifling corporate bureaucracy, more likely to tolerate experimental efforts; the third era “highly reliable organization defined by the corporate culture, too big, bureaucratic, and hierarchical to handle at-thefringes exploration, risk-averse, compromising innovation and entrepreneurship; and the fourth era intrapreneurship, or corporate catalysts, when the scale of a big company can unleash innovation rather than shackle it. Decentralized strategic and innovation activities, promoting agility, hospitable to catalysts (mission-driven leaders who corral corporate

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resources outside their traditional span of control to address challenges), motivated by autonomy and a sense of purpose. Successful intrapreneurship consists of incremental disruptive innovation within corporate social responsibility, avoiding extremes that are viewed as dangerous. Six patterns of successful intrapreneurship have been described: primary motivation, strategic scanning, greenhousing, visual thinking, pivoting, authenticity, and integrity. In addition, steps in the challenge of intrapreneurship include the following. 1) Risk taking and failure are acceptable; 2) all members of the team have to espouse intrapreneurship; 3) there has to be “room to play around”; and 4) success has to be incentivized. Drivers of selling and acceptance of intrapreneurship have been identified as well: 1) the level of the proponent’s social capital and 2) the intensity of the selling effort. Finally, the concept of “contamination” has been raised; innovators have to be protected from corruption by the HRO, yet at the same time they cannot be so walled off from the corporate culture that it blocks them from the large company resources.9-13 Transplant leaders must provide an environment that supports entrepreneurial innovation while leveraging the benefits of the HRO by providing opportunities for intrapreneurship. This may require that leaders act to insulate and protect innovative investigators from standard institutional processes. In addition, leaders must facilitate funding opportunities, including access to philanthropists who can embrace

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an ambitious vision as well as knocking down institutional barriers to partnership with industry and commercial innovation.

REFERENCES 1. Deal TE, Kennedy AA. 1982. Corporate cultures: the rites and rituals of corporate life. Harmondsworth, United Kingdom: Penguin. 2. Collins JC, Hansen MT. 2011. Great by choice. Uncertainty, Chaos, and Luck—Why Some Thrive Despite Them All. New York: HarperCollins. 3. Intra-Corporate Entrepreneuring http://www.intrapreneur.com/MainPages/History/IntraCorp.html. Accessed January 2012. 4. Macrae N. 1982. Intrapreneurial now. The Economist, April 17. 5. DeMott JS, Byrne R. 1985. Here come the intrapreneurs. Time, February 4. 6. Lubenow GC, Rogers M. 2008. The one time whiz kid professes no bitterness toward Apple, but he is plainly hurt by his abrupt ouster. Newsweek, September 29. 7. Editors of the American Heritage Dictionary. 1992. The American Heritage dictionary of the English language, 3rd ed. Boston: Houghton. 8. Anthony SD. 2012. The new corporate garage. Harvard Business Review, September. 9. Govindarajan V. 2013. HBR blog network. 10. Townsend JC, Heller C. 2012. Unlocking intrapreneurship, NextBillion.com. 11. Anthony S. 2012. HBR blog network. 12. Lewis KR. 2013. Fortune. 13. Foss NJ, Klein DG. 2007. The secrets of intrapreneurship. European Business Forum, issue 31, p 40-45.

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