Regina E. Herzlinger, Nancy R. McPherson Professor of Business Administration, Harvard Business School
Contact: rherzlinger@hbs.edu
Abstract
Timeline: Submitted: August 2, 2025; accepted after review September 24, 2025.
Cite as: Regina E. Herzlinger. 2025. Regi’s ‘Innovating in Healthcare’ Cases: What Makes for a Successful Woman Entrepreneur in Healthcare? Epic, Cleave, and Close Concerns. Health Management, Policy and Innovation (www.HMPI.org). Volume 10, Issue 2.
The three women CEOs of the healthcare case studies highlighted in this issue of HMPI (see below), had one thing in common: they were gutsy. Each saw a critical gap in the healthcare system and built something to address it.
Smart, strategic, tough. No Spanx, makeup, cooking, or clothing firms for them. There’s nothing wrong with traditional women entrepreneur routes; but these three women wanted to change the world, so they did what the big boys did: IT, wellness, and, get this, biotech– arguably the most complex and capital-intensive sector in healthcare innovation [1].
These women ignored the barriers that stymie most healthcare entrepreneurs: a powerful, consolidated status quo that blocks the innovators that threaten it; a bureaucratic and politicized third-party financing system; tough governmental requirements; islands of information, each with their own language, that impede outcomes accountability; powerful rival technologies; and fickle consumers who, unaware that their taxes and income pay for all of healthcare, demand that any healthcare innovation should be free. They never questioned their ability to build healthcare companies that did good—by controlling costs, expanding access, and improving quality.
And they did well. Did they ever.
One of those three is Judy Faulkner, the genius entrepreneur who started EPIC [2]. The dominant Electronic Medical Record firm in the United States, Epic was launched in 1979 by Judy with just $70,000 of seed capital from family, friends, and early colleagues. Faulkner grew the company from that point without any outside investment or acquisitions, , creating her own world on her own terms. When Epic built their “Intergalactic Campus” in Verona, Wisconsin back in the early 2000s, Judy encountered a surprising problem: the underground parking garages could not accommodate the local fire trucks. Rather than accept the mismatch, she worked with the city to build a new, smaller fire engine and donated it to the Verona Fire Department., When the campus opened, Judy came riding through on the new truck with her white Samoyed dog, McKinley, taped with black paper dots to resemble a Dalmatian. You have to love this woman: smart, and a lot of fun, too [3].
Just as iconoclastic is Amy Burroughs, who captained the Dartmouth women’s rugby team, Elegant Violence Inc., some 30 years ago while a student at Dartmouth College. After starting a small business in high school and programming for the CIA, she followed a conventional route only when she started working in brand management and became one of my Harvard Business School students. I knew almost immediately that she not only would become a Baker Scholar (top 5% of the class — very rare for a woman, especially in 1997 , but also, and much more difficult, that she would build a successful career. She joined Genentech and then moved into working with biotech startups and even did a tour in executive recruiting.
Burroughs eventually wound up at Cleave, a firm with a drug in testing to combat multiple myeloma but that had a serious side effect: blindness in some patients [4]. Who would want to take on that kind of challenge and head this firm? Well, Amy became the CEO, solved the blindness issue, and did it on a budget that felt like $3.50 cents in the wildly costly biotech world. And then she sold the company’s assets in 2023. Today, she is the CEO of Terns Pharmaceuticals, a publicly owned firm developing important new therapies for cancer and obesity.
Kelly Close has a different approach from Burroughs and Faulkner. Mild and self-spoken, she is a lioness at heart [5]. Close is a childhood diabetic who told her investment banking boss to go fly a kite when he refused to let her work remotely on the weekends while she cared for her ailing father. I believed in her, too, when she was my student in 1995 ; I know a lioness when I see one, even if she looks like a lamb.
In 2002, Kelly Close founded Close Concerns, a diabetes-focused healthcare information company, with her husband. The venture was entirely self-funded, launched with a lean and profitable model centered on subscription-based newsletters and consulting services for companies and organizations in diabetes care. Kelly personally handled both sales and strategy in the early days, and soon after, created a distinctive full-time and summer associates program that attracted undergraduates eager to work on meaningful problems in healthcare. The program became a launchpad for top medical and business schools—and a draw for high-performing students who wanted to travel the world to scientific conferences, gain mentorship, and contribute to work that mattered. It was a brilliant business model, and a brilliant success.
Simple Lesson: Believe in Yourself. Not so Simple: Making It Happen
Like all management bromides, ‘believe in yourself’ is easy to say. But you had better be good. All three women are fantastic, substantively and strategically. They know their IT, pharma, medical conditions. They are also extremely competent businesspeople: sneaky with their market strategies, brilliant with customer acquisitions, creative in scaling strategies, with a profound knowledge of finance. They know that success comes to she who works hard.
I cannot teach anybody how to be gutsy (although, as a personal aside, poverty helps. You have no way to go but up.)
But, with these case studies featured in this issue of HMPI, and many others, I can teach you how to align with the factors that block most entrepreneurs. And, I can help you to evaluate, start, scale and exit your healthcare innovation. Read our new book, Innovating in Healthcare: Text and Cases (HBS publishing, 2026), and tell me what you think.
References
- Herzlinger, Regina E., and Erik R. Sparks. “ABC Pharmaceuticals.” Harvard Business School Case 313-041, August 2012. (Revised August 2024.
- Herzlinger, Regina E., and Brian L. Walker. “Epic: The Future of Health Information Technology.” Harvard Business School Case 325-028, September 2024. (Revised March 2025.)
- Bruce, Giles. https://www.beckershospitalreview.com/healthcare-information-technology/ehrs/why-judy-faulkner-bought-a-fire-truck/?utm_source=chatgpt.com. January 20024
- Herzlinger, Regina, and Brian Walker. “Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery.” Harvard Business School Case 323-045, January 2023.
- Herzlinger, Regina E., and Brian L. Walker. “Close Concerns: Diabetes Research and Advocacy.” Harvard Business School Case 323-047, March 2023. (Revised June 2025.)
Epic: The Future of Health Information Technology
(Harvard Business School Case 325-028, September 2024 (revised March 2025); 27 pages)
Authors: Regina Herzlinger and Brian Walker, Harvard Business School
Abstract: How should the founder and leadership team of a health IT company with more than 45 years of market leadership prepare for the future, while navigating founder transitions and industry changes? Founded by Judy Faulkner in the late 1970s, Epic pioneered electronic health records (EHR) and has grown into a $4.9B revenue company, providing services to hospitals, health systems, and patients worldwide. Throughout its history, Epic has remained a private, debt-free company, resisting the urge to follow in the footsteps of its tech peers by going public.
Now, Epic faces the challenge of maintaining its leadership position in a rapidly evolving health information technology (HIT) landscape. Industry incumbents and new entrants, including Microsoft, Oracle, and Google, are eyeing healthcare, and innovations, especially in AI, may lead hospitals to consider alternative systems or niche products over Epic’s embedded capabilities. At the same time, Epic must anticipate future healthcare demands, navigate regulatory complexities, and prepare for leadership changes.
The company’s enviable market position and long-term planning provide a strong platform for future growth, but Epic must decide how to prioritize its objectives over the next five years and beyond. Should it focus on expanding its product offerings, enhancing system capabilities, or diversifying into new markets? How should Epic position itself to address the ongoing evolution of healthcare technologies and patient needs while ensuring the sustainability of its founder’s vision?
Keywords: Technological Innovation; Entrepreneurship; Health Care and Treatment; Private Ownership; Customer Focus and Relationships; Information Management; Organizational Change and Adaptation; Business Strategy; Competition; Health Industry; Electronics Industry; Information Technology Industry
Citation: Herzlinger, Regina E., and Brian L. Walker. “Epic: The Future of Health Information Technology.” Harvard Business School Case 325-028, September 2024. (Revised March 2025.)
Download the case here. For inquiries, contact Regina Herzlinger: rherzlinger@hbs.edu
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
(Harvard Business School Case 323-045, January 2023; 24 pages)
Authors: Regina Herzlinger and Brian Walker, Harvard Business School
Abstract: What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful therapy was on track but faced an unclear future. Overseeing the human trials of a refined second-generation drug candidate, Amy had led the company back from the “valley of death” after Cleave’s initial offering resulted in off-target toxicity. Still, after completing multiple dose escalation cohorts, Cleave’s scientists told Amy that they could not draw any definitive conclusions about the benefits of the drug. Amy and her team knew the importance of speed and capital in the high-risk business of oncology drug development where success often takes more resources and time than expected and competitors lurk. Nearing the close of a five-year investment window, should the thinly staffed Cleave 2.0 continue to recruit patients and clear dosing cohorts at a rapid rate, or should Amy prioritize funding and partnership discussions?
This case is suitable as a general business case for undergraduate and MBA students of any level on strategy, entrepreneurship, health care innovation, biopharma, cancer, FDA’s role in biopharma, funding early-stage biopharma ventures, biopharma clinical trials, and the healthcare industry.
Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry
Citation: Herzlinger, Regina, and Brian Walker. “Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery.” Harvard Business School Case 323-045, January 2023.
Download the case here. For inquiries, contact Regina Herzlinger: rherzlinger@hbs.edu
Close Concerns: Diabetes Research and Advocacy
(Harvard Business School Case 323-047, March 2023 (Revised June 2025); 21 pages)
Authors: Regina Herzlinger and Brian Walker, Harvard Business School
Abstract: This case describes the Exit considerations of Kelly Close, HBS MBA, and founder of the primary distributor of diabetes newsletters. It is part of the fourth module in the Innovating in Health Care HBS MBA course, which contains cases of other health care firms that are contemplating various exit strategies, such as EPIC, Ajax, and Sword. Kelly Close was diagnosed with diabetes at the age of 18 and understood the importance of consistency and iteration. These principles had also informed her professional work, which started with a rapid promotion from financial analyst at Goldman Sachs to an analyst position in the office of the CEO. Having lived with the disease for years and worked within the industry the majority of her adult life, Kelly was highly aware of the knowledge gaps and inequitable access to research that not only disadvantaged patients but also diminished the care by medical practitioners and systems. She recognized an opportunity, “to help improve patient outcomes by making everyone smarter about diabetes and obesity and to advocate for action,” but she had never wanted to develop her own organization or pursue an entrepreneurial venture. Her expertise was sound, but to deploy it in a meaningful way, she would not only need to create a product or service offering but also develop a sustainable operating model that addressed the problems facing the primary stakeholders in the diabetes healthcare ecosystem. This case recounts her successful career, after graduating from HBS, to become the primary distributor of diabetes newsletters, and asks the students to discuss her next steps. This case is suitable as a general business case for undergraduate and MBA students of any level on strategy, entrepreneurship, health care innovation, diabetes and obesity, digital healthcare information, pharmaceuticals and medical devices, and the healthcare industry.
Keywords: Diabetes; Health; Health Care; Health Care And Treatment; Health Care Outcomes; Health Care Industry; Knowledge Dissemination; Outcome or Result; Equality and Inequality; Business Model; Entrepreneurship
Citation: Herzlinger, Regina E., and Brian L. Walker. “Close Concerns: Diabetes Research and Advocacy.” Harvard Business School Case 323-047, March 2023. (Revised June 2025.)
Download the case here. For inquiries, contact Regina Herzlinger: rherzlinger@hbs.edu
