Educating Innovators

A NextGen Free Standing Perspective Article

Based on an interview with Joshua Makower, M.D., M.B.A.

Medical devices play a very important role in the diagnosis and treatment of diseases, and their constant development through technological innovation is essential for progress and improvement in the quality of patient care. This is especially true among surgeons, whose craft is inherently linked to the use of technical equipment. Historically, largely because of their immersion in the profession and consequent experience and familiarity with its practice, surgeons have made key contributions to its advancement, introducing major breakthroughs such as anesthesia and asepsis. While surgeons still contribute significantly to the innovative process, the environment in which they do so has greatly transformed over the last few decades.


Dr. Joshua Makower

The practice of medical device innovation in today's era has been described as facing "unprecedented opportunity and formidable roadblocks." [1] On the one hand, physician-innovators now have access to a plethora of sophisticated technologies and vast international communication networks, a promising recipe for exponential progress and exciting breakthroughs. On the other hand, they are faced with dauntingly rigid regulations and fiscal demands by institutional bodies such as the FDA and managed care organizations. [2] Additionally, the rapid specialization of research in all scientific disciplines including surgery and engineering has made it less likely that an individual identifying a need in the operating room would be sufficiently informed in engineering to see an idea through to clinical fruition. [3]

To streamline the development of future surgeon-innovators, today's surgical leaders are calling on their colleagues not only to actively develop and embrace new technologies but also—and perhaps more importantly—to support and participate in progressive educational initiatives, such as redesigning curricula and reinvigorating ties with industry. [1] At such an exciting and uncertain stage, the field faces a critical moment for engaging the next generation of medical professionals who will take up the torch in expanding this crucial pursuit for innovative surgical treatments that may ultimately define medical practice in the twenty-first century.

According to Riskin et al. [1], all of the existing academic centers of surgical innovation, which amount to a mere "handful," have come into being over the last five years. One of these centers is Stanford School of Medicine, which, in 2001, launched their integrative Biodesign Innovation Program, a one-year fellowship in medical device development whose central mission is to create innovation leaders in the same way medical, law, and engineering schools train students entering their respective disciplines. [3]. The program unites physicians, scientists, and engineers to accelerate idea generation and new product development by harnessing the synergy of interdisciplinary collaboration. As a testament to Stanford's initial success, an additional branch was introduced four years later specifically dedicated to the development of surgical devices.

Stanford's Biodesign Innovation Program was closely modeled on the Pfresh Tech Program introduced at Pfizer in the 1990s by Dr. Joshua Makower. Dr. Makower, Consulting Associate Professor of Medicine at Stanford and the Innovation Program's co-founder and past director, is a leader in the medical device industry, with over a dozen patents in the fields of cardiology, general surgery, drug delivery and urology. He is also founder and CEO of the medical device incubator ExploraMed and the founder of numerous start-up companies. Makower, who completed his B.S. degree in mechanical engineering at MIT and his medical degree at NYU, also holds an M.B.A. degree from Columbia University.

Rather than enrolling in a residency program following his M.D., Makower took a job at Pfizer in their device division and founded their Innovation Group, where he analyzed the process of innovation within medicine, and tried to make it happen within the company. "Pfizer would buy innovative companies, and when they were brought into the corporate structure they would stop innovating," Makower explains, "so one question my manager posed to me was, how can we innovate internally? And why can't we come up with the next great thing?" Dr. Makower began by looking at entrepreneurs and talking to the founders of recent acquisitions by Pfizer. "The real missing focus [at Pfizer] was that no one was finding out what the real problems were; no one in the company was actually going into the Operating Room or the clinic to just watch what was going on." Rather, they were relying on secondhand information from physician reports, which often suffer from limited imaginative potential. Doctors tend to "pose questions based on technologies they already know are available" and, furthermore, because they have to attend to the acute needs of patients and the procedures at hand, they "can't just sit back to think and evaluate."

Therefore, Makower proposed the "Pfresh tech" structure, where engineers would spend time in the clinical setting and experience patient care in a given field firsthand in order to better identify unmet needs. According to Makower, it succeeded in generating a bank of patents; unfortunately, however, the other critical requirement for technology invention and implementation, i.e. a willingness at the corporate level to make risky investments in these fledgling ideas, was missing. "That was where the model ran into trouble. Big corporations don't like taking risks like that and it's hard to incentivize individuals to make huge investments," Makower explains. It was at this point that he transported his idea to Stanford, where with Dr. Paul Yock he co-founded the Biodesign innovation program.

By training surgeons to recognize needs in the operating room and translate them into new technological solutions, Makower and his colleagues envision weaving innovation into the very fabric of surgical training. "Through programs like the one we are pioneering [at Stanford]," Dr. Makower indicates, "we hope to be providing specific training to surgeons on how to master their innovative skills and be aware when these needs face them in everyday clinical practice." The first year of the fellowship begins with an intensive "boot camp," where fellows learn about some of the most important issues such as patents, funding resources, regulatory pathways, and technology transfer. Following this, fellows embark along the path towards innovation by taking guided steps along the Program's curriculum, beginning with a two month or longer "needs finding" process. Here, they rotate through medical subspecialties such as plastic surgery, orthopedics, vascular surgery, minimal access surgery, robotic surgery, etc. to potentially identify opportunities for "technology sharing" between fields. Needs finding is followed by the ranking of needs, brainstorming, prototyping and designing, and the fellowship culminates with a final presentation and externship, which provides students with experience in a venue of their choosing, such as with a start-up, a clinic, or even the FDA. In terms of delivering results, the program appears to be working; as of last summer, its 38 alumni had filed 31 patent applications. [4]

By offering innovation-oriented curricula within academic, interdisciplinary environments, programs like the Stanford Biodesign fellowship have the potential to enable aspiring physician-innovators to capitalize on opportunities and overcome roadblocks. These types of programs are also important because their successes serve to quiet critics who caution that collaborations between universities and industry might compromise the academic integrity of participating institutions. [5] "Right now," remarks Makower, "in a lot of university settings, business is a bad word and technology transfer is left to just happen." The outlook for innovation in such an ivory tower environment becomes progressively bleaker, as regulatory and economic hurdles increase in magnitude and scope. It may thus be time to reassess the potential risks and benefits associated with university-industry collaboration. [2] In 1996, for example, changes in FDA regulations added approximately two years and $10 million to the cost of developing and bringing a new medical product to the US market. As a result, the US public has been waiting longer than those overseas for access to new or improved medical technology. [5]

The demonstrated benefits of stronger university-industry interdependence, including "access to a partner's superior capacities or capabilities (e.g. new materials, research tools), and in the case of shared assets, creation of critical mass to conduct research and development," offer compelling reasons for institutions to consider offering progressive educational programs linked to the medical device industry and for students, doctors and professors to participate in them. [6] Currently, this trend is growing, as universities such as Johns Hopkins, Purdue, Indiana, and Minnesota are building programs that parallel the one at Stanford.

When asked whether he would encourage the next generation of physicians and/or engineers to consider a career in this industry, Makower replied without hesitation, "Absolutely. Everybody wins in this industry. If you have a successful technology, you're helping patients and doctors, and saving healthcare costs." And while he doesn't deny the fact that significant challenges face those involved in the industry, he insists that they shouldn't serve as a deterrent. "Some of the biggest roadblocks are the unwillingness of systems to change and the unwillingness of people to be open-minded, but this has been around as long as humans have been on the earth." All things equal, he continues, "those people who see opportunity for change always face challenges. But that's part of the game." As the field of surgical innovation continues to grow, now more than ever is the ideal time for creative-minded medical students to join the ranks of Dr. Makower and his students and engage in the development of the next generation of medical technology.  

Tavé van Zyl is a writer for the Next Generation and a member of the Harvard Class of 2008.

Joshua Makower, MD, MBA is Consulting Associate Professor of Medicine at Stanford and the Stanford Biodesign Innovation Program's co-founder and past director.

Works Cited
  1. Riskin DJ, Longaker MT, Gertner M, Krummel TM. "Innovation in surgery: a historical perspective." Ann Surg. 2006 Nov; 244(5):686-93. Review.
  2. Benson, J.S. "Forces Reshaping the Performance and Contribution of the U.S. Medical Device Industry." Food Drug Law J. 1996; 51(2):331-6.
  3. Gertner, M. "Biomedical Innovation, Surgical Innovation, and Beyond." Proceedings from the National Collegiate Inventors and Innovators Alliance; The NCIIA 9th Annual Meeting. March 17-19, 2005. San Diego, CA <www.nciia.org/conf05/cd/papers/gertner.pdf>
  4. White, Tracy. "Breeding Innovation: biodesign training in a nutshell" Stanford Medicine Magazine. Fall 2006 <mednews.stanford.edu/stanmed/2006fall/makower.html>
  5. Press, Eyal; Washburn, Jennifer "The Kept University." Atlantic Monthly, 2000 Mar; 285(3); 39-42, 44-52, 54.
  6. Kereiakes, D.J., Willerson, J.T., "Medical technology development and approval: the future is now." Circulation. 2004 Jun 29; 109(25):3078-80.
  7. Gelijns AC, Thier SO. "Medical innovation and institutional interdependence: rethinking university-industry connections." JAMA. 2002 Jan 2; 287(1):72-7.

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