Along with the technology advancements, the role of the anesthesiologist has grown from a silent supporter of the surgeon to a patient guardian in the perioperative period. A recent study underlined the importance of Anesthesiology Preoperative Clinic visits before elective surgery, revealing a significant reduction of in-hospital mortality in patients that were evaluated in a preoperative clinic before surgery.12 Anesthesiologists often are also involved in addressing questions regarding the quality of life and end-of-life decisions. They are also interventionalists, surgeons, applied pharmacologists, and experts in providing relief for patients with complex pain histories. Anesthesiology requires understanding of anatomy, physiology, chemistry, physics, and engineering (Figure 3).
The nature of providing anesthesia and critical care requires constant critical re-evaluation of the status quo, anticipation, and adaptation in a highly dynamic environment. It is our opinion that anesthesiology requires major collaborative efforts and a constant evolution in anesthesia technologies to accomplish a successful procedure and guarantee uninterrupted patient safety for a very broad patient population.
Anesthesiologists wear different hats when they work with surgical, medical, or radiology colleagues. The ability to fluidly transition between these roles is another key aspect that make anesthesiologists such unique physician providers. This adaptability requires creative problem-solving capabilities and the ability to promptly work collaboratively in a high-stress environment. Although anesthesiologists often may not be the “primary” providers to their patients, they have to have a deep understanding of virtually all medical and surgical conditions to offer appropriate care. Arguably, no other specialty provides this breadth of services in such diverse settings. We believe that these features of our profession provide us with necessary skills to become successful innovators in nearly all aspects of medicine.
Diverse talents and interests are also strengths of anesthesiologists. Staff and resident anesthesiologists at our teaching institution consist of cancer biologists, computer scientists, electrical engineers, material scientists, mechanical, chemical and bioengineers, neuroscientists, pharmacologists, political scientists, public health experts, and historians. It is understandable that not every department in the country is composed of a similarly diverse group of faculty members and trainees. It is our opinion, however, that many current academic departments could form collaborations with other departments and industry and develop successful entrepreneurial training programs. Given the interdisciplinary work of anesthesiologists, research should not only be performed within the “well-defined boundaries” of the field of anesthesiology. This just furthers isolation and trivializes our medical/innovative contributions in the eyes of our other medical colleagues, the public and industry.
HOW TO TRAIN AN ENTREPRENEUR?
A declared goal of this opinion piece is to provide a possible curriculum outline with certain core elements, rather than a detailed program description, as this may be significantly different between the individual trainees. In addition, we would like to stoke a conversation between residents and departmental and hospital leaderships on how to approach this challenging task in a mutually beneficial and cost-effective manner. It is imperative that anesthesiologists continue to innovate and actively seek ways to train the next generation of physician-innovators. We believe that it would be useful to develop a career track in medicine that is meant for physician-innovators with an entrepreneurial spirit.
In an effort to address formal entrepreneurial training among anesthesiologists, Stanford University established the Stanford Anesthesia Innovation Lab (SAIL).13 SAIL is composed of a diverse group of physicians, scientists, engineers, and entrepreneurs with the goal to foster medical device development. In fact, the current chief executive officer is a recent Stanford Anesthesiology Residency graduate. Many of the team members have cross-disciplinary backgrounds. In addition, Stanford established SAIL Innovator Training, which includes a longitudinal research track throughout residency followed by a fellowship year afterwards that provides core competency training for successful device prototyping, business development, and market entry.13 In brief, this program’s staff and resources help identify unmet clinical needs, assess the ideas for patentability, and evaluate the market situation that the innovative product would enter.
The SAIL program particularly seeks to support projects that involve technologies that can be prototyped rapidly and validated clinically. For the residency track trainees, an annual $10 000 research stipend is granted and additional departmental funding may be accessible. Clear milestones are defined for the CA-1 to CA-3 years including a project outline and application for intramural funding, development of the initial prototype, and plans for clinical validation. An individualized curriculum is then designed with access to business, information technology, and engineering education. Graduates from this residency program then may stay on as junior faculty members with the agreement of 80% protected time toward their projects.13 Ongoing projects thus far include a portable device for the induction of prehospital hypothermia (Thermapeutics), technology to improve blood product tracking within hospital settings (ColdLink), and a magnetic tool to facilitate intubation (ClearSight).13
Although none of the authors of this opinion piece have any personal or financial affiliation with Stanford University and/or the SAIL program, we are very intrigued by the well-articulated curriculum and overall opportunities the program appears to offer. Stanford University naturally is a near-perfect place for such an initiative, given its intellectual and resource-rich environment. It remains to be seen, however, if this program will yield financially successful companies or licensing agreements that in turn will pay for the upfront costs. It will be interesting to see which particular elements of the program are critical for the innovative success and thus could be adopted by other universities as a blueprint for such a curriculum. Not every anesthesiology department may be willing or able to invest a significant amount of money in such program. Certainly it is in our specialty’s interest to see a program such as SAIL continue to succeed. We firmly believe that external funding sources including private investors and local as well as international companies ought to be included in the development of a research/innovation training pathway and in the development of facilities that can house innovative entrepreneurism.
Other academic institutions, such as Johns Hopkins University and University of California, San Francisco, also offer research tracks for critical care, basic science, and global health with individualized annual goals and adjustable protected time.14,15 To the best of our knowledge, however, these tracks as of now are not aimed at fostering commercialization of biomedical innovations.
HARVARD ENTREPRENEURIAL ANESTHESIOLOGY RESEARCH TRACK
The structure of the anesthesiology residency and the overall daily routine of anesthesiologists lend themselves well to a longitudinal education that could foster entrepreneurial thinking and allow for gradual project development. In addition, with the exception of the intensive care unit and pain medicine rotations, there is little longitudinal patient care required by anesthesiology residents. Therefore, residents in good standing could be excused from clinical duties on a short notice without significantly compromising patient care or clinical education.
As of today, a CA-3 resident can obtain up to 6 months of protected time to conduct supervised research projects. It is conceivable that one could break up this block to provide protected time for research trainees as early as postgraduate-1 or CA-1 (postgraduate-2) year. Additional time should be allocated as the project requires with the understanding that the resident may graduate later than his or her peers in class. There has to be a clear understanding and motivation by the program to regularly afford the trainee hours or days of protected time on a short notice to accommodate the needs to further the research project. This time may be necessary to hold meetings with members of the laboratory, collaborators, mentors, lawyers, the technology transfer office, and is pivotal to allow for uninterrupted progress. It is this flexibility that could make an innovative entrepreneurial training program so valuable and potentially successful. On a different note, the protected time could be used toward additional graduate education, be it specific classes in business, engineering, information technology, etc or even a masters degree (MBA, MS). We believe that the prototypical trainee would be a highly motivated individual willing to accept a higher call burden or other measures to compensate for the time missed.
Given Boston’s rich educational and innovative environment, it should be possible to build on existing alliances between institutions to develop an innovative curriculum, which we named Harvard Entrepreneurial Anesthesiology Research Track (HEART). Already-existing platforms for academic device developments in the Boston area might be used to help in the establishment of the HEART program. Two of these programs are “The Harvard Medical Device Innovation Initiative” and the Massachusetts Institute of Technology’s “Medical Device Design” course.16,17 These classes create an arena for physicians to present clinical problems to biomedical engineering students. Under the physician’s guidance, the student team then develops a medical device prototype over several months that is presented to a panel of entrepreneurs and venture capital investors for their feedback. Yet, these classes and labs are primarily located outside the hospital campus and that creates barriers for busy physicians to get involved.
As discussed previously, the eventual curriculum may be very different for the individual trainee, but to us it seems relevant to include some of these following elements and opportunities (Table 2). The departmental support needs to continue into the early stages of the trainee’s faculty careers. This should include bridge funding by the department. In addition, funding sources, such as Small Business Innovation Research and Foundation for Anesthesia Education and Research grants (FAER), could be helpful.18 Small Business Innovation Research is a funding mechanism that encourages domestic small businesses to engage in Federal Research/Research and Development that has the potential for commercialization. Collaborations with academia are possible. Also, the FAER leadership might consider the introduction of a funding mechanism specifically for research aimed at technological innovation and commercialization. This may include clauses that would remunerate FAER in the case of commercial success. It is the authors’ beliefs that eventually direct collaborations with industry could further help funding this program.
Beyond the funding and curriculum questions, it is important to address issues of IP rights and to create an infrastructure, including access to laboratory space, industry resources, such as good manufacturing practices, and prototyping capabilities. We consider it vital to have access to industry resources early on, as these entities understand the process of market entry very well and can help perform necessary experiments and tailor a regulatory pathway in an efficient manner. A close interaction of academia and industry early on also might result in a more refined and potentially more successful business plan. We would like to reiterate that none of the authors have any conflict of interest pertaining to a possible HEART program or potentially affiliated programs and institutions.
DESTIGMATIZING ACADEMIA–INDUSTRY RELATIONSHIPS
The traditional bench-to-patent pipeline that prevails in the research community of many academic institutions is anachronistic when viewed through the lens of medical innovation that needs rapid scalability. The creation of disruptive, innovative healthcare technologies requires a faster and more nimble process than what currently exists. The historic developmental model of internal funding, research, publication, patent acquisition, and licensing needs to evolve into more diverse and collaborative structures. In our opinion, innovation in this domain requires a complex marriage of academic and private sector resources. Forming alliances with healthcare-focused incubators and accelerators, pharmaceutical and biotech companies, and venture capitalists are important as innovators seek to reconcile the cost of product development and the need to retain ownership of their ideas.
Clinician innovators may avoid collaborating with industry professionals at the infancy stage of the product development process possibly fearing that venture capitalists will exploit their naïveté and take significant equity in the end-product. Some scientists resort to the familiarity of the academic product development pipeline only to arrive at the harsh realization that they have forfeited most (often times all) of their stake in the technology. A university usually owns any IP that is discovered, designed, created, or conceived by a member of staff during the course of their employment or which makes “significant” use of the institution’s resources.19
A disappointing, but exemplary, illustration of this situation was the legal dispute between Dr. Renee Kaswan and the University of Georgia Research Foundation (UGARF). Dr. Kaswan was a veterinary ophthalmology professor at UGA when she invented a therapy for chronic dry eye trademarked as Restasis. UGARF owned the patents to the drug and licensed the veterinary development to Kaswan and human development to Allergan in 1993.20 However, in 2002, UGARF agreed in writing to assign Dr. Kaswan the patents for her invention. While the contracts were being drafted, the Food and Drug Administration approved Restasis for human use in December 2002.20 UGARF promptly reneged on their agreement and preemptively sued Kaswan for “trademark infringement” while simultaneously withholding her portion of the royalty income. Eventually in 2010, UGARF agreed to a settlement payout of $20.2 million to Kaswan.20 This example shows that it has to be in the interest of investigators and universities to improve and streamline relationships among themselves and with industry and to develop road maps for fair IP policies to avoid the aforementioned damages.
A key element of fostering innovation and entrepreneurial research is allowing a bidirectional exchange of ideas and resources between academia and industry. Although concerns about conflicts of interest are valid, a restrictive approach to this vital relationship is prohibitive of innovation. For too long, the relationship between academia and industry has been too loose. As a result, new healthcare technologies are largely being developed by industry and presented to the healthcare system, which then has to adopt it. Academic medicine must exist to spur innovation, not to adopt it. We should no longer rely on “outsiders” to innovate for the “insiders.” Existing innovative academic efforts should be fostered and expanded. Therefore, closer academic–industry relationships could be of great help.
EVOLVING ACADEMIA–INDUSTRY RELATIONSHIPS
Academia and industry are distinct entities with distinct strengths and weaknesses. Academic medical research has become an increasing challenge, given the rising costs of research with a budget from the National Institutes of Health (NIH) that has been at best flat for the past years. At the same time, many biotech and medical device industries are struggling to come up with new blockbuster drugs or disruptive technologies. For that reason, AstraZeneca and Sanofi21 recently agreed to swap 210 000 compounds of their respective libraries. Other steps in the right direction recently have been made. A new program called Accelerating Medicines Partnership is trying to address the mismatch of research costs and marketable compound output.10 NIH, Food and Drug Administration, nonprofit organizations, such as the American Diabetes Association and Alzheimer Association, as well as major industry partners, such as Pfizer, Merck, Sanofi, Johnson & Johnson, Biogen Idec, GlaxoSmithKline, are joining forces.10 Over 5 years, the NIH will invest $119 million and the industry partners $111 million. Patient advocacy groups will also contribute $1 million and aid in defining research goals.10
Another interesting approach is the Belfer Center for Applied Cancer Science within the Dana-Farber Cancer Institute, which describes itself as an “industry-inspired, self-sustaining scientific center with the mission to improve patient outcomes by discovering more efficacious cancer therapies.” For this purpose, the Belfer Center fosters collaborate between academic and industry-trained scientists and pharmaceutical and biotechnology companies.11 In brief, academic and industry-employed scientists work side-by-side on various research projects. It is this longitudinal collaboration starting at early stages of discovery that makes this concept so intriguing. The old concept of approaching industry after a long stretch of academic investigations is broken up and synergies between academia and industry can be developed much sooner. This close proximity and dissolution of the traditional “silo structures” are at the core of newly formed collaborations between academia and industry. This increased transparency between academia and industry will hopefully also lead to more trust between these entities.
We believe that anesthesiologists should seize the opportunity to expand their role in medical innovative entrepreneurism. The development of focused entrepreneurial training programs in conjunction with goal-directed, in-house industry collaborations may allow physician anesthesiologists to become leaders in medical innovative entrepreneurism.
The field of anesthesiology has the unique opportunity to shape a generation of innovative physician entrepreneurs. The inherent clinical and intellectual challenges faced on a daily basis by anesthesiology providers foster the critical thinking required of true innovators. Given the need of new innovative therapies and devices in an age of contracting research budgets, industry and academia are joining efforts to optimize research output while decreasing costs. It is the authors’ strong conviction that anesthesiologists should lead these efforts. Stanford’s SAIL program and its associated training program is an important step in the right direction to further enhance the necessary skills of academic anesthesiologists to succeed as entrepreneurs. As a potential alternative, we propose the creation of the “HEART,” a longitudinal training pathway within the anesthesiology residency program as outlined previously. The authors of this manuscript hope to open up a debate among the leadership of academic anesthesiology programs with the goal to augment the entrepreneurial endeavors of the next generation of anesthesiology physician scientists.
Name: Albert H. Kwon, MD.
Contribution: This author contributed to the concept, manuscript composition, and editing/revision of the study.
Name: Zwade J. Marshall, MD, MBA.
Contribution: This author helped in manuscript composition.
Name: Christoph S. Nabzdyk, MD
Contribution: This author contributed to the concept, manuscript composition, and editing/revision of the study.
This manuscript was handled by: Nancy Borkowski, DBA, CPA, FACHE, FHFMA.
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5. Bause GS. The 1847 Murphy chloroform inhaler. Anesthesiology. 2010;113:778
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Copyright © 2017 International Anesthesia Research Society
12. Blitz JD, Kendale SM, Jain SK, Cuff GE, Kim JT, Rosenberg AD. Preoperative evaluation clinic visit is associated with decreased risk of in-hospital postoperative mortality. Anesthesiology. 2016;125:280–294.