- Email: [email protected]
Operative innovation and device development: A trainee's perspective
Operative innovation and device development: A trainee’s perspective Farokh R. Demehri, MD, Ann Arbor, MI
Farokh R. Demehri, MD, is a chief resident in general surgery and Pediatric Innovation Fellow at the University of Michigan. As a trainee, he has worked on device development in pediatric enteral access with James D. Geiger, MD, and device solutions for short bowel syndrome under the mentorship of Daniel H. Teitelbaum, MD. (Surgery 2017;161:887-91.) From the Department of Surgery, University of Michigan, Ann Arbor, MI
THE MISSION OF ACADEMIC SURGERY is commonly described as 3-fold: providing excellent patient care, advancing the field of surgery through research, and developing future surgical leaders through education. The training of surgical innovators has always been a key component of the academic surgical mission---even if it has not been identified as such. Many of the great advancements in surgical history have been initiated by innovative surgeons, often during their training. For example, Dr Robert E. Gross’ famous procedure involving ligation of a patent ductus arteriosus was developed and tested while he was chief resident in surgery under the tutelage of Dr William E. Ladd. Similarly, Dr Thomas J. Fogarty conceived his embolectomy catheter prior to medical school while working as a scrub technician and first saw it used clinically while he was a surgery resident.1 The world of device development and innovation has changed markedly over time, with greater regulatory oversight, the more crowded space of commercial biotechnology and a more complex pathway to clinical implementation. The general principles of innovation, however, have not changed, nor has the role of surgery trainees in driving innovation in surgery. This manuscript The author declares no conflicts of interest. Accepted for publication August 16, 2016. Reprint requests: Farokh R. Demehri, MD, Department of Surgery, University of Michigan, 1500 E. Medical Center Drive, 2207 Tc, Spc 5342, Ann Arbor, MI 48109. E-mail: fdemehri@ umich.edu. 0039-6060/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2016.08.056
addresses the surgery trainee interested in innovation as well as the training program committed to producing the next generation of surgeon innovators. First, the term innovation is defined as the process of taking an idea or invention to clinical application. In this regard, innovation is related to but distinct from discovery, invention, and entrepreneurship.2 It is through innovation that discoveries from the surgical science laboratory and inventions of creative surgeons navigate the often convoluted route to product development and clinical use. The importance of the trainee in surgical innovation is due to the privileged role of the surgery resident. The first and perhaps most important step of innovation is clinical need identification. Residents are the front line of patient care---in the emergency room, clinic, and operating room. Identifying a clinical need requires the ability to recognize problems in handson patient care by fearlessly questioning the status quo. Clinical needs might include ineffective treatments, concerns of patient safety, or inefficient care. The resident, often the most ubiquitous team member, has the most opportunities to identify these problems. In addition, the trainee has some element of benign ignorance as an attribute. Although the experienced surgeon may be complacent in accepting age-old techniques that have produced seemingly acceptable results in his or her practice, all aspects of care are equally new---and therefore equally questionable---to the trainee. By empowering trainees to identify clinical needs and pursue solutions, surgery-training programs often recruit their most effective drivers of innovative change. SURGERY 887
888 Demehri
INNOVATION TRAINING MODELS The author is a surgery resident who has been fortunate to have fruitful experiences in innovation during training. This opportunity was through 2 types of experiences in device development: a traditional bench-to-bedside translational project and a more focused innovation practicum. The former endeavor focused on translating a device used to study the concept of distraction enterogenesis---or mechanical bowel lengthening---to a clinically applicable device for use in patients with short bowel syndrome.3 The latter experience was as a Medical Innovation Fellow with the University of Michigan Pediatric Device Consortium. Both types of training opportunities have merits and each has a role for the trainee wishing to gain experience in surgical innovation. Translational research involves the application of laboratory-based discoveries to a clinical need. In the traditional model of medical discovery, this is the final stage---the product of years of work to understand a scientific problem before reducing this understanding to a clinically applicable solution.2 For the surgery trainee with a fixed amount of time dedicated to academic development, involvement in the translational step of a longer research endeavor can be productive. Although the trainee involved in such work might miss some of the freedom and creativity associated with the initial stages of innovation (need identification and solution ideation), the trainee benefits from involvement in the key translational stages of a well-developed product albeit within the time constraints of training. A focused innovation practicum offers the trainee the opportunity to gain instruction and experience with the specific innovation skillset. The most well established of these is the Stanford Biodesign program; other programs include the University of Michigan Pediatric Device Consortium and the Texas Medical Center Biodesign program. Although these have somewhat different structures and clinical foci, they share a common mission of teaching medical device development as a distinct discipline through a practical, projectbased approach. This is accomplished by recruiting fellows from diverse backgrounds---medicine, engineering, business, design, research, and law, among others. These fellows collaborate through the innovation process: clinical immersion and need identification, solution ideation, business validation, regulatory assessment, prototype development, and the iterative process of device development and testing.
Surgery April 2017
The full process might (and usually does) take place over a greater time period than the innovation program itself. These skills, however, allow the trainee to either continue a project with the innovation team after completing the program or apply these skills to future translational endeavors. The expertise of having been trained formally in all of the processes of device development can serve as valuable “currency” for future jobs in both academia and industry. As will be evident in this series of papers on innovation, cooperation between academia and industry is important in today’s world. Although these types of innovation training experiences have different strengths, the programs that sponsor them share several attributes to create a productive environment for innovation training. Residency programs interested in preparing future surgeons to succeed at innovation must foster an environment of interdisciplinary collaboration, ensure academic productivity for trainees to reach career goals, and enable diverse mentorship relationships. THE INNOVATION ENVIRONMENT Just as a scientific research program requires a unique environment---with laboratory infrastructure, animal facilities, basic science collaborators, and skilled technicians---the innovation environment has several features that allow for success, which include interdisciplinary collaboration, stakeholder engagement, and design capital. The surgical innovation process is inherently interdisciplinary, and the innovation environment must support such collaboration. Perhaps the most important ingredient of the aforementioned innovation training programs is the forging of interdisciplinary teams from diverse backgrounds. To the surgeon, engineer, and businessperson, the arena of device development may appear equally familiar and equally foreign. An innovation project will require inevitably the expertise of an engineer, and a sophisticated device will likely require specialized subcontractors. Similarly, having business expertise is critical, because the viability of a product’s commercial potential is just as important as its clinical need and efficacy if it is to reach the marketplace. Other key collaborators include those with experience in intellectual property and those with insight into device regulation. The innovation environment allows for ready access to the key stakeholders involved in the clinical need of interest. It is a mistake to consider
Surgery Volume 161, Number 4
the innovation process a highly secretive one, in which a device is kept “under wraps” until a finished product is finally revealed. Indeed, the opposite is true. The process must be informed through countless interactions with stakeholders: clinicians, patients, payers, industry members, and other investigators. Avoiding these interactions misses opportunities to strengthen the innovation through feedback from other members of this community of innovation who will be required eventually to endorse it. Despite the somewhat sensitive topic of the often maligned and misunderstood interaction between academia and industry, the innovation process requires early and consistent interaction with industry, which will eventually be key to the commercialization of a product. This need for engagement of stakeholders is balanced, however, by the very real need for protection of true intellectual property and measured disclosure. Through consultation with mentors and experts in intellectual property, this engagement can be fruitful without compromising the value of the innovation. Finally, the allocation of adequate design capital is critical for a productive environment of innovation. For the trainee, perhaps the most important resources are time and freedom. As discussed later, the pressures of clinical training and academic productivity are often at odds with the openminded creativity required for innovation. Necessary material resources include design space, prototyping facilities, and machining expertise. The ability to design, build, and test prototypes rapidly is critical for efficient solution development. For an innovation project to gain momentum and reach a milestone of the commercialization pathway, there must be funding opportunities available. Extramural funding sources, such as the National Institutes of Health (NIH), have traditionally not applied to technology-driven projects. Internal funding by institutions has served to bridge this gap until sufficient development has been reached to seek industry collaboration. More recently, however, the need to support surgical innovation has been echoed by an increased emphasis on collaborative, translational research by government funding bodies. For example, the NIH National Center for Translational Sciences was established to emphasize collaboration between clinical and scientific disciplines as well as between industry and academia. Through its Small Business Innovation Research and Small Business Technology Transfer, the National Center for Translational Sciences
Demehri 889
provides funding for early commercialization efforts between small businesses and researchers. The Food and Drug Administration also has dedicated resources specifically to enable commercialization of promising technologies to address unique clinical needs via its Office of Orphan Products Development. In addition to offering funding opportunities through its Orphan Grants Program, its Humanitarian Use Device program provides a streamlined regulatory pathway for devices intended to treat rare diseases. ACADEMIC PRODUCTIVITY At times, the ingredients that create an ideal environment for device innovation run contrary to those that foster an environment for traditional academic productivity for trainees. Consider the following mantra in innovation and technology development: “fail fast, fail often.” At each step of the innovation process is a necessary amount of inefficiency. Need identification requires thorough exploration of many clinical needs, only a few of which will merit further work. Similarly, solution ideation should involve creative, seemingly impractical solutions that require time and resources for investigation before pursuing an ideal solution. In some ways, this approach is not very distinct from that of traditional scientific exploration via hypothesis testing. Indeed, the innovation process requires hypothesis testing to be performed in quick succession. The distinction is the following: rather than thoroughly exploring the precise mechanisms by which each hypothesis fails or succeeds, the innovator must move on to testing the next possible solution. This process can be both time and resource intensive. For the trainee who is usually restrained to 1 or 2 years of academic development time or is otherwise working between full clinical duties, this process can be frustrating and appear unproductive. Whereas a well-designed scientific experiment should yield a publication regardless of positive or negative results, failed solutions during the innovation process usually do not result in such evidence of what is now appreciated as academic productivity (ie, a publication). It is possible to balance traditional academic productivity and the innovation process. This balance may be achieved through secondary clinical projects for trainees. In addition to yielding publications, clinical projects may verify the clinical need of the innovation project. For example, a clinical project assessing the outcomes of a procedure may identify complications that are not addressed with current technology. This clinical
890 Demehri
need may serve as the foundation of an innovation endeavor---perhaps to design a device to mitigate the risk of this complication. Alternatively, the innovation project can serve as a source of scientific exploration. By being thoughtful about the outcome measures used while testing prototypes, questions of basic science (ie, discovery) might be explored by gaining insight into mechanisms by which a device functions. This understanding might aid further solution development while contributing to greater scientific knowledge. Also, the use of novel testing platforms may be of interest to other investigators, again warranting publication. Given the conflict between traditional academic productivity and the innovation process, some have called for a paradigm shift in training and models of career advancement to nurture young surgeon innovators.4 Metrics used for academic career advancement, such as publication in highimpact journals and NIH funding, might be better balanced with intellectual property and achieving milestones in the device commercialization pathway (eg, patents, industry funding, start-up companies). For the contemporary trainee, a productive environment will support success by both traditional and new metrics. MENTORSHIP For the surgery trainee with an interest in innovation and device development, the longevity of that interest relies on the trainee’s confidence that this will lead to a viable career. While basic science and health services research have established track records of supporting academic careers, device development and innovation remains a relatively untested pathway. A trainee may be discouraged by this lack of precedent, which may temper his or her desire to make device development a primary academic pursuit. This is where mentorship (and insight by the department and university/hospital leadership) plays a critical role. In addition to encouraging and supporting innovation-minded trainees, a mentor may provide an example of how to structure an academic career in the innovation realm. Mentorship is a critical ingredient in career success and satisfaction in academic surgery in general.5 The importance of strong, diverse mentorship is amplified in a field as poorly defined as innovation and device development. The innovation trainee should foster relationships with multiple mentors, because each mentor may play different, equally important roles in informing
Surgery April 2017 the trainee’s development.6 Several types of mentorship relationships have been described.7 Among other mentor types, it is crucial for the trainee to identify an inventor mentor and a clinician mentor. An inventor mentor is an individual who has navigated successfully the pathway of device development from conception to commercialization. Regardless of his or her specific role---surgeon, engineer, or businessperson---this individual has achieved the innovator’s dream of seeing an idea implemented clinically. The inventor mentor may be a serial innovator, an entrepreneur, or a clinician, most of whom have likely failed multiple times in the innovation process. This type of mentor knows the course to success, as well as the pitfalls and detours that await the novice innovator. There is no single recipe for device development success; each invention has a unique set of challenges in development, regulatory processes, and commercialization. The innovation trainee should draw on the experiences of the inventor mentor (or several inventor mentors) to help chart a course though these challenges. Such mentorship is so important to the success of translational projects that the identification of mentors is a central element of initiatives in translational research funding.8 The clinician mentor is an individual who has incorporated innovation and device development into a successful academic career. Although clinical specialty is not important---surgeon or otherwise--the fact that this mentor has forged a unique path in academic medicine makes this individual a very valuable resource. The clinician mentor may be a traditional researcher with translational success, a clinician-entrepreneur, or a surgeon-inventor who has licensed an idea. In addition to providing practical advice for career development, the clinician mentor should understand the ethical challenges inherent in device development for a clinician. Because the first priority of the surgery trainee should be that of patient care, the clinician mentor plays a key role in navigating the ethical issues of patient safety, conflict of interest, and informed consent in technology development.9 DISCUSSION It is an exciting time to be a surgery trainee and innovator. With the rapid expansion of surgical technologies and surgically treatable diseases, there is a growing role for the trainee to drive the development of novel solutions for surgical needs.
Surgery Volume 161, Number 4
As training programs increasingly begin to recognize the importance of fostering an innovation environment, support and mentorship for trainees pursuing a career in this area will continue to grow. The author would like to acknowledge James D. Geiger for his mentorship and guidance. This manuscript is inspired by the innovation curriculum developed by Dr Geiger for the Michigan Pediatric Device Consortium.
REFERENCES 1. Hunter J. Historical perspective of surgical innovation. In: Stain SC, Pryor AD, Shadduck PP, editors. The SAGES manual ethics of surgical innovation. Switzerland: Springer International Publishing; 2016. p. 1-8. 2. Krummel TM. Inventing our future: training the next generation of surgeon innovators. J Pediatr Surg 2009;44:21-35.
Demehri 891
3. Demehri FR, Utter B, Freeman JJ, Fukatsu Y, Luntz J, Brei D, et al. Development of an endoluminal intestinal attachment for a clinically applicable distraction enterogenesis device. J Pediatr Surg 2016;51:101-6. 4. Fernandez-Moure JS. Lost in translation: the gap in scientific advancements and clinical application. Front Bioeng Biotechnol 2016;4:43. 5. Ries A, Wingard D, Gamst A, Larsen C, Farrell E, Reznik V. Measuring faculty retention and success in academic medicine. Acad Med 2012;87:1046-51. 6. Sambunjak D, Marusic A. Mentoring: what’s in a name? JAMA 2009;302:2591-2. 7. Detsky AS, Baerlocher MO. Academic mentoring–how to give it and how to get it. JAMA 2007;297:2134-6. 8. Pienta KJ. Successfully accelerating translational research at an academic medical center: the University of MichiganCoulter translational research partnership program. Clin Transl Sci 2010;3:316-8. 9. Geiger JD, Hirschl RB. Innovation in surgical technology and techniques: challenges and ethical issues. Semin Pediatr Surg 2015;24:115-21.
Farokh R. Demehri, MD, is a chief resident in general surgery and Pediatric Innovation Fellow at the University of Michigan. As a trainee, he has worked on device development in pediatric enteral access with James D. Geiger, MD, and device solutions for short bowel syndrome under the mentorship of Daniel H. Teitelbaum, MD. (Surgery 2017;161:887-91.) From the Department of Surgery, University of Michigan, Ann Arbor, MI
THE MISSION OF ACADEMIC SURGERY is commonly described as 3-fold: providing excellent patient care, advancing the field of surgery through research, and developing future surgical leaders through education. The training of surgical innovators has always been a key component of the academic surgical mission---even if it has not been identified as such. Many of the great advancements in surgical history have been initiated by innovative surgeons, often during their training. For example, Dr Robert E. Gross’ famous procedure involving ligation of a patent ductus arteriosus was developed and tested while he was chief resident in surgery under the tutelage of Dr William E. Ladd. Similarly, Dr Thomas J. Fogarty conceived his embolectomy catheter prior to medical school while working as a scrub technician and first saw it used clinically while he was a surgery resident.1 The world of device development and innovation has changed markedly over time, with greater regulatory oversight, the more crowded space of commercial biotechnology and a more complex pathway to clinical implementation. The general principles of innovation, however, have not changed, nor has the role of surgery trainees in driving innovation in surgery. This manuscript The author declares no conflicts of interest. Accepted for publication August 16, 2016. Reprint requests: Farokh R. Demehri, MD, Department of Surgery, University of Michigan, 1500 E. Medical Center Drive, 2207 Tc, Spc 5342, Ann Arbor, MI 48109. E-mail: fdemehri@ umich.edu. 0039-6060/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2016.08.056
addresses the surgery trainee interested in innovation as well as the training program committed to producing the next generation of surgeon innovators. First, the term innovation is defined as the process of taking an idea or invention to clinical application. In this regard, innovation is related to but distinct from discovery, invention, and entrepreneurship.2 It is through innovation that discoveries from the surgical science laboratory and inventions of creative surgeons navigate the often convoluted route to product development and clinical use. The importance of the trainee in surgical innovation is due to the privileged role of the surgery resident. The first and perhaps most important step of innovation is clinical need identification. Residents are the front line of patient care---in the emergency room, clinic, and operating room. Identifying a clinical need requires the ability to recognize problems in handson patient care by fearlessly questioning the status quo. Clinical needs might include ineffective treatments, concerns of patient safety, or inefficient care. The resident, often the most ubiquitous team member, has the most opportunities to identify these problems. In addition, the trainee has some element of benign ignorance as an attribute. Although the experienced surgeon may be complacent in accepting age-old techniques that have produced seemingly acceptable results in his or her practice, all aspects of care are equally new---and therefore equally questionable---to the trainee. By empowering trainees to identify clinical needs and pursue solutions, surgery-training programs often recruit their most effective drivers of innovative change. SURGERY 887
888 Demehri
INNOVATION TRAINING MODELS The author is a surgery resident who has been fortunate to have fruitful experiences in innovation during training. This opportunity was through 2 types of experiences in device development: a traditional bench-to-bedside translational project and a more focused innovation practicum. The former endeavor focused on translating a device used to study the concept of distraction enterogenesis---or mechanical bowel lengthening---to a clinically applicable device for use in patients with short bowel syndrome.3 The latter experience was as a Medical Innovation Fellow with the University of Michigan Pediatric Device Consortium. Both types of training opportunities have merits and each has a role for the trainee wishing to gain experience in surgical innovation. Translational research involves the application of laboratory-based discoveries to a clinical need. In the traditional model of medical discovery, this is the final stage---the product of years of work to understand a scientific problem before reducing this understanding to a clinically applicable solution.2 For the surgery trainee with a fixed amount of time dedicated to academic development, involvement in the translational step of a longer research endeavor can be productive. Although the trainee involved in such work might miss some of the freedom and creativity associated with the initial stages of innovation (need identification and solution ideation), the trainee benefits from involvement in the key translational stages of a well-developed product albeit within the time constraints of training. A focused innovation practicum offers the trainee the opportunity to gain instruction and experience with the specific innovation skillset. The most well established of these is the Stanford Biodesign program; other programs include the University of Michigan Pediatric Device Consortium and the Texas Medical Center Biodesign program. Although these have somewhat different structures and clinical foci, they share a common mission of teaching medical device development as a distinct discipline through a practical, projectbased approach. This is accomplished by recruiting fellows from diverse backgrounds---medicine, engineering, business, design, research, and law, among others. These fellows collaborate through the innovation process: clinical immersion and need identification, solution ideation, business validation, regulatory assessment, prototype development, and the iterative process of device development and testing.
Surgery April 2017
The full process might (and usually does) take place over a greater time period than the innovation program itself. These skills, however, allow the trainee to either continue a project with the innovation team after completing the program or apply these skills to future translational endeavors. The expertise of having been trained formally in all of the processes of device development can serve as valuable “currency” for future jobs in both academia and industry. As will be evident in this series of papers on innovation, cooperation between academia and industry is important in today’s world. Although these types of innovation training experiences have different strengths, the programs that sponsor them share several attributes to create a productive environment for innovation training. Residency programs interested in preparing future surgeons to succeed at innovation must foster an environment of interdisciplinary collaboration, ensure academic productivity for trainees to reach career goals, and enable diverse mentorship relationships. THE INNOVATION ENVIRONMENT Just as a scientific research program requires a unique environment---with laboratory infrastructure, animal facilities, basic science collaborators, and skilled technicians---the innovation environment has several features that allow for success, which include interdisciplinary collaboration, stakeholder engagement, and design capital. The surgical innovation process is inherently interdisciplinary, and the innovation environment must support such collaboration. Perhaps the most important ingredient of the aforementioned innovation training programs is the forging of interdisciplinary teams from diverse backgrounds. To the surgeon, engineer, and businessperson, the arena of device development may appear equally familiar and equally foreign. An innovation project will require inevitably the expertise of an engineer, and a sophisticated device will likely require specialized subcontractors. Similarly, having business expertise is critical, because the viability of a product’s commercial potential is just as important as its clinical need and efficacy if it is to reach the marketplace. Other key collaborators include those with experience in intellectual property and those with insight into device regulation. The innovation environment allows for ready access to the key stakeholders involved in the clinical need of interest. It is a mistake to consider
Surgery Volume 161, Number 4
the innovation process a highly secretive one, in which a device is kept “under wraps” until a finished product is finally revealed. Indeed, the opposite is true. The process must be informed through countless interactions with stakeholders: clinicians, patients, payers, industry members, and other investigators. Avoiding these interactions misses opportunities to strengthen the innovation through feedback from other members of this community of innovation who will be required eventually to endorse it. Despite the somewhat sensitive topic of the often maligned and misunderstood interaction between academia and industry, the innovation process requires early and consistent interaction with industry, which will eventually be key to the commercialization of a product. This need for engagement of stakeholders is balanced, however, by the very real need for protection of true intellectual property and measured disclosure. Through consultation with mentors and experts in intellectual property, this engagement can be fruitful without compromising the value of the innovation. Finally, the allocation of adequate design capital is critical for a productive environment of innovation. For the trainee, perhaps the most important resources are time and freedom. As discussed later, the pressures of clinical training and academic productivity are often at odds with the openminded creativity required for innovation. Necessary material resources include design space, prototyping facilities, and machining expertise. The ability to design, build, and test prototypes rapidly is critical for efficient solution development. For an innovation project to gain momentum and reach a milestone of the commercialization pathway, there must be funding opportunities available. Extramural funding sources, such as the National Institutes of Health (NIH), have traditionally not applied to technology-driven projects. Internal funding by institutions has served to bridge this gap until sufficient development has been reached to seek industry collaboration. More recently, however, the need to support surgical innovation has been echoed by an increased emphasis on collaborative, translational research by government funding bodies. For example, the NIH National Center for Translational Sciences was established to emphasize collaboration between clinical and scientific disciplines as well as between industry and academia. Through its Small Business Innovation Research and Small Business Technology Transfer, the National Center for Translational Sciences
Demehri 889
provides funding for early commercialization efforts between small businesses and researchers. The Food and Drug Administration also has dedicated resources specifically to enable commercialization of promising technologies to address unique clinical needs via its Office of Orphan Products Development. In addition to offering funding opportunities through its Orphan Grants Program, its Humanitarian Use Device program provides a streamlined regulatory pathway for devices intended to treat rare diseases. ACADEMIC PRODUCTIVITY At times, the ingredients that create an ideal environment for device innovation run contrary to those that foster an environment for traditional academic productivity for trainees. Consider the following mantra in innovation and technology development: “fail fast, fail often.” At each step of the innovation process is a necessary amount of inefficiency. Need identification requires thorough exploration of many clinical needs, only a few of which will merit further work. Similarly, solution ideation should involve creative, seemingly impractical solutions that require time and resources for investigation before pursuing an ideal solution. In some ways, this approach is not very distinct from that of traditional scientific exploration via hypothesis testing. Indeed, the innovation process requires hypothesis testing to be performed in quick succession. The distinction is the following: rather than thoroughly exploring the precise mechanisms by which each hypothesis fails or succeeds, the innovator must move on to testing the next possible solution. This process can be both time and resource intensive. For the trainee who is usually restrained to 1 or 2 years of academic development time or is otherwise working between full clinical duties, this process can be frustrating and appear unproductive. Whereas a well-designed scientific experiment should yield a publication regardless of positive or negative results, failed solutions during the innovation process usually do not result in such evidence of what is now appreciated as academic productivity (ie, a publication). It is possible to balance traditional academic productivity and the innovation process. This balance may be achieved through secondary clinical projects for trainees. In addition to yielding publications, clinical projects may verify the clinical need of the innovation project. For example, a clinical project assessing the outcomes of a procedure may identify complications that are not addressed with current technology. This clinical
890 Demehri
need may serve as the foundation of an innovation endeavor---perhaps to design a device to mitigate the risk of this complication. Alternatively, the innovation project can serve as a source of scientific exploration. By being thoughtful about the outcome measures used while testing prototypes, questions of basic science (ie, discovery) might be explored by gaining insight into mechanisms by which a device functions. This understanding might aid further solution development while contributing to greater scientific knowledge. Also, the use of novel testing platforms may be of interest to other investigators, again warranting publication. Given the conflict between traditional academic productivity and the innovation process, some have called for a paradigm shift in training and models of career advancement to nurture young surgeon innovators.4 Metrics used for academic career advancement, such as publication in highimpact journals and NIH funding, might be better balanced with intellectual property and achieving milestones in the device commercialization pathway (eg, patents, industry funding, start-up companies). For the contemporary trainee, a productive environment will support success by both traditional and new metrics. MENTORSHIP For the surgery trainee with an interest in innovation and device development, the longevity of that interest relies on the trainee’s confidence that this will lead to a viable career. While basic science and health services research have established track records of supporting academic careers, device development and innovation remains a relatively untested pathway. A trainee may be discouraged by this lack of precedent, which may temper his or her desire to make device development a primary academic pursuit. This is where mentorship (and insight by the department and university/hospital leadership) plays a critical role. In addition to encouraging and supporting innovation-minded trainees, a mentor may provide an example of how to structure an academic career in the innovation realm. Mentorship is a critical ingredient in career success and satisfaction in academic surgery in general.5 The importance of strong, diverse mentorship is amplified in a field as poorly defined as innovation and device development. The innovation trainee should foster relationships with multiple mentors, because each mentor may play different, equally important roles in informing
Surgery April 2017 the trainee’s development.6 Several types of mentorship relationships have been described.7 Among other mentor types, it is crucial for the trainee to identify an inventor mentor and a clinician mentor. An inventor mentor is an individual who has navigated successfully the pathway of device development from conception to commercialization. Regardless of his or her specific role---surgeon, engineer, or businessperson---this individual has achieved the innovator’s dream of seeing an idea implemented clinically. The inventor mentor may be a serial innovator, an entrepreneur, or a clinician, most of whom have likely failed multiple times in the innovation process. This type of mentor knows the course to success, as well as the pitfalls and detours that await the novice innovator. There is no single recipe for device development success; each invention has a unique set of challenges in development, regulatory processes, and commercialization. The innovation trainee should draw on the experiences of the inventor mentor (or several inventor mentors) to help chart a course though these challenges. Such mentorship is so important to the success of translational projects that the identification of mentors is a central element of initiatives in translational research funding.8 The clinician mentor is an individual who has incorporated innovation and device development into a successful academic career. Although clinical specialty is not important---surgeon or otherwise--the fact that this mentor has forged a unique path in academic medicine makes this individual a very valuable resource. The clinician mentor may be a traditional researcher with translational success, a clinician-entrepreneur, or a surgeon-inventor who has licensed an idea. In addition to providing practical advice for career development, the clinician mentor should understand the ethical challenges inherent in device development for a clinician. Because the first priority of the surgery trainee should be that of patient care, the clinician mentor plays a key role in navigating the ethical issues of patient safety, conflict of interest, and informed consent in technology development.9 DISCUSSION It is an exciting time to be a surgery trainee and innovator. With the rapid expansion of surgical technologies and surgically treatable diseases, there is a growing role for the trainee to drive the development of novel solutions for surgical needs.
Surgery Volume 161, Number 4
As training programs increasingly begin to recognize the importance of fostering an innovation environment, support and mentorship for trainees pursuing a career in this area will continue to grow. The author would like to acknowledge James D. Geiger for his mentorship and guidance. This manuscript is inspired by the innovation curriculum developed by Dr Geiger for the Michigan Pediatric Device Consortium.
REFERENCES 1. Hunter J. Historical perspective of surgical innovation. In: Stain SC, Pryor AD, Shadduck PP, editors. The SAGES manual ethics of surgical innovation. Switzerland: Springer International Publishing; 2016. p. 1-8. 2. Krummel TM. Inventing our future: training the next generation of surgeon innovators. J Pediatr Surg 2009;44:21-35.
Demehri 891
3. Demehri FR, Utter B, Freeman JJ, Fukatsu Y, Luntz J, Brei D, et al. Development of an endoluminal intestinal attachment for a clinically applicable distraction enterogenesis device. J Pediatr Surg 2016;51:101-6. 4. Fernandez-Moure JS. Lost in translation: the gap in scientific advancements and clinical application. Front Bioeng Biotechnol 2016;4:43. 5. Ries A, Wingard D, Gamst A, Larsen C, Farrell E, Reznik V. Measuring faculty retention and success in academic medicine. Acad Med 2012;87:1046-51. 6. Sambunjak D, Marusic A. Mentoring: what’s in a name? JAMA 2009;302:2591-2. 7. Detsky AS, Baerlocher MO. Academic mentoring–how to give it and how to get it. JAMA 2007;297:2134-6. 8. Pienta KJ. Successfully accelerating translational research at an academic medical center: the University of MichiganCoulter translational research partnership program. Clin Transl Sci 2010;3:316-8. 9. Geiger JD, Hirschl RB. Innovation in surgical technology and techniques: challenges and ethical issues. Semin Pediatr Surg 2015;24:115-21.