Innovation and Entrepreneurship in Surgery: Creating a Culture for Success



Innovation and Entrepreneurship in Surgery: Creating a Culture for Success


Mark S. Cohen







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INTRODUCTION

The future of health care rides on a wave of technological advances that improve not only patients’ lives but also their experience and how they can be treated in a personalized and multidisciplinary environment. Clinicians are key stakeholders in this environment where medical technology is exponentially advancing. As such, surgeons and trainees are exposed daily to new technologies being applied to their practice. More than ever, they need to have the right tools to understand how these technologies affect patient care and improve surgical diseases, but also how to decide which technologies are the safest and most impactful for their patients.


Surgeons at academic medical centers are well exposed to the missions of education, research, and clinical excellence and are continually pushing the field forward to improve care. In this role, they are commonly involved in trialing new surgical devices and are sought by industry to collaborate and develop new surgical technologies. They see problems in their practices each day that they would like to solve or improve, making them natural innovators. While identifying surgical problems is important, having the right tools to create surgical innovations that can move out of the academic environment and have meaningful impact for patients is a skill set that in the past has not been cultivated, promoted, or rewarded in academic institutions.

The goal of this chapter is to provide an overview of how building a culture in academic surgery that cultivates and rewards surgical innovation and creates multidisciplinary diverse teams can have meaningful and long-lasting success. Such efforts create value for surgeons and trainees participating in these innovative and creative endeavors, but also create meaningful impact for patients, additional sources of funding for academic departments, and build a more collaborative environment for solution implementation.


THE INNOVATIVE PROCESS

In looking at the innovation process one must start with a problem to be solved. Whether this is a need for a new device that helps with a procedure, a new drug to treat a disease, a better diagnostic tool, a new process that is more efficient, or creating a digital or virtual solution to a problem, every new innovation hinges on the problem it addresses. Therefore, as with any research effort, it is imperative to spend some quality time early on defining the problem to be solved and determining whether this is a problem that is worth solving. Problem identification, while it appears straightforward, requires a multidisciplinary approach. For every problem and solution, there are numerous stakeholders affected by both and the “value” of a solution is defined by its net positive impact across this entire map of stakeholders. Defining those stakeholders and engaging them early in the solution development process is imperative to obtaining critical feedback that can make or break an idea or solution moving forward to impact.

While there are many methods to problem identification and solution generation, the process of “design thinking” is a very effective way to create high-value solutions to meaningful problems that can move forward more easily to create impact in the market. Design thinking is an iterative process for solving complex problems. Since most problems in medicine are relatively complex, this process lends itself well to medical innovations. The common steps in design thinking include problem identification; ideation and prototype solution development; concept hardening/prototype testing and iterative solution de-risking; and finally generating the high-impact value proposition. While these steps are often performed sequentially, they may be done out of order depending on the solution and circumstances of the problem1 (Figure 8.1).


Problem Identification

The first and most important step in this innovation process is problem identification. Once a stakeholder map is generated around a problem, it is important to get feedback from as many stakeholders as possible about the impact the problem has on each of them. Empathizing with the “pain” of the problem for stakeholders is
crucial to defining the problem through a diverse lens. An example of this could be the problem of an anastomotic leak after bowel resection. Anastomotic leaks while uncommon with current anastomotic staplers can be a devastating problem for patients when they occur. This complication not only affects the patient, but also can affect their families, and prolonged hospital admissions add significant costs to the healthcare system that affects payors and insurance providers. While some surgeons create their anastomoses entirely with sutures, others use stapling devices that may be faster but have similar failure rates. Understanding the problem and impact of current solutions from each of these stakeholder lenses will be important in order to develop a new solution that best addresses each of their concerns. This stakeholder engagement is called customer discovery and is a pillar of the innovation process. Many good ideas fail in the real world due to a lack of extensive customer discovery as they either solve a problem for which customers do not need a new solution or do not adequately solve the problem the customer really has.







Scoping the Problem

Another important aspect to problem identification is scope. If the problem is only experienced by a small number of stakeholders, then it will often be very challenging to gain investors and resources to move the solution into the market unless the solution is highly impactful and one finds the right niche community to support its development and implementation. For solutions that have high value and impact millions of stakeholders, gaining investment and adoption can be much easier. An example might be the problem of postprocedural complications. While this problem affects millions of people per year globally, on root cause analysis, one would quickly determine that this problem is multifactorial and depends greatly on the type of procedure performed. As such, a single solution could never address all postprocedural complications. Instead it would be better to focus on a more
solvable problem such as catheter-associated urinary tract infections after laparoscopic appendectomy procedures. Such a solution may be easier to develop and test in a group where the problem is more specifically understood. It is very important therefore to take the time to perform root cause and stakeholder analyses of what one wants to solve for the customer, and then understand the scope of how big or small the problem is for the market. This process will also help one understand the level and types of resources needed to advance the solution.


Evaluating Current Solutions and Stakeholder Feedback

After scoping and problem identification, the next step in the process is to determine what if any solutions currently exist for the problem and what are their limitations. This step will help develop the value or competitive advantage of the solution over existing technologies. Creating this competitive value is very important to gain interest not only from stakeholders who seek a better solution but also from investors who see a market advantage they can capitalize on if they provide resources to move the solution forward.

The most significant question that has to be addressed by any innovative solution is stakeholder buy-in (i.e., who will care if I solve this?) and who is affected by the solution one is proposing. As part of that identification, it is also important to determine whether that effect is positive or negative. For example, if one creates a new smartphone app that uses the camera and artificial intelligence algorithms to diagnose macular degeneration, while it may be a great potential solution and win for primary care physicians and patients, this solution may be looked at negatively by the ophthalmology community where their practice and billing would be negatively affected by such a technology. Negative influencers can have as great an impact on whether a technology makes it to the market as positive influencers so it is critical early in the solution development process to think about the effects of that solution on all stakeholders.


Ideation and Solution Development

Once the focused, specific problem to be solved has been defined and initial stakeholder input is obtained, the next phase of the innovation process is ideation and brainstorming potential solutions. Many successful companies and entrepreneurs advocate that the best solutions come from a diverse, team-based approach to brainstorming and problem-solving. Through the power of diversity of thought and experience, these multidisciplinary teams can create solutions that address the problem through multiple lenses and viewpoints, which often create more powerful and resilient solutions when the complexity of the problem is high. Using a diverse group to brainstorm also allows new ideas to be rapidly tested against the problem conceptually from multiple perspectives where gaps in the solution can be more quickly identified. Generating multiple solutions helps identify weaknesses in solutions as well as which ideas have the best chance at solving the problem for the most stakeholders. This helps focus solutions down more quickly to a lead innovation with which to move forward for testing.


Concept Hardening and Prototype Testing

After defining a lead solution to move forward, the idea needs to be thoroughly tested to determine how it will perform at solving the problem for stakeholders. Feedback during this period will identify additional weaknesses that can be used
to update the solution to overcome and to better fit the needs of the customer. With each iterative improvement, the solution should go back to stakeholders to get more feedback to make sure the changes indeed make the solution better for them each time. This iterative process shores up weaknesses in the solution and “hardens” it to be more resilient to weather the challenges it will face in the market. Innovation concepts that have been hardened in this way are more likely to garner investors and additional stakeholder buy-in.


Creating a Compelling Value Proposition

Once a solution for a defined problem has been created and tested to make sure it solves the problem well for key stakeholders, the new innovation now needs resources, finances, and support to move forward to impact in the market. To gain these resources and support, the solution needs to be framed as a compelling value proposition. A value proposition essentially is an easily understood statement that puts forth the rationale for an innovation. In simple terms, a value proposition can be stated as: Stakeholders have a problem they would like solved, and the proposed innovation solution is better than existing alternatives, resulting in a compelling value to the customer.2

Defining “value” to stakeholders depends on the impact the problem has on the stakeholder as well as the limitations of current solutions being used to address or circumvent the problem. Value is often expressed in a quantifiable magnitude such as benefits of cost, time, outcomes, etc. For example, “the new solution will save $3000 per procedure,” “our device will decrease operative times by an average of 35 minutes,” or “this solution will result in 10% fewer wound infections than standard methods.”

In the design thinking process, once a solution has gone through initial concept hardening to create a more compelling value proposition, that value proposition must then be tested further to collect enough data that the innovator and investors feel that the solution will weather market forces and create meaningful impact. This is a time for additional customer discovery with the lead product to test its value for solving the problem. Stakeholders can be separated by their level of influence on the use of the solution as well as their level of motivation for adopting the new solution. Those who pay for a product or solution typically rank higher on the axis of influence, while those who gain or lose financially as a result of adopting an innovation are typically the most motivated to promote or block implementation of the solution. Customer discovery is always better done in person and it is important for the innovation team to be prepared with the right questions to ask stakeholders to ensure they are really assessing how the solution brings value to solve the problem for the stakeholder.

A value proposition in many ways is a hypothesis that must be tested to prove its validity and meaning to stakeholders. Since this testing and validation process often has some cost associated with it, the scope of that cost may depend on the size of the problem being addressed, the invasiveness of the solution to patients, and the level of testing that was needed for current approved solutions in the market. The innovation will also need to be evaluated on how it will get into the market and how it will be adopted once in the market. This often will require understanding and navigation of its regulatory pathway, intellectual property, adoption in the market, competitive advantage, and reimbursement strategy especially if it is replacing or competing with existing solutions. All of these factors can create costs and hurdles that the innovation must clear to move forward. Identifying these hurdles early
is critical in order to understand the cost, time, and process needed to overcome them. If these hurdles are too costly or too time-consuming, it may limit the viability of the innovation moving forward into the market. Defining these hurdles and failure of progression early in the process is highly important to avoid putting significant resources and time into ideas that will not ultimately succeed in the market. For each of the hurdles that can be overcome or mitigated, the technology becomes less risky from an investment standpoint and instead becomes de-risked and more likely to generate revenues or succeed in the market. As such, the more de-risked an innovation becomes, the higher the chance investors or strategic partners will be interested in putting additional resources into it to move it to the next level.

The high cost associated with moving innovations out of academia and into the market is often more than the innovator or an academic institution can bear alone and therefore partnerships with industry or investors become paramount for these technologies. Creating a compelling value proposition with early de-risking of the technology is the best way for an inventor to gain resources, partners, and investors to help move the technology through these premarket hurdles to where it can be used in the clinic.


BUILDING A CULTURE OF INNOVATION

Culture is often labeled as part of the “soul” of an organization. Culture is based on values, traditions, beliefs, and rules. For an academic surgery department, culture must also align with the institution(s) that comprise the surgeons’ work environment, which often includes hospital networks and clinics, medical schools, and universities. Academic culture has long been driven by research, education, and clinical excellence. However, an integral part of those missions is to advance the field and improve the lives of patients. In this domain, innovation plays a critical role and brings together all three primary missions in a way that can leverage change and growth and adoption of new technologies in a meaningful way. Innovation, therefore, has long been an integral part of the DNA or fabric of academic medical centers, but until recently has not been a focus for developing meaningful resources to promote development and success internally. “Creating a true culture of innovation in an academic medical center has been a challenge in the past due to the rigors of academic careers, required milestones for faculty and institutions, and limitations stemming from financial concerns or mistrust of developing partnerships with Industry.”3 Fortunately, we are now in a time where new disruptive innovative technologies in health care are entering the market every week. Expansion, consumerism, and competition for patients and their healthcare dollars have created a new opportunity for hospitals to gain a competitive advantage in crowded healthcare markets. No longer can the standard academic missions be the only reason patients come to academic medical centers, but instead patients are now demanding value-based care and the most advanced, cutting-edge medical technologies and treatments. This has created a competitive atmosphere where institutions must be able to develop and disseminate innovation in order to thrive and successfully compete. This competitive culture between hospitals and institutions creates a necessity for innovation, and institutions are now realizing that putting resources into developing innovation and entrepreneurship may provide them with a competitive advantage over their peers.

In order to create a successful culture for innovation at an academic department of surgery, there are several resources that need to be made available to innovators
and several traditional barriers that need to be brought down. Traditionally, academic institutions have discouraged faculty from participating in entrepreneurial activities through a number of “barriers” including lack of recognition for faculty engaging in this work, lack of opportunities for academic promotion and advancement based on innovation entrepreneurial endeavors, and lack of financial resources to help with innovation efforts. Added to this were stricter policies in the last decade regarding industry-academic relationships, conflict of interest and its management, and moving university intellectual property into startups and license deals. These barriers varied across institutions but together provided significant challenges for many surgeon-innovators and entrepreneurs to move their ideas forward or out of the university in an efficient manner.

To create culture change, one must first understand the existing local culture, the existing barriers to change, and the stakeholders affected by a change in culture. Culture change requires significant stakeholder buy-in as well as momentum from other outside efforts that allows acceptance of a new paradigm or mental model to exist and be sustainable. In the Department of Surgery at the University of Michigan, an initial stakeholder analysis was performed along with significant “customer discovery” and needs assessment. While there were a few faculty actively engaged in innovation and entrepreneurial efforts, most felt this was time spent away from the research, education, and clinical care missions upon which their academic careers and salaries were being evaluated. Additionally, there was no “extra funding” available for higher risk ideas that did not generate publications or grant applications.

As with many changes in culture, things often start with one new idea that leads to a ripple effect that then leads to several other great ideas that together build a wave of momentum that drives adoption and assimilation. In order to ensure culture change is adopted in an organization, there usually needs to be complete buy-in and often meaningful initial efforts spearheaded by leadership so that everyone within the organization feels like buy-in is acceptable and supported. In early 2014 under the leadership of Medical School Dean, a $4.35M gift from the William Davidson Foundation was awarded to the University of Michigan to support programs that accelerate the flow of U-M-generated ideas to the marketplace and spur economic activity in southeast Michigan. The medical school committed additional funds and together with $2.9M from the foundation gift created the Medical School’s Fast Forward Medical Innovation (FFMI) effort to stimulate faculty innovation and entrepreneurship at the medical center. The remaining $1.45 million of the gift went for programs in the U-M Office of Technology Transfer and Center for Entrepreneurship.4

Over the next year, FFMI partnered with the Michigan Economic Development Corporation to create seed programs to fund promising medical innovation projects from multidisciplinary faculty teams. These awards ranged from $20,000 to $30,000 for early-stage projects to $100,000 to $200,000 awards for more advanced and de-risked innovations and covered therapeutics, devices, diagnostics, and digital health solutions. While this effort engaged faculty across the medical center, funding several projects a year and providing project management and oversight, it did not focus initially on educating faculty with tools to successfully develop their innovations and navigate them outside the university or engage more fully with industry partners. With dedicated leadership from physician-innovators and business experts, the program continued to grow. During this time the Department of Surgery developed its own Leadership Development Program (LDP) to provide senior and mid-career faculty with opportunities to learn important leadership
skills to be able to take on new roles in the department and across the institution. Drawing on the success of the LDP and the Innovation programs created by FFMI, an opportunity existed to build on that momentum and synergize the two together to create the first Surgical Innovation and Entrepreneurship Development Program (SIEDP) which was run over a 9-month period in 2016.


THE SURGICAL INNOVATION AND ENTREPRENEURSHIP DEVELOPMENT PROGRAM

In 2016, the Department of Surgery in collaboration with FFMI ran the first Surgical Innovation and Entrepreneurship Development Program (SIEDP) where 13 surgery faculty (from new assistant professors to senior leadership and the department chair) participated in a 9-month training program where they had sessions 1 day per month covering the commercialization process from idea generation all the way to technology development, patent submission, customer discovery, funding, and implementation. All of the faculty participated on teams and learned this process, culminating in “final pitch” grand rounds, which were done in a Shark Tank style where industry experts and Venture Capital partners outside the University could evaluate the technologies more thoroughly. The program started with a departmental mission-focused ideation and brainstorming session where novel ideas around education, research, clinical excellence, and branding were put forward and voted on by the entire department at its annual retreat. Faculty teams were placed on each project and these projects were then developed in parallel with faculty-initiated individual innovation projects through the course.5

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May 5, 2022 | Posted by in GENERAL SURGERY | Comments Off on Innovation and Entrepreneurship in Surgery: Creating a Culture for Success
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