Case study bringing a surgical innovation to market final

Case Study: Bringing a Surgical Innovation to Market |1

Procurement and Innovation Adoption in Health Systems Case Study: Bringing a Surgical Innovation to Market Dr. Anne Snowdon RN, BScN, Mc, PhD, FAAN Chair, World Health Innovation Network Scientific Director & CEO, Supply Chain Advancement Network in Health Odette School of Business University of Windsor

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Table of Contents Introduction and Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Project Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1. Identifying Health System Priorities and Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2. Research and Development (R&D), Prototype, Pilot Testing . . . . . . . . . . . . . . . . 5 3. Implementation and Early Adoption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4. Diffusion, Scaling and Widespread Adoption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Key Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1. The Value of Strategic Partnerships to Support Innovation Adoption . . . . . . . . . . 9 2. Demonstrating Value in a System Focused on Cost Savings to Achieve Successful Adoption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3. The Challenges of Procurement Processes for Technology Solutions . . . . . . . . 10 4. Scalability Across Organizations and Regions versus Scalability Across Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

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Introduction and Background This case study is one of a series entitled: Procurement and Innovation Adoption in Health Systems. The purpose of these case studies is to provide real-world evidence of the impact of innovation procurement practices to inform policy, build capacity for innovation adoption in health systems and to be used as education tools for organizations considering, or involved with, innovation adoption, evaluation and scalability in health systems. The case studies provide an overview of the barriers and facilitators of innovation adoption, the opportunities to strengthen innovation adoption processes for vendors, innovators, industry, government and health system leaders. In particular, the cases will describe the processes of introducing innovation into health systems and, where relevant, the impact of existing procurement processes on innovation adoption in healthcare organizations.

The case methodology uses the innovation adoption framework described in the report of the Ontario Health Innovation Council (2015).1 The innovation journey framework begins with identifying the health system priority or need for an innovative solution and captures evidence of impact and outcomes as the innovation project is designed and implemented by health organizations. The case follows the progress of the implementation of innovation and describes outcomes relative to the potential for the innovation to be adopted and scaled across health systems. Innovation projects are empirically studied using key informant interviews to examine the experiences and outcomes of innovation teams in the Ontario health system. Key findings emerged from the analysis of interviews conducted by the WIN research team. The findings are organized according to each phase of the innovation adoption journey with key lessons learned summarized at the end of each innovation case. This case summary is an adaptation of the original full-length case study report and has been altered to ensure the anonymity and confidentiality of the key participants and project team. The intent of this summary version of the case is to provide an overview of the key findings and lessons learned to build knowledge and capacity for innovation across health systems through knowledge dissemination.

This project is funded by OntarioBuys, an Ontario government program, which makes investments to support innovation, facilitate and accelerate the adoption of integrated supply chain, back-office leading practices and operational excellence. OntarioBuys helps drive collaboration and improve supply chain processes in Ontario’s broader public sector. The views and opinions expressed in this case study do not necessarily reflect the official policy or position of the Government of Ontario.

1

Ontario Health Innovation Council. The Catalyst: Towards an Ontario Health Innovation Strategy [Internet]. 2014. Available from: http://www.ohic.ca/sites/default/files/OHICReport.PDF

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Project Summary This demonstration project follows the introduction of a new technology that offers a solution for surgical visualization to improve accuracy, safety and effectiveness of surgical care for patients. As such, this demonstration project was designed as a post-market, prospective, randomized control trial to examine the impact of the innovative technology on surgical outcomes. The project engaged key participants from the Company, the health system, researchers and surgeons. The following case summary features highlights from the thematic analyses captured in the case.

1. Identifying Health System Priorities and Needs The health system need for this innovative technology emerged from a sub-specialty of surgeons who use a microscope to visualize the surgical site for patients, which offers very limited visualization for the surgeon during these complex surgeries. The innovative technology featured in this case was developed after significant engagement with surgeons in order to define the challenges of operating on patients using existing technologies (i.e., microscopes) in the marketplace. The Company was inspired by the challenges surgeons faced in their practice and created an innovative technology for surgeons to enhance the surgeon’s visibility during surgical procedures in one particular surgical sub-specialty. Remarkably, the solution developed by the Company was not a solution that surgeons had specifically identified; rather, surgeons seemed to have the perception that they operated with the best tools available and achieved the best possible outcomes given available technology. This Company, however, saw an opportunity to transform current surgical precision and accuracy by offering surgeons a solution most had not even considered a possibility. The challenge for the Company, therefore, was to create the right partnerships early on to engage surgeons in the R&D phases as key experts in order to ensure the technology achieved the best possible outcomes for both surgeons and patients.

The Company worked with surgeons to clearly understand the challenges they faced, which informed the design of the technology to support surgeons to improve accuracy by providing greater visibility of the surgical field intraoperatively. As surgeons described their challenges using microscopes to visualize the surgical site, a number of functional features of the innovative technology were designed to solve the challenges that surgeons faced in delivering surgical care. In contrast to the current standard in this particular surgical field, the value believed to be added by this surgical technology offered both efficiency (less time in the operating room) and effectiveness (i.e., being able to do complex surgeries more accurately) for surgical procedures.

To develop its external partnerships, the Company spent significant time, energy and resources engaging the relevant surgical specialists across North America, forging relationships with key opinion leaders in surgery who were engaged as advisors, codesigners and early adopters of the technology. The Company’s engagement strategy was designed to involve surgeons in identifying the most significant challenges of their surgical practice to inform the design features of the technology that would address and

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overcome surgical challenges. Key opinion leaders assumed an important role in supporting market entry of the company’s technology. The Company networked and leveraged contacts to engage the most respected and cutting edge thought leaders in the field of surgery. Relationships with key opinion leaders served two purposes – the Company could validate the features of their technology to ensure it addressed the challenges these surgeons were experiencing, and the key opinion leaders were able to contribute ideas, input and feedback regarding the development of the product. Surgeons described the importance of working with the technology to have the opportunity to improve their surgical technique given the greater visualization the technology offered.

Surgeons also identified the common practice of testing new technologies within research studies, which offered surgeons early access to cutting edge, innovative technology to determine its value in quality of patient care. Engaging pioneering surgeons as co-design partners was important for the Company’s success in the design features of the technology to support early adoption, particularly among surgeons in U.S. health systems.

In an effort to further validate and identify key challenges surgeons experience during surgical procedures, the Company expanded their engagement of the surgeon community by dedicating time and resources to have surgeons visit their facility to demonstrate the features of the technology. This engagement strategy built extensive relationships with surgeons who were motivated to have input into the design of the product features that would overcome the challenges they experienced during surgical procedures. For the Company, this partnership approach with end-users further supported the technology’s value proposition for surgeons. The Company recognized the importance of clinician engagement to not only evaluate the technology, but also to bring informed surgical expertise to procurement processes in the event the technology was considered for adoption by health system organizations. The Company’s market access strategy was to attract the surgeons’ interest in the technology by engaging them in problem solving and co-design of the features of the technology, which then created awareness of the innovation among surgeons of the new technology entering the market.

The surgeons readily saw the value of the technology to their surgical practice and became powerful champions to achieve procurement of the technology in their respective hospitals, particularly in U.S. health systems.

2. Research and Development (R&D), Prototype, Pilot Testing With respect to prototyping, the Company’s strategy focused on a “quick and nimble mantra” wherein “speed to market” was the Company’s priority. Despite having many options and features possible for the technology, efforts focused on creating a technology solution that worked well, was safe and then getting it quickly into the hands of the endusers (i.e., the surgeons) so that product improvements can be made overtime as the product is used in surgical settings. The Company strategy ascribed to the notion that the solution will “never be 100 percent right,” which enabled its speed to market with a solution that offered value to surgeons based on direct input and design features from expert surgeons. As a Canadian start-up, the co-founders recognized the need to resource an in-house regulatory approval team that would navigate the approval pathways in the U.S. (FDA), Canada (Health Canada), Europe (CE Marking) and beyond.

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While Australian and Canadian regulatory processes were described as comparable, FDA and European requirements were described as “the most difficult” to navigate. Three key differences in regulatory requirements included: (i) how devices are classified (a Class I device in the U.S. is not defined the same way as a Class I device in Europe, and there are four classification levels in Europe and Canada, and only three in the U.S.); (ii) the degree to which supporting clinical data are required—while all countries require clinical data for high(er) risk devices, the nature and rigour of the data can vary; and (iii) differences in requiring a predicate device comparison (i.e., in the U.S., demonstration that a medical device is substantially equivalent to another device (or devices) already cleared by the FDA). The FDA was perceived to have among the most onerous requirements for regulatory approval, including biocompatibility analysis results, software design documentation and sterilization information. While onerous, the U.S. approval process was expedited by FDA outreach and support programs that targeted different phases of the process; in contrast, the less onerous Canadian approval process nonetheless incurred delays for the Company while they waited for Health Canada approval.

During the prototyping phase, the Company engaged surgeons to provide ideas and feedback about the technology design features. In order to ensure close attention to surgeons’ feedback, the Company established a ticketing system to track and triage feedback as evidence to inform decisions on what modifications to make to the technology and/or what features to add to future versions of the products. Most of the Company’s initial prototyping and pilot-testing relationships were from academic centres in the U.S., where key opinion leaders (surgeons) worked within large, affluent health systems that, relative to Canadian health systems, were more willing and able to procure the technology to get the product into the market more quickly.

Indeed, while the Company has since expanded its adoption into the province of Ontario, adoption has been limited to the realm of research rather than procurement. For the Company, Ontario research grant funding represented an opportunity to further support product R&D, specifically using clinical trials, so as to generate the clinical evidence necessary for further adoption. The funding also serves as a means to work around capital expenditure budget limitations that preclude more austere health systems from purchasing the solution. In either case, the engagement of surgeons in gaining rapid market feedback allowed the Company to “fail early, fail cheap.” Getting feedback on product features early in the design process to avoid lengthy development costs of features deemed not worthy or valuable by surgeons, which also enabled a clear focus on the minimum viable product features for the product. In addition, the rigorous postproduct launch ticket system provided ongoing feedback from early adopters to offer a constant line of sight into the use of the product in surgical settings to monitor product performance, to inform the design of new features and to inform the Company how it could potentially diversify the product to achieve further market growth.

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3. Implementation and Early Adoption The Company’s innovation was supported by the detailed input and feedback of first adopters that were viewed as strategic partners that “pioneered” product development with the Company and then supported successful access and deployment of the technology into surgical settings. The Company leveraged the input and advice of surgeons not only for their expertise and experience, but to also support procuring the technology so that these same surgeons could use the technology that they helped design. This approach leveraged the inherent competitiveness among surgeons, whereby when one surgeon is viewed as leading new and innovative surgical outcomes, his or her colleagues are highly likely to want to adopt the new surgical technique to achieve the same or better results to support and align their professional profile with leaders in the surgical community. Likewise, the incentive for adopting the technology solution in U.S. hospitals was the importance of driving revenues for hospitals by establishing their profile as leading surgical practices and innovation. The strategy of leveraging the competitive nature of surgeons and the highly competitive, privatized health system in the U.S. was highly successful for this company. Sales quickly exceeded 30 units deployed in U.S. hospitals only months after FDA regulatory approvals were obtained.

The innovation adoption environment for this Company was vastly different in Canada.

Despite the opportunity this technology offered to achieve more accurate surgical procedures to strengthen patient outcomes, Canadian clinicians and company officials alike view the probability of successful adoption of the technology as being less likely due to the constraints of capital equipment budgets in most Canadian hospitals. From the healthcare organization’s perspective, this was attributed to two factors: one, simply, is that hospitals in Ontario are operating with a “frozen budget,” which, in light of planned wage increases, essentially means that hospitals have to operate with 2-to-5 percent less funding capital per year, and a capital expenditure on a solution such as this one seems highly unlikely. The second, related factor is that the identification of reduced health costs resulting from this solution are difficult to track. The reduction of symptoms may in turn cause a reduction in the cost of prescribed medications, but that is not a cost borne by the hospital purchasing the surgical solution. Thus, the presumption shared by both the Company and Canadian hospitals is that research trials can and will generate the evidence of whole-system impact needed to convince hospitals that this solution should be part of the standard of surgical care.

Accordingly, the early success of “getting into the Ontario market” has been limited to use of the technology for research and pilot-testing, with no direct link to procuring the technology. And while recruitment challenges have delayed the production of clinical outcome evidence, early indications from the project surgeons suggest that the solution is relevant and useful in practice—they want to continue using the solution and struggle to imagine “going back” to the preceding status quo of surgical care without the visualization the technology has to offer. Despite this enthusiasm and without additional clinical evidence of impact, further entry of the product into Canadian health systems is anticipated to require either additional research funding opportunities to fund the purchase of the technology, or philanthropic funding to enable hospitals to purchase the technology with funds that are not constrained by operating or capital equipment budgets.

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Although health system costs and strengthening patient outcomes are centrally important to both the Canadian and U.S. markets, the Company believes that having the support and buy-in of surgeons is not sufficient to achieve adoption and procurement of the product in these markets. The Company believes that compared to clinicians’ influence, the influence of hospital administration is growing relative to the procurement of innovative technologies in healthcare, a trend that is perceived by the Company to account for the dominant focus on achieving the lowest cost when procuring new products rather than achieving the greatest value for patients. The importance of measuring and achieving value when making procurement decisions, wherein value is a function of both cost and patient outcome, is perceived by the Company as a paradigm shift that not all hospitals have fully embraced. This is considered to be one of the Company’s biggest challenges, to demonstrate the value of the solution for health systems that are more heavily focused on cost. This is a particularly difficult challenge for this Company as the surgical innovation they offer is not a single product, but rather a suite of products that are combined to offer a complete solution that realizes much greater value than one single product component could otherwise achieve. The Company has responded to this challenge by designing a tool to measure the return on investment for use of the technology. It is anticipated this may offset the challenge of procurement decisions based heavily on cost by providing hospitals with a tool that measures how quickly the cost savings can be realized once the surgical technology is adopted. This tool has not yet been introduced to the market to understand its adoption and use in the market.

Indeed, when a company brings to market an innovation that is designed to drive value through integration of technologies and processes, as is the case here, the procurement climate in Canada can be challenging, as most RFPs concentrate on determining whether a single product meets defined functional features or requirements and at what cost. It is often the perception of industry that RFP processes that focus on specifications and cost limit the ability of the health organization to fully examine the value of the outcomes the product can deliver – value for patients (e.g., faster recovery, better outcomes), value for health provider teams (e.g., greater accuracy and surgical safety), value for organizations (e.g., lower costs per case due to improved safety, shorter lengths of stay and faster surgical procedure time) and value for health systems (especially relative to reduced cost and greater quality care outcomes). The movement in Ontario toward integrating Outcome Based Specification into procurement processes signals a recognition of the need to take into account value; the spread and uptake of such an approach to procurement will surely bode well for companies like this one that offer innovative surgical solutions that create downstream system savings.

4. Diffusion, Scaling and Widespread Adoption While this Company is still in the stage of early adoption, the prospects for widespread adoption and scalability appear to be promising, particularly for the larger U.S. and global markets. With respect to global markets, the Company’s regulatory team has been active in mapping out approval standards and pathways in European and Asian health system markets. These systems are large and many have significant funding availability due to the revenue drivers of privatized health system structures.

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Another condition for widespread adoption that the Company is counting on is scalability across surgical applications. The technology was initially designed and marketed for a specific surgical application. However, the features of the technology provide many opportunities for scalability across new surgical specialties, which the Company has not only anticipated, but has also leveraged extensively in its market growth strategy. The Company is now reaching out to surgeons in a variety of specialties to view the technology and its capabilities, with the objective of inspiring new groups of surgeons to consider novel applications of this surgical innovation. Significant efforts in the U.S. market have included the Company’s strategy to engage other specialized surgeons with the hope that they will also lobby their respective hospital organizations to procure the solution.

Accordingly, the Company is actively cultivating ideas for new applications from a variety of surgical specialists, which is now their market growth strategy: as sales continue to grow and resources are invested into the next generation of the surgical technology, the Company faces the welcomed challenge of having to balance growth with continued responsiveness to the market and developing application of their technologies in new clinical applications.

Key Findings 1. The Value of Strategic Partnerships to Support Innovation Adoption For this Company, partnership development was critical in terms of fueling a crossfunctional solution development team with input from external key opinion leaders and surgeons who openly engaged in co-design of the technology. The engagement of key opinion leaders was of considerable value in highlighting the real-world challenges, insights that provided the Company with an understanding of the needs of surgeons and that supported the successful development of the surgical solution to offer safer, more efficient surgical care for patients. Thus, key benefits resulting from strategic partnerships as a market engagement strategy included obtaining valuable market feedback on product design and raising the Company’s profile with the surgical community to raise awareness of what the technology could achieve. Furthermore, strategic partnerships with surgeons demonstrated the value of building relationships with end-users to support market access and support adoption of the technology into hospital systems.

2. Demonstrating Value in a System Focused on Cost Savings to Achieve Successful Adoption The Company in this case study clearly recognized that the decision to procure their surgical solution did not rely just on the opinions and influence of surgeons. Hospital administrators must see the value in what the technology offers in terms of both the cost and value to patients. The Company’s two-pronged approach to getting their technology adopted by hospitals entailed engaging the interest of surgeons first, as this type of technology would only be procured in hospitals if the surgeons were aware of the technology and viewed the technology as being able to advance quality of care and patient outcomes. Subsequently, once afforded an opportunity to pitch the technology to hospital administration for procurement, the Company perceived they could demonstrate

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the potential cost savings and value that could be derived through improved quality outcomes and efficiencies in specialized surgical care. In profit-driven health systems such as the U.S., the Company was able to demonstrate a projected return on investment that resulted in the technology paying for itself in less than two years following its adoption and use in the surgical setting. The Company found the improved efficiencies and effectiveness the technology offered had great appeal in the competitive, for-profit climate of the U.S. market, where time savings in planning surgeries and operating room time are significant. Some early adopter sites reported a 15 percent increase in operating room capacity, which increased the number of surgeries being completed per week. In contrast, while Ontario and Canada share the interest in more efficient and effective solutions, the focus on immediate costs of the technology with less attention to the downstream value of the solution has limited the adoption of the technology in this setting. Canadian health systems do not have the incentive of revenue generation that is prevalent in the U.S., which limits the ability of the Company to use the return on investment strategy to demonstrate value of the technology in this system. In addition, a significant challenge in the Canadian system is the reliance on capital budgets, which are severely constrained in Canada, limiting the ability for most hospitals to invest in the Company’s solution.

3. The Challenges of Solutions

Procurement Processes for

Technology

Procurement of new technologies in hospitals typically focuses on procuring a specific product. Requests for proposals (RFPs) detail the functional requirements of the product being procured, to which companies respond detailing the features of their products and the cost of the product, which is evaluated by the procurement team. The technology in this case was not a single product or device, it was a suite of technologies that offered a surgical solution for specialized surgeries. The Company experienced substantial challenges in getting hospitals to overcome their reluctance to focus procurement on a suite of technologies and products that offered a new solution to complex surgical challenges. The Company’s innovation offered hospitals a solution that integrates tools, software and surgical processes, that enabled pre-surgical planning and new visualization during the actual surgical procedure. Without the incentive of increased revenue, which is characteristic of the U.S. system, such a solution poses a challenge to procurement in a Canadian context. The Company is challenged to respond to RFPs that focus on individual products with specified functional features when their technology does not lend itself to the individual product specification requirements of most RFP processes. Further, it is not likely hospitals would have enough awareness of the Company’s surgical solution to be able to consider the multiple product components that would have to be considered when designing the RFP. Adoption of innovative solutions in Canada are currently limited to research-based infrastructure purchases, rather than to sales directly to hospitals to support surgical programs. While such trials generate valuable evidence of clinical impact for the Company that can be used to demonstrate value when marketing the product, there remains a certain pessimism of this Company as to whether the solution will be procured in Canadian health system settings.

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4. Scalability Across Organizations and Regions versus Scalability Across Clinical Applications The Company has two important options for scalability of the innovative solution to support market growth through widespread adoption. The most common approach to scaling and spreading innovation is to expand early adoption of the solution to as many hospitals and surgical centres that offer the specialized surgical care for which the Company’s technology was designed. In the current surgical market, this sub-specialty is of significant size and value and the Company’s technology solution is one that can be widely utilized worldwide. The second, more future-oriented strategy for scaling this technology solution is to scale across surgical specialty applications. The uniqueness of this Company’s technology offers new applications to a variety of different surgical procedures, which in turn enables scalability across surgical applications in addition to scalability across geographical regions. This unique dual scalability model offers tremendous potential market value to this Company, which will require similar strategic partner engagement to design solutions that meet new surgical program challenges and needs. For example, the core feature of the technology solution, namely the bridging and integration of surgical planning and execution, can be applied widely to many different surgical specialties, thus offering vast market growth potential and product development to this Company.

Conclusions This case has illustrated how two of the key features of the Ontario health system make it challenging for companies to get their products adopted in clinical settings. One is the highly-constrained capital budget structure that profoundly limits a hospital in procuring new, innovative technologies that require capital investment, such as the suite of products identified in this case. The second challenge is related to procurement approaches whereby RFPs are typically structured to procure a single product with detailed functional specifications determined by the organization, based on their knowledge of current products in the market. The structure of the RFP needed to procure innovative technologies, such as the solution featured in this case, would either need to focus on procuring a solution or procure specific outcomes to a clinical challenge. Procurement teams in most health organizations may not have the tools to identify clinical challenges that clinicians are experiencing, given that few clinicians participate in designing RFP specifications to overcome patient care challenges. In addition, the structure of how RFP responses are evaluated would need to change substantially, from evaluating the functional specifications of a product towards evaluating how the technology solution demonstrates value in overcoming priority patient care challenges. In order for procurement processes to be supportive to the adoption of innovative solutions, a strategy to procure solutions to health system challenges would need to be implemented. The Canadian health system does not have the key incentive of revenue generation for driving innovation adoption, hence, other strategies for determining value and focusing on solutions to patient care challenges must be considered.

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This case highlights the opportunity for considering how procurement processes can be structured to focus on achieving value and solutions to complex patient care challenges and as an alternative to procuring specific products well-known to the health system market. In addition, in order for such a paradigm shift from focus on products to a focus on solutions to occur, health systems must more actively engage clinician teams in working with procurement teams to develop the capacity (i.e., the knowledge, skill and ability) for designing procurement processes that are closely linked to solving clinical challenges to support innovation adoption that can be transformational in the delivery health care services.

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Authors The World Health Innovation Network would like to acknowledge the work of: Representatives from the World Health Innovation Network Project Lead, Ryan DeForge, Senior Research Associate Anne Snowdon, Academic Chair Carol Kolga, Senior Research Associate Renata Axler, Senior Research Associate Melissa St. Pierre, Research Associate Deborah Tallarigo, Knowledge Dissemination Specialist

Produced by: Dr. Anne Snowdon, Academic Chair, World Health Innovation Network, and Scientific Director & CEO, Supply Chain Advancement Network in Health, Odette School of Business, University of Windsor Original release date: March 2018

World Health Innovation Network T: 519.253.3000 x6336 E: winhealth@uwindsor.ca Windsor, Ontario