CHALLENGES TO THE HYBRID MEDICAL IMAGING INDUSTRY IN CANADA JULY 2013 Turning Challenges into Opportunities TABLE OF CONTENTS Contents ACKNOWLEDGMENTS____________________________________________________________i BACKGROUND___________________________________________________________________1 IDENTIFICATION OF CHALLENGES________________________________________________ 4 POTENTIAL SOLUTIONS__________________________________________________________6 SUMMARY______________________________________________________________________14 APPENDIX______________________________________________________________________15 ACKNOWLEDGEMENTS This “Challenges to the Hybrid Medical Imaging Industry in Canada” report was compiled by Matt Harmin, MA Student, School of Environment & Sustainability, University of Saskatchewan and edited by Karen Mosier, Research Facilitator, Western College of Veterinary Medicine, University of Saskatchewan. A very special thank you to Dr. Baljit Singh, Associate Dean (Research), Western College of Veterinary Medicine, University of Saskatchewan and Dr. Paul Babyn, Medical Imaging, College of Medicine, University of Saskatchewan for their comments and feedback regarding this report. i BACKGROUND PARTNERS On May 16th, 2013 an all-day transdisciplinary “Frontiers in Hybrid Medical Imaging Technology” workshop was held at the University of Saskatchewan in Saskatoon, Saskatchewan. This event was supported through a partnership between the Natural Sciences and Engineering Research Council of Canada (NSERC) Partnership Workshops grant (award value $25,000) and industry support from Siemens Canada Ltd ($1500). The Sylvia Fedoruk Canadian Centre for Nuclear Innovation also partnered with the University of Saskatchewan by providing in kind support for this event. LEADERS Dr. Baljit Singh, Associate Dean (Research), Western College of Veterinary Medicine, University of Saskatchewan, was the academic leader and Dr. John Root, Interim Executive Director, Sylvia Fedoruk Canadian Centre for Nuclear Innovation, was the nonacademic leader for this workshop. PARTICIPANTS Participation was restricted to 40 participants by NSERC and was by invitation only. They were selected according to their expertise and experience in the field of hybrid imaging as well as to their potential input to the workshop discussion (see Figure 1). Please see the Appendix, Table 1 for a detailed list of workshop attendees. 1 BACKGROUND Figure 1 – Workshop: Participants & Organizers AIMS The aims of this workshop were: To build new collaborations between Canadian researchers, industry and government To identify the most important challenges facing the nuclear-based hybrid medical imaging industry in Canada OUTCOMES The outcomes of this workshop were: 1. Inform attendees of new technical innovations in the hybrid imaging field related to diagnosis and treatment of various human diseases (see Figure 2) 2. To determine the research priorities and knowledge gaps in the use of various imaging technologies such as PET, CT, MRI and synchrotron in the diagnosis and treatment of various human health conditions from the perspectives of industry, government and university 3. Identify areas of potential future collaboration between academic, industry and government leaders and researchers regarding hybrid imaging 4. Form at least one interdisciplinary team that will develop one project within 612 months 2 BACKGROUND Figure 2 – Workshop: Plenary Session, International Speaker, Dr. Markus Schwaiger, Klinikum rechts der Isar Technical University of Berlin CHALLENGES FACING THE HYBRID MEDICAL IMAGING SECTOR By using this forum to bring together and engage experts in hybrid medical imaging, many with direct experience of the issues at hand, our aim was to develop a more nuanced understanding of the challenges facing the hybrid medical imaging sector and determine viable, actionable ways to address these matters in ways that made sense from multiple stakeholder perspectives. TOP 10 PRE-IDENTIFIED CHALLENGES Prior to the workshop, participants were solicited for their opinions regarding major challenges deterring the advancement of hybrid medical imaging technologies in Canada. Participants represented academia, government, and industry. These responses were thematically organized, eventually resulting in 10 dominant themes which articulated in a broad way the nature of the challenges facing the advancement of the hybrid imaging industry in Canada. The top 10 pre-identified challenges were determined as follows: 1. Collaboration (e.g., the development of teams, interdisciplinary teams, multiple stakeholders including patients, funding bodies, researchers, challenges of partnering with industry) 2. Funding (e.g., basic & clinical research, intellectual property protection, pilot commercialization, trainee support, travel & communication for network development) 3 BACKGROUND 3. Development and Exploitation of Existing Infrastructure (e.g. exploitation of existing imaging research infrastructure such as synchrotron, and personnel) 4. Evidence based medicine (e.g., need for basic and translational research, and integration of multiple technologies) 5. Training (e.g., Critical Mass, Interdisciplinary Training for Hybrid Imaging, Clinical-Basic Training) 6. Lack of Industrial Partners and Opportunities for Government-Industry Collaborations 7. New opportunities (e.g., outside of current directions) 8. Commercialization (e.g., IP, route to commercialization, length of regulatory approval process, risks of litigation) 9. Integration of Technologies 10. Diagnosis & Therapy (e.g., new technologies, applications for diagnosis and therapy for conditions such as neuro-degeneration pain, reducing imaging costs 4 IDENTIFICATION OF CHALLENGES TOP 7 CHALLENGES A DOTS exercise was used to allow workshop participants to vote on the challenges they perceived as most significant through two rounds of voting scheduled throughout the day. First the pre-identified challenges submitted by participants were narrowed to seven. The top seven challenges (that received the most votes) were: 1. Evidence-Based Medicine (15%). 2. Collaboration (15%) 3. Funding (14%) 4. Diagnosis and Therapy (13%) 5. Training (12%) 6. Infrastructure Development (11%) 7. Lack of Industry Partners (10%) Figure 3 Workshop: DOTS Exercise - Dr. Susan Kraft, Colorado State University 4 IDENTIFICATION OF CHALLENGES TOP 4 CHALLENGES Next, these seven challenges were further distilled, leaving four areas of opportunity to optimize the advancement of the hybrid medical imaging field in Canada. These four issues articulate the greatest areas of need, and are situated at the nexus of government, industry, and the academy’s ability to advance hybrid medical imaging as a field for the betterment of public health in Canada. These top four identified challenges were: 1. Collaboration (e.g. the development of teams, interdisciplinary teams, multiple stakeholders including patients, funding bodies, researchers, challenges of partnering with industry) – 22% 2. Funding (e.g. for basic and clinical research, intellectual property protection, pilot commercialization, trainee support, travel and communication for network development) – 16% 3. Evidence-Based Medicine (e.g. need for basic and translational research, and integration of multiple technologies) – 16% 4. Development and Exploitation of Existing Infrastructure (e.g. exploitation of existing imaging research infrastructure such as synchrotron, and personnel) – 13% Figure 4 Workshop: DOTS Exercise - Flip Charts with dots assigned to each challenge 5 POTENTIAL SOLUTIONS BREAK-OUT SESSIONS After identifying these top four challenges we held break-out sessions. The breakout groups were led by Dr. Steven Beyea, Dalhousie University; Dr. Michael Noseworthy, McMaster University; Dr. Jaswant Singh, University of Saskatchewan; and Dr. Martin Yaffe, University of Toronto. Each group discussed one of the four identified top challenges. Guiding questions for the breakout sessions included: Has this issue presented itself to you in your role in academia/government/ industry? How? How does this issue specifically hinder the advancement of hybrid medical imaging technologies in Canada? What solutions do you suggest to address these challenges? What has been overlooked in our discussion around these issues so far? With these questions as a guide, the discussion in the breakout sessions evolved organically to incorporate as much input as possible from each stakeholder present. The following problem statements and recommendations result in a new level of commitment to and awareness of the opportunity to capitalize on these challenges, and address them as a set of opportunities to move hybrid medical imaging technologies forward in Canada. Figure 5 – Workshop: Plenary Session, Dr. John Root, Sylvia Fedoruk Canadian Centre for Nuclear Innovation [left] & Dr. Andrew Goertzen, University of Manitoba [right] 6 POTENTIAL SOLUTIONS AREAS OF OPPORTUNITY The following problem statements and recommendations result in a new level of commitment to and awareness of the opportunity to capitalize on these challenges, and address them as a set of opportunities to move hybrid medical imaging technologies forward in Canada: Challenge #1 - Collaboration The delivery of hybrid medical imaging technologies to the marketplace results from a concerted effort that involves industry, government, health administrators, and academic researchers. The ability of these groups to collaborate effectively will undergo continuous improvement, and the ability to improve collaborative capacities will help alleviate the challenges in the other areas of opportunity. The key theme here is to utilize the unique capacity of each stakeholder group and allow synergies to emerge from each group. Collaborations between industry and the academy can be difficult to establish if short term gains are unclear. There can be tension between focusing on clinical application and industrial development and maintenance of academic freedom. Comprehending the complex nature of ownership in public/private partnerships is not always straightforward. It can be difficult to spread research funds to all parties involved while still targeting investment in the most productive research communities. It can be unclear what clinical questions future hybrid imaging technologies are meant to answer. Beginning the research program can often require an industry connection, however, industry often wants to invest in relationships with proven track records. Clinical questions can be very different from basic research questions. All research needs to eventually lead to the advancement of clinical practice. 7 POTENTIAL SOLUTIONS Potential solutions discussed in the “Collaboration” breakout session included: 1. Identify collaborators in your field willing to form strong interdisciplinary teams and work to maintain these new relationships i.e., email, face-to-face meetings, etc. 2. Interdisciplinary teams function well with focused intentions and consistent messaging. 3. Formalize the collaboration to help ensure mutual respect of all the resources allocated to the project i.e., mandate, member commitments, timeline. 4. Train students with the needs of industry in mind well i.e., equipped to step into research and development. 5. Utilize your University’s capacity to support “incubation” of new technologies and start-up businesses. 6. Develop the infrastructure for partnerships to emerge between veterinary & human sciences. 7. Establish early the contributions of each member, the attribution of credit for the work and ownership of IP in interdisciplinary research teams through a formal agreement. 8. Confer legitimate value to industry partners through human capital development or evidence for the value of marketization. Figure 6 Workshop: Plenary Session Industry Speaker, Dr. David Faul, Siemens Healthcare 8 POTENTIAL SOLUTIONS Challenge #2 - Funding Funding remains a key obstacle to overcome in advancing collaborative research projects. Funding for basic research is diminishing, and conditions for funding are often strict. Companies that do not have research & development in Canada are not eligible to partner with academics for tri-council funding opportunities. Industry reality problems do not always attract the attention of Universities. There is a mismatch of interests and technological readiness levels. Intellectual property agreements can bog down the funding process. Variability in University capacities can make industry investment in new research partnerships risky. The funding bar is being set higher, making it more difficult for junior researchers to establish a foothold. Academia is concerned with funding knowledge production while industry is concerned with funding product development. Ultimately both have benefits to taxpayers and the alignment of these interests is key. The academic funding cycle can occur too slowly to satisfy industry partners. Meanwhile industry partners are not enabled to “sponsor” research they would like to see done. Figure 7 Workshop: Plenary Session Speaker, Dr. Curtis Caldwell, University of Toronto 9 POTENTIAL SOLUTIONS Potential solutions discussed in the “Funding” breakout session included: 1. Identify areas in which industrial best interests coincide with provincial best interests. Use these areas of need to establish a reciprocal spirit of partnership that both parties are eager to fund. Utilize charitable organizations created to better connect the worlds of science, business and government like MaRS as a template. 2. Focus on areas in which academics are willing to align themselves with issues of high priority to industry. Use these areas of matching interest as a basis for fund matching through public/private partnerships. 3. Networking events are a basis for funding partnerships to be created. Use these types of events to leverage large partnerships and compete effectively for large grants. 4. Establish well developed industrial liaison offices. A consortium of Universities and research groups could be represented by one office, making the interface between industry and academia much simpler. 5. Identify Canadian companies with the capacity to support research and development partnerships with public institutions. Make their investments pay off with research outcomes that are relevant to product marketization. Figure 8 Workshop: Plenary Session International Speaker, Dr. John Katsaras, Oak Ridge National Laboratory 10 POTENTIAL SOLUTIONS Challenge #3 – Evidence-Based Medicine The value of evidence lies in its relationship to reimbursement, the issue is in the evaluation of evidence, and how a lack of evidence can impact the acquisition of unproven technology. Inter-provincial variations can impact what constitutes evidence, and where. Academics must balance randomized controlled trials with publishing the papers necessary to advance their careers. Who is responsible for underwriting the development of these portfolios of evidence? Cross vendor data is not always accessible. The inability to receive coverage for an imaging service while the evidence is still in development is problematic for evidence collection. Potential solutions discussed in the “Evidence-Based Medicine” breakout session included: 1. Systematic reviews of existing evidence can be helpful for building the case of developing new technologies. 2. Develop guidelines and standard protocols for assessing clinical evidence. Establish key criteria for the introduction of new technologies. 3. Utilize all available data types: assess cost-effectiveness, registries, randomized controlled trials, toxicity data, and imaging effects on clinical outcomes. 4. Post market data collection can be an under-utilized approach. The Canadian public system is rich with data. 5. Utilize whole system statistical models that can illustrate the synergies between higher efficiency, positive clinical outcomes, and the investment of public funds. Health economic modeling that can illustrate cost savings, and relate an imaging decision to a business decision constitutes relevant evidence to health administrators. 6. Develop federal level cooperation to enable the provinces to work together to aggregate evidence. 7. Develop a sustainable reimbursement model. There is value in the evidence; it is worth paying for. 11 POTENTIAL SOLUTIONS Challenge #3 – Infrastructure Development and Use Fully capitalizing on existing infrastructure is one of the single biggest areas of opportunity to move hybrid medical imaging forward as a field in Canada. Weak collaboration with industry does not fully utilize the research infrastructure available within the academy. Make sure to maximize potential for basic research while still optimizing contributions to studies that examine clinical application and translation. Canada is a relatively small market to industrial partners and the benefits of research collaborations need to be clearly illustrated. There is a need for imaging modalities that can investigate large animal models, infrastructure to house the animals, and a secure source of funding for research groups organized around this research area. Figure 9 Dinner: Speaker, Frank Nolan, NSERC Prairies Regional Office 12 POTENTIAL SOLUTIONS Potential solutions discussed in the “Infrastructure Development and Use” breakout session included: 1. Utilizing the research infrastructure for both animal and human medical research whenever possible. Develop the resources and personal to conduct clinical trials in both research contexts. 2. Maximize industrial involvement with industrial liaison officers & technology transfer offices. Establish partnerships between cities with large medical imaging centers. 3. Utilize collaborative research networks as an umbrella group to connect human and technical resources for basic and clinical research outcomes. 4. Develop symbiotic relationships with industrial partners that allow them to benefit from top researchers and unique expertise available. 5. Conduct frequent workshops to communicate cutting edge research techniques and facilitate networking between industry and academia. 6. Plan now for the future with a cohesive vision that will optimize use of existing infrastructure, and develop the necessary infrastructure in a timely fashion. 7. Develop relationships with existing industrial partners in Canada i.e., Anrad, Calgary Scientific, Clarion, CPI, Imaging Dynamics, Johnsen Ultravac, Matrox, Media Pattern, Mevex, RMD, Teledyne Dalsa, Ultrasonix. Figure 10 Dinner: Dr. Baljit Singh, Western College of Veterinary Medicine, University of Saskatchewan [left]; and Jean Pruneau, Health Canada [right]. 13 SUMMARY The development, testing, and marketization of sensitive imaging tools and their optimal use has the potential to allow for more precise diagnosis and treatment of disease, reduction of healthcare costs through optimization, and the realization of the full potential return on the investment already made in imaging research in Canada for its partners in industry and government. Creating an environment with diverse stakeholder groups represented (i.e., academia, industry government), this “Frontiers in Hybrid Medical Imaging Technology” workshop not only allowed us to promote collaborations between academia, industry and government, but it provided a unique opportunity to identify key challenges to the advancement of the hybrid medical imaging sector in Canada. These challenges were narrowed down to the top four challenges, culminating in breakout sessions centered on the key issues identified and stakeholder developed principles and strategies to overcome these challenges. By engaging the community with direct experience of the issues we positioned ourselves to develop a more nuanced understanding of the issues facing the hybrid medical imaging sector, and determine viable, actionable ways to address these issues that make sense from multiple stakeholder perspectives. Figure 11 Dinner: Speaker, Dr. Paul Babyn, College of Medicine, University of Saskatchewan 14 APPENDIX Table 1: Workshop Participants 15 NAME Dr. Gregg Adams Gurpreet Aulakh ORGANIZATION University of Saskatchewan Canadian Light Source EMAIL gregg.adams@usask.ca gurpreet.aulakh@usask.ca Dr. Paul Babyn Bassey Bassey Dr. Steven Bayea Christopher Bowman Dr. Curtis Caldwell Dr. Dean Chapman Dr. Martin Charron Saskatoon Health Region & University of Saskatchewan Physics Dalhousie University Mitacs University of Toronto University of Saskatchewan Sick Kids Hospital paul.baby@saskatoonhealthregion.ca bassey.bassey@usask.ca steven.beyea@dal.ca cbowman@mitacs.ca Curtis.Caldwell@sunnybrook.ca dean.chapman@usask.ca martin.charron@sickkids.ca Colleen Christensen MEI Healthcare Group & MEI Healthcare International Ltd. cr_christensen@yahoo.ca Matthew Dalzell Tom Ellis Dr. David Faul Dr. Andrew Goertzen Matt Harmin Sylvia Fedoruk Canadian Centre for Nuclear Innovation Canadian Light Source Siemens Healthcare University of Manitoba School of Environment and Sustainability matthew.dalzell@usask.ca tom.ellis@lightsource.ca david.faul@siemens.com Andrew.Goertzen@med.umanitoba.ca farminharmin@gmail.com Dr. David Jaffray University of Toronto David.Jaffray@rmp.uhn.on.ca Dr. Floris Jansen Dr. James Johnston Dr. John Katsaras Dr. Wahid Khan Dr. Susan Kraft Dr. Glenn Laba Piotr Maniawski Mercedes Martinson Dr. Monique Mayer Dr. Jitender Mohindroo Dr. James Montgomery Sally Moore Gerald Moran Karen Mosier Frank Nolan GE Healthcare University of Saskatchewan Oak Ridge National Laboratory University of Saskatchewan Colorado State University University of Saskatchewan Philips Healthcare Physics University of Saskatchewan GADVASU, Ludhiana, INDIA University of Saskatchewan Small Animal Clinical Sciences Siemens Canada Ltd. University of Saskatchewan NSERC Prairies Regional Office jansenfl@ge.com jd.johnston@usask.ca katsarasj@ornl.gov khan.wahid@usask.ca Susan.Kraft@colostate.edu glenn.laba@usask.ca piotr.maniawski@philips.com schrodingers.cat@usask.ca monique.mayer@usask.ca jmohindroo@yahoo.co.in james.montgomery@usask.ca sally.moore@usask.ca gerald.moran@siemens.com karen.mosier@usask.ca frank.nolan@nserc‐crsng.gc.ca APPENDIX Dr. Michael Noseworthy Dr. Zisis Papandreou Vladimir Pekar Jean Pruneau Dr. Raj Rangayyan Dr. John Root Guy Roy Nazanin Samadi James Schellenberg Dr. Glen Schuler 16 McMaster University University of Regina Philips Healthcare Health Canada University of Calgary Sylvia Fedoruk Canadian Centre for Nuclear Innovation Innovation Saskatchewan Biomedical Engineering Cubresa University of Saskatchewan Klinikum rechts der ISAR Technical University of Berlin nosewor@mcmaster.ca zisis@uregina.ca vladimir.pekar@philips.com jean.pruneau@hc‐sc.gc.ca ranga@ucalgary.ca john.root@usask.ca Guy.Roy@InnovationSask.ca nazanin.samadi@usask.ca jschellenberg@cubresa.com glen.schuler@usask.ca Dr. Markus Schwaiger Dr. Tawni Silver Dr. Baljit Singh Dr. Jaswant Singh Dr. Liz Snead Shunmugavelu (Sham) Sokka Cynthia Stewart University of Saskatchewan University of Saskatchewan University of Saskatchewan University of Saskatchewan Philips Healthcare GE Healthcare m.schwaiger@lrz.tu‐muenchen.de tawni.silver@usask.ca baljit.singh@usask.ca jaswant.singh@usask.ca liz.snead@usask.ca sham.sokka@philips.com Cynthia.Stewart@med.ge.com Dr. Jim Thornhill Dr. Hugh Townsend Haresh Vachhrajani University of Saskatchewan and Saskatoon Health Region University of Saskatchewan Saskatoon Cancer Centre jim.thornhill@usask.ca hugh.townsend@usask.ca haresh.vachhrajani@saskcancer.ca Dr. Sheldon Wiebe Bryan Witt Dr. Martin Yaffe Dr. Roger Zemp Saskatoon Health Region & University of Saskatchewan Saskatoon Health Region University of Toronto University of Alberta sheldon.wiebe@saskatoonhealthregion.ca bryan.witt@saskatoonhealthregion.ca martin.yaffe@sri.utoronto.ca rzemp@ualberta.ca