Simulation Opportunities for the Health Technologies Industry Sector: National Research Council Canada Partnering for the Future

Robert DiRaddo and Christine Bryce talk about the National Research Council of Canada’s simulation technology development.

Realism. Convenience. Affordability. These are objectives the National Research Council of Canada (NRC) has embraced over a successful history of developing simulation technologies for applications varying from vehicle part manufacturing to food packaging to medical device design.

Today, NRC is advancing these goals and building on past success to usher in a new era of user-centric, real-time simulation throughout the health technologies industry sector. NRC developed NeuroTouch, the surgical virtual-reality (VR) simulator, in collaboration with teaching hospitals from across Canada and is now deploying it to an international group of early adopters. This development lays the foundation for future development to bridge technology gaps and ultimately contribute to better patient care.

Simulation for surgical training

Surgical expertise is well-developed in industrialized regions, but challenges remain worldwide, due to gaps in training and in the requirement to perform a wide variety of operations. Constrained health care systems allot less and less operating room (OR) time to teaching (Roberts et al, 2012). Considering that 11% of the global burden of disease can be treated with surgery (Ozgediz et al., 2008), effective and affordable training takes on even more significance. Mimicking pilot training, the adoption of simulation in surgical training curricula will elevate the expertise of surgical residents and favourably impact patient care.

“In the next 5-10 years, I expect every major neurosurgery centre to have simulators,” predicts Dr. Rolando Del Maestro, Director of the Neurosurgical Simulation Research Centre at the Montreal Neurological Institute and Hospital (MNI), a pioneer of simulation in surgical training and an early supporter of this R&D program at NRC. “Simulators allow us to see how the best neurosurgeons do procedures, and haptics provide insight to what sensible cues they are responding to. We can train people to that level of expertise and develop benchmarks for excellent performance.” Simulation allows students of all surgical specialties to understand the technical attributes necessary for a specialty, teachers to implement technical instruction based on competence rather than time spent in a program, and patients to benefit from the increased safety gained from repeated rehearsal of operative and other procedures. In addition, there is potential for regular assessment of individual competence so that technical abilities remain constant and may even improve.

The development of NeuroTouch through the formation of a group of early adopters established the user-centric approach which has proven pivotal to producing realistic exercises that surgical residents can relate to.

“I see high potential for consortium-wide studies in simulation performance,” says Dr. Joshua Bederson of The Mount Sinai Hospital in New York City. “We can involve thousands of participants, from students and residents to expert surgeons, in a multi-institutional study on specific surgical tasks and set international standards for performance in surgical simulation.”

Dr. Bederson has performed such studies on smaller participant groups including expert neurosurgeons and students. While students’ skills did not reach the maximum score of experts over four repetitions, additional coaching sessions between repetitions proved effective in accelerating improvement, indicating how to improve teaching of the technique.

Moving forward beyond NeuroTouch, NRC is well-positioned to address a variety of anatomic and surgical specialties by providing unique, integrated expertise in robust, real-time finite element simulation; affordable human-machine interactivity; and biological tissue models. Improving realism, convenience and affordability will expand offerings to include hybrid VR-mannequin training and extension to mass diffusion mobile platforms.

Simulation for distance learning

Dr. Allan Okrainec of the University Health Network (UHN) in Toronto welcomes the concept of mass diffusion. His research team pioneered “telesimulation”, distance learning of surgical skills utilizing simulation, back in 2007 with the first-ever training course in laparoscopic surgery delivered via Skype, to surgeons in Botswana. Numerous successful training courses have followed around the world.

“Telesimulation is absolutely the way of the future,” he declares, conceding that while travel to training sites by expert trainers will never be eliminated, “simulation provides pre-training and supplements to on-site visits thus improving adoption and retention of new procedures.”

January 2014 marked the launch of a new UHN research study which partners with Korle-Bu Teaching Hospital in Accra, Ghana, and uses VR in telesimulation for the first time (Figure 1). This project, funded by Grand Challenges Canada and in partnership with NRC, has provided a pediatric surgical simulator to Ghana surgeons for training of Endoscopic Third Ventriculostomy (ETV), employed to treat hydrocephalus. Buildup of cerebrospinal fluid in the skull affects about 1/500 births and is readily treated surgically, but currently less than 10% of children in east, central and southern Africa receive treatment, according to Dr. Okrainec. The four-week training period went well and testing results are eagerly anticipated to demonstrate the success of this training technique and confirm continuation to the next phase of the project.

Further technological improvements can only benefit the affordability, convenience and robustness of telesimulation: better telecommunication, video quality, and interconnectivity “so that all simulators can ‘talk’ to each other,” envisions Dr. Okrainec. “We could upload patient-specific images to connect all simulators on the same case before surgery, to share expertise and learnings, and work together to improve patient outcome.”

Simulation for Personalized Rehearsal

The integration of patient-specific images with surgical simulation presents a significant opportunity: the ability to rehearse a high-risk procedure, using data for the actual patient, in a realistic yet safe environment. CT and MRI scan images can be transformed into three-dimensional renderings and incorporated into an exercise offering haptic feedback so that best approaches may be formulated before stepping into the OR.

Simulators, and the surgeons using them, will only be as good as the data they rely on. High-quality images clearly are needed to plan and execute excellent patient care, including surgery. Leveraging its expertise in processing and augmenting large information sets from images and sensors, as well as in differential tissue behaviours, NRC is actively working with Canadian industry to move simulation into the rehearsal domain and optimize creation of the ready-for-simulation patient case.

A key technology gap, says Dr. Bederson, is the development pipeline. “Better haptics mean that it is harder and longer to generate rehearsal scenarios. The high sophistication and detail within NeuroTouch makes it a challenge.”

Adds Dr. Del Maestro: “If surgical rehearsal were generally viewed as a prerequisite to high-risk surgery, it could hasten regulatory approval and wide acceptance of surgical simulation.”

Simulation for Surgical Robotics

“It began in the mid-1990s with the desire to move imaging and other technologies into the OR,” says Dr. Garnette Sutherland of the University of Calgary, and ultimately translated into the ability to perform robotic surgery within the bore of the MR magnet from a remote sensory immersive work station. Robotics in surgery “are a disruptive technology, completely different from before” and rely on state-of-the-art engineering to recreate the sight, sound and touch of microsurgery. “Technology push may come from engineers, but there needs to be a technology pull; neurosurgeons need to be convinced that the technology will either make the performance of surgery easier and/or improve patient outcome.”

Wider adoption of surgical robotics would be facilitated by realistic training modules, and interactive simulation is a natural mechanism to provide it. Like simulators, robotics rely on high-quality imaging, force feedback (haptics) and efficient computation for success, albeit at a far higher level of sensitivity to actually duplicate the movements of instruments in a surgeon’s hand. Dr. Sutherland points to the current computational gap as a barrier to wider distribution: “Currently, no computer can deal with the complexity needed for patient-specific cases, and none can replicate the past memory and experience that help surgeons ‘guess’; for instance, predicting the site where bleeding will start. Can a computer learn to guess?”

Simulation for Rehabilitation and Wellness

In the movie Star Trek II: The Wrath of Khan, the Kobayashi Maru exercise tests potential starship captains on their management of a doomed mission, ending in the destruction of either the merchant ship they were trying to rescue or their own ship. Dr. Del Maestro’s research team at MNI, working with Dr. Penny Werthner and Sommer Christie from the University of Calgary, designed their own Kobayashi Maru simulation of surgery where bleeding could not be controlled and the patient was doomed to die. Unexpectedly, two expert surgeons beat the scenario and stopped the bleeding by focusing all energies into locating the bleeding source. EEG measurements on the participants (Figure 2) showed that for those considered most expert, no difference was observed between real and simulated situations, whereas residents showed a measurable difference.

“Can we teach this highest level of focus to junior residents?” muses Dr. Del Maestro. The research team at MNI aims to understand how surgical errors and other stresses in the OR affect surgeons. “Errors always occur – there are always situations not encountered before, but with experience, it is easier to analyze and manage the error. Simulation can help us understand, and teach, the analysis-management processes an expert demonstrates.”

Research on stress control using simulated environments can be translated to everyday life situations outside of surgical training, especially considering the increasing trend of outpatient and home care. For example, rehabilitation programs could be accessed from home, customized to the needs of individuals using VR-based tools to demonstrate and evaluate exercises and tasks. A range of programs addressing mental and physical wellness needs can be developed, based on proven fundamental expertise in biomechanics and interactive feedback.

Simulation for Human Factor Engineering (HFE)

Human factor engineering and evaluation have become an important aspect of device development, especially in a field where safety is critical and use errors have a direct impact on the health and welfare of millions daily. The Food and Drug Administration of the USA has established guidelines and a reporting procedure for HFE as part of medical device pre-market review.

“Human factors go beyond ergonomics and design to safety and security, so not just ease of use but safe use,” notes Patricia Debergue, researcher at NRC. “A new device undergoes many stages of development, from idea to mock-up to refined design, and testing is associated with every stage.” Testing in the hands of not just the developers, but most importantly the intended users, whoever they may be: health care professionals, home-based caregivers, or individuals administering to themselves; ages from elderly to children; various physical abilities and/or constraints.

Companies developing new devices, especially smaller companies, may look to external sources of specialized expertise and infrastructure to generate objective data, mitigate risk, minimize reliance on animal testing, and ultimately reduce the number of iterations within a development cycle. Simulation can aid in the testing by imitating the intended uses and use environments, early in the life cycle of the new product when the design can still be changed. For instance, a developer testing a novel surgical instrument needs to not only replicate physical attributes of the device and the biological tissue, but also capture the real situation as much as possible, such as light level, noise and distractions of the OR, in order to recreate the level of focus required. Both physical modelling using polymer or biological tissue mock-ups and VR representation can help to collect meaningful usability test data under realistic conditions and carefully observe users’ approaches and reactions to the new product or design. NRC has a comprehensive biomechanics, tissue and polymeric testing capacity ideally suited to support such work. (Figure 3)

Summary

This overview offers a window into the future role of simulation across the health technologies industry sector; medical training, distance learning, personalized rehearsal, robotics, rehabilitation/wellness and human factor engineering. Current technological gaps are already being narrowed as innovative medical devices are being developed by companies from large multinationals to small businesses. NRC partners with such innovators to help mitigate the risk and accelerate the development cycle, offering simulation and software solutions which realistically mimic actual applications, customized to users’ needs.

According to Rolando Del Maestro, “Our goal should always be excellent patient care and excellent patient outcome ... Simulation is a step change in medicine, and as globalization of this technology occurs it may rival the importance of the introduction of anesthesia or sterile technique to surgical outcomes. Transitioning this dream to an approachable reality will result in a worldwide improvement in the care of surgical patients.”

About the Authors

Robert DiRaddo, Ph.D., joined NRC in the early 1990s, working on simulation for the automotive, packaging and petrochemical industries. In the mid-2000s, Robert initiated the development of simulation for the health care sector with NeuroTouch, which is currently installed at 17 locations worldwide. E-mail: robert.diraddo@cnrc-nrc.gc.ca

Christine Bryce, Ph.D., has 15 years’ experience in the petrochemical industry. Currently an independent consultant, she supports R&D documentation and project development in fields varying from oil and gas to health care, carbon capture, and linguistics. E-mail: christine.bryce@bell.net

References

Roberts NK, Brenner MJ, Williams RG, Kim MJ, Dunnington GL. Capturing the teachable moment: A grounded theory study of verbal teaching interactions in the operating room. Surgery 151(5):643–650, 2012.

Ozgediz D, Jamison D, Cherian M, McQueen K. The burden of surgical conditions and access to surgical care in low- and middle-income countries. Bulletin of the World Health Organization, 86(8):646-647, 2008.