The Medical Holography Story
With current medical imaging technologies, such as CT and ultrasound, surgeons need to develop the skill to look at a series of two-dimensional images of an organ and from those images, build a mental model of how the organ looks in three dimensions. This skill is critical to the successful treatment of many diseases, especially as the number of minimally-invasive, image-guided procedures grows. A new technology called the Holoscope can ingest medical images of a patient’s heart and display a three-dimensional holographic image of that heart. It allows the surgeon to not only see the heart directly in 3D, but to explore, rotate, and slice the hologram in real time. The Holoscope technology was recently launched and highlighted during a state visit from the President of the State of Israel to UHN.
Though medical holography was not developed by TECHNA, it was still a project to bring it into the hospital and integrate it into the operating room. Unlike with well-established technologies, the procurement and medical engineering pathways are not well-established for a first-in-the-world technology, nor is it clear how a technology like holography can change clinical workflows and practices. The TECHNA Technology Team took point on the years-long project to bring medical holography to the Peter Munk Cardiac Centre (PMCC). The project involved spearheading interactions with Finance, Medical Engineering, the Vendor, UHN Digital, and affected clinical departments as well as with research ethics, public affairs, and staff education.
Over the past 7 years, the TECHNA Institute at UHN has developed a model to facilitate the development of novel medical technology and to integrate it into the day-to-day operations of a Canada’s largest tertiary care centre. We have built a core team of professionals – engineers, project managers, and regulatory experts – who are conversant in all aspects of medical technology.
The recent introduction of the Holoscope, the world’s first medical holography system, developed by Israeli company RealView Imaging, provided an excellent case study in the challenges and solutions to bringing exciting, world-first technology into the hospital.
Medical Holography: The Vision
The process started when Dr. Barry Rubin, Medical Director of the Peter Munk Cardiac Centre (PMCC) at UHN, learned about RealView Imaging and their new holography technology, and committed to making PMCC the world’s first holography-enabled cardiac centre.
Hospitals have been acquiring 3D imaging for decades. MRI, CT, PET, ultrasound, and other imaging modalities routinely collect volumetric images, but until now these images have always been displayed on flat 2D screens. Much of the depth information is thereby lost.
The complex optics in the Holoscope “print” light in 3D within gesture range of the user, allowing them to interact directly with the hologram while maintaining full depth perception. The promise of the technology is a more intuitive understanding of the spatial relationships between structures in the image volume, allowing clinicians to make better diagnoses, improve planning for surgical procedures, and enhance guidance for minimally-invasive therapies, which are wholly dependant on medical imaging.
The pitch sounded highly promising, but the technology had yet to be used with patients. The only way to unlock that promise is to get the technology inside the walls of the hospital and to start using it.
Procurement: Challenges and Concerns
There were a few wrinkles in the procurement process introduced by the fact that the Holoscope is the first technology of its kind and the fact that UHN was to be its first commercial installation.
UHN, having made many procurements of technology over the years, has a very comprehensive template for a procurement agreement – some 50-odd pages covering a wide range of issues. The breadth of the agreement required multiple rounds of communication with RealView, which TECHNA staff mediated. Some of the sections, such as the turnkey requirements for installation, would have been readily available from an established manufacturer with an existing product line but had to be developed from scratch for the Holoscope.
An additional step in the process that had to be dealt with was the process for approving a non-competitive procurement. Given that the Holoscope is first-in-the-world technology, not soliciting competing bids was uncontroversial since there were no competitors on the market, but still had to be dealt with.
Another challenge to the procurement of a first-in-the-world technology was the mitigation of risk. For technology with a proven track record, or for incremental improvements on old technology, the risks are well understood and can be mitigated. Brand new technology raises a number of additional questions, both for the hospital and for the Vendor. From UHN’s perspective, the main questions were:
- Will the technology work at all?
- Will the Vendor, who has spent years developing technology, be able to shift to supporting the technology and what will the response times be?
- Even if the technology performs as specified, will UHN derive any benefit from it?
From RealView’s perspective, a principal concern was that UHN invested sufficient time and resources in using this technology in order to generate an informed opinion of its usefulness.
The result of expressions of these concerns from both sides resulted in language in the procurement agreement to mitigate against those risks.
Most medical equipment is paid for out of a hospital’s capital or operational budget. Not so for leading edge experimental equipment. The purchase of the Holoscope was made possible by donations from generous benefactors, notably Harry Rosenbaum of Great Gulf Homes Charitable Foundation and Jeff and Honey Rubenstein. These donations were solicited and coordinated by the Toronto General & Western Hospital Foundation. While purchase of the Holoscope would not have been possible without the Foundation, their involvement introduced additional coordination with the Finance and Procurement departments for the more mundane tasks such as the issuing of a purchase order and the payment on invoices.
Keeping the Foundation in the loop during the operationalization of the Holoscope was also important since the availability of such leading-edge technology and the opportunity to interact with it presented a significant opportunity to retain existing donors and attract new ones. TECHNA staff were able to tailor demonstrations to clinical and administrative audiences as well as give lay demonstrations for those coming in from outside the hospital.
Research Ethics, Health Canada
The standard UHN procurement process assumes that the manufacturer of a device that the hospital is acquiring has received a Health Canada licence for it. This was not the case for the Holoscope. As a result, the route to using the Holoscope with UHN’s patients was through Health Canada Investigational Testing Authority (ITA). The ITA process, in turn, required clinical protocols led by PMCC cardiologists and cardiac surgeons, and approved by the hospital’s Research Ethics Board.
Crafting protocols to evaluate a technology that no one else in the world has used clinically presented a significant challenge. At the outset of the process, no one at PMCC had first-hand experience with the technology. It took multiple rounds of communication between RealView and PMCC clinicians, mediated by TECHNA staff, to draft the first protocols. RealView staff travelled to UHN on multiple occasions to lay the groundwork for integrating the technology into the hospital and to discuss potential applications with PMCC staff. Those visits were coordinated by TECHNA. PMCC clinicians travelled to Israel to get introduced to the technology, first in prototype form, then the first commercial unit.
The result of these efforts were two approved protocols: one for use with diagnostic imaging, the other for use during catheter-based cardiac procedures. The protocols were designed to allow clinicians to evaluate the Holoscope without affecting the standard of care delivered to the patients. The low-risk level of these protocols made the approval of the protocols and the subsequent issue of the ITA from Health Canada straightforward, but the requirement for the protocol approvals and for the ITA added significant time and effort to the process of procuring the technology.
The two initial protocols provided the foothold necessary to get the Holoscope into UHN and to enable its first use with humans, but the effort to further expand the use of the Holoscope has not stopped with those initial protocols. With the Holoscope’s arrival at UHN, its introduction to a wider range of potential users has been possible and there has been a concerted effort by PMCC and TECHNA to introduce the technology to many clinicians, focused initially on cardiology and cardiovascular disease, in order to broaden UHN’s experience with medical holography.
This effort will continue to involve the creation of clinical protocols until such time as RealView Imaging acquires a medical device licence from Health Canada. In the meantime, the existence of two approved protocols and the accompanying ITAs facilitates the creation of new protocols by allowing the new protocols to build on the existing ones.
Coordination with the Medical Engineering Department
As with most medical technology, the introduction of the Holoscope required coordination with the Medical Engineering department. In this case, it was a straightforward process with few challenges: Medical Engineering was able to provide space for the assembly, calibration, and electrical certification of the device by the team from RealView.
The Holoscope requires patient images in order to display holograms. Those images can either be streamed directly from the acquisition modality or pulled from the hospital’s image archive. RealView also intended to provide remote support from Israel, requiring an external connection through the hospital network and into the Holoscope’s computer.
The device’s requirement for images that could potentially contain patient health information (PHI) required assessment by UHN’s Privacy Office.
Coordination with the Medical Imaging Department
The connection of the Holoscope to the clinical image archive required coordination with the Medical Imaging department. This process was straightforward, except for the fact that the RealView team had never connected to a hospital PACS system before. In order to mitigate the risk of a failure, a test of the connection was arranged prior to delivery of the Holoscope, where a TECHNA staff member ran software provided by RealView on the UHN network as a proxy for the Holoscope itself.
Coordination with the Digital Security Team
The fact that the Holoscope would be connecting to the Hospital network, and in particular the fact that RealView would be performing remote support, required analysis by the Digital Security team. As a result of that analysis, RealView was required to re-work the design of the communication flow between the different components of their system. The Digital Security team also required a penetration test on the system after it had been assembled at UHN. TECHNA worked with RealView ahead of delivery, allowing the company to address potential issues while the first system was still at their facility. This pre-test allowed the integration with the hospital network to occur smoothly.
The impact of the Holoscope on the physical environment is minimal compared to imaging scanners and other large pieces of complex equipment. Its system is composed of the main unit, which is mobile, and a secondary control station for use in imaging-enabled procedure rooms that have a separate control room. The main Holoscope unit requires a 20 A power receptacle, which is present in most modern operating rooms, and a network connection to pull images from the hospital database of medical images (called PACS).
The amount of work required to retrofit a procedure room to accommodate the Holoscope system is minimal but since the system is mobile, the process needed to be repeated in all suites where the Holoscope is likely to be used. In this particular case, two cath labs and two imaging-enabled operating rooms had to be outfitted with the dedicated Ethernet cable required to connect the main Holoscope unit to its control station, while a room in the Echocardiography Lab where diagnostic ultrasound scans are performed required the installation of a 20 A power receptacle. Wherever possible, the work was done in conjunction with planned retrofits to minimize cost and operational impact.
It was not just clinical spaces that required upgrading. The Medical Engineering bay needed a 20 A plug installed so that the Holoscope could be assembled and tested there. A 20 A plug was also required for the room where the Holoscope resides when not in clinical use, so that it can be used to review holograms and for training and demonstrations outside of the operating suite. TECHNA worked with UHN’s Facilities department to ensure all work was done.
Finding a place for the Holoscope to live when not being used with patients was a challenge in itself. UHN cath labs and operating rooms are consistently challenged for space. Empty rooms never stay empty for very long. It was due in large part to TECHNA’s wide range of contacts within UHN that we were able to secure space in a lab in Medical Imaging dedicated to the interface between radiology and other disciplines, creating not only a good physical space but a philosophical fit as well.
A new piece of equipment will require that the resources to train staff on its use be put in place. With a first-of-its-kind piece of equipment, that training has to be designed in the first place. Something with unique capabilities like the Holoscope will also generate a great deal of curiosity from the UHN community. TECHNA made sure to respond to requests for staff education and presentations on the Holoscope and its capabilities, and to provide opportunities for staff to interact with the new system.
The installation of medical technology in a hospital does not usually warrant engagement with the hospital’s Public Affairs team, but with the introduction of leading edge technology, this was an opportunity to reinforce Peter Munk Cardiac Centre’s track record for world firsts. The visit to Toronto of the President of Israel, Mr. Reuven Rivlin, provided an ideal opportunity to make a formal announcement of the deployment of medical holography at PMCC.
TECHNA worked with UHN’s Public Affairs team and with RealView staff to make sure that the demonstration to the Israeli president went off without a hitch.
Moving Forward and Continued Research
With leading-edge technology such as the Holoscope, the work does not stop with the arrival and commissioning of the device. We are just scratching the surface of the technology’s potential with the two protocols currently approved. More work is required in order to determine potential uses and benefits of medical holography and the best ways of its integration into clinical workflows to achieve those benefits.
Throughout the whole process and in the work yet to come, the TECHNA team was well-positioned to coordinate the activity of multiple hospital departments and to navigate the challenges that arose to ensure that UHN maximized the potential of that first conversation between Dr. Rubin and RealView Imaging many years ago. The scope of the effort extended well outside standard medical technology acquisition and installation processes, requiring a breadth of knowledge that encompassed legal, ethical, financial, logistical, clinical, and hospital infrastructure – core competencies that have been a focus of TECHNA’s team building.