By Matt Skoufalos
Medical imaging modalities and the patient-specific information they provide continue to be increasingly integrated in nearly every aspect of medicine, from diagnostic applications to treatment planning to surgical interventions.
The ability to gather as much information before proceeding with surgical procedures has always aided the teams performing them, and the ever-tighter integration of higher-quality medical imaging data within the surgical suite continues to offer clear pathways to better physician decision-making, and thereby, hopefully, better outcomes. How these technologies and approaches to surgery intersect — and what leveraging them means for patients and staff in those surgical environments in which they can be implemented — is determined by the give-and-take among original equipment manufacturers (OEMs), their customers and the conditions their solutions are attempting to negotiate.
Rob Fabrizio, director of strategic marketing, diagnostic imaging for FUJIFILM Healthcare Americas Corporation, said that the foremost concern among working with any medical imaging equipment is mitigating the impact of ionizing radiation on anyone in the room. Dose reduction standards have influenced the design and operation of imaging devices for the past two decades. Additionally improvements to detector sensitivity, after-image processing, and peripheral technologies are also helping clinicians arrive at the lowest possible safe radiation dose.
“There’s a high awareness among both surgeons and staff in the room to be very conscious of dose, and how much dose patients are getting in these surgical imaging procedures,” Fabrizio said. “How dose affects both patient and staff safety, and focusing on technologies that minimize dose, has always been a focus for Fujifilm.”
Those priorities are reflected in the design of the Fujifilm FDR Cross C-arm, which has transitioned from image intensifier detectors to digital radiography (DR) detectors, which are both larger and offer a larger field of view as compared with their predecessors. Those features can help improve procedural efficiency by simply offering a better-quality image. The DR detectors generate about 30 percent less dose than image intensifier detectors do, Fabrizio said, and Fujifilm is also finalizing an updated version of its long-length DR detector for surgical applications in which a longer field of view is beneficial.
“We’ve been providing articulating holders so surgical teams can add a long-length field of view pre, post and during surgery procedures,” he said. “The new model is lighter-weight and thinner, and will be much more conducive to the OR and supine imaging. Most of the long-length imaging is done upright, weight-bearing, but doctors love to be able to take a long length of view to make sure the hardware’s positioned correctly.”
As a completely battery-operated system, the FDR Cross C-arm also addresses another concern in the operating room: that of cable management within the sterile field. With no cables to manage, that’s one less piece of technology to disinfect or reposition. Additionally, an articulated tube head enables the C-arm DR detector, which is itself removable, to function as a portable detector. The detectors on the FDR Cross are also interchangeable, allowing for fields of view from 14 inches by 17 inches up to 17 inches by 17 inches, which also affords “a more traditional X-ray type of view for both fluoroscopy and X-ray,” Fabrizio said.
“Imaging access has always been a priority on the portable X-ray machines; something like the Cross allows clinicians to capture both fluoro and X-ray images with one system, and without having to pull the C-arm out and bring in the portable. Having DR in our other models, they’re able to capture X-ray images in the surgery suite in that fixed holder.”
Technologies such as these emerge from the development process with no small amount of input from potential customers in the medical imaging and surgical spaces. Fabrizio said development of the FDR Cross began with a prototype system on which customers offered their critiques for at least two years before Fujifilm released the final product. Those field tests help product developers refine their approaches as well as inspiring the iterative tweaks that follow in future versions of the products.
“It’s not usable on an actual patient, but we bring it into the OR, see what’s good and bad, hear their input, and what they think they would like to see in the system,” he said. “Then, we come back and incorporate those things so they can use them later. There’s also a lot of new features that will be coming down the road; a lot of focus on feedback that we’ve gotten for demonstrations.”
“Fujifilm has always prided itself, from one product to the next, on revolutionizing the way things are done,” Fabrizio said. “Advances going forward are making things lighter-weight, higher-quality, lower-dose. Fujifilm can make those detectors thinner, lighter and sharper; refining those images at fractions of doses captured with other systems. In trying to lower dose even further, you get systems where batteries last longer, and they can run on batteries that are lighter-weight and easier to use.”
Fujifilm Global Vice-President of Endosurgical Research and Development Stephen Mariano said that the development of medical imaging technologies for the endoscopic and surgical space is directed at developing the smallest form factor possible to support minimally invasive surgical procedures. At the same time, technologies are evolving to incorporate functionality that will deliver as much information as possible to a surgical team, the better to allow them to visualize procedures as they go.
“From an imaging perspective in the operating room, I believe the future is going to be around functional imaging; imaging that gives you more information than just visualization,” Mariano said. “It’s got to have information about the patient’s physiology and how the tissue behaves. Can we visualize things like a tumor, and see the margins better? Those are the things that are going to help improve outcomes, when surgeons can be more effective looking at the tissue.”
From high-resolution image capture to after-image processing technologies powered by artificial intelligence (AI), surgical teams can improve their workflow, make better decisions, and produce better clinical outcomes with the additional information provided by next-generation imaging devices. As endoscopic and minimally invasive procedures progress towards endoluminal procedures – those begun using natural orifices in the human body – the next technological leap will be to understand how to leverage imaging modalities to provide even more information to the surgical team.
“Surgeons are always looking for more information to make better decisions,” Mariano said. “We talk a lot about navigation, decision support tools, multispectral imaging. Can we get a couple more road signs? Can it be more efficient, more effective?”
By combining flexible endoscopy with minimally invasive techniques in a single solution, the next endosurgical imaging devices will incorporate tools into a single package that supports a variety of imaging modalities in a single system. Technologies like the Fujifilm ELUXEO Vision system are designed to provide additional data points in this way, by visualizing specific types of tissue and blood flow. ELUXEO Vision helps prevent tissue necrosis by identifying hemoglobin oxygen saturation (StO2) levels in tissue without the need for fluorescent dyes. However, to bring these advanced insights into a hospital or health care system requires collaboration not only among product developers and the clinicians for whom their work is intended, but with the decision-makers whose input can shape the landscape of surgical processes for a network of professionals.
“Our technology has a lot of great solutions, but we have to match those to the problems,” Mariano said. “The innovation comes from when you’ve got that match. That’s why collaboration is so critical. It’s not just a new technology, a new idea, it’s really got to solve a problem. The problems are usually what they’re trying to do in the OR, what they’re trying to do for this patient.”
“But the days of the surgeon just wanting the newest technology are gone,” he said. “There are stakeholders in the health care system; department heads and administration have different problems. How do we evaluate the technology across the organization? We always end up starting with academic settings because you have to prove the principal benefit. But you’ve got to get it into the rural and community hospitals where there’s so much benefit.”
“How do I add to what they have today and make those rolling changes?” Mariano said. “That’s going to be critical to getting the technology into the hands of a vast majority of surgeons. You can’t dramatically change the workflow if you want to reach the masses. I think we have to look at the workflow and how does this fit, how does it build on what they have today, what they know, and build on their training.”
Although maybe 15 percent of the surgical imaging market may be currently dedicated to the hybrid OR space, Kris McVey, vice president of interventional radiology and cardiology, advanced therapies business at Siemens Healthineers North America has a lot of faith in the future of the hybrid OR, specifically as it relates to interventional imaging.
“More procedures are shifting into these multidisciplinary hybrid OR environments,” McVey said. “I think a lot of it is around the procedure mix that they plan to support, and working with the lights and booms and video integration that’s part of it. It takes a lot to plan for these rooms, but it really starts with the procedure mix that they’re trying to accomplish.”
The hybrid OR space “is definitely the most complex in terms of planning and what’s needed,” he said.
It can include the integration of various specialty technologies, from lighting and booms to anesthesiology, imaging and infection control. Siemens Healthineers has placed a strong focus on infection control, starting with the anti-microbial paint that covers its imaging systems. Its hybrid OR designs help preserve laminar air flow by eliminating the need to mount C-arms in the ceiling of a surgical suite. And investments in needle guidance help to accentuate pre-surgical planning to improve the speed and efficiency of injection-guided procedures.
The complexity of the working environment means working closely with other OEMs to bring a hybridized solution together.
“Flexibility has been a big piece of this,” McVey said. “It’s a lot of project management and consulting, where we partner with the customer and work within the project management team to meet our goals. It’s also about listening to our customers and understanding their design and construction needs. We have key opinion leaders that we talk to, we have an advisory committee that supports and lends itself to our roadmap. We also design our products to meet regulatory constraints, and I see them becoming stricter in the OR environment.”
Rose Gioiosa, director of key opinion leader (KOL) engagement in the advanced therapies business at Siemens Healthineers North America, sees more and more integration of other modalities in the OR, the better to integrate study data or patient information into a system that will better leverage those patient-specific details to provide “a 3D roadmap.” This roadmap will help physicians leverage imaging with fewer contrast agents, delivering quicker procedure times.
“The overall goal is what’s best for the patient,” Gioiosa said. “If we can do anything to reduce radiation, or procedure time, that’s what we’re going to do. We have thought leaders that will push the envelope, and that’s why we have these forums, so we can change medicine in those ways. As the complexity of cases increases, we start to see patients who are sicker and sicker, and we need to adapt and grow and change with that so we’re able to treat those patients.”
“As we continue to develop these tools, it’s how can we bring these modalities into the OR,” McVey said. “Cutting down the clinical care pathway time leads to better clinical outcomes.”
