Robotic Surgery: Cutting Through to the Latest

Robotic assistance during surgical procedures has largely been provoked by surgeon demand. Robotic-assisted surgical devices feature smaller, more precise instruments so the surgery can be done without an open procedure and with improved dexterity. A robotic strategy can offer better—even 3D—visualization of the surgical site, reduced post-operative pain, and minimal scarring. The technology has entered the fabric of healthcare so strongly that medical schools and residency programs have embraced surgical training using robotic technologies.

The surgical robotics sector is also hampered by a high capital investment and operating cost—robotic equipment doesn’t come cheap, and specialized instruments and consumables add to the cost. Currently it’s mostly well-funded, larger teaching hospitals able to afford them. Smaller institutions like ambulatory surgical centers (ASCs) and local community hospitals are often unable to front the cost, fueling inequities in care and efficiency.

And even for larger hospitals, the drop in elective surgeries over the last two years as a result of the COVID-19 pandemic offset the high investment in capital equipment. The supply of critical components for surgical robotic technologies was also hampered and continues to recover.

“The COVID-19 pandemic, along with various other factors, contributed to a global semiconductor chip shortage, wreaking havoc on the supply chain, especially for hardware components—critical to the manufacture of surgical robots/robotic devices,” said Shawn Vanseth, business development specialist at MedAcuity, a Westford, Mass.-based software development partner for medical devices, healthcare technologies, and regulated robotics. “Thousands of components are needed for complex surgical robotic devices, putting a heavy reliance on global manufacturers and suppliers of these components and parts.”

“Impact to device OEMs is felt at both the business and technical levels,” Vanseth continued. “Business tradeoffs are being made to maintain project schedules; they’re resorting to using available components instead of the ‘best.’ Creative workarounds by product owners and system architects to find available processors and components to work with are creating a two-fold problem: making redesign decisions on the fly that disrupt project management schedules, and product managers and system architects spending time on unplanned activities—time away from the actual development effort.”

The pandemic made the significant expenditure needed for surgical robotic equipment more difficult to justify. But the technology’s promise of better visualization, dexterity, and outcomes can’t be ignored. The idea of a shared risk model between the vendors and hospitals is emerging for more apt ways to obtain the devices and have the manufacturer be a part of the costs and risks.

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<!– This article will examine surgical robotic technologies from several device makers in the space as well as speak with manufacturing partners involved at the component level.

Asensus Surgical

The Durham, N.C.-based digital laparoscopy and surgical robotics company’s claim to fame is the Senhance surgical robotic system, which earned FDA clearance in 2017 for laparoscopic abdominal surgery. The system builds on the foundation of laparoscopy, with haptic feedback and eye-sensing camera control.

Senhance notably uses an open architecture so existing OR technologies and tools can be integrated, reducing hospitals’ capital investments and supporting surgeons’ preferences. According to Asensus, the system was engineered to effectively manage operating costs to make robotic surgery more cost-effective per procedure via fully reusable instruments. Senhance’s digital laparoscopy mimics traditional approaches with a familiar interface to lower training burden and ease adoption via a lower learning curve.

The robot is powered by the company’s augmented intelligence system, the Intelligent Surgical Unit.

“The ISU is the world’s first and only augmented intelligence system approved by the FDA for use in surgery, recently receiving FDA 510(k) clearance for the expansion of machine vision capabilities,” said Anthony Fernando, president and CEO of Asensus. “The newest ISU features include digital tagging, image enhancement, and enhanced camera control through machine learning based on anatomical structures while performing surgery. This technology can also measure in 3D with millimeter accuracy during surgery to determine both straight-line and topographic distances over the folds and recesses of the abdominal cavity. Additionally, digital tagging now pinpoints specific anatomical locations during the course of a complex operation that may be utilized as landmarks and teaching aides.”

According to the company, this will be the first time these features are clinically available in soft-tissue minimally invasive abdominal surgery. It will serve as a surgeon decision support tool to potentially reduce variability and lower complications. Senhance’s indications currently include laparoscopic abdominal surgery, laparoscopic inguinal hernia and cholesystectomy (obtained in 2018), general surgery (obtained in 2021), and performed its first pediatric procedures in 2020. Five millimeter diameter articulating instruments for Senhance earned FDA clearance last July as well.

“We are reimagining surgery and continuing to innovate and deliver digital support tools for surgeons and surgical teams to drive consistency in surgery and help drive lower complications,” Fernando concluded.

Titan Medical

The Toronto-based firm is currently developing Enos, a single-access robotic-assisted surgical system. Enos features a surgeon workstation, 3D HD monitor, and ergonomic chair so the surgeon can sit upright instead of looking down. Its patient cart houses the trocar with a light system, cameras, and surgical instruments.

The system operates through a single 25 mm incision to reduce trauma and post-operative pain, as well as minimize scarring and increase recovery time. The system was designed to take up less OR space and ease maneuvers with a simple setup, so it can be used in a smaller OR and allow room for all the clinical staff.

“We use a small 25mm insertion tube to insert two dexterous multi-articulating arms with 10 optional end effectors, and two lighted camera systems—a 2D HD camera and a 3D HD camera that articulates,” said Paul Cataford, interim CEO of Titan Medical. “It elevates, tilts, and pans under surgeon control to ensure visibility of the surgical field at all times. The small size of the instruments and cameras coupled with the wide range of motion allows for creation of a larger operating volume in the body.”

Titan developed Enos with surgeon input as well as proprietary software to operate it. Thus far, Enos has performed over 70 preclinical surgeries in human cadavers and animal testing with successful outcomes.

“We have completed the design and documents transfer work so our manufacturing partner can commence building systems for an anticipated summer delivery of our first complete Enos surgical system,” Cataford said.

“We are targeting to submit our IDE application to the FDA and commence human clinical trials in 2023 and expect to submit our De Novo application to the FDA in 2024. We expect possible market authorization from the FDA and full commercialization of the Enos surgical system to occur in 2025.”

Galen Robotics

The Baltimore-based firm was founded in 2016 out of Johns Hopkins University’s Laboratory of Computational Sensing and Computation to commercialize a robotic ear, nose, and throat (ENT) microsurgical system (REMS) to expand the surgical population by boosting ergonomics and tool stability during narrow corridor procedures.

The company is developing a single-platform solution to help surgeons across several disciplines without disturbing existing workflows. A paradigm of “cooperative control” aims to boost control and enable minimally invasive interventions for ENT, spine surgery, and tissue reconstruction.

Galen’s robot is meant to be more versatile compared to those designed for one type of surgery. The company expects to provide a cooperative robot to assist surgeons with long or delicate operations, with a goal of working with existing tool sets and workflows.

“We are constantly exploring new approaches in supporting cardio and neurosurgical along with “soft” spine and ENT procedures with an expectation to improve safety and precision through robotically supported 3rd party instrumentation,” said Bruce Lichorowic, Galen’s president and CEO. “In addition, the data collected from the Galen robots will open up new horizons to advance best practices, training and real-time applications. The development of an ‘App Store’ will be an industry-first, whereby Galen will produce a library of specific applications surgeons may on use on-demand.”

The company also aims to address costs challenges of the old capital purchasing model. Galen hopes to provide its robot “as a service” so ASCs can afford them through a pay-per-usage system instead of an upfront cost.

“We will launch our Digital Surgery as a Service Program that will make Galen the first surgical robotic company to launch as a service,” said Lichorowic. “In this shared risk model, hospitals and ASCs in return will need to commit to a set number of cases per year.”

Even Robots Need Partners

As surgical robotics exhibit a wider range of features for a growing number of procedures, design and manufacturing of the systems, specialized instruments, and software becomes more complex. Thankfully, manufacturing partners to surgical robotic device makers can help provide the specialized components, software, and manufacturing services device makers don’t have the capacity to make.

“This space, maybe even above and beyond the current medical device space, is looking for very challenging and tight tolerance products,” said Ryan Aleshevich, medical sales manager at Cadence, a Staunton, Va.-based full-service contract manufacturer for the medical, automotive, defense, and industrial markets. “Within this, I have seen some very complex machining needs. Price continues to drive many supplier selection decisions and customers need speed early on. We are responding to these trends by adding machining capabilities. The market is also moving toward reposable products that are not fully reusable and not disposable, but products used a certain number of times (maybe five or 10 times) before being discarded. This helps allow the high-priced, complex components since they are not fully disposable.”

MPO spoke to the following experts over the past few weeks to gain insight into manufacturing trends in surgical robotics and how manufacturing partners are keeping up with the evolving sector:

Tom Amlicke, software architect and robotics system engineer at MedAcuity.

Peter van Beek, business development director—medical at maxon, a Taunton, Mass.-based provider of precision drive systems.

Wes Conger, engineering director at Cortland Biomedical, a Cortland, N.Y.-based manufacturing partner for custom biomedical textiles.

Barry Parker, vice president of product management at Tecomet, a Wilmington, Mass.-based manufacturing partner of complex, high-precision products for the medical device and aerospace markets.

Sam Brusco: What role do your company’s components, software, or services play in surgical robotic technologies?

Peter van Beek: Custom designed maxon motors with low inertia, cogging, and friction provide a touch-like haptic forcep feel, which the surgeon uses to perform the surgery, located on the surgeon’s console side. The traditional robotic surgical suite consists of three parts but only two contain maxon components (the surgeon’s console and the actual surgical robot or surgical robot carts). On the surgeon console haptic side, maxon motors provide the feel to the forceps. When the surgical cart motors make contact with an obstacle inside the body or while cutting or clamping, the level of force is felt haptically on the surgical console’s forceps. On the surgical robot side, maxon supplies complex drive assemblies and drive electronics, which move the endoscopes and laparoscopic surgical tools.

Wes Conger: We’re developing innovative biomedical textiles, which are a viable and advantageous alternative to traditional metal in robotic devices because of their ability to be thinner, lower profile, cost-effective, and support better articulation. Incorporation of textiles into surgical robotics systems such as robotic arms enables greater flexibility and smoother movements. For a wide range of surgical applications requiring gripping, cutting, or suturing, textiles can give the “hand” on a robotic device more degrees of freedom and improved orientation. Textiles are now commonly being used as tethers for actuators, and even as replacements for stainless steel wire in robotic-assisted laparoscopic staplers. Contrary to some misconceptions, transitioning from metal to textile components in robotic devices does not mean sacrificing strength—in fact, in some cases textiles using modern high-performance fibers can be even stronger than metals, while also having the flexibility to conform to twists, bends, and grooves in a device.

Barry Parker: Historically, Tecomet provided precision manufactured components of robotic assemblies as well as the assemblies themselves. OEM companies largely partner with the navigation and related software elements along with the robotic platforms, and our role has been to manufacture primarily the “end effectors” of the robotic platform and provide design services to integrate existing instruments with robotic platforms. The components and assemblies routinely require extreme precision and can be difficult to manufacture and measure. In these cases, we partner with OEMs to provide inputs on design for manufacturability (DFM) and the best metrology approach to assure the design intent is accomplished.

Brusco: How does your company innovate to keep up with rapidly evolving robotic surgical technologies?

Amlicke: We’re investing in more MATLAB and Simulink coding licenses to train our engineers to use these technologies we see as critical to dealing with the supply chain challenge. Using these tools in combination, we can simulate and test a design for a surgical robotic device/system without the final hardware. This allows us to do a lot of work while waiting for the hardware to arrive. We use hardware simulators to connect our algorithms to real sensors and actuators to verify their capabilities without having the final hardware. One of the key business benefits of modeling and simulating dynamic robotic systems is the ability to maintain efficiency and velocity on the project.

van Beek: We are always pushing and pursuing new technologies related to materials, design, and magnet materials. However, many advancements in the surgical robotic world are being created by both industry leaders and new startups, which are challenging traditional approaches. Surgeons using existing platforms provide feedback and requests for improved versions, wanting or needing an improvement of some sort for a specific surgery or alternate outcome. Also, re-design of legacy platforms always pushes the design to higher performance, which is worthy of the system upgrade and its associated cost. Manufacturers armed with needs contact us to determine what’s possible because we’re an existing supplier or a market leader. New custom drive systems initiate a “project” between companies, which results in regular meetings to define a specification, production schedule, and quality requirements. We work in close collaboration with our customers to realize the desired outcome.

One recent maxon advancement that has impacted the surgical robotic field dramatically is a new planetary gearbox “GPX Ultra performance,” which utilizes ball bearings internally to dramatically increase efficiency above 90 percent (even for 3- or 4-stage versions), continuous/peak torque at output, lifetime, and back-drivability. This gearbox allows more of the motor torque to be utilized at output versus lost to heat in the gearbox and/or for a smaller motor to be used. We also developed a custom motor design that minimizes rotor inertia and friction, resulting in a touch-like, haptic experience for the surgeon.

Conger: Identifying the right design parameters for the surgical robotics platform’s purpose can be challenging.  A textile product developer should work closely with the medical device manufacturer to first understand exactly how the textile will be used. Specifications to establish early in the design process include what the surgical application is, whether there are any size constraints, and if there are any bends or grooves in the device. This will drive an informed recommendation regarding the textile configuration and, very importantly, the material selection. For example, when strength is key, ultra-high molecular weight polyethylene may be the best material choice, but if stability and chemical resistance are the top priority, liquid crystal polymer (LCP) may be preferable.

To strike the right balance of size and strength of braiding parameters, the textile product developer should do extensive mechanical testing—including tensile strength, elongation, and diameter measurements. Textiles have more compliant properties than metals in terms of torque, flexibility, and strength. When looking to replace a metal with a textile, the textile should have a high modulus to limit elasticity in the intended application.

Parker: We have followed this market closely as it has evolved in both the general surgical and orthopedic robotics markets. We innovated around two areas: the design services aspect and how we provide those services. We have multiple teams to address specific manufacturing challenges and found ways to better partner with customers through the development process. We have continued to invest in new technologies, dedicated equipment and personnel to facilitate development of new products with OEM customers so design transfer to production goes smoothly and quickly. We are currently working to further establish our LaunchRight™ Innovation and Development approach, an expansion of our dedicated resources and personnel to optimize customer designs and get them to market more quickly. –>