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We’re providing a deep look
into the trends shaping surgical robotics
Surgical robotics developers notched milestone after milestone in the first half of 2025 as the two largest manufacturers in medtech prepare for a big push.
In April, Johnson & Johnson MedTech announced the first procedures using its investigational Ottava robotic surgical system. Shortly after, Medtronic said it submitted its Hugo robotic-assisted surgery (RAS) system to the FDA in a bid to enter the world’s largest robotic surgery market.
Hugo is already approved for use in Europe, Canada and Japan, but the world hasn’t yet had a good look at Ottava, for which J&J plans an FDA de novo submission. For this surgical robotics issue of Medical Design & Outsourcing, however, we interviewed J&J leaders about two of their systems that are already on the market: the Monarch robotic bronchoscopy platform and the Dualto Energy System, the latter of which was designed for use with Ottava.
Medtronic and J&J are taking aim at Intuitive, which is fortifying its head start and expanding manufacturing operations while navigating new tariff challenges as both an importer and exporter. In this issue, Intuitive leaders — including outgoing CEO Gary Guthart and new CEO Dave Rosa — offer a tariff strategy discussion that could help other device developers survive the trade war.
Intuitive’s efforts are paying off elsewhere, perhaps most notably at Capstan Medical, the structural heart surgical robotics startup led by former Intuitive engineers and backed by Intuitive Ventures. Capstan’s novel mitral valve and robot-powered catheter delivery system were recently used for the first time in humans, and this month’s cover story offers design and development insights from Capstan CEO Maggie Nixon and R&D Head Greg Dachs.
This issue also features a Q&A with Zimmer Biomet Chief Information and Technology Officer Shaun Braun, who discusses the value of connected data in orthopedic robotic surgery, ZB’s growing digital ecosystem, and innovations needed from other medtech developers.
We’ve also got technical tips and updates on high-resolution disposable endoscopes, robotics component micromolding, intellectual property protection, surgical robotics instrument miniaturization, telesurgery research and a microrobotics system for autonomous thrombectomies.
Finally, we’ve recently published three special reports related to surgical robotics, all available for you to download free of charge. These Medical Design & Outsourcing and MassDevice special reports cover surgical robotics (wtwh.me/ roboticsreport), nitinol innovations (wtwh. me/nitinolreport) and orthopedic device companies (wtwh.me/orthoreport).
As always, I hope you enjoy this edition of Medical Design & Outsourcing — and thanks for reading.
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DEPARTMENTS
HERE’S WHAT WE SEE:
We’re providing a deep look into the trends shaping surgical robotics
IMAGING:
This breakthrough for high-resolution disposable endoscopes comes from an unlikely source
INTELLECTUAL PROPERTY:
Proactive IP strategy to navigate your medtech startup through uncertain times
MOLDING:
Micromolding for surgical robotics can offer better functionality and lower costs
PRODUCT DEVELOPMENT:
Three methods to consider for miniaturizing instruments for robotic assisted surgery
RESEARCH:
Cleveland Clinic reports world’s first transcontinental robot-assisted focal therapy procedure for prostate cancer
SUPPLY CHAIN:
Intuitive’s trade war strategy holds lessons for other device developers
TUBING:
CASES
Led by Intuitive Surgical vets and backed by Intuitive Ventures, Capstan Medical is developing technology for robot-assisted transcatheter heart valve replacements.
This microrobot system is designed to float inside a stroke patient for autonomous thrombectomy
MEDTECH ARMS ITS MONARCH ROBOT FOR FUTURISTIC LUNG CANCER THERAPIES
Monarch President Aleksandra Popovic explains what’s special about the upgraded system and offers advice for developing robotics and AI.
ZIMMER BIOMET SEEKS A ZBEDGE FOR ITS ROSA ROBOTIC SURGERY
Competition is stiff in the ortho robotic surgery space, but Zimmer Biomet bets data-driven patient management is the ace up its sleeve.
What J&J MedTech’s new Dualto says about the OR of the future — and Ottava
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Valens Semiconductor was the first company to release to market an A-PHY-compliant chip, and is moving forward with various engagements on medical endoscopes.
By Eyran Lida Valens Semiconductor
Two trends are dictating the evolution of endoscopes: higher quality imaging and a transition to disposable architectures.
Each of these introduce new challenges for system designers. The breakthrough might come from an unlikely source: the automotive industry.
Automotive OEMs have been attempting to integrate higher resolution sensors inside their vehicles to reach higher levels of autonomous driving. Cars have as many as 20 highbandwidth sensors, each delivering gigabits of data to compute units elsewhere in the vehicle.
Just like in the medical industry, this data is safety critical, as excessive latency or errors in the video/data could result in death. In both of these industries, data is often uncompressed to ensure artificial intelligence algorithms are streamlined.
This breakthrough for high-resolution disposable endoscopes comes from an unlikely source
Device manufacturers working on disposable endoscopes with better imaging are using a new standardized connectivity technology developed for automakers.
The similarities between the automotive and medical industries don’t stop there. In many use cases, steady-state white gaussian noise dominates the noise profile. Automotive and medical, on the other hand, both must contend with fast transient noise profiles. In automotive, this could be from large electrical transients surging within the car during startup, for example, while in medical this could occur during the operation of electrosurgical equipment.
Legacy connectivity solutions could sufficiently handle these interferences when carmakers integrated sub-gigabit sensors for relatively low-resolution cameras. But as sensor resolutions rise and the signal-to-noise ratio decreases, connectivity solutions have become a bottleneck for innovation.
The MIPI A-PHY standard
As a result, carmakers called for the creation of a new standardized connectivity technology that could handle long-reach, high-speed sensors safely and reliably.
The MIPI Alliance, a collaborative global standardization organization, created the MIPI A-PHY standard. It can handle bandwidth up to 16 Gbps per link, with a clear roadmap to 32 Gbps, enough to support the highest resolution sensors on the market today and in the foreseeable future. A-PHY can extend interfaces up to 15 meters in automotive, and longer for nonautomotive configurations.
Most importantly, it was designed from the ground up to handle the fast, transient noise types commonly found in automotive, and in medical. A-PHY reaches a packet error rate of 1E-19, orders of magnitude lower than competing legacy solutions. >>
Image courtesy of Valens
IMAGING
Medical use of MIPI A-PHY
Fiber-based endoscopes are limited in the video quality they can support due to the mechanical constraints of fiber bundles, imposing low video resolutions and severe optical aberrations.
The transition to high-imagequality videoscopes has been hampered by limitations of video connectivity technologies as well as reliability issues. Many doctors have complained about dropped frames and latency during surgeries.
Links in videoscopes today are prone to dropping during the use of electrosurgical equipment. These scopes rely most often on direct connections from the sensor to the processing unit, which can only be possible with lowbandwidth (low camera resolution) connectivity. Another option utilized by endoscope manufacturers is a low pincount proprietary imaging interface, but once again bandwidth is limited in this configuration.
tip. Chips based on the A-PHY standard can operate over unshielded channels and over cables that are less than 1 mm in diameter, or 30AWG wires, which would allow for an extraordinary field of view for medical professionals.
A-PHY and the disposable endoscope trend
A-PHY was originally designed to miniaturize the serializer, transferring the digital processing to the deserializer. This is perfect for the disposable endoscope architecture, with a miniature, low-power, low-cost serializer in the disposable section of the endoscope and the smart deserializer in the non-disposable section.
A final benefit provided by the A-PHY standard for disposable endoscopes is easier manufacturability. Splitting the endoscope into a variety of assembly elements could lead to significant manufacturing cost reductions. Instead of producing the endoscope as a whole, manufacturers could separately
Valens Semiconductor was the first company to release to market an A-PHYcompliant chip, and we are moving forward with various engagements on medical endoscopes. Some are preparing for clinical trials, while others are readying to seek FDA approval.
From the feedback we’re receiving from our endoscope customer and partners, our automotive-grade A-PHYcompliant chips could be exactly what is needed to deliver high-resolution disposable endoscopes to the medical industry.
Eyran Lida is the co-founder and CTO of Valens Semiconductor, overseeing the company’s technology strategy. With 33 years of experience in communication systems software and 85 U.S. patents, Lida is an international expert in wireline hardwired DSP modem design and one of the lead technical contributors to the MIPI A-PHY standard.
The automotive-grade MIPI A-PHY standard does away with these issues, facilitating long-reach, high-bandwidth links that work free of errors. In addition, the standard’s ability to converge multiple interfaces — including power and general-purpose input/output (GPIO) — helps with miniaturization efforts.
The unprecedented EMI resilience of A-PHY allows for one other benefit that could be uniquely relevant for medical endoscopes: bending of the endoscope
produce the optical head, insertion tube, handler/control-section, and the connection cord, with simple assembly at the end of the process. The A-PHY standard is robust enough to handle the many in-line connectors that this kind of manufacturing process would require.
The MIPI A-PHY standard is available for the medical device industry, with a variety of silicon vendors offering A-PHY compliant serializer/deserializer (SerDes) solutions.
Images courtesy of Valens Semiconductor
By Gregory Schwartz Greenberg Traurig
Proactive IP strategy to navigate your medtech startup through uncertain times
Medtech companies can use their intellectual property to send a powerful message to potential buyers and investors.
What can medtech companies do to position themselves for an exit despite these turbulent times?
Medtech companies can put themselves in a better position for acquisition by having a firm understanding of their competitive landscape and how their technology fits within this competitive landscape. Companies that tell a compelling story of how their IP portfolio strengthens their market position and provides a competitive advantage are attractive targets. This not only gives medtech companies a powerful message to potential buyers and investors, but can also lead to premium valuations.
By Ryan Sharp Greenberg Traurig
approach this volatility with some hesitation to entertain and close M&A deals. Access to venture capital is harder as well. Most investors are taking a wait-and-see approach, evidencing a preference for the dust to settle before committing to significant investments.
Despite the above, large medtech companies are still making strategic plays for complementary technology that either supplements existing business or provides access to new ones. At the moment, opportunities are greatest for those companies with regulatory approval and strong intellectual property (IP) protection because shortening the time to market makes targets more attractive in the current climate.
Are governmental changes impacting the approach to IP protection?
Ongoing changes to the government administrative agencies in the U.S. are also reaching the U.S. Patent and Trademark Office (USPTO). While these changes may impact the timelines for obtaining a patent, at this time, they do not merit wholescale changes to a company’s approach to obtaining IP protection. Fees at the USPTO continue to rise, so it is important to develop a strategy for protection that ensures coverage for core technologies as well as building a strong fence around those core technologies and the improvements that come later. Given that a strong IP portfolio can be a key driver in the valuation of a company and can help prevent competitors from entering the market, it’s more important now than ever to work with strategic IP counsel.
The relationships between various patent offices globally are seeing some impacts from the current volatility. In some cases, we are seeing a more national approach that deemphasizes the value of patents in countries outside the U.S. Despite some impacts, there currently does not appear to be
any action that is significant enough to cause a large shift in approach to protecting IP. However, this is something that is worth monitoring, as smaller fringe markets may become less worth the IP investment.
What sort of IP do buyers like to see?
Buyers are looking for strategic IP portfolios including patents that not only clearly cover core technologies, but also build a strong patent fence around those core technologies and later improvements. It can be particularly helpful to keep a patent application pending so a buyer can have the flexibility to make updates to the patent portfolio based on their own strategy, as well as their business goals, as they sometimes are not directly aligned with the goals of the selling company. A wellconstructed IP portfolio, including trade secrets and trademarks, adds credibility and signals innovation, competitive advantage and potential revenue.
IP is a key driver in M&A because it can shorten time to market and strengthen negotiating positions. For smaller medtech companies, a robust IP portfolio can make them more attractive targets and can significantly increase deal valuation.
IP is not limited to just patents. Trademarks protect brand identity, while copyrights can cover software or marketing materials. A collective strategy showing commitment to all facets of IP can differentiate a target from others, especially in a tight market. Again, this is not simply IP for the sake of IP, but instead a thoughtful approach to IP that fits the business goals of the company.
Micromolding for surgical robotics can offer better functionality and lower costs
Micromolded plastic has function, miniaturization and automation advantages over machined metal for surgical robotics components and instruments.
Micromolding offers promising new ways for medtech companies to deliver innovative products that save more lives while reducing the cost of implementation. While injection molding isn’t new, recent breakthroughs are expanding what injection molding can achieve in medical device manufacturing.
One area where micromolding offers groundbreaking possibilities is advanced robotic-assisted surgery (RAS) systems. Until the 1980s, manufacturers relied primarily on metal for most surgical devices. Metal is biocompatible, sterilizable, durable and easy to machine into the geometries needed for
But as device complexity increased, metal components became much more expensive to produce. Production was time-consuming and often generated large amounts of scrap, which raised manufacturing costs and product prices.
Initial medtech applications of injection molding
Although invented decades earlier, injection molding of plastic components became a viable, large-scale commercial option in the 1970s. Engineers recognized its ability to produce increasingly complex components. Instead of spending minutes to machine a single metal part, large multicavity molds could produce dozens in a matter of seconds.
Injection molding also improved part quality, offered process repeatability, and allowed for tight tolerances while drastically reducing material waste and scrap cost. By the
1980s, medical device manufacturers had widely adopted injection molding for its clear performance and cost advantages.
High performance polymers lead to a breakthrough
At the same time, material engineers began focusing on high-performance polymers. Up to that point, the largest barrier for adopting injection molding was the lack of polymers suitable for medical use. Biocompatibility was essential, and at the time, metal outperformed polymers. That changed when high-performance polymers like polyetheretherketone (PEEK), liquid crystal polymer (LCP), polyethersulfone (PES) and polyphenylene sulfide (PPS) entered commercial use. These polymers offered better lubricity, can be sterilized like metal, and in some cases were more biocompatible than the metals used in medical devices of that era.
As injection molding scaled commercially, engineers began to see some of the limits of molded components. Larger, simple components transitioned easily to injection molding, but smaller intricate parts still required traditional metal fabrication. As a result, micromolding technology became a key area of development focus. At the same time, high-performance polymers reached cost parity — and in some cases, even fell below biocompatible metal options.
Micromolding replaces metal in most RAS systems
Today, micromolding plays a critical role in manufacturing RAS systems because of the ability to achieve complex geometries, lower manufacturing costs, and improve overall device functionality. Micromolding has made lifesaving, minimally invasive care significantly more accessible and affordable.
Micromolding will play a central role for increasingly complex medical devices such as surgical robotics systems. Photo courtesy of Viant
Simultaneously, integrated metal parts for RAS systems have stagnated. While metal parts can be fabricated at a micro level, creating complex geometries with traditional metal fabrication techniques can introduce challenges that micromolding avoids.
For example, RAS systems use multi-degree-of-freedom joints with internal channels for high-flex cables, irrigation and suction, and sensor integration. Machining metal into such small, curved internal channels is extremely difficult, especially at scale, and the cost of producing these metal components is a significant problem for most commercial manufacturers.
Why RAS systems are moving toward micromolded plastics
Micromolding reduces manufacturing costs by improving material efficiency and production speed. It also shortens cycle times, and in most cases costs less than their metal counterparts, a reversal from when micromolding first emerged.
Improved device functionality is another reason RAS systems are shifting
to high performance plastics. During calibration of these systems, engineers depend on each part to meet tight specifications. Metal components can have slight deviations, often requiring device-by-device calibration to ensure smooth operation. Micromolding produces components that match, leading to a more efficient calibration process. Specialized additives like barium or carbon can enhance functionality, improving radiopacity during RAS operations.
The present and future of micromolding
Viant recently partnered with a customer to develop a micro-insertmolded component critical to end effector function. Metal wasn’t an option, as the part needed to provide electrical insulation.
Viant selected a high-performance plastic and developed a custom micromolding process to meet all performance requirements, including complex geometry and durability. The project required intensive engineering
during development and resulted in an optimized solution that provided a validated, repeatable process that delivers complex, life-saving components for RAS devices at a lower cost than metal alternatives.
The shift from metal to micromolded, high-performance plastics is accelerating. Its use already extends beyond RAS and is helping to reshape the possibilities within the medical device industry.
As medical device complexity increases, so does the need for scalable, precision-engineered solutions. Micromolding will play a central role in meeting that growing demand, driving innovation across the next generation of medical technology.
Martin Johnson is VP of technical solutions – polymers at Viant. Johnson has deep expertise in micromolding, a foundation in mold making, and decades of experience in scientific injection molding for the medical industry at leading contract manufacturers.
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Three methods to consider for miniaturizing instruments for robotic assisted surgery
As
smaller,
robotic-assisted surgery (RAS) instruments
become ever
fundamental principles of mechanical engineering dictate the extent of useful work they can achieve.
Miniaturization is a key innovation goal for many robotic-assisted surgery (RAS) companies. Smaller instruments and cameras reduce the invasiveness of the path required to access the surgical site, helping to minimize the trauma of surgery.
Yet miniaturization also impacts the ability of RAS systems to navigate to the surgical site, visualize the procedure and perform useful work. A balance needs to be struck by combining an understanding of scientific principles with knowledge of surgical applications. This article looks specifically at the ability to perform useful work with miniaturized instruments.
Instrument miniaturization requires consideration of the physics concept of work done — force multiplied
by distance — at the output of the system. This is what constitutes the ”useful work’” and it dictates what can be achieved with small instruments in a confined space. Instruments must be able to exert sufficient force with sufficient control, despite their miniaturization. The method of actuation plans a significant role in the miniaturization challenge.
Mechanical work and surgical robotics miniaturization: three methods to consider
At present, commercially successful RAS systems generally use relatively large, external electric motors with actuation transmitted through the instrument to the distal end effector with tensioned wire. >>
Surgical robotics instrument miniaturization has implications for force transmission, cable tension, friction — and dexterity and control.
Photo courtesy of Sagentia Medical
However, reducing instrument size has implications for force transmission, cable tension, and friction, which in turn impact dexterity and control — and the ability to perform useful work. Consequently, different approaches to actuation may be necessary for RAS systems with miniaturized instruments. Several methods warrant consideration.
1. Actuation at the point of application
This involves the development of lowcost micro actuators. These must be commercially viable in an instrument likely to have a limited number of use cycles. It assumes that the means of actuation is compatible with common sterilization techniques.
On one hand, miniature actuators based on well-established phenomena such as piezoelectric actuation and magnetostriction are yet to deliver, despite many years of academic exploration. Tantalizing headway has been made in soft robotics using carbon nanotubes to fabricate miniature actuation components, but this has not unlocked a viable route for commercial systems to date.
On the other hand, shape memory alloys (SMAs) like nitinol offer interesting actuation possibilities for RAS systems. They deliver a very compact muscle that’s controllable with electrical signals rather than cables. Once SMAs are heated, they do need time to cool down, but this approach could be suitable for tasks that can be performed very slowly.
2. Pneumatic and hydraulic systems
Fluid power for instrument control also deserves consideration. Pneumatic and hydraulic systems tend to be associated with heavy machinery, but developments in lightweight industrial robotics could be transposed to surgical applications. While it has typically been resisted in commercial RAS systems (possibly due to clinical concerns around failure modes), fluid power as a low-friction, low-crosstalk means of transmission could be useful in delicate and intricate applications. Including one end effector with a hydraulically actuated closing force within a single-port or endoluminal system would release space for additional cable actuated instruments or a larger imaging system. There is enough innovation potential to warrant continued investigation, particularly in some natural orifice procedures.
3. Novel mechanical configurations
Currently, end effectors on RAS systems usually resemble a human arm. The only variation is whether hinges are pivots/ball-and-socket joints (like an arm) or segmented joints (like a spine). However, there are other ways to form an articulated actuator.
Concentric tube robots have been prototyped for minimally invasive surgery within confined spaces, including endoluminal applications. Constructed from pre-curved, super-elastic tubes slotted together in a flexible drive shaft assembly, they can assume complex 3D curves, with individual tube sets designed to produce the necessary curves for a given surgical procedure. Some of these solutions use magnetic actuation to facilitate travel via narrow lumens into areas that are hard to access, while respecting anatomical constraints.
Challenges surrounding tool exchange during endoluminal procedures mean the development of multifunctional tools also holds promise. However, since robotic instruments are typically limited-use products, materials and manufacturing processes must lie within acceptable costs per procedure. This should be carefully considered before highly intricate assemblies or novel materials are designed into instruments.
Blend pragmatism with creative problem-solving
The development of RAS systems with miniaturized tools demands a combination of pragmatism and creative problem-solving.
While mechanical work is an important factor, there are alternative means of performing useful work. For instance, for some forms of therapy, there is potential to cut, seal or ablate tissue using energy provided in the form of radio frequency, microwave, ultrasound or laser. Combined cutand-seal instruments are already available, replacing the need for mechanically complex cutting mechanisms.
RAS innovation needs to draw on novel enabling technologies and materials, applied using first principles scientific understanding. Together, these factors will enable further tool miniaturization that enhances RAS systems’ ability to perform useful work, mechanically or otherwise.
Rob Morgan, VP of medical at Sagentia Medical, began his career at Smith+Nephew before joining the R&D consultancy formerly known as Sagentia Innovation. He has a PhD in physics and is passionate about innovation in surgical robotics.
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Cleveland Clinic reports world’s first transcontinental robot-assisted focal therapy procedure for prostate cancer
The Focal One Robotic HIFU system’s dynamic focusing probe images a patient’s prostate from inside their rectum. Illustration courtesy of EDAP Technomed
"After a while, I forgot that I was doing a remote surgery," Cleveland Clinic urologist Dr. Ruben Olivares said of EDAP's Focal One system.
Cleveland Clinic says one of its doctors used a robot-assisted system for minimally invasive treatment of prostate cancer in a patient more than 7,000 miles away.
The team used the robotic Focal One high-intensity focused ultrasound (HIFU) system to deliver focal therapy for ablation of non-metastatic
“Focal therapy involves using a robotic arm to deliver ultrasound waves to the prostate to treat prostate cancer,” Cleveland Clinic Abu Dhabi Department Chair of Urology Dr. Waleed Hassen said in a video posted to LinkedIn. “In this case, while I was at the bedside with the patient in Abu Dhabi, I was able to transfer controls of the robotic arm to my colleague in Cleveland. … He was enabled to seamlessly perform the procedure from beginning to end without my intervention. It was as if he was in the room sitting next to me.”
The Cleveland Clinic urologist operating the system from Ohio was Dr. Ruben Olivares, who said in the video, “After a while, I forgot that I was doing a remote surgery.”
The prostate tumor ablation procedure requires no major surgery or radiation exposure. It took about an hour and was completed without any complications, Cleveland Clinic said.
It’s the latest advance in telesurgery as medical device developers and researchers combine robotics, device connectivity and advanced imaging to make life-saving technologies available across the globe — and beyond.
“This milestone reinforces Cleveland Clinic Abu Dhabi’s dedication to providing world-class expertise to those who need it the most,” Cleveland Clinic Abu Dhabi CEO Dr. GeorgesPascal Haber said in the video. “It sets the stage for a future where geographical boundaries no longer limit access to excellence in healthcare.”
The Focal One Robotic HIFU system
Austin, Texas-based EDAP Technomed (the U.S. subsidiary of France-based EDAP TMS) won FDA clearance in 2018 for prostate tissue ablation with its Focal One device, but the company said the remote technology used in this first-of-its-kind procedure is not yet available for sale.
The goal of this first procedure was to successfully demonstrate feasibility and gain valuable insights, the company said in a statement shared with Medical Design & Outsourcing. “The next step is to conduct additional procedures with the Cleveland Clinic teams to gather additional clinical feedback and finalize the technical requirements for commercialization.” >>
The Focal One Robotic HIFU system features a dynamic focusing probe for high-resolution, real-time ultrasound imaging and HIFU energy delivery.
“HIFU technology directs highintensity sound waves through an ultrasound probe to a precisely controlled focal point within the prostate,” EDAP explains at its website. “This rapid concentration of energy increases the temperature at the targeted area, causing coagulation
The Focal One robotic automatic positioning system has five degrees of freedom and submillimetric accuracy for precise targeting of the tumor in 5 mm increments (up to 40 mm) while protecting the patient’s rectal wall.
“Robotic execution of planned ablation is performed with unparalleled accuracy, ensuring safe and effective outcomes,” the company says.
EDAP says the Focal One device ablates 30 cc per hour, or up to
with real-time ultrasound to provide accurate precision,” the company continued. “This allows the urologist to contour precisely to target the lesion and avoid critical structures.
HIFUsion is an open-platform concept that uses the latest DICOM standard compatible with all MRI scanners and most fusion biopsy platforms.”
Safety features include a rectal cooling system with realtime monitoring and control of the company’s patented Ablasonic cooling liquid. The system also monitors the rectal wall’s position in real time with ultrasound to automatically adjust the probe with the robot, and can also detect patient movement to automatically halt the ablation.
“Unlike other focal therapy treatment technologies requiring surgeons to manually position needles based on 2D visual feedback, Focal One’s design allows the treatment to be controlled through a fully digital 3D interface,” the company said in its statement. “The personalized treatment plan is developed by the surgeon using an intuitive on-screen interface, while the fully robotic positioning system ensures precise delivery of HIFU energy driven by the surgeon-defined treatment plan. This sophisticated design allowed the development of a Focal One remote workstation that mirrors the dual treatment screens on the Focal One system and provides real-time communications between the Focal One remote workstation and the Focal One system. This achievement demonstrates
“While I was at the bedside with the patient in Abu Dhabi, I was able to transfer controls of the robotic arm to my colleague in Cleveland. … He was enabled to seamlessly perform the procedure from beginning to end without my intervention. It was as if he was in the room sitting next to me.”
necrosis that destroys cancerous cells while sparing the surrounding healthy tissue. This precision minimizes damage to critical surrounding structures, significantly reducing side effects.”
Ultrasound imaging frequency is typically in the 3-10 MHz range around 0.02 W, while the Focal One HIFU therapy uses focused ultrasound beams at 3 MHz at 200 W.
three times faster than other HIFU technologies. The total procedure time is usually 45 to 90 minutes, including set-up and planning.
Proprietary HIFUsion software allows the physician to overlay “MRI and/or 3D biopsy data for precise contouring,” the company says.
“Focal One integrates preoperative MRI and 3D biopsy data
The Focal One Robotic HIFU system is a minimally invasive approach to treating prostate cancer. Image courtesy of EDAP Technomed
that the Focal One system is ideally suited for this type of telecollaboration.”
The potential applications go beyond prostate cancer. In March 2024, the FDA gave the Focal One HIFU system a Breakthrough Device designation for treating deepinfiltrating endometriosis.
“Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” EDAP Technomed CEO Ryan Rhodes said at the time.
In March 2025, the company secured a CE mark for treating posterior deep endometriosis infiltrating the rectum and surrounding structures. The company is also evaluating the technology for treating benign prostatic hyperplasia and conducting clinical
research on the treatment of tumors in organs such as the pancreas.
EDAP had 130 active Focal One systems placed as of the end of 2024, including 65 in the U.S., the company said in its most recent annual report.
“The majority of academic centers using the Focal One system are collecting data following an Investigational Review Board approval in order to continue building clinical evidence and long-term HIFU outcomes,” the company said. “These various sources of clinical data are a basis for individual sites to present abstracts at regional, national or international conferences and submit manuscripts for peer-review to renowned journals and publications. This holds the potential for the FDA, which cleared HIFU for prostate tissue ablation in 2015, to re-evaluate the technology in the future for prostate cancer indication.”
“Unlike other focal therapy treatment technologies requiring surgeons to manually position needles based on 2D visual feedback, Focal One’s design allows the treatment to be controlled through a fully digital 3D interface.”
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Intuitive Surgical’s approach to the global trade war set off by President Donald Trump’s import taxes could help other device developers and manufacturers navigate tariff turmoil.
In 2024, Intuitive manufactured 98% of its robotic systems in the U.S., 70% of its endoscopes in Europe, and about 80% of its instruments and accessories in Mexico, CFO Jamie Samath said while discussing the company’s financial and operating results for the first quarter of 2025.
“We source raw materials and other components that go into these finished products from suppliers around the world,” he said. “The net result of our manufacturing footprint and global customer demand is that Intuitive is both a significant U.S. manufacturer and has become a significant net U.S. exporter.”
On the same call, Intuitive CEO Gary Guthart described the surgical robotics leader’s “principles for navigating the current environment.”
An Intuitive Surgical endoscope assembler at work in one of the device developer’s European manufacturing facilities Photo courtesy of Intuitive Surgical
Intuitive’s trade war strategy holds lessons for other device developers
Intuitive leaders Gary Guthart, Dave Rosa and Jamie Samath discuss supply chain and pricing strategies in the face of new tariffs.
“Our first priority is to assure supply of our products to our customers globally,” he said. “We have spent years becoming a trusted provider of great products and services, and our first commitment is to maintaining the status for those who depend upon us. We believe that high-quality, minimally invasive care at industrial scale will remain a global need, regardless of trade policy. And our long-term opportunity remains robust. We will continue to manage the business for the long-term and invest toward improvement in the Quintuple Aim.”
(If you’re not familiar with the Quintuple Aim, Guthart has defined it in recent years as the mission “to deliver better patient outcomes and improved patient and care team experiences, while lowering treatment costs, reducing the duration of hospital admissions, and enabling access to care.”)
Guthart said price hikes aren’t on the table just yet. >>
“Given potential changes in our costs and our customers’ costs across their enterprise, we do not plan reflexive changes to our pricing in that dynamic, near-term environment,” he said. “Our second priority will be to optimize our production costs and rebalance product flows within our existing manufacturing and supply chain footprint as policies begin to stabilize. Finally, we will adjust our supply chain strategy and assess adjustments to our pricing when we see the signs of a durable planning environment for trade.”
Intuitive is assuming that retaliatory tariffs will go into effect after Trump’s 90-day pause lapses.
“We’ll see how that plays out,” Samath said. “…With respect to the manufacturing operations in our supply chain, to the extent that there are lowhanging fruit that isn’t disruptive to our partners and our employees, then of course we’ll pursue those. But I think our first move is to let things stabilize and evaluate then what’s possible. We’ll do that concurrently across the year, and we will consider things like: Do you have to invest to mitigate? What’s the time to receive the benefit? What’s the economic return of that?”
“There are complexities in some of the things that you might do from an operational perspective,” he continued, “so we don’t want to move too quickly, given how dynamic the environment is.”
Supply chain risk mitigation is ongoing
Intuitive President Dave Rosa — who takes over as CEO in July — said the device developer’s supply chain team can apply many of its core strategies to deal with new import taxes.
“It’s really two frames of reference that you ought to use. One is thinking about the parts that are coming into our factories, the ones that we assemble. And then the other frame of reference are the parts that are leaving our factories,” he said. “… Our teams have been working to get to industrial scale for years now, and so some of the processes that exist within this framework inside of Intuitive really center around assessing risk in all of our supply chain. We procure thousands of parts for our systems and instruments. And so our teams look through there, assess the risk and then ensure appropriate mitigations
are in place. [It’s] a robust process that runs on a daily basis.”
Those mitigations can include dual sourcing and building strategic reserves, Rosa said.
“If you look at our parts, our components and our products going to customers, we’ve done a lot of work to qualify some of our products under USMCA. We’ve optimized inventory around the globe ahead of some of these tariffs taking place,” he said. “And then if you look in the mid-term, we can use our existing manufacturing footprint that we have around the globe and optimize what products are manufactured in what area around the globe to help optimize some of the supply for our customers.”
“And then in the long-term, we can build our overall manufacturing footprint against the trade environment that ultimately stabilizes,” he continued. “That’s going to be a long-term way in which we help mitigate some of the supply risk, if you will, within our supply chains.”
Intuitive continues expansion Intuitive is expanding its U.S. footprint, Samath said, with two new facilities that opened this year at its Sunnyvale, California headquarters: a 912,000-square-foot facility for da Vinci systems manufacturing and R&D, and a 315,000-square-foot facility for Ion manufacturing and R&D.
The company also recently expanded its Peachtree Corners site in Georgia where the company makes da Vinci X and da Vinci Xi systems.
And before the end of 2025, Intuitive plans to open manufacturing facilities in Germany and Bulgaria while expanding its instrument manufacturing capacity in Mexico, Samath said.
“In addition to supporting our growth plans, we believe over time these new manufacturing facilities give us supply availability, quality and cost advantages from scale and factory automation,” he said.
The company added about 500 employees in the first few months of the year, half of them in manufacturing.
“Given long-term opportunities to drive the Quintuple Aim and grow revenue, our resolve to invest in R&D and innovation remain unchanged,” Samath said.
Intuitive Surgical CFO
Jamie Samath
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Led
by Liane Teplitsky, Artedrone is
developing
a magnet-steered robotics system that
can
navigate to blood clots for mechanical thrombectomies.
This microrobot system is designed to float inside a stroke patient for autonomous thrombectomy
Expanding care to stroke victims is one of medtech’s biggest opportunities, and startup Artedrone is developing a microrobot system that can navigate to blood clots for autonomous mechanical thrombectomies.
Backed by Truffle Capital, Artedrone has submitted findings from its preclinical program for publication in an unnamed research journal as it continues testing to lock in the Sasha system’s design for its first-in-human procedure sometime in 2027.
The Paris-based startup is trying to raise a €20 million Series B funding round to finalize that preclinical work and fund the first-in-human studies, with a Series C round following to finance a pivotal study by 2028.
“An idea behind the company is to democratize these very complex procedures,” Artedrone CEO Liane
Teplitsky, former head of global robotics at Zimmer Biomet, said in a Medical Design & Outsourcing interview.
The Sasha system is designed to use MRI or CT imaging — the same scans that can locate and confirm a blood clot in a stroke victim — to create a digital twin of the brain vasculature to chart a path for the catheter to reach and remove the clot.
At a cath lab or interventional neuroradiology lab, an interventionist would insert the catheter in the patient’s groin and up to their carotid artery.
“That’s the base camp,” Teplitsky said. “After that, you push a button and the robot is let out. It’s propelled by the blood flow — it’s not active in that way — until there’s a bifurcation, like a fork in the road. We’ve already pre-planned, we know exactly where we want to go, and that’s where our external magnet comes in. It pushes or pulls the magnet >>
The mechanical thrombectomy catheter in Artedrone’s Sasha system moves with the flow of blood toward the blood clot for capture and retrieval using suction. Illustration courtesy of Artedrone
[on the catheter] in the right direction, and then it continues along that pathway as we let out a little bit more line automatically to the next spot. If there’s another bifurcation, we use the magnet again.”
The blood slows as the catheter nears the clot that’s blocking the vessel, at which point the magnet positions the distal end of the catheter to grab the clot.
“It acts as suction like an aspiration catheter, but you see very different properties than a normal aspiration catheter,” said Teplitsky, who described it as a magnetic suction cup. “You turn on the suction and we have a feedback loop that tells us whether we’re really adhered [to the clot before] we start pulling back.”
The line is engineered to be flexible enough to navigate to the clot, but strong enough to grab and remove it, withdrawing back into the guiding catheter and out of the patient by the operator at the table.
Challenges ahead
“We want to get to Level II stroke centers, maybe even cardiac care centers where you have hands that are expert in getting into the carotid, and then after that they don’t have to get to that brain vasculature, which takes another two to seven years of training, depending on who you talk to and what country you’re in,” Teplitsky said.
“One of the biggest challenges and opportunities is that we know the interventional neuroradiologist will certainly have to be involved, but our long-term play is going to be in these Level II stroke centers, potentially with the interventional cardiologist as one of the leads,” she later
“One of the biggest challenges and opportunities is that we know the interventional neuroradiologist will certainly have to be involved, but our long-term play is going to be in these Level II stroke centers, potentially with the interventional cardiologist as one of the leads.”
“You basically push a button and it pulls it back through the vasculature,” she said. “[Like] an aspiration catheter, there’s always the risk of the clot breaking up as you pull back, but the bottom line is we’ve got the base camp catheter as close as we think we can get to it to be able to pull it back. … We have some pretty good results showing that it’s very effective.”
Teplitsky declined to divulge the system’s materials for competitive reasons. In a statement shared with Medical Design & Outsourcing after our interview, Artedrone said the microrobot’s magnetic suction cup “exhibits at the same time the appropriate magnetic properties for the magnetic actuation and the appropriate design to optimize the interaction with the clot.”
“The cup is connected to an innovative section with antagonist properties such as a high flexibility and a low strain,” the statement continued. “This section is connected to a multilayer structure with the appropriate properties for pushing.”
continued. “So how do we figure out the best way forward for our first-inhuman — which centers we want to go to, who do we want to partner with, and what does that look like — and really map that out with the risk-benefit for the patients?”
Locking in the system’s design, finalizing development and building documentation for regulatory review is “a relatively straightforward path at this point,” Teplitsky said, with FDA 510(k) clearance the likeliest route.
Their test equipment has so far included 3D models of pig and human anatomy with accurate vasculature, blood pressures, viscosity and temperature.
“I keep talking with my team about creating some IP around this test bench, because it’s been just about as much work as actually the product at this point,” she said. “We’ve learned some great lessons from that. Now we have a really robust in vitro model that translates to the in vivo model, so you can go in and feel very confident as you move from one to the next.”
But there are two big remaining challenges that are common for medtech developers working with robotics.
TOP: Before the procedure, CT or MRI scans would build a digital twin of the patient’s vasculature to map a path to the blood clot.
BOTTOM: Magnets on the Artedrone Sasha system’s robotic arm and catheter help the thrombectomy device on its pathway to the blood clot. Illustrations courtesy of Artedrone
“One is make sure that it’s really meeting a need, and I feel we’ve done this,” she said. “We know what we’re trying to do. There’s a huge need out there. People will be willing to pay for it because there’s this huge burden and huge costs associated with stroke, the third-leading cause of long-term disability in the world. The second [challenge] is ease of use. … Because of the user population that we want to go to, it really needs to be straightforward.”
The technology could end up being useful for other neurovascular procedures or in endovascular or cardiovascular applications.
“There’s definitely opportunity as we look at the whole system, not only the catheter component, but what we’re doing around imaging, AI, and catheter delivery,” she said. “All those different components could definitely be applied to different places.”
Go to wtwh.me/teplitsky to hear more from Teplitsky in a separate interview with our DeviceTalks podcast.
BY JIM HAMMERAND MANAGING EDITOR
novel mitral and tricuspid heart valves, as well as robot-assisted catheter delivery technology for minimally invasive implantation.
Capstan Medical is developing
Photo courtesy of Capstan Medical
Capstan Medical CEO Maggie Nixon didn’t get much rest the night before the firstin-human procedure using the structural heart startup’s novel mitral valve implant and surgical robotics system.
“It’s a combination of excitement and nerves, and if you don’t have both of those, I don’t think we’d be doing it right,” she said. “There wasn’t a lot of sleep.”
“When you’re bringing out a first-in-human with an instrument on an existing platform, it’s one thing,” she later continued. “But it’s different bringing out the entire integrated system all at once. We made a decision as an organization to bring out the robot, the catheter and the implant all together, rather than a staged approach.”
In an interview with Medical Design & Outsourcing, Nixon discussed the strategy of moving forward with the entire minimally invasive system at once, feedback from those first cases, the latest on Capstan Medical’s regulatory efforts, and an update on the startup’s tricuspid valve technology.
“We had an implant and a manual catheter before we had the robot. Initially, we were carrying on those programs in parallel, because you want to learn things about your implant, you want to learn things about your catheter, and you want to learn things about your robot, and we’re going to keep those going forward,” Nixon said. “But as we were looking at the scheduling, they were kind of converging, and every bit of information we had — both from our clinical advisors and our in-house teams — [indicated] the robot was going to be the right way. So we merged the programs and brought them all out together instead of doing it in stages, because it wasn’t going to be swings of a year. It was going to be swings of a couple of months.”
(continued on page 33)
LED BY INTUITIVE SURGICAL VETS AND BACKED BY INTUITIVE VENTURES, CAPSTAN MEDICAL IS DEVELOPING TECHNOLOGY FOR ROBOT-ASSISTED TRANSCATHETER HEART VALVE REPLACEMENTS.
(continued from page 31)
Feedback from doctors on the first two cases didn’t indicate a need for any major tweaks or fundamental changes, Nixon said.
“Mitral is not an easy procedure,” she said. “We went into our first-in-human and those cases went smoothly. A lot of that comes from the technology hitting on the right things we needed to do for that procedure. … We have the range of motion we need, we have the stability and control that we wanted, we’re finding patients to treat, and we’re not having any outflow obstructions. A lot of it is confirming that we’re on the right track. Our coordinated motion is working and our procedure workflow is
“... It’s different bringing out the entire integrated system all at once. We made a decision as an
organization to bring out the robot, the
catheter and the implant all together, rather than
a staged approach.”
Capstan’s regulatory pathway Capstan Medical is planning to file for FDA premarket approval (PMA) for the system as soon as 2028. The company has already filed a Q-Sub with the FDA and had what Nixon described as “a couple of good calls” with regulators.
“It’s been kind of fun. It’s really great to start to get down into the details of how we want to structure our future trials,” she said. “We’re starting by focusing on our implants. Sometimes that’s the longer-lead testing, so we want to make sure we’re deeply aligned with the agency on what testing is needed there. And then we’ve got our next round of questions already set up to make sure that we stay well aligned.”
Asked whether she’s concerned that cuts by the Trump administration to the FDA could delay or hinder Capstan’s progress, Nixon said they’re “definitely tracking it closely.”
“We reached out to our review team and our review team hasn’t been impacted, but we’re very sensitive to the environment they may be experiencing right now,” she said.
“We’re trying to work closely and be good partners.”
Similarly, her team is keeping an eye on Trump’s tariffs, though that’s less of an immediate concern.
“We are well positioned for ramping volumes even in our current footprint,” she said. “We actually have cleanroom capacity and capability to drive all the way into a pivotal trial.”
The latest on Capstan’s tricuspid technology
Capstan has continued work on its tricuspid implant since our last conversation with Nixon in December 2024. That novel implant will come after the mitral valve technology, but Nixon said the tricuspid project is “ramping very quickly.”
The main goal has been selecting an initial annular size for that novel implant, which like the mitral valve implant uses nitinol to expand when placed inside a patient’s heart.
“That’s been our key focus, making sure we’re dialed in there. Other than that, it’s just fine-tuning that to move into production,” she said. >>
This photo shows the articulated end of Capstan Medical’s delivery catheter prototype and the compressed mitral valve implant.
Medical designed its mitral heart valve implant with a self-expanding nitinol frame.
Celebrating Capstan’s first-inhuman procedures
Capstan Medical’s first-in-human procedures were conducted in Santiago, Chile. That’s the same city where Medtronic‘s Hugo surgical robotics system was first used on a human, and it’s where surgical robotics developer Levita Magnetics has been conducting research.
“This is the culmination of years of work. Bringing that integrated, seamless implant, catheter and robot together into these cases was incredible.”
“We’ve been incredibly impressed with Chile’s clinicians and capabilities, as well as the infrastructure they provide,” Nixon said. “They have been incredibly collaborative. We have protocols submitted, and we work very closely with their research coordinators and so on. The combination of skilled clinicians and good infrastructure all wrapped up with a collaborative regulatory pathway makes it very reasonable to consider. … And they don’t have the full suite of products that are in investigation or on the market, so there’s patient need. When you bring that capability and that patient need together, it works really well.”
After Capstan’s first-in-human operation, Nixon held a Zoom meeting with the entire company to share the good news before filling the board in — and then toasted the milestone with a pisco sour.
“This is the culmination of years of work,” she said. “Bringing that integrated, seamless implant, catheter and robot together into these cases was incredible.”
Capstan
Photo courtesy of Capstan Medical
Capstan Medical R&D Head Greg Dachs on robotic components and trade-offs
Greg Dachs joined Capstan this year as R&D head and previously worked on next-generation systems, instruments and technology at Intuitive.
He’s particularly passionate about user experience, the trade-offs that are inherent in surgical robotics design and engineering, and medtech innovations that can improve or save the lives of patients across the globe.
In an interview, he discussed the most critical components for robotics systems and the trade-offs engineers and designers commonly face.
“The motors, sensors and brakes end up often being the critical components. There’s a lot of them. Every degree of freedom on a robot has at least a motor and likely a gearbox, two or three sensors. All those things have to work together in harmony to get your system to work. And especially as you get closer to the patient with the robot, size constraints start to really matter. You want those motors to be small so you’re not taking up a bunch of space over the patient. As the motors get smaller, they’re less able to produce the amount of torque that you need for a given amount of power input, so they get hotter. Balancing how small can you get it while still maintaining the thermal performance that you need, there are lots of trade-offs there. And you want to get pretty close. You want to get just about as hot as you can, which isn’t that hot. It’s in the low 40s (degrees Celsius), which feels warm, but if you’re going to have this thing in contact with an anesthetized patient for a long time, even those low temperatures can do damage. We take a lot of care to make sure that we’re being safe. On the sensor side … we use magnetic sensors to figure out where the motor is. Those need to be reliable, they need to be accurate, they need to not generate too much heat, they need to package into the volume that you have. Lots of trade-offs and three-dimensional Tetris gets played around that. There are lots of strategic suppliers we work with there to make sure that we’re getting the best stuff and the best supply chain for it as well.”
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Go to wtwh.me/dachs to read the entire interview.
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J&J MEDTECH ARMS ITS
MONARCH ROBOT FOR
LUNG CANCER THERAPIES
MONARCH PRESIDENT ALEKSANDRA POPOVIC EXPLAINS WHAT’S SPECIAL ABOUT THE UPGRADED SYSTEM AND OFFERS ADVICE FOR DEVELOPING ROBOTICS AND AI.
BY JIM HAMMERAND MANAGING EDITOR
Johnson & Johnson MedTech‘s Monarch robotics-assisted bronchoscopy system reaches deep into the lungs for biopsies, offering a minimally invasive alternative to transthoracic needle biopsy while maximizing diagnostic yield for earlier, more definitive results.
“Robotics has significantly improved the patient experience because they [can get a more definitive diagnosis] and they’re given therapy within days of the exam,” Monarch President Aleksandra Popovic said in an interview. “Before that, a lot of patients would receive an exam and be told, ‘We don’t know yet what it is. We were not in the lesion, we didn’t get enough cells, we didn’t get enough tissue. You need to either come back or we can wait for your nodule to grow a bit.’ It’s very disruptive to a patient’s life.”
J&J just supercharged Monarch with the FDA-cleared Monarch Quest, which has upgraded hardware and software for improved navigation using data from its sensors and GE HealthCare 3D cone-beam computed tomography (CBCT) scans, helping the physician understand where the device is and how to get to the target.
“Physicians are going after smaller lesions and those that are deeper in the lung, and those are the best ones to catch early because the treatment is much better than [those that] grow bigger,” she said. “Monarch enables confidence in getting to these places, and with Monarch Quest we are taking the next step. We invented this category. We were the first robot there, and we are reinventing the category.” >>
Johnson & Johnson MedTech says its Monarch system’s telescoping scope-insheath design allows for independent articulation and insertion force redirection, enabling physicians to reach further into the lung and “make small adjustments to place the biopsy needle into different areas of the nodule.”
Image courtesy of J&J
What’s special about J&J’s Monarch robot
J&J acquired the Monarch system through its $3.4 billion purchase of Auris Health in 2019. The technology was developed for stability and flexibility, and Monarch’s robotic telescoping bronchoscope is a key feature.
“We have a scope-in-sheath design that gives rigidity and stability when you need it and flexibility when you want to make tight turns to really go very deep in the lung,” Popovic said. “… As you’re moving, there is no motion of the scope from the respiration. Once you’re there and you want to do a biopsy, it gives you a really stable channel to put any sort of device — diagnostic or therapeutic — through the robot and it gives you confidence it’s always going to go to the same place once you’re there.”
The system uses marionette wires running down the scope for control.
“The motors are outside of the body, so we control a passive bronchoscope actively from the arms,” she said. “That’s a safer way to do things, and our physicians like doing that because they can mentally separate the actuation from the devices.”
The latest version has three times more computing power with a new Nvidia chip and improved algorithms for better navigation that integrates that CBCT imaging, electromagnetic tracking, respiratory data and the scope’s vision.
“It’s truly real-time, AI-driven navigation, which gives much smoother navigation, much more precise navigation, and more confidence to go after really hard-to-reach nodules,” Popovic said.
The latest version has enough onboard computing power for more software updates as soon as this year to build its AI capabilities for improved navigation and segmentation. It also includes new cybersecurity protections,
including a physical door lock on the tower to limit access and a unique key for every customer.
The future of robotic bronchoscopy
Right now, the Monarch system is mostly used to help clinicians diagnose lung cancer, but the system is also cleared for therapeutic use.
“We talk about our product as an open product,” Popovic said. “We have a channel and we have a camera so you can use the camera and the channel at the same time, and physicians are using the robot also for therapy. The therapy isn’t developed a lot, but in the future our platform will be for diagnosis and therapy — and therapy will grow.”
Those therapies could include ablation or pharmaceuticals, but Popovic said they “are not taking sides” and “will enable everything.”
“We work very closely with our J&J Innovative Medicine group that is developing in situ drug delivery, so drugs are an opportunity. Some sort of energy deployment is also an
J&J wants to expand endoluminal robotics beyond bronchoscopy and already has clearance for urology procedures. Researchers have reported positive outcomes using Monarch for minimally invasive percutaneous nephrolithotomy to remove kidney stones.
“In addition to potentially helping urologists achieve stone-free patients in a single procedure, this approach could help reduce the need for retreatment after kidney stone removal and decrease risks and complication rates,” University of California, Irvine School of Medicine Urology Chair Dr. Jaime Landman said after the first robot-assisted kidney stone removal, which used the Monarch system.
Advice from the system’s development Popovic sees Monarch as a good example of what medical robotics should be now and in the future.
“You have to have a really good robot — stable, reliable, something that people have joy in using — and then you have to have a strong software backbone to add information and help people use the robot to its best capabilities,” she said, and that takes strong teams. “We spend a lot of energy getting the right people, and then very close collaboration between software and hardware. It
Testing is also crucial, with Popovic encouraging other device developers to organize verification and validation “in a very structured way. … not rushing, but doing it systemically so everything talks well together.”
“Testing with real-world data is the most important thing,” she said. “There are a lot of AI algorithms out there, but we as an industry have to come to a place where there’s a lot of trust in AI, and the way to build trust in AI is to test it and spend more energy in testing than in development in order for customers to have a good experience with AI. … The two most important things in AI [are] getting the right data — not a lot of data, the right data — and testing, being willing to spend most of your energy making sure the algorithm works versus making sure the algorithm is set up in the system.”
And what is the right data?
“The right data is from real cases, properly grouped, properly understood,” she said. “The wrong data is synthetic data, generic data that is not really giving the right focus.”
If you want to join Popovic’s team, she’s looking for engineers with a passion for improving medtech.
“There are a lot of engineers out there, but it’s a smaller group that’s passionate about impacting patients and physicians. That’s No. 1,” she said. “And then strong multidisciplinary skills. The best roboticist knows a bit of software, a bit of hardware, control systems, and some will be more experts in one or another, but we want people who are rounded engineers, who can think about a system and not only about the components. Those really thrive in this environment, and they are the best people we have.”
WHAT J&J MEDTECH’S NEW DUALTO SAYS ABOUT THE OPERATING ROOM OF THE FUTURE — AND OTTAVA
BY JIM HAMMERAND MANAGING EDITOR
Johnson & Johnson MedTech is keeping details of its Ottava surgical robotics system under wraps, but the new Dualto Energy System offers insight into the medtech developer’s vision for the operating room of the future.
J&J MedTech recently won FDA 510(k) clearance for the Dualto generator, which is indicated for surgical procedures requiring cutting or coagulation of soft tissue.
people are more connected.”
Makkar discussed the Dualto’s system’s design and how the world’s second-largest medical device company intends to meet the needs of operating rooms and ambulatory surgical centers (ASCs) for the next decade and beyond.
Size and simplicity
The Dualto system can power multiple electrosurgical tools, providing simultaneous energy generation for two clinicians for the first time, who can work on opposite sides of a patient during complex operations.
“ORs are complex spaces. There’s a lot of stress in that space. … Real estate is very precious in the operating room and the workflow needs to be simplified.”
The modular electrosurgical system combines four energy modalities from two previous-generation Ethicon generators: the Megadyne Electrosurgical Generator (monopolar and bipolar) and the Endo-Surgery Generator Gen11 (ultrasonic and advanced bipolar).
The Dualto system will be compatible with J&J MedTech’s Ottava system, the investigational surgical robot that recently had its first-inhuman cases. While those Ottava procedures did not use the Dualto system, they’re designed to work together in the same environment, said J&J MedTech Worldwide President of Endomechanical & Energy Sandeep Makkar.
“I cannot go into the specifics of the robotic system, but the general principles on anything we do in medtech innovation — particularly in medtech surgery innovation — is to make sure that our technology designs are more human,” Makkar said in a Medical Design & Outsourcing interview. “That’s a principle we follow regardless. On every platform, you’ll see our technology be more human in terms of the user interface and all of that. We also want to make sure that our care is more adaptive … and that
J&J says combining separate generators into one reduces the footprint by 46%, and minimizes electrical interference and distractions of multiple systems.
“ORs are complex spaces,” Makkar said. “There’s a lot of stress in that space. … Real estate is very precious in the operating room and the workflow needs to be simplified. There’s enough literature that tells us the more the workflow is interrupted and people are in and out of the sterile field, moving things around in the operating room — things that take too much space just present more risk for the patient, and it breaks that cohesiveness of the team.”
Simplicity — always a goal in medical device design — is even more important when patients are under the knife.
“The system combines multiple energy modalities for us into one unified, integrated platform and does it in a way that’s very simple to use,” he continued. ” … It’s simple to use across procedures, whether it’s an eight-hour procedure or a one-hour procedure, whether it’s an ambulatory surgical center or an operating room, and it does it in a way that’s adaptable to different care settings and also very easily upgradeable if you’re a single user versus a double user.” >>
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To minimize the system’s weight and reduce the total number of components, J&J uses a magnesium injection molding process called thixomolding, which is also used in the older Gen11 generator.
“The material is far more durable than standard alloys and is recyclable,” he said. “… We went through multiple rounds of design for manufacturing and design for assembly improvements, because it helps at the back end to improve your throughput, keep your costs down, and prevent end user errors.”
Computing power and connectivity
The Dualto Energy System gives clinical teams the choice of monopolar, bipolar, ultrasonic, or advanced bipolar devices and different combinations of them with different power settings. The Dualto system also allows physicians to save their own pre-configured settings to the system.
“Nurses have a high turnover in the operating room,” Makkar said. “The teams are constantly changing. If you’re a doctor and you have a new scrub tech in the operating room who doesn’t know the settings you use for a lobectomy or a wedge resection — your monopolar settings or bipolar settings or ultrasonic settings — it can cause stress: stress for the surgeon and stress for the scrub tech.”
Advances like modern microelectronics and microprocessors made it possible to combine these multiple energy generators into a single system, with proprietary software continuously monitoring the configuration of the system between the two modules.
Custom field programmable gate arrays (FPGAs) with more logic capabilities for faster processing capacity and speed help calculate tissue conditions in real time based on impedance and other measurements, with the algorithms optimized for different characteristics of diseased tissue and healthy tissue.
“Tissue is dynamic in nature. … As energy is delivered, tissue properties start to change, but if your energy doesn’t realize that it only pumps in a certain level of power every time, and that can quickly desiccate a tissue and not get you the desired tissue effect. It can quickly cut the tissue
coagulation in open and minimally invasive surgery.
without sealing the tissue first,” he said. “So you need energy algorithms that can sense the changing tissue characteristics, whether it’s the water in the tissue, the collagen content in the tissue, or fibrosis happening.”
“That’s why you need more compute power,” he later continued. “You need the real-time compute power and that speed and capacity to be able to make those quick calls and get the desired tissue effect.”
The system can also connect to J&J’s Polyphonic Fleet digital device management system.
“Polyphonic will not have patient identifiers, but for every case it will capture logs that get sent to the cloud, so in case there’s an error, the team can dig straight into the logs and figure out where the problem is,” Makkar said. “It helps troubleshoot things much faster. … For biomedical engineers, if there are 30 or 40 systems in the operating rooms, they don’t know where each of these systems are. Now you can almost name every system in Polyphonic Fleet. You could be a biomedical engineer
sitting miles away and track the performance of every generator in the specific ORs, so if something breaks down in any OR you can track that.”
What’s next for the Dualto Energy System?
The system is in a limited launch to learn more about user experience, with Makkar reporting “very strong positive feedback” in those early cases. More cases are planned before a full release in the second half of this year.
“It’s going to delight the end users because it’s a connected system,” he said. “It’s a cohesive system. It addresses their fundamental needs. It creates workflow efficiencies for them, reduces their cognitive burden, and it’s adaptable. You can use it in an ASC, you can use it in an operating room. You can use it with a single user, you can use it with double users. You can use it in a simple case. You can use it in an eight-hour-long complex case. And it combines not just the hardware, but the digital components of a connected ecosystem through Polyphonic Fleet.”
Photo courtesy of J&J MedTech
Johnson & Johnson MedTech Worldwide President of Endomechanical & Energy Sandeep Makkar
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Zimmer Biomet seeks a ZBEdge for its Rosa robotic surgery
COMPETITION IS STIFF IN THE ORTHO ROBOTIC SURGERY SPACE, BUT ZIMMER BIOMET BETS DATA-DRIVEN PATIENT MANAGEMENT IS THE ACE UP ITS SLEEVE.
Shaun Braun spent nearly 13 years at Stryker, where he helped build the digital infrastructure around the Mako robotic systems that took the orthopedic surgery space by storm.
He eventually joined soft-tissue surgical robotics company Intuitive as an SVP, but after a year there, a casual introduction to Zimmer Biomet CEO Ivan Tornos changed everything. Tornos, after all, has goals for Stryker competitor Zimmer Biomet to be nothing less than the “boldest medtech company on Earth.”
Said Braun of his initial meeting with Tornos, “I got a chance to feel the power, the energy, the boldness. He very quickly turned from, ‘Hey, tell me a little bit about your experiences,’ to, ‘I’ve got an experience for you.’”
In May 2024, Braun joined Zimmer Biomet as chief information and digital officer. Six months later, he added chief technology officer to his responsibilities.
“When Ivan crafted this role, it was, ‘Let’s bring it all together and drive enterprise technology with product technology and transform healthcare,’” >>
Zimmer Biomet’s Rosa robotic surgery system is a major component of the device developer’s ZBEdge ecosystem. Image courtesy of ZB
Braun said. “And that’s the journey we’re on.”
Zimmer Biomet has been competing against Stryker’s Mako robots with its own Rosa systems for knee, hip, brain and now shoulder procedures. Braun says ZB has an edge with its ZBEdge dynamic intelligence platform for hip and knee surgeries, which connects and collects data throughout the entire episode of care and serves it up to health providers and patients to inform better outcomes.
ZBEdge includes the company’s MyMobility app for iPhone and Apple Watch to track progress and keep patients connected with their care teams, the Persona IQ smart knee implant created with Canary Medical, and the recently released AI-powered ZBEdge Analytics.
“They have stuck to this journey for six-years-plus, when many other orthopedic companies have stopped the investment,” Braun said of Zimmer Biomet. “It’s about personalized intelligence. That’s what we are really driving. We’re the only company today that can take that preoperative information of the consumer/patient.”
Braun recently discussed ZBEdge, Rosa, and what’s next with Medical Design & Outsourcing. (The comments below have been lightly edited for clarity.)
MDO: What kind of challenges did ZB face with MyMobility?
Braun: “It’s hard to monetize these software solutions. For organizations, rightfully so, there’s [the question of] how are we going to monetize this and who’s going to pay for it? Is the consumer going to pay for it, the patient? Unlikely. Are the providers going to? An ASC, an IDN? Are the payers going to pay for it? Early days, there were a lot of challenges with how to monetize this. There’s shared value, and anytime there’s shared value, there’s kind of pinpointed value, right? We have over 250,000 patients that are running on MyMobility,
so Zimmer Biomet has cracked the code on getting individuals to download the application. We still have some work to do on how to monetize it more directly on the value we believe we’re providing. … A lot of orthopedic companies have been challenged with whether to place the robot and then get pulled through from an implant perspective. We believe we’ve got something very unique now with ZBEdge Analytics and MyMobility. We are actually getting approached by third-party groups that have broader wellness platforms or work more specifically with large organizations that have to support their own employees. They are looking to pay us and white-label what we’ve built out, because there’s so much depth. … For us, it is agnostic to implant. Many of our technologies are agnostic to implant. We believe that power, that intelligence layer, needs to preside as such.”
Any updates on your partnership with Canary Medical?
Braun: “Bill [Hunter, Canary’s CEO,] has been doing some incredible work with us looking at patient recoveries and starting to find some unique biomarkers. The economic cost of individuals being nervous about their recovery curve — coming into ERs or asking for an extra scan — there are some early indicators that if someone is actively looking at their data, there’s
a reduction of 40% of unneeded return visits. That is a massive number. We’ve got white papers and abstracts we’re putting in for AAKHS (American Association of Hip and Knee Surgeons) this year. That’ll be super exciting for orthopedics in general to see.”
How do you handle the interface and communication with healthcare providers, because every doctor I’ve ever met has a really busy schedule?
Braun: “The vast majority are, ‘Wow. Is this going to be a burden to me and my care teams?’ Because it’s alert fatigue. So the team had to be very thoughtful about the most important information. You can turn off a lot of the noise for certain customers, and you can give other customers the full breadth of the data that they want. Our current model is simple dashboards with color, the notion of, ‘Who do you need to zoom in on?’ These are daily readouts. So if everybody’s great, everybody’s on their recovery curve, within the track of their personalized journey? Nothing. Open up the dashboard? Great. If there are some yellows, reds, you can click. You can see, ‘Odd, they didn’t take that many steps,’ or, ‘They took too many steps. They’re gonna get some swelling because they are trying to get back to the marathon too fast.’ With generative AI and a lot of the large language models, we are already working on the next step. (continued on page 46)
ZBEdge Analytics takes data from a array of sources — such as the Rosa robotic surgery applications, MyMobility metrics collected via patient iPhone and Apple Watch, and the Persona IQ smart knee implant — and flows them onto a smartphone application where surgeons can assess patient performance. Image courtesy of Zimmer Biomet
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(continued from page 44)
So why do you have to even look at a dashboard? Why do we have to construct dashboards, and everybody looks at data differently? Have a very natural interface in the morning on your drive in. ‘Tell me about my patients. Tell me about Sally or Joe.’ The data is there, the technology is there to enable that for folks who are more comfortable with that level of interaction. That’s going to be the pathway. It’s super exciting, because it’s now.”
the surgeon profiles that are looking for a much more simple registration process and decision-making process based on their own personalized inputs.”
Where would you like to improve on Rosa?
Braun: “I think that the bigger area of focus we have is this robustness of data and bringing that personalized intelligence in a very seamless fashion back to the planning and decisionmaking in a personalized fashion for
“There are some early indicators that if someone is actively looking at their data, there’s a reduction of 40% of unneeded return visits. That is a massive number.”
Is there a name yet for the voice assistant you’re developing?
Braun: “We need to get the marketing team involved because there are a lot of thoughts around that. You’ve got to be careful with names.”
What kind of results are you seeing with Rosa, and how does it fit into the whole ZBEdge ecosystem?
Braun: “Rosa, historically, has been very data rich to take the procedure that the surgeon was used to and bring a robotic form factor to it that still allows a lot of the depth of detail for those surgeons to drive. That has worked really well for certain surgeons, especially internationally. Incredible results. Inside the U.S., there’s, ‘Simple sometimes is better.’ We have a really exciting launch that’s coming out here at AAHKS (Oct. 23–26, 2025 in Dallas). We’re calling it internally our Rosa Knee with Optimize. I think it’s going to have an exciting impact, because it takes some elements of the complexity and it really gives surgeons the opportunity to put some of their personalized, intelligent decisions into the platform so the action when you’re in the operating room is much more efficient. For certain surgeons, they are still going to want to see all the dials and gauges when they’re deciding on their alignment philosophies. Others have a certain philosophy in mind, and then they want to roll with it. We’ve seen some competitive platforms go with a pretty simple, ‘Here’s your plan, your scan, and get after it.’ So I think this will be really impactful for some of
each of those patients. That’s the part that we’re really excited about with ZBEdge Analytics that gives that post-game film about the decisions you made and results you saw. It starts to get into some recommendations around adjustments they may want to make, obviously leaving the decisionmaking in the hands of the surgeons and the care teams. But the interesting part now is that alignment philosophy is all the rage: kinematic, mechanical, all kinds of variations of it. It’s almost like Harry Potter sorting hats. Surgeons may think they’re a certain alignment philosophy, but the data we found with some of our surgeon developers are like, ‘Wow, I thought I was Hufflepuff, but [they’re a Gryffindor]. They love the fact that the data that we’re showing them around the decisions they made as Rosa captures all that, it feeds back into what alignment philosophy are you actually deploying, irrespective of what you think you are deploying. I thought this was really interesting. Many of the surgeons say, ‘I have these edge cases where I have a decision box that I’m making.’ There’s art in that. ‘How far do I do this? What kind of flexibility do they have in their soft tissue? How much do I probably want to make up for some long-standing alignment challenges they’ve had throughout their life?’ That’s an edge case. Now we give them the ability to get that playback off those decisions they made where they can say, ‘Wow, you know what? I’ve seen about 10 of those turn out. I’m going to be a little more aggressive in the fact
that I’ll follow that philosophy more,’ or, ‘I’m not seeing the results that I would have expected,’ so they’ll adjust. … Our ability to leverage data, this personalized intelligence layer across all the assets we have, from a PACS imaging perspective, with Medstrat, from MyMobility all the way across to ZBEdge Analytics, we feel it’s just going to really put into surgeons’ hands their data, their decisions, and their journey going forward with their patients.”
What innovations do you need from other medtech developers to advance your technology?
Braun: “Surgical navigation in the operating room. There’s a huge amount of opportunity. … When you think about inefficiency in the operating room, if there can be more real-time registration with — let’s be honest, our phones have got some incredible cameras and LiDAR — there’s a ton of technology out there today that when it gets to a point that it can be deployed, [it] will really speed up the registration process that robotic platforms have to navigate.”
Zimmer Biomet Chief Information and Technology Officer
Shaun Braun
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