What J&J MedTech’s new Dualto says about the OR of the future — and Ottava

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.

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-in-human 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 people are more connected.”

Makkar discussed the Dualto system’s design, features 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.

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.”

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 — what 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.

Customized field programmable gate arrays (FPGAs) with more logic capabilities for faster processing capacity and speed to 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 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, fibrosis that is 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 a eight-hour-long complex case. And it combines not just the hardware, but the digital components of a connected ecosystem through Polyphonic Fleet.”