Risks Rise As Robotic Surgery Goes Mainstream

As robotic-assisted surgery moves into the mainstream, so do concerns about security breaches, latency, and system performance. In the operating room, every second is critical, and technology failures or delays can be life-threatening.

Robotic-assisted surgery (RAS) has around for a couple decades, but it is becoming more prevalent and significantly more complex. The technology often includes a variety of processing elements and sensors, built on architectures capable of crunching massive amounts of data and providing real-time feedback to surgeons and their support teams. But these machines also are increasingly connected to the internet — either directly or through some other network — and this is where many problems begin.

“Robotic surgery systems have developed into a mainstream tool for hospitals. They allow for more precision and less-invasive operations, exceeding the capabilities of traditional surgery, said Marc Witteman, CEO of Riscure. “But as with all connected devices there is a security risk, which has recently become apparent in the many ransomware attacks. Imagine that your urgent medical procedure halts due to a hacker-invoked system crash. Or even more advanced, suppose the procedure is hijacked and deliberately made to mal-perform.”

While much of this equipment is still used for on-site surgeries, it can be used remotely.

“This is where 5G comes into play,” Witteman said. “This technology offers low latency and high reliability and is suitable to remotely control RAS. But while 5G technology is designed for security, this covers only part of the risk. Indeed, a strong design mitigates attacks that exploit limitations of the technology, but an even bigger threat is in the implementation. Embedded systems software is increasingly complex, and we know that devices typically contain hundreds of vulnerabilities. There are weaknesses in the product that do not impede normal operation. However, an attacker who knows those weaknesses, and who can combine them for malicious ends, can exploit them.”

Those breaches also raise privacy concerns, and the less secure the networks — which is a problem with surgeries performed remotely for rural areas — the greater those concerns.

“The confidentiality and integrity of crucial control and telemetry signals sent over a network link should always be protected with strong end-to-end mutual authentication between devices,” said Mark Knight, director, architecture product management at Arm. “To implement this, the robot and the remote doctor’s controller should have strong, secret credentials protected within a hardware root of trust. A root of trust provides trusted functions that higher-level device services can use to ensure security. Security frameworks and certification programs, such as PSA Certified, can offer a standardized approach to security, allowing the entire value chain to work with consistent requirements to implement security measures that are right-sized for the use case. Widely deployed network transport protocols such as TLS can then use the secured credentials to underpin device-to-device authentication, helping to mitigate the risk that control signals are intercepted or modified.”

Yet even day-to-day interruptions can cause issues. Service fluctuations can bring a surgery to a halt, and operations that are performed remotely may be impacted by everything from weather to geopolitics. Because this is still relatively new, regulations and best practices will take time for formulate.

“There are challenges with remote surgery,” said Sathish Balasubramanian, head of products at Siemens EDA. “Many of the surgical procedures require high precision. Local robotic-assisted surgery provides that benefit. However, remote surgery depends on a highly reliable network with high bandwidth and low latency. During the operation, especially with a 3D vision support, a delay of 4 to 5 seconds is like an eternity and may be critical to the success of the operation. Additionally, the FDA still needs to address some of the open issues. During the remote operation, if the lead doctor with full qualifications is not present in the operating room, how will the FDA regulate that? If something goes wrong, who would be responsible? The lead doctor who performed the operation remotely, the assistant doctors in the operating room, or the manufacturer of the surgical equipment?”

RAS origins
In the 1970s, NASA came up with the idea of doing surgery remotely. Thirty years later, robotic-assisted surgery (RAS) started to enter the field of medicine. On September 2, 2001, a group of French doctors in New York operated on a patient located in Strasbourg, France, using the Zeus surgical robot. Called the Lindbergh operation, it was the first successful telesurgery procedure to remove the gallbladder from a patient.

This approach has been well tested since then. Today, many leading institutions, including the Mayo Clinic, Stanford, MIT, UCLA, and USC Medical perform robotic-assisted surgery on a routine basis. RAS benefits include higher-precision and better results than human doctors in some cases, and most important, faster recovery times for patients.

With robotic-assisted surgery, after a surgeon makes the initial incision, the RAS-trained surgeon will operate on the patient by controlling a console equipped with 3D HD vision capability and a joystick-like controller. Viewing through a 3-D camera, the surgeon manipulates the robot to do whatever is required. The surgeon is still in control the whole time, but may never actually touch the patient.

Fig. 1: Some robotic equipment is equipped with multiple robotic arms to perform major surgeries and can weigh up to 1,200 pounds. Source: Corindus, a Siemens Healthineers Company

With the rollout of 5G, the use of RAS is expected to expand in coming years. That will open the door to more expertise everywhere, but as the electronics become more advanced, so does the potential for the technology to cause problems.

“Silicon design and selection in designing robotic-assisted surgical equipment can be complex,” said Lang Lin, principal product specialist at Ansys. “Power, performance, and area (PPA) are important. Security is the fourth design pillar after PPA. Similarly, security can be measured at hardware, firmware, and software levels just like power. It just gets more complicated than power or performance, but the silicon-level security is definitely the root of trust. The semiconductor industry and EDA community have begun taking security design and verification seriously in recent years.”

Security needs to be implemented at every level, not just at the chip level, and it needs to be updated as new threats emerge.

“To minimize risks posed by software vulnerabilities, the RAS manufacturers should consider security all along the product development cycle,” said Riscure’s Witteman. “This starts by training the development team, making them aware of typical vulnerabilities and security best practices. After that, implementation reviews and product testing should be a repetitive part of the process until the product is complete. Finally, a certification should confirm that the product is secure indeed and that it can be applied at low risk. Without these steps we may expect similar incidents as the ones seen in our critical infrastructure, undermining public confidence in new technology.”

Why it matters
The digitalization of surgery is a huge step forward, both in terms of predictability of results and the ability to go back through data if something goes wrong to determine what happened, when it happened, and potentially why.

Today, robotic-assisted surgery is used in many areas, including cardiac, colorectal, endometriosis, general surgery, gynecology, transoral (head and neck), thoracic, urology, and more. The technology can be used for inpatient surgery, as well as outpatient and remote surgery.

Knee replacement operations are the most common inpatient surgery. According to Harvard Health, 730,000 knee replacements are performed every year in the U.S. Recently, handheld robotic devices have become available to perform knee and hip operations. Because each person’s knee or hip size is different, the operation requires precise measurement and data collection to create the replacement parts. Smith & Nephew reported that using such handheld robotic devices for automatic data capturing reduced required data point collection by 72% and increased the data point collection area 2.5-fold. As a result, faster surface model generation can be achieved with 40% reduction in workflow and ultimately cost savings.

Compared to traditional surgery, robotic-assisted surgery provides more precise and steady motion without fatigue. It is not uncommon for a surgical team to take hours to perform an operation. Lengthy procedures can cause surgeons to experience hand tremors due to stress on the hands. With mechanical precision enabling better dexterity, the robot can operate on smaller areas than human hands are able to. A 3D high-definition microscope and monitors help surgeons clearly see the patient’s condition. Higher precision and efficiency allow operations to be performed in less time, causing less fatigue for the surgeons and less patient blood loss.

The patient experience is also improved because robotic-assisted surgery requires smaller incisions, causes less pain, and requires less patient recovery time. This also decreases the possibility of infection after the surgery.

“Robotic-assisted surgery has made significant contributions in the field of medicine,” said Subh Bhattacharya, AMD‘s lead for Healthcare & Sciences. “The specialty-trained surgeon controls the robot arms using the ‘augmented-reality’ joysticks to operate on the patient. Taking the minimally invasive approach, it only requires a tiny incision as small as 8mm and can perform a high-precision procedure in a much shorter time than humans can. This allows patients to recover much faster with minimum blood loss. What used to be a week-long stay in the hospital can now be accomplished in an outpatient procedure. This enhances patient experience and saves costs.”

Designing robotic-assisted surgical equipment is complex. Designers have to consider precision electromechanical movements, motor control, 3D technology, and HD camera design. Chip material selection and architecture can determine whether to build everything into a system-on-chip, a system-on-module, or even a system-in-package. Those choices can have a big impact on system performance, power consumption, the number of I/Os and the speed of network connections, as well as software choices and capabilities, security, safety, reliability, and cost.

In the past, medical equipment manufacturers relied on OEMs specializing in electromechanical designs. With advances in chips and packaging, more medical equipment manufacturers are now making complete robotic-assisted surgical equipment systems.

“Intuitive’s da Vinci surgical system is the pioneer in the field of robotic surgery,” said AMD’s Bhattacharya. “Other major companies like Medtronic and Johnson & Johnson are preparing to market their own surgical robotics system, as well, for general surgery using SOMs and embedded SoCs. In the past, building a robot was much more challenging. Now, the advent of adaptive SoC technology with accelerators, required connectivity I/Os, and associated software stacks of OS, middleware, and accelerators are making designing these robotic systems faster.”

Fig. 2: Simplified view of robotics stack tools and components. Source: AMD

Data speed matters
In 2019, interventional cardiologist Ryan Madder, M.D. successfully completed 36 Percutaneous Coronary Intervention (PCI) simulations using dedicated fiber 5G public networks. The simulations were carried out between Waltham, MA, and San Francisco, roughly 3,000 miles away. This was a good first step.

Successful remote surgeries depend on reliable, high-speed, wireless networks, such as 5G. Reliable network infrastructures are also important. In theory, 5G can reach speeds of 20Gb per second with latency of 1ms. In reality, however, today’s 5G has only reached 5% of its potential maximum speed.

Nearly everyone has experienced the frustration of internet disruptions. However, in remote surgeries, the impact of any outage is more than just an inconvenience. What if the network stalls during the surgery? “Reboot the system” is what an ISP would normally tell the network users to do. For RAS, this is not a good option.

One solution is to have redundancy. But incorporating redundancy increases investment costs, and it doesn’t address issues such as latency, which can be caused by anything from traffic surges to aging circuits. Even sticky keys can cause problems, where repeatedly striking a key initially seems to have no impact, then suddenly causes letters to appear on the screen. If that happens during a cutting procedure, will the robot repeat the same procedure multiple times? How would the surgeons or the IT professionals know if the network is delayed, frozen for a short time, or completely down at that moment?

Therefore, it is critically important to have secure and reliable network system performance (5G) during the remote surgery procedures. These requirements include:

• Sustainable high-speed performance;
• Minimum latency in milliseconds;
• Reliable network connection during the whole operation;
• Redundancy or backup/failover set-up;
• Security of hardware and software, and
• In remote, less developed areas, reliable infrastructure — including a stable power grid/electricity supply.

Finally, dealing with surgical equipment failure is another major challenge. What is the emergency procedure if robotic-assisted surgical equipment failure occurs? Should the patient be sewn up manually at that point? How would this impact the patient’s health? These are all unanswered questions.

The future
Robotic-assisted surgery is just beginning to be deployed on a mass scale. New technologies are being integrated into equipment to improve performance and reduce downtime.

“AI and digital twins will improve future performance,” said Siemens’ Balasubramanian. ” It is important to have a minute-by-minute record of the procedure, and the digital twin technology will certainly be able to record the procedure and provide future analysis to improve the process and for educational purpose. There is great hope that as time goes by robotic-assisted surgery will increase accuracy, efficiency, and safety, while potentially reducing healthcare costs.”

It also can help provide access to specialists in remote areas where there are none. “Access to surgical expertise is limited in many rural areas of the U.S., as well as in many parts of the world,” said Santosh Kesari, M.D., Ph.D., and co-founder and director of Neuro-oncology, Pacific Neuroscience Institute in Santa Monica, CA. “It is expected that more and more hospitals and health institutions will be using robotic-assisted surgical equipment not only for in-person care, but also for remote surgeries. The technology will continue to evolve and innovate. Future equipment will be more versatile, flexible, lighter weight, and more AI-based. Other types of robotic equipment, such as handheld devices will also be developed and will enable accelerated telehealth/remote care.”

Some of this also will depend on how quickly high-speed communications infrastructure is deployed. So while 5G will help — it has a peak data rate of 20 Gbps with latency of 1 ms — 6G is expected to be even better. In theory, the peak data rate of 6G will reach one terabit per second with a latency of 0.1 ms.

But speeds can vary greatly depending upon where the technology is deployed and how those speeds are measured. Opensignal, an agency keeping track of 5G performance around the world, notes that South Korea frequently has taken the lead in achieving the fastest 5G performance, for example with Ultra-Wideband download speeds of 988.37 Mbps. However, Verizon recently measured a peak performance of 1.13 Gbps. The speed varies based on the placement of 5G antennas and is very location-specific. A peak performance achievement at one time does not mean that it is consistently sustainable. Now at 1 Gbps, 5G still has a long way to go before it will reach 20 Gbps.

In short, remote robotic-assisted surgical concepts have a great deal to offer the medical community. There are countless benefits. But ramp-up time will depend upon many factors, from secure chips to robust communications systems, and the ability to monitor all the components in multiple connected systems that all need to work together for RAS to be successful.