But big market predictions are often vague on the specifics. Where specifically is the market opportunity for robotically assisted systems? What are the challenges manufacturers face in the highly regulated medical tools market? What are the market drivers and technological advancements behind the trends? I caught up with Darren Porras, Market Development Manager of Medical at Real-Time Innovations (RTI), for a look at what’s really happening (and what’s coming down the pike) for the medical robotics market. GN: In what procedures have medical robots become standard? Why those procedures, and what does that say about the earliest iterations of the technology? Darren Porras: Robotically-assisted systems are increasingly being used today for a broad array of procedures: General Surgeries (e.g. GI, Colorectal), Urological, Gynecological, Neurovascular, Orthopedic (hip/knee implants), and Spinal procedures. These systems provide greater control of surgical instruments and improved visualization to enable more precise and reproducible treatment. For patients, this means less trauma and faster recovery times. Laparoscopic robotic systems that consist of surgeon-controlled instruments inserted through abdominal ports are the most commercially available systems today to surgically treat a number of cancers, including prostate, bladder, and rectal cancers. While the initial laparoscopic robotic systems expanded upon the already established minimally-invasive approach for laparoscopic procedures, these systems continue to evolve, and other form factors and device architectures are now in use and emerging. For orthopaedic and spinal procedures, robotic arms and intelligent hand-held devices are assisting surgeons in guiding tools for precise placement and treatments. Flexible robotic systems incorporate steerable catheters, bronchoscopes, and other devices to perform lung biopsies and percutaneous cardiovascular interventions. These systems provide deeper access into internal anatomy and through natural orifices. GN: Given the market for medical interventions and the evolving technologies, where are the big market opportunities for medical robots, and why is that the case? Darren Porras: Market opportunity in healthcare is really about how to most effectively and efficiently improve patient care and outcomes. The role of robotics in augmenting surgical tasks during the procedure is only a part of this. The digital transformation in healthcare is redefining how patients are diagnosed, treated, and monitored. This transformation incorporates devices, intelligence, and interoperability of systems and data prior to surgery, during surgery, and for follow-up after surgery. Device manufacturers that develop robotic platforms that integrate holistically and seamlessly with the clinical workflow and leverage data-driven technologies across the device ecosystem will transform minimally invasive surgery. It’s important to note that the majority of surgeries being performed today are not robotic or even minimally invasive. There is a significant opportunity for robotics across all procedure types to improve surgical treatments and patient care. As surgical procedures increasingly utilize data and interoperable intelligent systems to realize clinical efficiencies, assist in decision-making, and automate procedural tasks, robotics will play a key role in meeting the needs of healthcare systems and patients. GN: Can you speak to some of the challenges manufacturers still face, particularly in areas like system development and issues like safety/reliability, interoperability, and cyber security? Darren Porras: These systems pose many technical challenges and new computing paradigms. Evolving technologies and increasing complexity presents a steep learning curve to development teams and a lot of risk. With many competitors entering the market and the need to accelerate feature development, companies must focus their teams on what differentiates their products and leverage state of the art technologies, tools, and reusable reference architectures. Surgical robotics are complex, distributed systems of computing nodes, cameras, sensors, instruments, and other devices that all must work as one integrated system. It’s a data connectivity challenge with a number of simultaneous and demanding requirements for reliability, performance, cybersecurity, and interoperability. Cybersecurity is a big concern. While regulatory bodies, device manufacturers, and hospitals are increasingly collaborating to improve the security of devices and hospital systems, cybersecurity breaches are now a common occurrence. The threat landscape has changed- a couple of teenagers with tools readily available on the internet can launch ransomware attacks and bring down medical devices and vulnerable hospital networks. The consequences of a breach can lead to patient harm, product recalls, and exponential costs to companies that may also include disclosure of trade secrets/IP. Regulatory bodies are raising the bar for approval with updated cybersecurity guidance and increased scrutiny. Device manufacturers must design secure communications into the product at the “white-board” stage across the device ecosystem to secure data components across multi-domain networks while satisfying demanding performance requirements and diverse use cases for system and data access. These challenges require new software architectures and state-of-the-art, distributed connectivity solutions that enable intelligent, secure, and real-time connectivity across devices, systems, and network domains from the edge to the cloud. Beyond APIs, connectivity frameworks are needed that enable interoperable, reliable, and flexible architectures that are scalable. Device manufacturers can’t afford to redesign their systems or update hardware whenever they release new features. Leveraging connectivity frameworks enables development teams to focus on their core competencies and application development- thereby accelerating time to market. GN: What’s on the horizon in terms of capabilities? How will AI and automation play a bigger role going forward? Darren Porras: Robotic systems will increasingly become ‘digital platforms’ that leverage data integration and intelligent connectivity across devices to enhance the surgical procedure itself while also being an integral part of a digital surgery ecosystem. By leveraging this interoperability of systems of systems, the power of the convergence of these technologies will truly transform patient care. This requires increasing integration of imaging, visualization, and intelligence through dedicated but increasingly distributed systems and networks. Device and edge-distributed processing are increasingly important for safety-critical robotics applications where key requirements are latency, reliability, and security. This distributed architecture allows systems to process data locally to execute intelligent device functionality efficiently. Remote-teleoperation is another exciting area where we are already seeing systems capable of performing remote surgeries across 5G networks. These capabilities allow surgeons worldwide to collaborate, enable greater access to expert treatments, and reach remote and underserved populations. AI algorithms will enhance the sensing capabilities of surgical instrumentation based on physiological parameters and sensor fusion (e.g. blood perfusion, temperature, pressure sensors). AI will also be leveraged to realize increasing levels of surgical precision, autonomous functionality, and consistency of surgical procedures. Leveraging data, visualization, and intelligence across distributed devices and networks, these systems will provide real-time guidance during the procedure while also assisting in pre-operative surgical planning and post-operative device and procedure optimization. For example, data and metrics collected from the procedure may be used to provide feedback to improve the next surgery and train other surgeons. Clinical teams across the world may leverage this data to collaborate, advance, and standardize surgical treatments. This offers an incredible opportunity to provide universal access to high-quality care and patient outcomes. GN: What’s your sense of the market appetite for medical robots within both the medical and patient communities? Any pushback from healthcare workers? Any reticence among patient populations? Darren Porras: The high cost of these systems is one key barrier. With new competitors entering the market and as the designs of these systems continue to evolve, it’s anticipated that these factors will drive down costs. Another barrier is the learning curve required by the clinical teams to operate and the difficulty in incorporating these systems into the clinical workflow and hospital ecosystem. Robotically-assisted systems have made great strides in the technical arena- but that’s not sufficient to transform surgery. A system may incorporate the most innovative technology. Still, if the technology is inaccessible, whether due to cost factors, insufficiently trained staff, regulatory constraints, or unavailable due to reliability or security issues- this presents a significant hurdle. Device companies need to incorporate best practices in system design and security and evolve functionality quickly to meet the needs of the clinical teams, the hospitals, and the patients. As the utilization of robotic systems grows and these systems demonstrate value and improved patient care across the care cycle, this will continue to fuel further adoption. While there is a perception that surgeons will be “replaced”, this is not actually the way increasing automation usually plays out in a highly skilled industry. Industry professionals need to collaborate with clinical stakeholders to embrace how procedures can optimally incorporate robotics to elevate what is possible to be done in surgery today and standardize more precise surgical treatments to a greater patient population. At the end of the day, nobody resists what is best for the patient. Patients are calling for technologies that enable the most effective treatments, faster recoveries, and reduced complications. As technology continues to transform patient care, medical device manufacturers must adapt to the needs of the patient, the procedures, and the clinical teams. Surgeons are already taking advantage of the benefits of improved ergonomics, greater visibility, and the ability to treat patients earlier and with higher precision. These systems will continue to improve the automation of surgical tasks and the clinical workflow. By leveraging intelligent and distributed connectivity, it will be difficult to imagine surgeries without robots in the not-too-distant future.
