During our recent webinar, “From Innovation to Commercialization: Navigating the Surgical Robotics Market,” we received many questions about the growing surgical robotics market. This week on the Ascential blog, our experts tackle your most pressing questions about surgical robotics from trending technical advancements to system serviceability to managing an R&D team.
Reliability
Q. As the complexity of robotic systems increases, achieving reliability becomes more challenging. How can you create a reliability program to deal with complexity and to produce a reliable product upon release?
A. Ensuring the reliability of increasingly complex robots is critical to commercial success. It is important to start with a comprehensive system view, breaking down all components into functional subsystems to identify high-risk areas early. By focusing on subsystem testing where most changes and moving parts exist, risks can be mitigated more efficiently.
This approach can be supplemented by adhering to established standards like the IEC for reliability growth and using statistical methods to simulate workflows, even before complete systems are available for testing.
As part of the development and commercialization pathway, achieving FDA clearance involves rigorous usability, validation, and verification testing. By thoroughly understanding product performance (rather than just passing regulatory tests), you can ensure the highest standards of customer experience and reliability.
A limited market release can also help to gather real-world feedback from early users, allowing for timely enhancements based on actual performance and user experience, ultimately delivering a robust and reliable product to the market.
Serviceability
Q. What are the serviceability challenges for surgical robots? Is it possible to service them without large-scale or whole-unit replacement?
A. Surgical robots are highly complex devices, requiring meticulous setup and regular maintenance to ensure optimal performance. Upon installation, engineers unbox, set up, and calibrate the equipment, followed by certification from the biomedical engineering department. Regular maintenance is performed under service contracts, with field engineers conducting preventative maintenance and on-site repairs when unexpected issues arise. Occasionally, devices must be returned to the factory for extensive repairs or recalibrations.
Size and complexity are significant challenges in the serviceability of surgical robots. Transporting a 900-lb. piece of equipment for repairs requires specialized shipping solutions and logistics providers. However, advancements in technology will ease these challenges. As surgical robots become more miniaturized, their serviceability will improve, making maintenance more akin to that of consumer electronics, reducing the need for large-scale interventions.
Process
Q. What synergies need to exist between cross-functional teams within an organization for a robotic system to have commercial success?
A. Achieving commercial success for a robotic system, especially in the medical field, requires seamless collaboration among a cross-functional team within an organization. During the development phase, it is crucial to involve team members from R&D, product and marketing, regulatory, and quality departments. This collaborative effort ensures that a concept can be effectively transformed into design criteria, prototypes, and eventually a minimally viable product (MVP). External development partners can also provide significant support, particularly for small to mid-size companies, by bringing additional expertise and resources.
In the commercial phase, the synergy between different teams becomes even more critical. The sales team must engage with clinical advocates and negotiate with C-suite executives, while legal and IT teams play vital roles in contract negotiations and ensuring data protection. Once contracts are finalized, the field service team handles the installation and certification of the product, while the clinical launch team trains medical staff on its usage.
Continuous post-market support from compliance, regulatory, and customer experience teams is essential to address any issues that arise, ensuring the product’s reliability and user satisfaction. Overall, involving service engineers and focusing on design for manufacturability (DFM) and design for serviceability (DFS) from the early stages are key to creating a product that is not only innovative but also practical and sustainable in the market.
Trends
Q. Are single-use devices, such as endoscopic devices, useful alternatives to reusable devices?
A. Single-use endoscopic devices can offer value, particularly due to stringent cleaning requirements associated with reusable devices. There have been major corrective and preventive action (CAPA) issues reported by the FDA related to inadequate cleaning procedures, highlighting the potential risks of reusable equipment. Single-use devices mitigate these risks, reducing the likelihood of contamination and eliminating the need to sterilize equipment before use.
Single-use devices can also provide another point of differentiation and become a new revenue stream. These products will become a consumable that will continue to be purchased for ongoing use.
That said, the adoption of single-use devices must be balanced against their costs. The financial viability depends on the specific use case, including the type of therapy or diagnostic procedure, and the volume of usage. For instance, in certain medical scenarios like IVF, some consumables are designed to be disposable due to their low cost, while more expensive components are reused to maintain economic feasibility. So, the decision to use single-use devices involves a careful consideration of both safety and cost-effectiveness, ensuring that the benefits justify the expenses within the clinical context.
Q. Do you think that IoT and electronics will be irrelevant in the near future as AI and automation drive innovation in robotic surgical devices?
A. Despite rapid advancements in AI and automation, IoT and electronics will remain highly relevant in the foreseeable future, especially in the context of robotic surgical devices. The value of connectivity in medical devices cannot be overstated. Modern surgical robots generate vast amounts of data from motors, sensors, and other components. Uploading this data to the cloud and analyzing it in real-time is critical for predictive maintenance, enhancing device performance, and ensuring patient safety. While data security remains a significant concern, robust solutions are in place to address these challenges effectively.
The integration of IoT allows for a more predictive approach to device maintenance and operational efficiency. By continuously monitoring device performance and logging data, manufacturers can identify potential issues before they become critical, ensuring timely intervention and reducing downtime. Additionally, this data-driven approach supports ongoing product improvement and innovation, as insights gathered from IoT-enabled devices can inform future developments.
The intersection of IoT, AI, and connectivity introduces complex discussions about data ownership and protection in healthcare. Ensuring that the right data is accessible to the appropriate stakeholders while maintaining privacy and security is a multifaceted challenge. As AI continues to evolve, it will complement IoT by enhancing data analysis capabilities, further underscoring the continued relevance and importance of IoT and electronics in the medical device landscape.
Q. Do you foresee robotic surgery becoming fully automated?
A. We believe that the future of robotic surgery will involve a synergistic relationship between human surgeons and robotic systems, leveraging the strengths of both to achieve the best possible results for patients.
Surgical procedures involve a high degree of variability and often require real-time decision-making. Human engagement will remain crucial to address unexpected situations and ensure optimal patient outcomes. Ideally, robotics will be an advanced tool that improves surgical precision and outcomes, providing guardrails to avoid human errors but ensuring the surgeon’s control over each procedure.
As technology improves and robotic systems are more widely adopted, the critical balance between automation and human expertise will ultimately deliver the best patient outcomes.
As the surgical robotics market continues to grow, maintaining a focus on patient safety, a clear development pathway, and continuous improvement will be key to achieving widespread adoption and success. At Ascential, we are committed to advancing development of cutting-edge robotic systems and supporting the medical community in delivering superior patient care.