By Sean Fenske, Editor-in-Chief
 
Robotic surgical and navigation systems have garnered the attention of surgeons and healthcare professionals for approximately the last 25 years, beginning with the debut of Intuitive Surgical’s da Vinci offering. During that time, the robotic-based products within orthopedics have exploded. Every major player in the industry has a surgical robot they’ve acquired and continued to develop.
 
Undoubtedly, those robotic surgical and navigation systems were developed, in part, with the aid of specialized suppliers that maintain expertise in the capabilities necessary to design and manufacture these complex products. As such, it’s important to hear directly from such companies involved in these processes to avoid potential complications.
 
Fortunately, Intech Medical is one such firm and its Global Sales Director, Romain Ibled, took time to address a number of questions around this topic. He shares insights on development challenges involved with robotic surgical and navigation systems, how a service provider can assist, and how development of these products can differ from other medical device design and manufacturing work.
 
Sean Fenske: How much of the work you’re doing for companies is specifically in support of robotic surgical and navigation systems?
 
Romain Ibled: Our expertise in robotic and navigation systems began with the integration of Intech Athens (formerly known as Turner Medical Inc.), which had been collaborating with major robotic platforms in the orthopedic industry.
 
We successfully expanded these capabilities to our other sites in France and Malaysia, providing our customers with a global presence in this field. Early development efforts allowed us to partner with various industry players and startups in this rapidly growing market, which is expanding at a rate of 15% year over year. Currently, Intech collaborates with dozens of robotic platform providers, positioning us as a leading Robotics & Navigation partner capable of manufacturing at scale. We specialize in intricate mechanical components with tight tolerances, such as high-precision devices, assemblies, and navigated instruments and probes—all essential for these systems.

 
Fenske: What are the most significant differences between designing technologies for robotic systems versus devices that go into the surgeons’ hands directly?
 
Ibled: Enhancing the accuracy and repeatability of surgical procedures is the primary goal of robotic and navigation systems. This requires adhering to tighter tolerances than your “typical” manual surgical instrument, which significantly raises the bar for manufacturing and inspection of mission-critical dimensions.
 
Tight tolerances must be meticulously controlled throughout all stages of production, from machining to coating, to ensure the precision required for these advanced systems.
 
Fenske: Is human factors engineering still as important with robotic surgical system device development?
 
Ibled: Robot-assisted surgery and navigation systems enhance the “arms and eyes” of the surgeon, enabling them to enhance their skills for superior patient care. As a result, human factors engineering becomes even more important with this new generation of surgical systems in orthopedics and soft tissue. Our customers want to ensure the procedure flow and the excellence of the surgical team are supported by high-quality systems.
 
As a leader in this segment, we prioritize engineering and innovation in manufacturing to deliver the expertise and results our clients need to bring such advanced technologies to market. Our early participation in the design and development stages is crucial to provide a broad range of value-added services including design for manufacturing expertise, which can also lead to developing new manufacturing processes.

 
Fenske: When it comes to robotic surgical and navigation systems, for what tasks are orthopedic device OEMs seeking the most help?
 
Ibled: Many OEMs develop their early platforms internally to maintain full control over these cutting-edge innovations. However, when it comes to scaling production, they seek robust, competent partners such as Intech for early design integration, design optimization, and manufacturing support. It is rare for OEMs to build their robotic systems entirely in-house. Many OEMs view Intech as the ideal partner offering extensive expertise and a distinctive integrated engineering approach that accelerates the development and launch process.
 
Fenske: What important considerations are overlooked by designers of robotic surgical and navigation systems?
 
Ibled: One significant challenge is ensuring feasibility on a large production scale. Designers often overlook the limitations of manufacturing tools when specifying tight tolerances. Achieving process capability under these constraints requires thorough consideration during the design phase, which requires highly integrated cooperation between the OEM and a CDMO like Intech

 
Fenske: So development of robotic surgical and navigation systems requires greater collaboration among the service providers and the OEM since there are sophisticated subsystems and software. Is that accurate?
 
Ibled: Yes, manufacturing robotic and navigation systems demands deeper and broader levels of collaboration due to their technical complexity, but also due to the involvement of multiple specialties at the OEMs. Design for manufacturing (DFM) is crucial for project success. Additionally, the existing inspection methods are challenged due to narrow tolerance bands. We frequently engage in developing new inspection correlation methods with our customers to ensure alignment. Intech has developed a specific multi-disciplinary cooperation model and a robust supply chain that allows us to be involved early in the process, resulting in a faster time to market compared to the traditional sequential approach.

 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
 
Ibled: Intech is strategically committed to robotic and navigation systems because we believe, alongside our customers, they represent the future of the standard of care and offer significant benefits to patients. With 450,000 square feet of manufacturing floor space across our nine global facilities, we are uniquely positioned for growth in this segment. Together, we tech care.
 
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