MANUFACTURING KNOW-HOW AND OEM CONSIDERATIONS
Robot-assisted medical procedures are becoming more pervasive, increasing from 1.8% to 15.1% of all general surgeries between 2012 and 2018.1 Despite the capital expense of orthopedic robots, hospitals are spending millions to add them to their surgical suites. This white paper discusses considerations when manufacturing robotic and surgical navigated instruments and what to look for in a partner.
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Robots assist in guiding surgeons by maintaining instrument alignment beyond natural human capability. Early results show benefits with clinical outcomes, particularly in spine procedures, which include some of the highest rates of infection and revision in orthopedics. Robots are truly making procedures safer and more successful.
Leaders like Medtronic, Stryker and Zimmer Biomet are paving the way in robotics and surgical navigation. Orthopedics’ five largest companies, as well as a handful of mid-sized and small players, have entered the market with their own competitive solutions. Today, surgical navigation and robotic systems are used in joint replacements, spine, trauma and more.
With demand for the technology here to stay, contract manufacturers see opportunity to get involved too. However, not every supplier is up for the task. Engineering these incredible machines and the instruments they use requires marrying precision manufacturing with the inspection methods capable of measuring such demanding precision. This calls for specialized machining capabilities and know-how. With such high stakes, a manufacturing partner must possess the expertise to complete the project within specifications and compliance requirements as well as the willingness to collaborate to meet launch dates.
WHAT MAKES MANUFACTURING ROBOTIC AND NAVIGATIONAL INSTRUMENTS UNIQUE?
BIGGER ASSEMBLIES WITH MORE PARTS
While most orthopedic instruments may consist of only a few components, robotic and navigated surgical instruments can incorporate more than a dozen. As the part count increases so does the risk of components improperly fitting. It is important to consider the component interdependencies and how to maintain tight tolerances over the stack-up of all the components, particularly over longer lengths of material.
The aggregation of tolerance stack-ups across the components of a robotic assembly, and the need to maintain a precise end point for the robot, may require some manufacturers to implement new processes to attain repeated and reproduceable results. Secondary processes to attain certain feature tolerances also may be necessary.
Achieving tighter tolerances demands special equipment, not only to manufacture parts but to inspect them. For example, MedTorque’s climate-controlled metrology lab can stabilize temperatures to prevent false measurements that may be present in non-controlled environments. Where tight tolerances cannot be achieved via primary machining processes, secondary operations to dial in niche features may be needed.
3 CONSIDERATIONS FOR DEVELOPING ROBOTIC SURGICAL INSTRUMENTS
WHAT ELEMENTS ARE CRITICAL TO THE OVERALL FUNCTION OF THE INSTRUMENT?
Defining the features that are essential for function and critical to quality rather than classifying every dimension or feature as essential is important to ensure instruments are manufacturable within cost constraints. Considering the interrelationships of the components and how that instrument will work with others in the system should take priority. The tolerances that govern these features when combined are of utmost importance.
It is helpful for OEMs to stay open minded about concept changes as they work with manufacturers to develop instruments. The goal of a true partner in manufacturing should be to assess the design and leverage experience to meet your products’ requirements through effective design and manufacturing recommendations. While adjusting the design for manufacturability and working through process development takes time, patiently walking the long road can actually compress the timeline and reduce risk as you smoothly move toward achieving your ultimate objective.
CAN YOUR CONTRACT MANUFACTURER MEET YOUR GOALS?
Finding the right partner to ensure your project meets your specifications and deadline is essential. While many manufacturers are eager to get into robotics work, OEMs should look for those that can prove their know-how, demonstrating capability in their manufacturing processes to achieve the level of quality assurance required for robotic and surgically navigated instruments. Here are important elements to consider when evaluating a prospective contract manufacturer.
Meeting the extreme tolerances required for robotic instruments may take multiple operations and processes to produce repeatable and accurate parts. Having the capabilities under one roof ensures proficiency across processes as well as consistency and alignment with the overall goal. Outsourcing a critical process may introduce unnecessary risk. Manufacturers that have the equipment to perform multiple processes in-house will have better control over production, enhancing quality and eliminating such risk.
In addition to precise manufacturing machinery, a valued partner also has inspection capabilities to ensure precision throughout the entire process. Instruments need to be inspected quickly in a way that’s consistent with their intended use. Collaborating on inspection is key exercise that helps OEMs and manufacturers align on inspection methods.
Collaboratively managing a timeline and mutually understanding milestones ensures the partnership will meet a new product launch on time. A contract manufacturing partner must understand the deliverables for each milestone, whether it be for a prototype lab, verification/validation activity or final production. Understanding these ahead of when they’re needed prepares the team for successful execution.
ARE YOU WILLING TO COLLABORATE?
While a manufacturer should work diligently to meet or exceed your expectations, it is critical for OEMs to be partnership-minded as well. A lack of trust, respect and dialog can doom a project. Success stems from a symbiotic relationship with give and take, allowing concepts to become reality.
1. INSTRUMENTATION FOR ROBOTIC-ASSISTED SPINAL SURGERY
With the high revision and potential infection rates in spinal surgery, a major medical device OEM in the spine segment saw an opportunity for a disruptive market technology to improve efficacy. Its team was ready for rapid introduction of its robotically assisted platform but needed a manufacturer that could provide the precision necessary for the system’s surgical instruments.
Each instrument for the robotic system required precise positioning and straightness across the overall length. This seemed nearly impossible for most manufacturers previously approached. To add to the complexity, the customer chose a newer material with properties known to pose machining challenges, yet these obstacles could not jeopardize the tolerances required. Meeting the highly compressed and aggressive launch date added another layer of pressure.
MedTorque’s niche experience in manufacturing long, cannulated instruments for other tight-tolerance applications was an attractive option for partnership. In addition to requiring our specialized machining capabilities, a partner with the know-how and skill set was key to the OEM’s decision.
Both teams worked collaboratively on the issues they encountered along the way, transforming lessons learned into best practices and proprietary processes. Working hand-in-hand provided collaboration that aligned all stakeholders from the shopfloor to inspection through engineering and executive leadership.
MedTorque’s customer was able to release its robotic platform within specifications and on schedule, leading the industry charge in robotic spine platforms. It remains partners with MedTorque and continually leans on us for future product line extensions and enhancements.
2. NEW APPLICATION FOR NAVIGATED ROBOTIC PLATFORM
A major orthopedic medical device OEM sought to augment its current surgical robotic system by expanding into applications for spinal surgery.
This OEM needed a partner who could help coordinate between its team developing the robotic systems and its spine application group dispersed across the country. It had early conceptual instrument drawings and non-robotic predicate instruments but needed assistance in realizing the product.
MedTorque’s engineers stepped in to provide major design for manufacturing enhancements to help our customer refine its tolerances. The inputs provided were the result of capability demonstrated by previously produced navigated surgical instruments and our expertise in manufacturing tight tolerances. Taking into consideration our inputs, one of the customer’s redesigned instruments was reduced from three components to one, thus simplifying and streamlining manufacturing. Throughout the project, MedTorque’s team provided collaboration with our customer’s dispersed groups and maintained expectations, dates and milestones.
Following MedTorque’s guidance, the initial prototypes met surgeons’ needs and validation units ensured the designs met inputs. With successful development behind them, our customer-initiated production and will now expand its orthopedic footprint and enable high-volume surgeons to achieve time neutrality in robotic procedures.
As robotic and navigation technology evolves, orthopedic device manufacturers will continue to adapt their existing systems to meet demand from hospitals and surgeons. The strongest OEM/manufacturer partnerships will achieve great innovation and precision that significantly improves efficacy for better outcomes that ultimately make a world of difference for patients’ lives.