Surgical instrument design and manufacturing is characterized by continuous innovation and advancement, driven largely by the ever-expanding applications for creative robot-assisted and minimally invasive (MI) surgical procedures. As a result, surgical instrument design, material selection, and manufacturing are trending toward more complex, multifunctional instruments that help surgeons perform procedures more efficiently, reducing risk to the patient and improving surgical outcomes.
Many orthopedic designers and manufacturers are creating more ergonomic, precise, and efficient instruments to help reduce surgeon fatigue. This often involves advanced materials, improved handling features, and enhanced functionality.
“In addition, there is a growing trend toward the development of smart instruments that integrate technologies such as robotics, artificial intelligence, and real-time data feedback,” said John Phillips, president of the implants and instrumentation division for Phillips Precision Medicraft, an Elmwood Park, N.J.-based manufacturer of advanced orthopedic implants, instrumentation, sterilization delivery systems, cases, and trays. “These advancements aim to improve surgical outcomes, reduce the risk of complications, and enhance the overall surgical experience for both surgeons and patients.”
With the increasing sophistication of minimally invasive and robotic surgeries, “new types of instruments and tools are emerging,” added Granger Lubich, engineering manager for instruments for rms Company, a Cretex Medical company based in Minneapolis, Minn., that provides precision machining, additive manufacturing, and metal fabrication services for the medical device industry. “For example, there is a notable shift toward the adoption of single-use, disposable instruments and surgical kits, moving away from reusable metal tools. This move is driven by a desire to simplify the supply chain and eliminate the logistical challenges and risks of reprocessing instruments.”
James B. Schultz, vice president of customer solutions for ECA Medical, a Thousand Oaks, Calif.-based provider of single-use, surgery-ready, torque-limiting instrument and procedural kits for the orthopedic and spine market segments, agreed.
“New technologies, materials, and manufacturing processes are enabling a move from expensive reusable instruments to more cost effective and sustainable single-use solutions in many orthopedic and spine procedures,” said Schultz. “Clinically robust, single-use solutions that offer economic value are becoming critical alternatives to traditional reusables and cases/trays for ambulatory surgery centers to increase caseloads, improve operating room turnover, minimize capital expenditure and personnel costs, and simplify lifecycle management.”
Latest Trends
According to Allied Market Research, the global surgical equipment market, valued at $35.6 billion in 2022, is projected to reach $59 billion by 2032, growing at a compound annual growth rate of 5.2% from 2023 to 2032.1 Key drivers are the growth of older age groups and continued instrument innovations that have expanded the scope of procedures that can be performed.
Surgical instruments are any components or devices used during surgical procedures that support the preparation, implantation, or maintenance of surgical devices or implants, but do not remain in the body. This is a broad category with a variety of product types that serve specific purposes in the operating room (OR). Instruments can range from FDA-designated Class I to Class III, depending on the level of risk; however, most surgical instruments are classified as Class II (if instrumentation is packaged with implants, they may be up-classified to Class III).
Common instruments are retractors, holders, screwdrivers, drills, and taps. Robotics and supporting navigation tools are also considered instruments. Disposable instruments are becoming more popular in hospitals for reducing infection risks and the cost of sterilization. Additive manufacturing (AM) methods can also be used to create customized instrumentation, often with fairly quick turnaround times, for scheduled surgeries.
Surgical instruments are subject to a variety of regulatory and end-user requirements, including cleanliness, dimensional tolerances, and even customer scrutiny. “For instance, producing an inner component for a surgical robot assembly requires a different set of requirements compared to crafting a hip broach, reamers, inserter shaft, or implant sizer/trial,” said Lubich. “Requirements would also differ between a handheld surgical tool and a power tool component. Managing these different requirements within the surgical instrument category represents a unique challenge compared to the more specialized and uniform nature of other medical devices.”
Perhaps the most significant trend impacting orthopedic instrumentation is the steady shift toward ambulatory surgical centers (ASC). “Nearly 70% of all surgeries are now in ASCs and some procedures, such as sacral joint procedures for pain management, are being safely conducted in the physician’s office,” said Schultz. “Orthopedic procedures are among the most profitable for ASCs, with a broader range of indications that are approved for reimbursement by CMS [Medicare and Medicaid] and other payors.”
Single-use or one-way, sterile-pack, surgery-ready instrument sets and sterile implants are ideal for higher volume/lower complexity cases in trauma, extremities, large joints, sports medicine, and spine, which are increasingly treated at ASCs. Disposable, single-use surgical instruments include retractors, arthroscopes, shavers, drills, saws, bone cutters, and nail drivers. Single-use orthopedic tools are also gaining favor as a method of improved infection control.
The ASC has become a quasi-production line for surgeons who benefit from faster OR turnover, enabled by optimized and tailored instruments for specific surgery types. “Implant OEMs enjoy the lower cost of sales per transaction and potential to increase their market share and maintain or grow margin with surgery-ready product lines,” said Schultz. Ultimately, single-use solutions eliminate instrument reprocessing hassles, streamline workflows, and reduce cross-contamination risks.
Another big trend is customization. OEMs want instruments that have a high degree of customization, such as different coatings, logos, and construction techniques. For more complex surgical procedures, there is a demand for specialized instruments to meet the specific needs of innovative surgeons. These include instruments for carpal tunnel procedures, and longer instruments and enhanced distal configurations for better exposure to surgical sites for bariatric patients. The growing interest in patient-specific implants also has a corresponding need for customization in instrumentation. “For example,” said Lubich, “drill guides may need to be tailored to match the implant geometry.”
All MDMs want to enjoy the benefits of automation and robotics—both as functions in their orthopedic devices and instruments, as well as in their manufacturing methods. Robotic-assisted surgery is moving quickly to the forefront, often taking existing instrumentation and integrating it with a robotic approach, supported by sensor technologies, data analytics, advanced software, simulation, and other Internet of Things (IoT) processes. Increasingly complex and miniaturized components often push the limits of manufacturing, including higher precision metrology technologies that can accurately measure these tight tolerances.
Robotics will continue to be at the forefront of instrument manufacturing, noted Phillips. “Phillips Precision Medicraft, for example, has fully embraced all types of emerging technologies—from integrating high-volume five-axis robotic cells with EROWA smart pallet changer technology to a series of new collaborative robots servicing legacy equipment and two new horizontal machining centers, each capable of running 24 hours a day—which have dramatically impacted our overall manufacturing capabilities,” said Phillips.
What MDMs Want
MDMs often have specific requirements and expectations when it comes to surgical instrument manufacturing. Although exact priorities vary among MDMs, precision and quality are typically at the top of the list. These companies expect their instrument designs to be manufactured with high accuracy, ensuring precise measurements, sharp cutting edges, and reliable performance. Quality control processes, such as stringent testing and inspections, are crucial to ensure these demands are being met.
With the high level of innovation happening in the orthopedic industry, OEMs are eager to work with manufacturers that embrace innovation and incorporate the latest technological advancements in their manufacturing processes. “These include the ability to use advanced materials, such as titanium or cobalt-chrome, as well as integrate smart technologies for data reporting, smart machine monitoring, and the use of robotics to increase capacity, throughput, and speed to market,” said Phillips.
MDMs also want their contract manufacturers (CMs) to provide more services, especially sound knowledge/advice regarding regulatory and compliance standards, such as ISO 13485. This can be especially valuable during design for manufacturability (DFM). CMs must adhere to strict regulatory guidelines to ensure the safety, efficacy, and reliability of the surgical instruments they manufacture.
Second on the list is cost-effectiveness and efficiency. While maintaining quality and precision, orthopedic OEMs are always on the lookout for cost-effective manufacturing solutions. “They seek manufacturers that can optimize production processes, reduce waste, and offer competitive pricing without compromising quality,” said Phillips. “This may involve streamlining manufacturing workflows, utilizing automation, or adopting lean manufacturing principles.”
Cost-effectiveness also means vertical integration, which is highly valued by MDMs as a way to reduce costs, improve communication, develop in-depth partnerships, and reduce time to market. Vertical integration shortens the supply chain and makes DFM easier and faster, with all the experts at the same location. The earlier the CM becomes involved in the design process, the more advantageous it is for all stakeholders. “For example, a significant obstacle in manufacturing complex components is often the GD&T [geometric dimensioning and tolerancing] structure, which is typically determined by the product's design alone,” said Lubich. “Conducting a thorough review of GD&T in relation to the manufacturing process can maximize the manufacturability of a device.”
Vertical integration leads to overall faster production, communication, and decision making—all of which makes it easier to determine the perfect balance between cost, complexity, and functionality—in a timely manner. OEM implant firms are cost-sensitive and eager to reduce both up-front and lifecycle costs. “Best solution at best price point for the procedure and delivery model are key,” said Schultz. “Implant firms are flexible on instrument configurations that will meet clinical needs, yet also reduce costs.”
Technology at the Forefront
Design to cost and design for manufacturability are critical attributes for surgical instruments. Achieving these requires a unique understanding of materials, clinical procedures, surgical techniques, and OR process flows. Compared to implants, a larger variety of advanced materials exist that can be considered for surgical instruments, including polymers. Medical-grade polymers have been engineered in recent years that can make very robust single-use instruments that retain or improve upon the ergonomics, aesthetics, weight, and balance of a reusable metal instrument set—at a fraction of the cost. Properly designed instruments using polymers can mimic stainless steel and provide competitive solutions at a fraction of the cost for a wide range of orthopedic and spine implant procedures. “For example, we have 100% polymer forceps for demanding trauma and extremity procedures,” said Schultz. “Our polymer instruments have a wide range of spine applications, including sacral joint procedures, as well as hand-operated and power-driven torque limiters for trauma, extremity, large joint, and scoliosis spine cases.”
Surgical instruments usually consist of multiple components, which require precise assembly. Therefore, each component must be held to a closer tolerance during manufacturing so, at the time of assembly, the device works as designed. Larger parts can be more challenging to make, which is why more CMs are turning to horizontal machining. “Our horizontal machining centers allow us to make larger parts faster and more efficiently,” said Phillips. “One of the benefits of the machine’s horizontal orientation is how much better it is at chip evacuation, extending tool life, and its ability to hold more parts on its tombstones than a vertical machine. They cut faster than vertical mills, and can run lights out without sacrificing precision. In addition, since horizontal machines are designed to cut bulkier materials, faster speeds and feeds are common, leading to reduced cycle times.”
Producing surgical instruments requires efficient and highly automated manufacturing processes such as machining, injection molding, assembly, and kitting. A new automated hybrid technology being used in the aerospace and automobile industries (and has strong potential for orthopedic devices) is called additive fusion technology (AFT). Developed by Switzerland-based 9T Labs, AFT produces continuous fiber composites and outperforms traditional subtractive manufacturing and machined metal components.2 AFT is a three-step process: 1) import CAD files, 2) start the AM process that places thermoplastic filaments (for example, PEEK) beside unidirectional continuous fiber-reinforced tapes (for example, glass or carbon), and 3) a compact compression press fuses the preform parts and shapes them into final parts. The final high-performance composite parts can have up to 60% fiber volume content in a thermoplastic matrix.3
MDMs are increasingly committed to sustainable operations, conserving resources (including energy), reducing emissions, and minimizing and recycling waste. Not only is this good for the environment, it also reduces operational costs and boosts brand recognition—customers want to do business with companies that share a commitment to the environment. For example, the carbon footprint of single-use instruments is less than reusables. “Studies show they are 33% to 50% more environmentally friendly than reusable sets,” said Schultz. “Reprocessing of reusable sets in sterile processing departments requires harsh chemical cleaning agents and over 60 gallons of fresh water to rinse one tray of instruments and similar amounts for steam sterilization before the next surgery.” Some procedures require four to seven trays or more, with only 30% of the instruments being used. “There are also sustainability programs that permit complete collection and recycling of single-use instruments and procedural kits, including all the plastics and metals that allow for repurposing of components and materials,” said Schultz.
Technologies rooted by IoT—automation, robotics, artificial intelligence (AI), vision/optics, and data analytics—provide increased quality, productivity, process stability, and reduced downtime. Automation and robotics are making machining and laser processing more efficient, especially with intelligent machine controllers and systems. “At Phillips, we have an array of IoT tools in our IoT toolbox such as real-time data management boards on our manufacturing floor, smart machine monitoring systems like FactoryWiz, cutting tool vending systems on our facility floor that are remotely connected to suppliers, and machines communicating with machines to complete a task,” said Phillips.
“Tools like TMAC by Caron Engineering, with adaptive load monitoring, enable us to factor in changes throughout a tool's lifecycle, offering predictive insights into tool longevity,” added Lubich. TMAC interfaces directly with the CNC control and uses high-precision sensor technology to optimize machining and make real-time corrective adjustments through material cutting. “Also, the utilization of FactoryWiz monitoring software further enhances connectivity with machine tool data, facilitating real-time or predictive decision-making processes.”
AM and AI Accelerate Innovation
A well-established disruptive technology in surgical instrument manufacturing is additive manufacturing/3D printing (AM/3DP). When used to make single-use instruments, AM can be a cost-effective way to manufacture these metal and plastic disposable products. AM can also be used to produce patient-specific custom surgical guides. In addition, it can speed up the process of iterative design. Prototypes are required for various phases of development, from concept through DFM—in many cases, development timeline segments can be compressed from weeks to days by leveraging AM technology to support proof-of-concept and the ever-present goal of faster speed to market.
“Complex instrument designs can benefit from enhancements or simplification through additive manufacturing,” said Lubich. “AM offers an opportunity to overcome design constraints associated with traditional machining methods. Less obvious advantages of additive manufacturing lie in decreasing the weight of instruments, especially considering the limitations imposed by robotics, ergonomic implications for surgical staff, or logistical considerations for reprocessing.”
A recent application of AM in the orthopedic instrument space is the creation of external fixators—complex devices that stabilize broken limbs after high-energy accidents. Researchers at Sanford Health System, headquartered in Sioux Falls, S.D., have designed a low-cost, 3D-printed external fixator that is as effective at stabilizing fractures as traditional external fixators made of carbon fiber or stainless steel. Telescoping cylinders that set the appropriate length of the fixation device are the key feature. Components of the device can be AM-printed on the same print bed in slightly less than two days. About 10 external fixators can be fabricated in a month using a standard desktop 3D printer.4
AI—the next big disrupter—is just starting to penetrate the surgical instrumentation field. It can be used to create a surgical plan that includes patient-specific instruments that optimize implant alignment and patient outcomes. Vision-based AI surgical tracking technologies can extract movement and orientation data from the surgical instrument to assess navigational routes and position/placement of instruments and tools (for example, catheters).
“AI allows us to answer questions in new ways and offers insights into problems we've plateaued in trying to solve for many years,” said Cody C. Wyles, M.D., director of the Orthopedic Surgery Artificial Intelligence Laboratory at the Mayo Clinic in Rochester, Minn. “It allows us to treat our patients in a more personalized way.”5
The lab is staffed with eight surgeons, four data scientists, radiologists, and a lab manager. Research is focused on developing orthopedic surgery-focused AI tools. In radiology, for example, AI applications include annotation and documentation of implant angles. For hip surgery, AI-enabled imaging greatly shortens the time required to document hip-cup positions. Wyles stated that, when comparing two x-rays side by side, AI algorithms can detect measurements of even less than 0.1 millimeter of movement in the patient's anatomy.
“AI-enabled tools such as risk prediction or annotation are not to replace a physician," said Wyles. “The physicians are critical to interpreting information provided by these capabilities and making decisions. Rather than replacing a radiologist or orthopedic surgeon, the tools make these providers more effective.”
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