Today’s surgical instrument designs require the highest level of craftsmanship, detail, and functionality. “Designs are gradually becoming integrated,” said Kai Wissner, CEO for Hipp & Son, a Neuhausen ob Eck, Germany-based contract manufacturer of custom-built, high-precision surgical instruments for minimally invasive surgery (MIS), open surgery, and single-use applications such as custom saw blades. “Where previously three or four instruments were required, now only one instrument is needed. This speeds up surgical procedures, but also places higher demands on tolerances and manufacturing technologies.”

“Surgical instrument manufacturing is now a precision-driven, digitally enabled discipline,” added John Ruggieri, senior vice president of business development for ARCH Medical Solutions, a Bloomfield Hills, Mich.-based precision developer of orthopedic instruments, implants, and robotic-assisted surgical devices. “The industry is moving toward robotic-compatible, navigation-enabled, and smart instruments, supported by advanced materials and additive manufacturing.”

Medical device manufacturers (MDMs) are keen on developing robotic instruments that target a greater variety of MIS applications. Surgical instruments continue to follow a path of innovation, “with a focus on minimally invasive and robotic-assisted technologies,” said David Cabral, president and CEO of Five Star Companies, a New Bedford, Mass.-based contract manufacturer of medical instruments and implants and a preventative maintenance provider for procedural and consignment instrument kits.

As existing robotic systems are validated on new procedures, and new robotic instruments are becoming less invasive, the size of these instruments becomes increasingly small. “For single-port procedures, the entire set of instruments—scissors, two graspers for suturing, and a camera—must all function within a space roughly the size of the cross-sectional area of a dime,” said Jeffrey Haag, vice president of technical solutions for Precera Medical, a Minn.-based provider of components and assemblies for traditional, MIS, and robotic surgery applications including end-effectors such as graspers, scissors, blades, staplers, and vessel sealers.

Single-use instruments, in particular, are growing in popularity, especially in ambulatory surgery centers (ASC). ASC surgeries require an agile delivery model to simplify case flow and cut costs. “This highlights the growing demand and need for tailored instrument kits supporting the bell curve of implant sizes and the single-use, sterile-pack, and surgery-ready alternative that not only saves money but makes money by permitting surgeons to achieve excellent outcomes and also conduct more cases per day,” said James B. Schultz, vice president of sales and marketing for ECA Medical, a Thousand Oaks, Calif.-based instrument MDM providing complete design, development, and manufacturing of single-use, surgery-ready instruments and surgery-specific kits. “Surgical instruments that are single use and sterile are now seen as value creation tools in the procedure and make instrumentation a potential profit center versus a historic cost center.”

Latest Trends

The surgical instrument market continues to evolve, driven by automation, cost pressures, and patient outcomes. “We’ve seen increased utilization of single-use pre-sterilized instruments as a significant market trend, and we believe this growth will continue,” said Brian Nissen, director of engineering for Cretex Medical | QTS, a Bloomington, Minn.-based contract manufacturer that provides finished device assembly, kitting, packaging, and sterilization management for the medical device industry.

Single-use instruments can be more convenient for hospitals and ASCs because they do not require the sterilization that reusable instruments do. “ASCs in particular,” said Nissen, “have limited storage space and reprocessing and sterilization capacity, meaning there is less capacity for keeping reusable instruments on hand.”

Traditionally, added Nissen, “a surgeon would have a separate instrument for dissecting, placing, and then closing. We’re moving more and more toward a single instrument that can perform all three tasks. As the complexity of instruments increases, they become that much more difficult to effectively reprocess and re-sterilize. In this environment, single-use instruments become increasingly attractive.”

Innovative applications of Class I devices have led to some healthcare systems moving away from individual instrument use and toward the design of multi-use instruments “that reduce the frequency of device exchanges during surgery,” said Cabral. “This ensures the surgeon has minimal delays and distractions in the procedure, while staying focused on the patient and task at hand.”

Whenever there are reusable instruments, regardless of the reprocessing and sterilization process, there will always be some degree of risk of contamination for staff and patients. As technology advances, instruments become more complex, which can make cleaning them prior to sterilization much more difficult. “If the instrument’s surfaces are not completely cleaned, the sterilization process will not be effective,” said Nissen. “With a single-use instrument, we have complete control over both the cleaning and sterilization processes.”

Injection-molded, single-use instruments in sterile kits offer operational advantages to implant firms and clinical teams. “They are becoming the new standard of implant MDMs for a wide range of implant types and surgical indications by providing clinical and financial benefits and marketing opportunities as the market shifts and evolves to meet surgeon needs and payor dynamics,” said Schultz.

Miniaturization of these instruments continues to be the main design request because smaller is less invasive and typically results in quicker procedures and reduced recovery times. 

Even so, as instruments get smaller, with less internal space, MDMs want multiple process steps to be provided by a single instrument. Open and MIS surgery instruments are also becoming increasingly detailed in order to guide the surgical procedure and further increase the chances of success. “For example, robotic actuators bring completely new degrees of freedom,” said Wissner. “These must be implemented by micromechanics. However, miniaturization must not compromise stability and reusability.”

A growing trend is to develop and manufacture instruments with a high degree of customization. “Not only are instruments expected to have multiple colors and finishes, but the trend is also to incorporate the highest level of design and detail along with different coatings, logos, and construction techniques,” said Michael Gauthier, president of Gauthier Biomedical, a Grafton, Wis.-based designer and manufacturer of instruments for orthopedic surgery, ranging from multi-color ratcheting and torque-limiting handles to fully custom orthopedic instruments.

What MDMs Want

MDMs are experts in design and clinical applications. “They frequently bring us designs with tight tolerances, complex geometric dimensioning and tolerancing, difficult materials, thin features prone to movement during machining, and other issues that make reliable, high-yield production a real hurdle,” said Dan Buttermore, vice president of engineering for Vantedge Medical, a San Jose, Calif.-based metals manufacturing partner for the medical device industry, including minimally invasive surgery and surgical instruments. “They want our early partnership on design reviews and targeted design for manufacturability [DFM] suggestions that improve manufacturability without compromising the device’s form, fit, or function.”

Excellent product quality, regulatory compliance, and competitive pricing are fundamental requests. “MDMs are looking for suppliers that can provide the highest-quality instruments with the ability to scale production to match the most demanding launch quantities and timelines,” said Gauthier.

Reliable on-time delivery is another non-negotiable expectation in today’s medical device market. “Delivery is enhanced by faster development cycles and quick‑turn prototyping, DFM support and collaborative engineering, and vertically integrated production, including machining, grinding, finishing, assembly, and sterile pack,” said Ruggieri.

MDMs continue to look for shorter lead times for prototypes, as well as streamlined and faster new product introduction launches. Product development teams are setting expectations for prototypes in days, versus weeks or months, which had been the previous norm for decades. “This becomes possible with the correct commitment to resources at the supplier level,” said Haag. “Having dedicated staff and equipment to support these challenges is a key to success.”

In a highly competitive market, MDMs always want to drive speed and cost consciousness. Controlling costs is also important for hospitals and ASCs. “Materials and designs that are easier to manufacture may not lend themselves as easily to reuse,” said Nissen. “Adopting single-use instruments can drive down costs.”

Sterile and surgery-ready products are in big demand to meet these market needs. To save money and boost efficiency, more MDMs are leveraging instrument designs across a broader range of implant types and procedures. “There are many common tools for extremity cases and trauma,” said Schultz. “Holistic and well-planned solutions that reduce non-recurring engineering costs that are associated with one-time charges to develop a product or provide a service, including lifecycle management, are critical.”

Some MDMs still think the most cost-effective way to build their surgical systems is by using existing or off-the-shelf instrumentation or developing instrumentation for their systems in-house. “However, deeply experienced and innovative manufacturers such as Gauthier are uniquely positioned to support MDMs in developing and producing high-quality custom instrumentation to meet their unique applications and provide a distinctive look and feel that communicates their specific brand’s image and message,” said Gauthier.

New Instrument Designs

Instrument design in orthopedics is evolving rapidly, driven largely by the surge in robotic-assisted surgery platforms, particularly for knee, hip, shoulder, and spine procedures, with artificial intelligence (AI) support. Improved designs lead to shorter, less invasive procedures, which tend to reduce the risk of infection and decrease recovery time. 

In response, there is a clear push toward smaller, more compact/complex instruments that enable minimally invasive approaches with smaller incisions, reduced soft-tissue damage, and quicker patient recovery. At the same time, designs are also incorporating higher functionality and more precise geometries for robotic end effectors with integrated navigation compatibility. 

“To meet these needs, we are continually investing in advanced capabilities such as top-tier CNC mill-turns, nano-Swiss lathes for ultra-precise small-part turning, and automated assembly and inspection systems,” said Buttermore. “These allow us to produce the highly complex, miniaturized parts required for next-generation robotic instruments in a cost-effective, repeatable way, ensuring consistency, reliability, and scalability as MDMs innovate in this fast-growing space.”

MDMs are designing increasingly smaller, more complex components with tighter tolerances and surface finishes. Small, delicate instruments must still be robust in performance. “Different materials are used that reduce friction and offer high strength,” said Wissner. “Hipp & Son now uses a total of 42 medical metals and plastics.”

Surgical instruments are also being tailored for specific surgery types. Fully loaded reusable cases and trays are no longer in vogue—they are very expensive and have unsustainable lifecycle costs. As a result, the instrument and implant delivery model is shifting toward optimized single-use, sterile pack, end-to-end solutions that cut costs, reduce inventory, curb reprocessing costs and hassles, and improve operating room case flow and throughput. New materials, machining processes, finite element analysis optimization, and thoughtful simplified sets tailored for a procedure will be core strategies that keep MDMs competitive.

“This approach is scalable, and instruments can be sold or bundled with the implant to provide a very competitive offering and brand solution,” said Schultz. “It also motivates MDM marketing teams to consider and exploit the changing environment in the ASC and position their products for broader adoption.” 

New Advancements

The number one goal for MDMs is to achieve the best patient outcomes possible. The less impact a surgical procedure has on the patient, the better. Smaller and more precise instruments mean smaller incisions and sutures and faster procedures. With this in mind, technological advancements continue to push toward smaller, more precise instruments, especially those used in robotic-assisted surgery. The need for improved inspection methods without increasing costs has also swelled.

For example, Vantedge Medical continues to invest in advanced inspection methods to keep pace with miniaturization. “We have integrated the latest AI-powered optical camera systems into our in-house engineered and built automated inspection equipment,” said Buttermore. “These systems handle high-magnification imaging and can distinguish subtle issues like micro-burrs or surface inconsistencies on tiny, machined parts with impressive speed and accuracy. These capabilities were not reliable even a few years ago—this translates into higher quality assurance, fewer escapes, and more efficient production, without added expense.”

Measurement technology must keep pace with both quick-response expectations and the downsizing of components. “We have invested in computed tomography scanning technology to give us the ability to quickly and accurately measure very small features and delicate parts, in a contact-free process,” said Haag. “Measurements are processed in a matter of minutes with little programming needed.”

The move toward ASCs (over 70% of all surgeries occur in the outpatient setting) is driving the need for single-use instrumentation applications in trauma, upper and lower extremities, sports medicine, and spine and large joints. This includes robotics as well as advanced imaging and navigation systems for diagnostics and perioperative use. Instruments are being designed specifically to work with next-generation, AI-based tools and systems for precise implant placement and to improve case flow while cutting overall cost. “It is an exciting time in our industry for the application of smart single-use and sterile pack technologies that provide clear return on investment; reduce selling, general, and administrative costs; and offer measurable surgeon and patient benefits,” said Schultz.

Precision electrolytic machining (PEM) is a technology that produces extremely small and precise features, especially for critical robotic surgery components. PEM is a non-contact process that removes material via a negatively charged tool (cathode) and a positively charged workpiece (anode) in an electrolyte bath that produces high-precision, burr-free, and complex 3D surface profiles. 

“We have implemented PEM in a way that allows for improved productivity via in-house automation for further processing,” said Haag. “We anticipate the use of this technology will continue to grow as the requirements for products continue to advance.”

Welding different materials can often be a challenge. Ultrafast lasers are becoming more prevalent and give users more tools to adjust beam parameters and optimize the penetration and integrity of welds. Every weld joint requires a unique set of parameters, and the ability to adjust these—such as power, pulse, pulse profile, and speed—all play a role in optimizing the process. “Hipp & Son uses various welding technologies with robots to ensure the process is stable and repeatable. Many complex milled or lathed parts require specific surface treatment after milling—we use robots in these areas as well, especially when tight tolerances are required,” said Wissner. 

Moving Forward

Instruments are becoming smaller and more integrated. Precise instruments can be manufactured very economically, even in high-wage countries, which was difficult to achieve two or three years ago. Many MDMs are also surprised to learn that batch sizes can be very small. “The new level of automation allows developers to design more boldly for single-use products and customized tools such as bone saws or drill guides,” said Wissner.

Single-use and sterile pack instruments and procedural kits will gain in popularity because they are clinically robust and provide economic value. Advances in materials and manufacturing techniques, combined with cadaveric studies with key surgeons and implant MDMs, have resulted in solutions that are equal to or better than reusable sets. “Surgeon advocates promote fast and broad adoption as they embrace tools and solutions that streamline their business, provide great solutions, allow more cases per day, and relieve operating room prep and turnover hassles for their nurse and scrub tech teams,” said Schultz.

AI, of course, will stay at the forefront of digital innovation with new applications that seem to evolve almost daily. For example, Five Star currently manufactures navigation devices for spinal surgery, advancing the limits of technology while introducing AI to further enhance surgical vision and precision. “We will continue to explore various AI applications,” said Cabral. “I don’t believe AI has limitations based on our current knowledge and experience. Its ability to learn, identify, and execute tasks can further assist surgeons in their navigation within the spinal area and throughout the entire body.”

Another technology disrupter—additive manufacturing (AM) of metals, polymers, and carbon fiber—is also changing the way surgical instruments and implants are being designed and manufactured. “Traditional manufacturing of instruments is being replaced by AM methods to form a complete product, needing only minimal finishing processes to remove any surface imperfections or roughness,” said Cabral.

In the near future, surgical instrument manufacturers will have to solve their reliance on polytetrafluoroethylene (PTFE), which is best known for its lubricious properties. Unfortunately, there are health and environmental concerns over the per-and polyfluoroalkyl substances (PFAS, also known as forever chemicals) generated in PTFE production. 

“More local regulations that restrict the use of PTFE will create complications for surgical equipment manufacturing and usage,” said Nissen. “We may run into situations where some devices will not be allowed in certain localities because of the materials used in their construction. Surgeons may need to adapt procedures to use different instruments in different areas. In the long run, this is going to require the redesign of devices, packaging, and even surgical procedures themselves.” 

What Are Surgical Instruments?
Surgical instruments are precision-engineered tools that translate surgical intent into controlled action—made possible through validated manufacturing, inspection, and traceability. Manufacturing processes must deliver tight tolerances, excellent surface integrity, and repeatable assembly—any deviations impact the instrument’s usability, jaw alignment, cutting efficiency, or clamping force. 

Any component, system, or procedural kit used to prepare or secure a medical implant is considered an instrument. Surgical instruments include cutting, grasping, clamping, retracting, and suturing tools such as scalpels, forceps, retractors, staplers, and robotic end effectors. The instrument definition is very broad and can apply to diagnostic equipment and patient-specific guides. 

Thousands of instrument types are tailored to achieve the best surgical outcomes—”ranging from a simple scissor that must be sharp and function as needed, to a complex, bone-cutting instrument that has an expected performance criterion, to a multifaceted instrument for the safe and effective installation of the spinal implant,” said David Cabral, president and CEO for Five Star Companies.

Standard classes of instruments under FDA guidelines are based on the risk factors (potential patient harm) presented by their use: Class I (low risk, most hand-held instruments), Class II (moderate risk, such as insulin pumps and syringes), and Class III (high risk, implantable devices such as pacemakers).

“Newer instruments are driven by robotics, such as articulated, robotic-compatible end effectors and modular minimally invasive shafts, where micrometer-level tolerances, low friction, and consistent mechanical transmission are essential for precise, repeatable motion in the operating room,” said Kai Wissner, CEO for Hipp & Son.

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.