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Single-use orthopedic tools and sterile procedure kits are trending, driven by infection control concerns and an increased focus on efficient outpatient surgical care. Growing demand has led to an influx of new products, as well as heightened competition among orthopedic companies that strive to provide convenient and safe disposable solutions.
Joint replacement specialists use the latest disposable devices for hip and knee replacement. Sports medicine surgeons can now reach for single-use arthroscopes, shavers, drills and saws. Increasing numbers of trauma cases include disposable bone cutters and nail drivers. Single-use kits and retractors have entered the spine surgery segment.
The single-use trend continues to evolve, and new applications are being developed as orthopedic device makers and contract manufacturers adjust their production strategies to bring innovative products to market.
Same-day Surgery Spurs the Movement
The movement of cases to ambulatory surgery centers (ASCs) has increased interest in disposable instrumentation, which streamlines workflows, reduces cross-contamination risks, improves surgical efficiencies and lessens the burden on sterile processing.
“The shift toward single-use sterile kits is driven by an increase in procedures performed at ASCs, where robust reprocessing capabilities aren’t always available,” said Chris Faresich, R&D Manager at Tyber Medical. “Single-use kits reduce turnover times between cases, making it easier to schedule and complete more surgeries.”
Several spine and foot/ankle companies are dedicated to solely using single-use instruments. Xenco Medical is one of those companies.
Xenco Medical recently launched the Multilevel Cervikit, a disposable instrument system for three- and four-level anterior cervical discectomy and fusion (ACDF) procedures. The sterile-packaged system was designed to streamline surgical care in ASCs by eliminating the need to reprocess instruments between cases, which lets surgeons perform cases without delay.
“Improving surgical turnover times allows facilities to maximize their investments in new products and increase efficiencies,” said Jason Haider, Founder and CEO of Xenco Medical. “Although there is variability in ACDF procedures, a two-level ACDF — the most common type — takes about 2.5 hours to complete. It takes about three hours to reprocess the instruments used in the case.”
Single-use kits also eliminate the possibility of surgeons using improperly sterilized instruments. “Cervikit’s hermetically sealed, disposable design eliminates the risk of postoperative infections by ensuring that the instruments are only opened and used when ready,” Haider said.
Tackling the Transition
The successful manufacturing of disposable instruments lies in materials science, according to Haider. For example, during Cervikit’s research and development (R&D) phase, Xenco Medical created injection-molded fiberglass-reinforced nylon instruments.
Various molds were designed for Cervikit’s complex composite polymer instruments, allowing for gamma sterilization and scaling. “The development of the molds required several years of R&D and careful design decisions,” Haider said. “But once the instruments are injection-molded, the process becomes cost effective.”
Producing and shipping disposable instruments creates several challenges for orthopedic companies, including potential quality control and supply chain issues.
Single-use instruments have a shorter shelf life than reusable ones, meaning companies need to manage their inventory levels more carefully to ensure that enough stock is available to meet demand while avoiding overstock and waste.
Disposable instruments are transported and stored under specific conditions to ensure their sterility, which creates additional logistical challenges.
Single-use instruments generate more material waste compared to reusable instruments, a factor that can be a challenge for companies that are committed to sustainability and reducing their environmental impact.
These challenges require device manufacturers to be proactive and strategic in their approach to meeting the growing demand for disposable instruments while maintaining the quality and reliability of their products.
Supply chain constraints have been one of the biggest hurdles faced by orthopedic manufacturers over the past year. “Lead times for sterile packaging materials have significantly increased, making it difficult to find reliable supply chain partners for sourcing materials as the demand for single-use kits continues to rise,” Faresich said.
Tyber Medical recently brought more of the production process in-house — including packaging, sealing and biological testing — to alleviate supply chain issues. “The move aims to improve the speed and efficiency of product delivery to our customers,” Faresich said.
Verification and validation testing of sterile packaging for single-use instruments is one of the most challenging regulatory requirements. Shelf-life testing is also time-consuming and costly.
“Our products have a minimum shelf life of five years,” Faresich said. “To maintain that requirement, we perform five-year accelerated aging tests with intermediate checkpoints and concurrent real-time aging studies. These tests can be expensive and often take several months to complete, depending on the temperature used for the accelerated aging process.”
Faresich said that Tyber Medical is leveraging a comprehensive range of materials, manufacturing processes and product families in the company’s sterile validation plan. “We approach verification and validation by considering not just the current system, but also potential projects, and test the most challenging products to maximize our validation results,” he explained.
The majority of Tyber Medical’s single-use products undergo gamma radiation sterilization. That might soon change due to the method’s rising cost. “We’re exploring the use of x-ray sterilization — because ethylene oxide is being phased out — and are preparing to have it as a future option,” Faresich said.
Tyber Medical has assessed several methods for holding single-use devices securely within sterile kits and has validated and brought in-house a sterilization pouch that can be vacuum-sealed. “This allows us to use multiple materials and sealing equipment, and provides us with more options and flexibility beyond relying on one vendor,” Faresich said. “It ensures that we have redundancies in packaging type and equipment to package our product effectively.”
Monitoring the Market
Orthopedic companies must ensure that their goals and internal processes are aligned with market trends. “Having the right team in place that understands verification and validation testing requirements and supply chain management is crucial,” said Faresich. “By balancing these factors and understanding where the market is going, you can achieve long-term success.”
Haider believes the design and production of sophisticated disposable instruments will continue to evolve as more complex cases move to outpatient facilities and surgeons perform surgery with more robust surgical plans. “The types of cases performed in ASCs will serve as the canary in the coal mine,” he said. “I think that’s a good metric to measure and predict where the disposable market is heading.”
