Mark Crawford, Contributing Writer02.14.22
Surgical instrument design and manufacturing continues to be a busy industry, despite the relentless COVID-19 pandemic and the drop in non-essential or elective surgeries. Many medical device manufacturers (MDMs) are still heavily focused on finding solutions to the negative supply chain impacts from the pandemic, including material shortages, incredibly long lead times, and fewer workers. Orthopedic device companies still struggle with supply chain speed and reliability, with some going as far as redesigning products to reduce the number of manufacturing steps and minimize the need for outside vendors as much as possible.
Although MDMs still prefer simpler designs and ease-of-use when possible, surgical procedures increasingly require devices with complex geometries, tight tolerances, miniaturized sizes, and special surface treatments and coatings. Surgical instrument design is becoming highly specialized, with a keen interest in robotic surgery, which often demands tight-tolerance features. “Manufacturing these features requires state-of-the-art equipment that is well maintained,” said Daniel Owens, vice president of innovations and technology for Paragon Medical, a manufacturer of surgical instruments, implants, and medical devices. “This includes CNC [computer numerical control] machines, as well as inspection equipment.”
“Major technology advancements in preoperative planning, visualization, and digital approaches are changing not only how today’s surgical procedures are performed, but also how instruments are both designed and manufactured,” added Barry L. Parker, vice president of product management for Tecomet, a Mass.-based provider of design and manufacturing solutions for a variety of surgical instruments.
This is especially true for the growing number of minimally invasive surgery (MIS) procedures and robotics, which have a growing impact on how instruments are designed and raw material choices. Tolerances are getting tighter for MIS and even more so for robotics and the high-precision controls they require. “These far-reaching surgical procedures also require systems that guarantee torque resistance,” said Thomas Guéguen, general manager for Forécreu America, a Chicago, Ill.-based provider of cannulated bars made from various types of steels and titanium alloys used in surgical instruments and implants.
To reduce time to market, MDMs seek rapid design iterations and short timelines, which often require advanced manufacturing technologies to achieve. With added pressure from healthcare systems to reduce overall costs, MDMs are also paying more attention to instrument lifecycle management, including packaging, sterilization, tracking, and logistics. To achieve cost reductions, companies are leveraging their supply bases by switching suppliers, modifying processes at current suppliers, or shortening supply chains. “However,” said Adam Paltzer, vice president of operations for Able Medical, a Gwinn, Mich.-based designer and manufacturer of implants and instruments for the orthopedic medical device market, “these changes can be complex and have the potential to impact safety and performance.”
Latest Trends
Instruments are used in the treatment of medical conditions, ranging from implants to surgical instruments and even the final packaging in which they arrive. Specialized tools are often needed for specific surgeries such as knee, hip, and spine. All surgical instruments have the primary function of either cutting or resection, alignment, measurement, retraction, impaction, driving, or torque. Energy-based instruments are used for tissue resection or electro-cauterization. Instrument complexity varies from being as simple as a one-piece hand retractor to a multi-component femoral cutting guide or an electronic device that monitors bodily functions.
Instruments used in orthopedic and spinal surgeries comprise three different categories, based on how they enable the surgical procedure: access, bone preparation, and implant-specific. Access instruments provide the retraction or dilation that allow the surgeon a clear path to the anatomical area in which the implant is being placed. Bone-preparation instruments cut, drill, or tap the bone or tissue in preparation for the implant. Implant-specific instruments are the most specialized as they facilitate the insertion of the implant.
“Implants are not one-size-fits-all, so the instruments must be able to accommodate the many variations needed to fit the anatomical needs,” said Chad Ryshkus, vice president of commercial operations for MedTorque, an Elmhurst, Ill.-based provider of orthopedic instruments and spinal implants for the medical device industry. “Trials, sizers, and inserters are some examples whose designs are such that they only work with a specific implant.”
A key challenge in manufacturing instruments is applying the appropriate amount of tolerance where needed and having the technology and equipment to inspect and measure this tolerance. As inspection technologies improve, MDMs can expand their product designs to include even smaller features and tighter tolerances. Achieving even tighter tolerances expands a medical engineer’s ability to make highly complex instrumentation that enhances advanced computer-assisted and robotic surgical approaches. MIS and robotics are extremely popular in the surgical field and are often integrated together to offer improved accuracy, speed, control, and efficiency. “All major OEMs have spectacular growth in their robotics divisions,” said Guéguen. “Robots have positioning challenges and their software is being constantly improved to hit perfect positioning. Total indicator readout, true position, and straightness are critical specifications.”
An increasing number of surgical procedures are performed at smaller medical centers, such as outpatient ambulatory surgical centers (ASCs), where reimbursement rates are lower.cost efficiencies, These environments are using more single-use and surgery-ready instrument sets, especially for lower-complexity implant procedures. In fact, the Centers for Medicare and Medicaid Services have removed about 300 primarily musculoskeletal procedures from in-patient only to outpatient settings, such as ASCs. As these centers expand to offer more services, their popularity will only accelerate as a large percentage of the population reaches advanced age. “With this shift, the ability of an ASC to provide instrumentation in sterile-packed, single-use configurations is essential,” said Paltzer. “The patient experiences better outcomes and reduced infection rates and the ASC saves money on resources for sterilization.”
Jim Schultz, vice president of customer solutions for ECA Medical Instruments, a Thousand Oaks, Calif.-based provider of single-use precision torque limiters, sterile pack, and surgery-ready procedural kits, agreed.
“There is a huge shift of surgeries to the outpatient surgery center market—over 66 percent of all surgeries by 2023,” said Schultz. “Orthopedic implant OEMs have strategic plans to support and grow this market segment by employing different instrument strategies and a streamlined fulfillment approach. This has given impetus to a fast-growing, sterile-pack, surgery-ready kit market that is based on single-use instrumentation, which is optimized and tailored for ortho implant procedures in this setting. Being clinically robust and ergonomically balanced, these sets are easy to handle and inventory and require no reprocessing or spares and repairs. Cost savings are between $200 to over $800 per surgery.”
What OEMs Want
The speed to launch new products in the orthopedic industry continues to be critically important. “With the increased time required by early product development and regulatory stages, shortening manufacturing time is one of the few areas of opportunity remaining for reducing the time to launch new products,” said Guéguen. “Additionally, device companies are continuing to pressure contract manufacturers to reduce costs.”
MDMs are hungry for any kind of modification or improvement that will shorten the manufacturing process and get products to market more quickly. OEMs often request quick turnaround for prototypes. There is also more interest in single-use (disposable) devices, which are increasingly viewed by MDMs as a way to deliver high performance at lower cost, especially in the ASC market. There currently is an industry-wide movement toward single-use, surgery-ready kits and instruments that can improve OR productivity, cut costs, and reduce carbon footprints.
For more complex surgical procedures, “we are seeing a need for specialized instruments to meet the specific needs of innovative surgeons,” said David Cabral, president and CEO of Five Star Companies, a New Bedford, Mass.-based manufacturer of surgical instruments and provider of surgical instrument repair and refurbishment. “These include instruments for carpal tunnel procedures and longer instruments and enhanced distal configurations for better exposure to surgical sites for bariatric patients. For surgeons who want to simplify a procedure, we have developed a set of radiolucent retractor blades that allow X-rays to be taken without disassembly of the surgical field. The blade material creates a transparent view of the site and the surgeon can continue his procedure unobstructed.”
As instruments become more complex, they become harder to deliver on time because they have more components and complicated sub-assemblies, which are increasingly difficult to source because of supply chain disruptions. MDMs continue to look fervently for supply chain solutions. Shorter supply chains with dependable, reliable, and competent providers are preferred to longer supply chains. Even better is full sourcing from a complete solutions provider (including packaging of the final product).
“OEMs are frustrated with the overall time it takes to get a product to market and are looking for ways to partner with trusted supply chain companies that can dramatically compress historical development and launch time frames,” said Parker. “So overall, they want partners that can rapidly iterate through design evolutions.”
Many OEMs have undertaken initiatives to consolidate the number of suppliers. However, the efficiencies gained by utilizing fewer suppliers must be supported by suppliers that can manage the entire value chain of manufacturing. “This includes everything from design and development assistance to prototyping to full-scale production,” said Ryshkus. “Owning all or most of the processes required to manufacture these devices increases the value of a partner-supplier.”
New Technologies
Manufacturing surgical instruments requires a level of technological detail and expertise well above “standard” machining and manufacturing. Technologies include the Internet of Things (IoT), automation, robotics, wireless, flexible electronics, advanced materials, additive manufacturing, optical inspection systems, laser micromachining, rapid prototyping, and cleanroom assembly. Detailed records on possible trace containments that may be present on the devices must be maintained for patient safety. Packaging and sterilization are equally important for protecting the device from the rigors of transportation to the surgical hospital or clinic.
Design to cost and design for manufacturability are important as healthcare systems struggle to control costs. This is often a challenge with complex instrumentation. Surgical instruments tend to require much tighter tolerances than implants. The tighter tolerances allow for a more precise cut and better accuracy in placing the implant, resulting in improved patient outcomes. In many cases, instruments have complex assemblies with moving and mating parts to deploy, manipulate, and remove implants or tissue. “This requires knowledge in tolerance stack-up analysis, process requirements, and wide-reaching knowledge of an array of secondary processes that increase our capabilities,” said Paltzer.
Intech Medical, a Rockaway, N.J.-based designer and manufacturer of sterilization cases and trays, has created a unique tray system that reduces costs and increases efficiencies in the operating room. Called Wash’InBox, this “mesh tray” allows an MDM to ship a surgical kit in a container that is usable to the hospital. Sometimes hospital staff remove all the components of a tray and transfer them to a traditional mesh tray.
This process can result in damage or loss of the components, which may carry a large cost for OEMs. “Implementing the Wash’InBox in an OEM’s supply chain reduces these transfers and the associated risk,” said David Hollner, plant manager for Intech Medical. “Hospitals also benefit in reduced processing cost, reduced surgical wait time, and overall increase in efficiency and output of their sterile processing facilities.”
In another cost-saving measure, partially glass-filled polymers such as Ixef by Solvay (which contains 50 percent to 60 percent glass-fiber reinforcement and provides remarkable strength and rigidity) offer molding opportunities that can produce complex and very strong instruments that, in many cases, mimic stainless steel but at a friendlier price point. “This has opened up huge opportunities to transition expensive machined parts to plastics without compromising functionality and improving time to market and overall sustainability goals,” said Schultz.
The IoT is being used to help track packaged products as they move through the supply chain. For example, Intech’s case and tray division is embedding sensor modules into its trays, making them compatible for universal deployment. “Several exciting sensor packages enable OEMs to track the critical phases of tray transport, use, and return,” said Hollner. “We have also developed a customizable tray specifically designed for compatibility with automated washing and decontamination procedures. This tray can achieve up to a 70 percent perforation rate.”
Additive manufacturing (AM) has developed a solid reputation in the implant manufacturing world. When designed for single-use instruments, AM will be a cost-effective way to manufacture these metal (or even plastic) disposable products. AM can also be used to manufacture surgical instrumentation, such as patient-specific custom surgical guides. AM can also speed up the process of iterative design. Prototypes are required for various design phases from concept selection onward. “In many cases, the development timeline segments can be compressed from weeks to days by leveraging AM technology to support surgeon labs with various designs for proof-of-concept and other necessary activities,” said Parker.
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 IoT processes. The goal of robotics is the highest possible accuracy—integration of the required advanced hardware/software typically results in multiple multi-level assemblies, which must fit together perfectly to connect the instrument to the robot arm. “Tolerancing and feature relationships are extremely important for maintaining this targeted accuracy,” said Parker. “This pushes some of the limits of manufacturing capability, but also pushes the limits of metrology capabilities to assure that we have produced what was intended.”
IoT and Beyond
IoT in healthcare (also known as the Internet of Medical Things) includes all medical devices, infrastructures, and applications that collect and transfer medical data over a network without any human intervention. Recent events—especially the COVID-19 pandemic—have accelerated the deployment of IoT applications, improving patient safety while reducing costs. As a result, the Internet of Medical Things is expected to grow at a compound annual growth rate of 31 percent by 2026.¹
When a surgical instrument is equipped with a chip and connected to an Internet-based platform, it becomes a connected surgical instrument that presents several real-time advantages, including:
As surgical procedures move toward ASCs, single-use, sterile packed products are increasingly popular. New sterilization methods, polymers, and other materials are providing different options for low-cost, high-quality instrumentation to meet these increased demands. In addition, sterile-pack implants are required in many countries to reduce infection risk and on-site handling and improve hospital efficiency. “This has necessitated the need for companion sterile-pack, surgery-ready instruments for implant fixation,” said Schultz. “This includes trauma, extremity, spine, and large joint procedures. This will be a significant trend over the next decade.”
Other operating-room challenges in the ASC can be met using modular trays that provide the surgeon with flexibility and set extensions based on patient profile. “Modularity can be designed into a tray layout, which increases access and use of space in the OR, increasing surgeon efficiency,” said Hollner.
In addition, medical-grade polymers have been developed in recent years that are used to make very robust single-use instruments that retain or improve upon the ergonomics, aesthetics, and weight and balance of a reusable instrument set—at a fraction of the cost. “These are optimized to perform perfectly throughout an entire surgical procedure—one time,” said Schultz. “However, the net cost is much lower and sustainability much higher. Studies show the carbon footprint of a single-use instrument set is about half that of a reusable set, making them very sustainable and nearly all the packaging and instrument components can be recycled.”
Virtually nothing is impossible to manufacture, noted Cabral.
“Typically, the design and tolerances displayed on a CAD program are not fully reflected in what is capable to achieve on a CNC machine,” he said. “This is best resolved by working with customers collaboratively through the design for manufacturability process to determine the actual requirements from the surgical instrument. What function are we trying to achieve and what characteristics of the design are critical to these functional needs? Once these design criteria are decided, the manufacture continues and the surgeon expectations are exceeded.”
OEMs and their CMs continue to search for ways that balance quality, technology, speed, and cost without sacrificing creativity, innovation, and product quality. To achieve this, MDMs expect more technology, materials, and regulatory guidance and expertise from their partners to mitigate risk and speed up time to market.
“The dynamics of the supplier/OEM relationship have drastically changed over the last few years, with OEMs looking to their suppliers to bring ideas and innovation by involving them much earlier in the instrument development process,” said Parker. “We are excited about expanding this type of collaboration and look forward to a greater role in helping our clients design and develop innovative, next-generation surgical tools and instruments that improve patient outcomes.”
Reference
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
Although MDMs still prefer simpler designs and ease-of-use when possible, surgical procedures increasingly require devices with complex geometries, tight tolerances, miniaturized sizes, and special surface treatments and coatings. Surgical instrument design is becoming highly specialized, with a keen interest in robotic surgery, which often demands tight-tolerance features. “Manufacturing these features requires state-of-the-art equipment that is well maintained,” said Daniel Owens, vice president of innovations and technology for Paragon Medical, a manufacturer of surgical instruments, implants, and medical devices. “This includes CNC [computer numerical control] machines, as well as inspection equipment.”
“Major technology advancements in preoperative planning, visualization, and digital approaches are changing not only how today’s surgical procedures are performed, but also how instruments are both designed and manufactured,” added Barry L. Parker, vice president of product management for Tecomet, a Mass.-based provider of design and manufacturing solutions for a variety of surgical instruments.
This is especially true for the growing number of minimally invasive surgery (MIS) procedures and robotics, which have a growing impact on how instruments are designed and raw material choices. Tolerances are getting tighter for MIS and even more so for robotics and the high-precision controls they require. “These far-reaching surgical procedures also require systems that guarantee torque resistance,” said Thomas Guéguen, general manager for Forécreu America, a Chicago, Ill.-based provider of cannulated bars made from various types of steels and titanium alloys used in surgical instruments and implants.
To reduce time to market, MDMs seek rapid design iterations and short timelines, which often require advanced manufacturing technologies to achieve. With added pressure from healthcare systems to reduce overall costs, MDMs are also paying more attention to instrument lifecycle management, including packaging, sterilization, tracking, and logistics. To achieve cost reductions, companies are leveraging their supply bases by switching suppliers, modifying processes at current suppliers, or shortening supply chains. “However,” said Adam Paltzer, vice president of operations for Able Medical, a Gwinn, Mich.-based designer and manufacturer of implants and instruments for the orthopedic medical device market, “these changes can be complex and have the potential to impact safety and performance.”
Latest Trends
Instruments are used in the treatment of medical conditions, ranging from implants to surgical instruments and even the final packaging in which they arrive. Specialized tools are often needed for specific surgeries such as knee, hip, and spine. All surgical instruments have the primary function of either cutting or resection, alignment, measurement, retraction, impaction, driving, or torque. Energy-based instruments are used for tissue resection or electro-cauterization. Instrument complexity varies from being as simple as a one-piece hand retractor to a multi-component femoral cutting guide or an electronic device that monitors bodily functions.
Instruments used in orthopedic and spinal surgeries comprise three different categories, based on how they enable the surgical procedure: access, bone preparation, and implant-specific. Access instruments provide the retraction or dilation that allow the surgeon a clear path to the anatomical area in which the implant is being placed. Bone-preparation instruments cut, drill, or tap the bone or tissue in preparation for the implant. Implant-specific instruments are the most specialized as they facilitate the insertion of the implant.
“Implants are not one-size-fits-all, so the instruments must be able to accommodate the many variations needed to fit the anatomical needs,” said Chad Ryshkus, vice president of commercial operations for MedTorque, an Elmhurst, Ill.-based provider of orthopedic instruments and spinal implants for the medical device industry. “Trials, sizers, and inserters are some examples whose designs are such that they only work with a specific implant.”
A key challenge in manufacturing instruments is applying the appropriate amount of tolerance where needed and having the technology and equipment to inspect and measure this tolerance. As inspection technologies improve, MDMs can expand their product designs to include even smaller features and tighter tolerances. Achieving even tighter tolerances expands a medical engineer’s ability to make highly complex instrumentation that enhances advanced computer-assisted and robotic surgical approaches. MIS and robotics are extremely popular in the surgical field and are often integrated together to offer improved accuracy, speed, control, and efficiency. “All major OEMs have spectacular growth in their robotics divisions,” said Guéguen. “Robots have positioning challenges and their software is being constantly improved to hit perfect positioning. Total indicator readout, true position, and straightness are critical specifications.”
An increasing number of surgical procedures are performed at smaller medical centers, such as outpatient ambulatory surgical centers (ASCs), where reimbursement rates are lower.cost efficiencies, These environments are using more single-use and surgery-ready instrument sets, especially for lower-complexity implant procedures. In fact, the Centers for Medicare and Medicaid Services have removed about 300 primarily musculoskeletal procedures from in-patient only to outpatient settings, such as ASCs. As these centers expand to offer more services, their popularity will only accelerate as a large percentage of the population reaches advanced age. “With this shift, the ability of an ASC to provide instrumentation in sterile-packed, single-use configurations is essential,” said Paltzer. “The patient experiences better outcomes and reduced infection rates and the ASC saves money on resources for sterilization.”
Jim Schultz, vice president of customer solutions for ECA Medical Instruments, a Thousand Oaks, Calif.-based provider of single-use precision torque limiters, sterile pack, and surgery-ready procedural kits, agreed.
“There is a huge shift of surgeries to the outpatient surgery center market—over 66 percent of all surgeries by 2023,” said Schultz. “Orthopedic implant OEMs have strategic plans to support and grow this market segment by employing different instrument strategies and a streamlined fulfillment approach. This has given impetus to a fast-growing, sterile-pack, surgery-ready kit market that is based on single-use instrumentation, which is optimized and tailored for ortho implant procedures in this setting. Being clinically robust and ergonomically balanced, these sets are easy to handle and inventory and require no reprocessing or spares and repairs. Cost savings are between $200 to over $800 per surgery.”
What OEMs Want
The speed to launch new products in the orthopedic industry continues to be critically important. “With the increased time required by early product development and regulatory stages, shortening manufacturing time is one of the few areas of opportunity remaining for reducing the time to launch new products,” said Guéguen. “Additionally, device companies are continuing to pressure contract manufacturers to reduce costs.”
MDMs are hungry for any kind of modification or improvement that will shorten the manufacturing process and get products to market more quickly. OEMs often request quick turnaround for prototypes. There is also more interest in single-use (disposable) devices, which are increasingly viewed by MDMs as a way to deliver high performance at lower cost, especially in the ASC market. There currently is an industry-wide movement toward single-use, surgery-ready kits and instruments that can improve OR productivity, cut costs, and reduce carbon footprints.
For more complex surgical procedures, “we are seeing a need for specialized instruments to meet the specific needs of innovative surgeons,” said David Cabral, president and CEO of Five Star Companies, a New Bedford, Mass.-based manufacturer of surgical instruments and provider of surgical instrument repair and refurbishment. “These include instruments for carpal tunnel procedures and longer instruments and enhanced distal configurations for better exposure to surgical sites for bariatric patients. For surgeons who want to simplify a procedure, we have developed a set of radiolucent retractor blades that allow X-rays to be taken without disassembly of the surgical field. The blade material creates a transparent view of the site and the surgeon can continue his procedure unobstructed.”
As instruments become more complex, they become harder to deliver on time because they have more components and complicated sub-assemblies, which are increasingly difficult to source because of supply chain disruptions. MDMs continue to look fervently for supply chain solutions. Shorter supply chains with dependable, reliable, and competent providers are preferred to longer supply chains. Even better is full sourcing from a complete solutions provider (including packaging of the final product).
“OEMs are frustrated with the overall time it takes to get a product to market and are looking for ways to partner with trusted supply chain companies that can dramatically compress historical development and launch time frames,” said Parker. “So overall, they want partners that can rapidly iterate through design evolutions.”
Many OEMs have undertaken initiatives to consolidate the number of suppliers. However, the efficiencies gained by utilizing fewer suppliers must be supported by suppliers that can manage the entire value chain of manufacturing. “This includes everything from design and development assistance to prototyping to full-scale production,” said Ryshkus. “Owning all or most of the processes required to manufacture these devices increases the value of a partner-supplier.”
New Technologies
Manufacturing surgical instruments requires a level of technological detail and expertise well above “standard” machining and manufacturing. Technologies include the Internet of Things (IoT), automation, robotics, wireless, flexible electronics, advanced materials, additive manufacturing, optical inspection systems, laser micromachining, rapid prototyping, and cleanroom assembly. Detailed records on possible trace containments that may be present on the devices must be maintained for patient safety. Packaging and sterilization are equally important for protecting the device from the rigors of transportation to the surgical hospital or clinic.
Design to cost and design for manufacturability are important as healthcare systems struggle to control costs. This is often a challenge with complex instrumentation. Surgical instruments tend to require much tighter tolerances than implants. The tighter tolerances allow for a more precise cut and better accuracy in placing the implant, resulting in improved patient outcomes. In many cases, instruments have complex assemblies with moving and mating parts to deploy, manipulate, and remove implants or tissue. “This requires knowledge in tolerance stack-up analysis, process requirements, and wide-reaching knowledge of an array of secondary processes that increase our capabilities,” said Paltzer.
Intech Medical, a Rockaway, N.J.-based designer and manufacturer of sterilization cases and trays, has created a unique tray system that reduces costs and increases efficiencies in the operating room. Called Wash’InBox, this “mesh tray” allows an MDM to ship a surgical kit in a container that is usable to the hospital. Sometimes hospital staff remove all the components of a tray and transfer them to a traditional mesh tray.
This process can result in damage or loss of the components, which may carry a large cost for OEMs. “Implementing the Wash’InBox in an OEM’s supply chain reduces these transfers and the associated risk,” said David Hollner, plant manager for Intech Medical. “Hospitals also benefit in reduced processing cost, reduced surgical wait time, and overall increase in efficiency and output of their sterile processing facilities.”
In another cost-saving measure, partially glass-filled polymers such as Ixef by Solvay (which contains 50 percent to 60 percent glass-fiber reinforcement and provides remarkable strength and rigidity) offer molding opportunities that can produce complex and very strong instruments that, in many cases, mimic stainless steel but at a friendlier price point. “This has opened up huge opportunities to transition expensive machined parts to plastics without compromising functionality and improving time to market and overall sustainability goals,” said Schultz.
The IoT is being used to help track packaged products as they move through the supply chain. For example, Intech’s case and tray division is embedding sensor modules into its trays, making them compatible for universal deployment. “Several exciting sensor packages enable OEMs to track the critical phases of tray transport, use, and return,” said Hollner. “We have also developed a customizable tray specifically designed for compatibility with automated washing and decontamination procedures. This tray can achieve up to a 70 percent perforation rate.”
Additive manufacturing (AM) has developed a solid reputation in the implant manufacturing world. When designed for single-use instruments, AM will be a cost-effective way to manufacture these metal (or even plastic) disposable products. AM can also be used to manufacture surgical instrumentation, such as patient-specific custom surgical guides. AM can also speed up the process of iterative design. Prototypes are required for various design phases from concept selection onward. “In many cases, the development timeline segments can be compressed from weeks to days by leveraging AM technology to support surgeon labs with various designs for proof-of-concept and other necessary activities,” said Parker.
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 IoT processes. The goal of robotics is the highest possible accuracy—integration of the required advanced hardware/software typically results in multiple multi-level assemblies, which must fit together perfectly to connect the instrument to the robot arm. “Tolerancing and feature relationships are extremely important for maintaining this targeted accuracy,” said Parker. “This pushes some of the limits of manufacturing capability, but also pushes the limits of metrology capabilities to assure that we have produced what was intended.”
IoT and Beyond
IoT in healthcare (also known as the Internet of Medical Things) includes all medical devices, infrastructures, and applications that collect and transfer medical data over a network without any human intervention. Recent events—especially the COVID-19 pandemic—have accelerated the deployment of IoT applications, improving patient safety while reducing costs. As a result, the Internet of Medical Things is expected to grow at a compound annual growth rate of 31 percent by 2026.¹
When a surgical instrument is equipped with a chip and connected to an Internet-based platform, it becomes a connected surgical instrument that presents several real-time advantages, including:
- Optimized inventory management and stocks monitoring—“When combining real-time asset tracking with big data, automated reports can be generated, thus helping to identify how surgical instruments are used and moved, how often they are sterilized, and if replacement is necessary,” stated David Ryan, CEO for SMADE, a new company and Intech spinoff launched in 2022 that focuses on IoT solutions for healthcare. “Inventory managers can then make informed decisions regarding productions and investments, avoiding unnecessary manufacturing or expenses and allocating resources more soundly.”
- Improved patient safety—Deploying smart tracking of surgical instruments provides an increased level of traceability of devices, as well as a precise inventory count of tools before and after a procedure, thereby limiting the risk of any adverse events resulting from retained surgical instruments. “Surgical instruments left inside the patient after surgery can lead to severe infections, if not death,” continued Ryan. “It is estimated that 1,500 cases of retained surgical bodies could be avoided every year in the U.S.² thanks to better tracking.” Smart surgical instruments also make it possible to track performance levels and verify sterilization cycles.
- Innovation—With edge computing and cloud computing, data from connected surgical instruments can be collected, analyzed, and processed, thus providing meaningful insights to surgical instrument manufacturers, which helps in the development of made-to-measure instruments quickly and cost-efficiently.
As surgical procedures move toward ASCs, single-use, sterile packed products are increasingly popular. New sterilization methods, polymers, and other materials are providing different options for low-cost, high-quality instrumentation to meet these increased demands. In addition, sterile-pack implants are required in many countries to reduce infection risk and on-site handling and improve hospital efficiency. “This has necessitated the need for companion sterile-pack, surgery-ready instruments for implant fixation,” said Schultz. “This includes trauma, extremity, spine, and large joint procedures. This will be a significant trend over the next decade.”
Other operating-room challenges in the ASC can be met using modular trays that provide the surgeon with flexibility and set extensions based on patient profile. “Modularity can be designed into a tray layout, which increases access and use of space in the OR, increasing surgeon efficiency,” said Hollner.
In addition, medical-grade polymers have been developed in recent years that are used to make very robust single-use instruments that retain or improve upon the ergonomics, aesthetics, and weight and balance of a reusable instrument set—at a fraction of the cost. “These are optimized to perform perfectly throughout an entire surgical procedure—one time,” said Schultz. “However, the net cost is much lower and sustainability much higher. Studies show the carbon footprint of a single-use instrument set is about half that of a reusable set, making them very sustainable and nearly all the packaging and instrument components can be recycled.”
Virtually nothing is impossible to manufacture, noted Cabral.
“Typically, the design and tolerances displayed on a CAD program are not fully reflected in what is capable to achieve on a CNC machine,” he said. “This is best resolved by working with customers collaboratively through the design for manufacturability process to determine the actual requirements from the surgical instrument. What function are we trying to achieve and what characteristics of the design are critical to these functional needs? Once these design criteria are decided, the manufacture continues and the surgeon expectations are exceeded.”
OEMs and their CMs continue to search for ways that balance quality, technology, speed, and cost without sacrificing creativity, innovation, and product quality. To achieve this, MDMs expect more technology, materials, and regulatory guidance and expertise from their partners to mitigate risk and speed up time to market.
“The dynamics of the supplier/OEM relationship have drastically changed over the last few years, with OEMs looking to their suppliers to bring ideas and innovation by involving them much earlier in the instrument development process,” said Parker. “We are excited about expanding this type of collaboration and look forward to a greater role in helping our clients design and develop innovative, next-generation surgical tools and instruments that improve patient outcomes.”
Reference
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.