Ranica Arrowsmith, Associate Editor02.18.15
“Philosophers are people who know less and less about more and more, until they know nothing about everything. Scientists are people who know more and more about less and less, until they know everything about nothing.” —Konrad Lorenz, zoologist, ethologist, ornithologist. The idea is familiar. Continuous, focused betterment can too easily become meaningless or fruitless. Cost cutting doesn’t end with a medical device costing $0. What really happens is that device manufacturers find innovative ways to either lower costs or increase functionality to increase value. A piece of paper can only be folded seven times—or so we were told, until California teen Britney Gallivan proved that a 4,000 foot piece of toilet paper could be folded a maximum of 12 times. She used a mathematical formula and little innovative thinking to consider folding paper a number of times in one direction instead of the presumed every other direction. She succeeded, and achieved what was once thought impossible.
Medtech faces a similar quandary. Physician and OEM clients of medical device manufacturers want lower and lower costs. They want better and better functionality. OEMs and their contract manufacturers seek design and manufacturing innovation that pushes the envelope a little bit further every year. Of all the industries in the world going “retro”—fashion, music, lifestyle—technology, much less medical technology, is not one of them. Upward and onward is and will always be the foremost consideration. It’s facile to ask, “just how efficient/cost effective/innovative can we be?” because with forced cost-cutting or innovation, there is no end in sight. Clients always want to pay less money, and always want better products. Specifically, orthopedic surgical instrumentation, which has been around ever since surgeons started sawing bones, derive advancement from innovation in surgery itself; from manufacturing techniques; from materials technology; from mechanical engineering advancements; from medical advancements; and from human creativity. In short, there are so many factors driving efficiency and innovation in orthopedic instrumentation that we won’t have to worry about stopping at just 12 folds.
Take Precision Medical Technologies Inc., a Warsaw, Ind.-based a contract manufacturer of orthopedic implants and instruments. The company has a spinal instruments business, and according to its website, sees the spinal instruments market as the “last frontier” for machining operations. Spinal surgery is one of the most delicate types of surgery that can be performed on a patient, as the spine houses the spinal cord and is connected directly to neurological function. The rise of minimally invasive techniques and instruments is particularly suited to the spine surgery market, as they lend themselves to delicacy and lower risk. Spine is the ideal area for manufacturers and end-users alike to work towards ultimately, perhaps, eliminating surgical cuts.
According to spine-health.com, the role of spine fusion instrumentation is to provide additional spinal stability while helping the fusion set. Various forms of instrumentation have been developed with the goal of improving the rates of successful spinal fusion.
Because bone tends to fuse more effectively in an environment where there is little motion, instrumentation that limits the motion most effectively at the fused segment is most successful. Spine instrumentation has developed over time from the 1950s, when Paul Harrington invented the first spine instrument set, to now, to be more three-dimensional. From screws and threaded cabling, to smooth bendable rods, to multiple-approach instrumentation (pedicle screws, anterior interbody cages and posterior lumbar cages), spine instrumentation has become smaller and more manageable over time to manage the delicate and crucial anatomy of the spine. New areas of development include smaller, lower profile instrumentation to reduce patient discomfort, implants that can be placed through minimally invasive approaches and bioabsorbable implants that can dissolve after the bony fusion has occurred. In some cases, rigid titanium or metal implants are too strong and can erode into bone. Therefore, some implants are now made from polymers that more closely resemble the characteristics of bone.
But manufacturers cannot lose sight of manufacturability and the ability to produce in volume.
“One of the largest concerns for us is a device’s design for manufacturability,” Chris Beatty, business development manager for Precision Medical Technologies, told Orthopedic Design & Technology. “Tight tolerances and complex geometries to manufacture are a necessary evil when it comes to innovation of devices. At the same time though, this drives cost up in an already cost sensitive environment. We appreciate when our customer gives us the opportunity to give feedback on the manufacturability of an item at the design stage. This gives the opportunity for the surgeons to get what they need from a design, and also gives us the opportunity to mold that design around a cost effective method to produce the product so everyone wins.”
James B. Schultz, executive vice president of ECA Medical Instruments Inc., a Newbury Park, Calif.-based manufacturer of single-procedure torque-limiting surgical instruments, fixed drivers and customized implant fixation kits, noted the importance of more delicate, minimally invasive instrumentation not just in the operating room but in outpatient settings such as ambulatory surgical centers (ASCs).
“OEMs that will win going forward, especially in trauma, extremity, small bone and certain spine implant procedures, will be the ones that provide best outcomes at best value in outpatient settings,” said Schultz. “Physicians also want minimally invasive surgery instruments that are tailored for this application.”
Fort Worth, Texas-based CoorsTek Medical, a materials-focused custom products manufacturer, also is seeing a push toward minimally invasive surgical (MIS) devices.
“Everybody wants instruments that their surgeons find easy to use and intuitive,” General Manager Andrew Fauth, Ph.D., told ODT. “The big push in the last couple of years has really been reduction in cost—how do we make instruments that are cheaper, but that also maintain key functionality? Especially when you look at joint reconstruction and some of these areas where you have large numbers of instruments and trays in a procedure, there has been a lot of focus on reducing the cost. These instrument sets can be tens of thousands of dollars or more per set. We want to be streamlining them for that ease of use and making them attractive to the surgeons and more beneficial to the patients. So for example, we’re seeing more focus on instruments that enable MIS procedures; smaller access procedures that require unique instruments to prep the joint surface, prepare for the implant, or insert the implant.”
Maintaining Momentum in Innovation
In 2000, Mike and Stacy Gauthier started a company called Gauthier Biomedical Inc. The biomedical engineers, who also happen to be husband and wife, had no customers, no contacts, and their only income was from Stacy’s job at Aurora St. Luke’s Medical Center overseeing its ventricular pump program. Mike’s first design was the company’s No-play ratcheting screwdriver, the design of which limits axial and side-to-side “play” or “wobble” between the shaft and handle. A ratcheting screwdriver has a mechanism in its handle that allows the user, when screwing or unscrewing, to reposition his hand for another turn without having to remove the head of the screwdriver from the screw’s slot. When using a ratcheting screwdriver, there’s no need to release the pressure on the screw or to remove the screwdriver’s head from the screw’s slot. Instead, the user just turns his wrist counterclockwise.
Gauthier’s patented No-play design has helped the company find great success from humble beginnings. The company’s first big sale came in 2003 from Zimmer Holdings Inc. for 450 ratcheting screwdrivers to include in surgical kits. The order was worth more than $90,000.
The Gauthiers began their company with literally nothing except their engineering expertise and a desire to create excellence in orthopedic instrumentation. An innovative idea 15 years ago brought them success, and the firm remains a powerhouse seller today. The Gauthiers proved to be serial innovators rather than the dreaded one-hit wonder, and the company now offers torque instruments, spinal instruments, silicone handles, fixed instruments and connectors, and adapters as well as ratcheting screwdrivers.
“Product development really begins by having a staff of instrumentation experts and this, I believe, is why Gauthier has been so successful at developing such a strong market presence over its 15 years,” said Dean Poulos, sales and marketing manager for Gauthier Biomedical. “We only have two salespeople in the entire company and by having a team of seasoned product development engineers rather than a team of overzealous salespeople, Gauthier Biomedical has been able to tap into our customers’ needs and partner with them to help drive innovation and bring product to market quickly and effectively. From the very first days of the company, the goal was simple: bring innovation and quality to the market and the rest will take care of itself. We’ve tried to build our company around this simple premise. If necessity truly is the mother of all invention then it’s important to be able to read the needs of the marketplace. The Gauthiers saw this and simply built a company best equipped to attain this goal. The Gauthiers recognized there was an unmet need for excellence in the orthopedic instrument marketplace. They took this opportunity to build and lead a strong team around them and quickly began to create some of the highest quality instruments on the market. In its 15 years, the no play ratcheting screwdrivers, for example, has become one of the best-selling instruments in the world.”
Gauthier places less emphasis on sales and more emphasis on internal ideas, having confidence that great ideas will breed success in the marketplace. A different yet equally valid approach is to focus on demand clients and then find ways to meet those needs effectively and efficiently.
“We are very market and customer driven,” said ECA Medical’s Schultz. “We partner with our OEM customers to develop leading-edge and novel solutions that are tailored for them. They may be configured for one procedure type or use common instruments, packaging and validations that can be leveraged across a wide range of procedures. This is especially true among foot and ankle, trauma and extremity OEMs. Although the spine market is fast moving to single procedure instrument kits as witnessed with our recent customized implant fixation kit project with Intelligent Implant Systems. It’s the world’s first fully disposable spine instrument kit and it recently earned U.S. Food and Drug Administration 510(k) approval. The majority of our funding is internal but we also have customer-funded development for customized solutions. It’s an exciting time in our market as it shifts from massive growth with limited cost concerns to reduced growth, a fragmented market, cost reduction and efficiency and scalability. New products and even legacy products are being scrutinized to determine what is the best solution and long term value.”
Manufacturing techniques should not be forgotten as an area in which innovation can occur. This is where instruments can be slightly modified, whether it is making a rod width a hair thinner or a handle slightly shorter to manage costs or improve function and versatility.
“One of the largest ways we drive innovation is by challenging our engineering staff to be creative in their approaches to machining a product,” said Precision Medical’s Beatty. “When you are traditionally machining a product, be it turning, milling, or even an EDM process, there are many different approaches that can be selected to yield the same result. By thinking outside the box about manufacturing, we can push the CNC equipment to the maximum of its capability. Another avenue we go down is trying to simplify the manufacturing process as much as possible for our shop floor operators. Standardizing equipment, tooling, and work holding are a few ways this is achieved.”
A One-time Thing
ECA Medical’s competencies lie in single-use devices. Disposables in orthopedic instrumentation is relatively new in comparison to other medical device sectors, because of the need for orthopedic tools to be strong enough to work with bone. In the past it has been more cost effective to make stainless steel or titanium instruments for orthopedic applications that can be re-used. But as materials science advances, re-usable devices become more sturdy and their traditional benefits become more attractive—namely, instruments are packaged in a ready-for-use, sterile tray; a decrease in infection risk; and less storage costs at hospitals and surgical facilities.
A 2014 report from the Freedonia Group predicted that U.S. demand for disposable medical supplies will grow 4.1 percent per year to $49.3 billion in 2018. An increasing volume of patient activity attributable to an aging population, a rising incidence of medical conditions, and the extension of health insurance coverage by the Affordable Care Act of 2010 will comprise the major forces that spur growth. The U.S. disposable medical supplies market also will benefit from a heightened focus on infection prevention throughout the healthcare sector. Pressures from the Centers for Disease Control and Prevention, the Joint Commission on the Accreditation of Healthcare Organizations, and other medical organizations will prompt hospitals, outpatient facilities, and other health establishments to follow protocols and standards aimed at keeping patients and staff safe from exposure to dangerous, potentially life-threatening pathogens during medical procedures. Orthopedic surgical kits and trays as well as specialty surgical instruments are included in the data.
“Physicians want an instrument that is easy to use, robust, ergonomically functional and most important, best suited for the job at hand,” said Schultz. Surgeons at ASCs are keen to drive out cost and are early adopters of single procedure instruments and kits. They don’t want to invest in capital equipment, more labor costs and be strapped with large and recurring operating costs. They want low cost, speed and efficiency. ASCs are fast-paced surgical production lines. Single-use sterile packed kits and instruments are an ideal fit.
“The market is embracing single-procedure instruments and procedural kits with great enthusiasm,” Schultz continued. “They understand the short term and long term benefits to the hospital, ASC, surgeons and patients. Every orthopedic and spine OEM firm has a single-use strategy and is deciding how to transform existing and new product lines to leverage this exciting new technology in North America, the European Union and emerging markets. The future will usher in change at a pace unprecedented in the industry. Consolidation, cost cutting, reimbursement rules, improved patient safety and overall efficiencies will be paramount. At ECA Medical Instruments we’ve made dramatic investments in people, process, capital equipment and infrastructure over the past three years. We’re staged to support our OEM customers today and flexible and scalable to support them locally and globally. It’s an exciting time to be in our industry.”
At CoorsTek, changing the material of a device is one way in which to meet demands for lower costs. The company has expertise in ceramics, metals and a variety of polymers. According to Fauth, a polymer option can save the manufacturer and client money by lowering production costs and also by potentially modifying a previously reusable device to a disposable one.
“When volume is a consideration, it’s much cheaper to use a polymer that can be molded or use different manufacturing methods that drive costs and ultimately price down,” Fauth said. “We see a lot more of that in sports medicine and general surgery, but it’s making its way to spine and even joint reconstruction. We’re starting to see traditional metal instruments such as cut guides migrate towards patient-specific yet disposable polymer metal blends, or even just polymers, because of cost of goods.”
* * *
When orthopedic surgeons cut, they are no often removing a problem like a general surgeon might remove a hernia or a tumor. They are most often fusing bones, fixing breaks or inserting pins and screws. Bone is by far the hardest tissue in the human body, so instrumentation that can withstand harsh usage is key in orthopedics. Cutting costs at the expense of durability is simply not an option.
Medtech faces a similar quandary. Physician and OEM clients of medical device manufacturers want lower and lower costs. They want better and better functionality. OEMs and their contract manufacturers seek design and manufacturing innovation that pushes the envelope a little bit further every year. Of all the industries in the world going “retro”—fashion, music, lifestyle—technology, much less medical technology, is not one of them. Upward and onward is and will always be the foremost consideration. It’s facile to ask, “just how efficient/cost effective/innovative can we be?” because with forced cost-cutting or innovation, there is no end in sight. Clients always want to pay less money, and always want better products. Specifically, orthopedic surgical instrumentation, which has been around ever since surgeons started sawing bones, derive advancement from innovation in surgery itself; from manufacturing techniques; from materials technology; from mechanical engineering advancements; from medical advancements; and from human creativity. In short, there are so many factors driving efficiency and innovation in orthopedic instrumentation that we won’t have to worry about stopping at just 12 folds.
Take Precision Medical Technologies Inc., a Warsaw, Ind.-based a contract manufacturer of orthopedic implants and instruments. The company has a spinal instruments business, and according to its website, sees the spinal instruments market as the “last frontier” for machining operations. Spinal surgery is one of the most delicate types of surgery that can be performed on a patient, as the spine houses the spinal cord and is connected directly to neurological function. The rise of minimally invasive techniques and instruments is particularly suited to the spine surgery market, as they lend themselves to delicacy and lower risk. Spine is the ideal area for manufacturers and end-users alike to work towards ultimately, perhaps, eliminating surgical cuts.
According to spine-health.com, the role of spine fusion instrumentation is to provide additional spinal stability while helping the fusion set. Various forms of instrumentation have been developed with the goal of improving the rates of successful spinal fusion.
Because bone tends to fuse more effectively in an environment where there is little motion, instrumentation that limits the motion most effectively at the fused segment is most successful. Spine instrumentation has developed over time from the 1950s, when Paul Harrington invented the first spine instrument set, to now, to be more three-dimensional. From screws and threaded cabling, to smooth bendable rods, to multiple-approach instrumentation (pedicle screws, anterior interbody cages and posterior lumbar cages), spine instrumentation has become smaller and more manageable over time to manage the delicate and crucial anatomy of the spine. New areas of development include smaller, lower profile instrumentation to reduce patient discomfort, implants that can be placed through minimally invasive approaches and bioabsorbable implants that can dissolve after the bony fusion has occurred. In some cases, rigid titanium or metal implants are too strong and can erode into bone. Therefore, some implants are now made from polymers that more closely resemble the characteristics of bone.
But manufacturers cannot lose sight of manufacturability and the ability to produce in volume.
“One of the largest concerns for us is a device’s design for manufacturability,” Chris Beatty, business development manager for Precision Medical Technologies, told Orthopedic Design & Technology. “Tight tolerances and complex geometries to manufacture are a necessary evil when it comes to innovation of devices. At the same time though, this drives cost up in an already cost sensitive environment. We appreciate when our customer gives us the opportunity to give feedback on the manufacturability of an item at the design stage. This gives the opportunity for the surgeons to get what they need from a design, and also gives us the opportunity to mold that design around a cost effective method to produce the product so everyone wins.”
James B. Schultz, executive vice president of ECA Medical Instruments Inc., a Newbury Park, Calif.-based manufacturer of single-procedure torque-limiting surgical instruments, fixed drivers and customized implant fixation kits, noted the importance of more delicate, minimally invasive instrumentation not just in the operating room but in outpatient settings such as ambulatory surgical centers (ASCs).
“OEMs that will win going forward, especially in trauma, extremity, small bone and certain spine implant procedures, will be the ones that provide best outcomes at best value in outpatient settings,” said Schultz. “Physicians also want minimally invasive surgery instruments that are tailored for this application.”
Fort Worth, Texas-based CoorsTek Medical, a materials-focused custom products manufacturer, also is seeing a push toward minimally invasive surgical (MIS) devices.
“Everybody wants instruments that their surgeons find easy to use and intuitive,” General Manager Andrew Fauth, Ph.D., told ODT. “The big push in the last couple of years has really been reduction in cost—how do we make instruments that are cheaper, but that also maintain key functionality? Especially when you look at joint reconstruction and some of these areas where you have large numbers of instruments and trays in a procedure, there has been a lot of focus on reducing the cost. These instrument sets can be tens of thousands of dollars or more per set. We want to be streamlining them for that ease of use and making them attractive to the surgeons and more beneficial to the patients. So for example, we’re seeing more focus on instruments that enable MIS procedures; smaller access procedures that require unique instruments to prep the joint surface, prepare for the implant, or insert the implant.”
Maintaining Momentum in Innovation
In 2000, Mike and Stacy Gauthier started a company called Gauthier Biomedical Inc. The biomedical engineers, who also happen to be husband and wife, had no customers, no contacts, and their only income was from Stacy’s job at Aurora St. Luke’s Medical Center overseeing its ventricular pump program. Mike’s first design was the company’s No-play ratcheting screwdriver, the design of which limits axial and side-to-side “play” or “wobble” between the shaft and handle. A ratcheting screwdriver has a mechanism in its handle that allows the user, when screwing or unscrewing, to reposition his hand for another turn without having to remove the head of the screwdriver from the screw’s slot. When using a ratcheting screwdriver, there’s no need to release the pressure on the screw or to remove the screwdriver’s head from the screw’s slot. Instead, the user just turns his wrist counterclockwise.
Gauthier’s patented No-play design has helped the company find great success from humble beginnings. The company’s first big sale came in 2003 from Zimmer Holdings Inc. for 450 ratcheting screwdrivers to include in surgical kits. The order was worth more than $90,000.
The Gauthiers began their company with literally nothing except their engineering expertise and a desire to create excellence in orthopedic instrumentation. An innovative idea 15 years ago brought them success, and the firm remains a powerhouse seller today. The Gauthiers proved to be serial innovators rather than the dreaded one-hit wonder, and the company now offers torque instruments, spinal instruments, silicone handles, fixed instruments and connectors, and adapters as well as ratcheting screwdrivers.
“Product development really begins by having a staff of instrumentation experts and this, I believe, is why Gauthier has been so successful at developing such a strong market presence over its 15 years,” said Dean Poulos, sales and marketing manager for Gauthier Biomedical. “We only have two salespeople in the entire company and by having a team of seasoned product development engineers rather than a team of overzealous salespeople, Gauthier Biomedical has been able to tap into our customers’ needs and partner with them to help drive innovation and bring product to market quickly and effectively. From the very first days of the company, the goal was simple: bring innovation and quality to the market and the rest will take care of itself. We’ve tried to build our company around this simple premise. If necessity truly is the mother of all invention then it’s important to be able to read the needs of the marketplace. The Gauthiers saw this and simply built a company best equipped to attain this goal. The Gauthiers recognized there was an unmet need for excellence in the orthopedic instrument marketplace. They took this opportunity to build and lead a strong team around them and quickly began to create some of the highest quality instruments on the market. In its 15 years, the no play ratcheting screwdrivers, for example, has become one of the best-selling instruments in the world.”
Gauthier places less emphasis on sales and more emphasis on internal ideas, having confidence that great ideas will breed success in the marketplace. A different yet equally valid approach is to focus on demand clients and then find ways to meet those needs effectively and efficiently.
“We are very market and customer driven,” said ECA Medical’s Schultz. “We partner with our OEM customers to develop leading-edge and novel solutions that are tailored for them. They may be configured for one procedure type or use common instruments, packaging and validations that can be leveraged across a wide range of procedures. This is especially true among foot and ankle, trauma and extremity OEMs. Although the spine market is fast moving to single procedure instrument kits as witnessed with our recent customized implant fixation kit project with Intelligent Implant Systems. It’s the world’s first fully disposable spine instrument kit and it recently earned U.S. Food and Drug Administration 510(k) approval. The majority of our funding is internal but we also have customer-funded development for customized solutions. It’s an exciting time in our market as it shifts from massive growth with limited cost concerns to reduced growth, a fragmented market, cost reduction and efficiency and scalability. New products and even legacy products are being scrutinized to determine what is the best solution and long term value.”
Manufacturing techniques should not be forgotten as an area in which innovation can occur. This is where instruments can be slightly modified, whether it is making a rod width a hair thinner or a handle slightly shorter to manage costs or improve function and versatility.
“One of the largest ways we drive innovation is by challenging our engineering staff to be creative in their approaches to machining a product,” said Precision Medical’s Beatty. “When you are traditionally machining a product, be it turning, milling, or even an EDM process, there are many different approaches that can be selected to yield the same result. By thinking outside the box about manufacturing, we can push the CNC equipment to the maximum of its capability. Another avenue we go down is trying to simplify the manufacturing process as much as possible for our shop floor operators. Standardizing equipment, tooling, and work holding are a few ways this is achieved.”
A One-time Thing
ECA Medical’s competencies lie in single-use devices. Disposables in orthopedic instrumentation is relatively new in comparison to other medical device sectors, because of the need for orthopedic tools to be strong enough to work with bone. In the past it has been more cost effective to make stainless steel or titanium instruments for orthopedic applications that can be re-used. But as materials science advances, re-usable devices become more sturdy and their traditional benefits become more attractive—namely, instruments are packaged in a ready-for-use, sterile tray; a decrease in infection risk; and less storage costs at hospitals and surgical facilities.
A 2014 report from the Freedonia Group predicted that U.S. demand for disposable medical supplies will grow 4.1 percent per year to $49.3 billion in 2018. An increasing volume of patient activity attributable to an aging population, a rising incidence of medical conditions, and the extension of health insurance coverage by the Affordable Care Act of 2010 will comprise the major forces that spur growth. The U.S. disposable medical supplies market also will benefit from a heightened focus on infection prevention throughout the healthcare sector. Pressures from the Centers for Disease Control and Prevention, the Joint Commission on the Accreditation of Healthcare Organizations, and other medical organizations will prompt hospitals, outpatient facilities, and other health establishments to follow protocols and standards aimed at keeping patients and staff safe from exposure to dangerous, potentially life-threatening pathogens during medical procedures. Orthopedic surgical kits and trays as well as specialty surgical instruments are included in the data.
“Physicians want an instrument that is easy to use, robust, ergonomically functional and most important, best suited for the job at hand,” said Schultz. Surgeons at ASCs are keen to drive out cost and are early adopters of single procedure instruments and kits. They don’t want to invest in capital equipment, more labor costs and be strapped with large and recurring operating costs. They want low cost, speed and efficiency. ASCs are fast-paced surgical production lines. Single-use sterile packed kits and instruments are an ideal fit.
“The market is embracing single-procedure instruments and procedural kits with great enthusiasm,” Schultz continued. “They understand the short term and long term benefits to the hospital, ASC, surgeons and patients. Every orthopedic and spine OEM firm has a single-use strategy and is deciding how to transform existing and new product lines to leverage this exciting new technology in North America, the European Union and emerging markets. The future will usher in change at a pace unprecedented in the industry. Consolidation, cost cutting, reimbursement rules, improved patient safety and overall efficiencies will be paramount. At ECA Medical Instruments we’ve made dramatic investments in people, process, capital equipment and infrastructure over the past three years. We’re staged to support our OEM customers today and flexible and scalable to support them locally and globally. It’s an exciting time to be in our industry.”
At CoorsTek, changing the material of a device is one way in which to meet demands for lower costs. The company has expertise in ceramics, metals and a variety of polymers. According to Fauth, a polymer option can save the manufacturer and client money by lowering production costs and also by potentially modifying a previously reusable device to a disposable one.
“When volume is a consideration, it’s much cheaper to use a polymer that can be molded or use different manufacturing methods that drive costs and ultimately price down,” Fauth said. “We see a lot more of that in sports medicine and general surgery, but it’s making its way to spine and even joint reconstruction. We’re starting to see traditional metal instruments such as cut guides migrate towards patient-specific yet disposable polymer metal blends, or even just polymers, because of cost of goods.”
* * *
When orthopedic surgeons cut, they are no often removing a problem like a general surgeon might remove a hernia or a tumor. They are most often fusing bones, fixing breaks or inserting pins and screws. Bone is by far the hardest tissue in the human body, so instrumentation that can withstand harsh usage is key in orthopedics. Cutting costs at the expense of durability is simply not an option.