Sam Brusco, Associate Editor02.12.18
Early surgical equipment more closely resembled instruments of torture rather than instruments of medicine. (Though to a degree surgery was torture before the mid-1800s, considering anesthesia wasn’t invented until then.)
First used during the early 1600s in pre-modern Europe, the “trephine” was a hand drill used to perform brain surgery. A metal pin mounted at the center of the tool was used to make the initial hole in the skull. Once the hole was set, the surgeon would then twist the trephine and its serrated edge cut away at the bone until it bore a circular hole large enough to (relatively, for the time) safely reach the brain. These grotesque surgeries were performed in attempts to treat epileptic seizures, skull fractures, and miscellaneous mental illnesses.
Early dentistry was no less horrifying. As if the sound of a dentist’s drill doesn’t inspire enough fear, a late 1700s practice for tooth extraction involved something called a dental “key.”
At one end of this key was a claw and bolster. The claw was placed over the tooth, and the bolster along the tooth’s root. The dentist then twisted and turned the key until the tooth was (painfully) pulled out, root and all. According to a 2005 Journal of the History of Dentistry review, the dental key caused more accidents and injuries than any other extraction instrument. (It was only popular because it was the quickest way to remove a posterior tooth.)
Orthopedic instrumentation also used to employ hand drills to cut into bone, as well as a rather unsettling device called an osteoclast. Educated readers may know that moniker now represents the bone cell that is critical in maintenance, repair, and remodeling of bones in the vertebral skeleton. Its origin is pretty much the exact opposite; the instrument was used in the mid- to late-1800s to break the deformed bones of children between its three legs.
Cringe-worthy as these instruments were, they were remarkable given the manufacturing methods available at the time. They were both relatively small and contained moving parts despite that modern machining and additive manufacturing still had centuries before their introduction. As surgery developed, the trade of instrument makers developed in tandem. Believe it or not, there was actually evidence that metal craftsmen who specialized in the manufacture of medical instruments existed as far back as the 1700s when surgery came into its own as a discipline.
The instruments then demonstrated both good quality and elaborate ornamentation that also served the purpose of providing a better grip for surgeons. The Industrial Revolution rationalized production methods, advancing instrument manufacture further. It developed into the high level of precision crafting practiced today—and because progress is exponential, even the modern methods of instrument manufacture are being refined at breakneck speeds to address orthopedic market shifts and the market’s associated instrumentation or delivery systems.
“The accelerated, widespread use of 3D printed components, assemblies, and implants has really changed the way we look at instruments and systems,” noted David Cabral, president of Five Star Companies, a New Bedford, Mass.-based contract manufacturer of orthopedic implants and instrumentation. “The conventional manufacturing methods continue, but the integrated use of 3D manufacturing adds a new element to the overall product development process. These elements may be the material type, how the part configuration affects another assembly, the final 3D component application, and any downstream methodologies that must be addressed as part of the product development cycle.”
Surgical instrumentation and delivery trends tend to follow the orthopedic industry in general. As the implants themselves evolve, so too must the equipment required to put them in place. For example, robotic or computer-assisted surgeries are now able to assist a growing number of orthopedic and spine procedures. Previously only available to assist partial knee and hip replacements, in November of last year Smith & Nephew’s NAVIO robotics-assisted surgical system was able to perform a bi-cruciate total knee replacement—a milestone for orthopedic surgery. This trend is a boon for patients and clinicians as it ultimately leads to shorter recovery times and less time spent on the operating table, but represents a unique challenge for contract manufacturers tasked with making instrumentation compatible with a robotic-assisted procedure.
“The introduction of robotics into orthopedic and spine procedures has seen significant growth over the past few years,” commented Chad Ryshkus, director of marketing and product development for MedTorque Inc., an Elmhurst, Ill.-based contract manufacturer of customized orthopedic instrumentation and implants. “The robot-related programs we’re participating in require tolerances that are extremely tight when compared to traditional tolerances. These robotic systems need to be precise because the software expects the working end to be in an exact position. If the tolerance stack-up is too significant, the potential error could defeat the purpose of a robotic system.”
Instrumentation is also changing as a result of orthopedic procedures in general becoming less laborious and time-consuming. Thanks to advances in surgical technique, anesthesia, and pain management, some surgeons are migrating more of their total joint procedures from the hospital into outpatient procedures. These procedures are hosted in ambulatory surgical centers (ASCs), which could potentially send patients home after one night—some even within a few hours. OEM implant manufacturers are rushing to claim more of this fast-growing ASC/outpatient market, and instrument manufacturers are following suit.
“The growth in ambulatory surgical centers (ASCs) across the U.S. is the single most influential trend that will impact instrumentation and delivery systems,” offered Lane Hale, president and CEO of ECA Medical Instruments, a Thousand Oaks, Calif.-based designer and manufacturer of single-use torque-limiting surgical instruments, fixed drivers, and customized implant fixation kits. “Analysts project that by 2020, 60 percent of all eligible procedures will be performed in the outpatient setting. The traditional model of sales reps shuttling around cases and trays and the wasted costs of shipping heavy trays around to lower volume surgery centers is not a sustainable model. More efficient instrument set configurations and delivery systems will need to be developed and deployed.”
Orthopedic OEMs responding to these trends seek to trim the cost of instrumentation and delivery systems because they focus most of their efforts on developing the implants themselves. Hip and knee products also continue to become increasingly commoditized, driving pricing pressures in that segment. Coupled with OEMs’ increasing tendencies to focus on their core competencies, much of the instrumentation and delivery system work is sourced to a strategic supplier with requisite knowledge and processes already in place.
“Outsourcing of instrumentation is accelerating,” explained Tobias Buck, chairman, founder, president, and CEO of Paragon Medical Inc., a Pierceton, Ind.-based Tier 1 supplier of custom and standard surgical instrument cases, trays and instruments, implantable components, and design and development services to the medical device industry. “OEMs are doing all within their power to outsource instrumentation to preferred and strategic suppliers, primarily due to the fact they want and need to focus on their core competencies. Instrumentation is, simply put, more difficult to manufacture due to the high mix/low volume nature of most instrument applications post- system launch, along with the level of geometric complexity, multiple components, and attendant finish requirements as compared to implants.”
Partnership with such a supplier offers the OEM custom solutions, low price points, and quick turnaround times that comply with all necessary regulations. But saving money is also a strong consideration for both orthopedic contract manufacturers and for their OEM clients.
“Another trend affecting the industry is the absence of feature-based price sensitivity, which is not as present as it should be,” Buck continued. “The marketplace needs to get real about how instruments are used and prepared for re-use. OEMs need to pursue category and system-based sourcing in lieu of transactional sourcing events—sourcing one widget to one supplier is not economically wise. It actually amplifies cost within the very context where cost must be removed in the value stream.”
To Re-Use or Not to Re-Use?
Single-use instruments have been used in medical procedures involving cardiac rhythm management and neuromodulation—among others—for a number of years. They are becoming increasingly viable as a way to save cost as well as prevent the potentially expensive risks of infection. The market is definitely growing for single-use instruments as well—according to a Freedonia Industry Study, U.S. demand for single-use medical supplies will expand 4.1 percent annually to $49.3 billion in 2018.
“I have seen the deployment of single-use instruments in the general surgical market for several years, with success,” Cabral noted. “With the current focus on infection control, these instruments can play a significant role in eliminating the root causes of surgical site infections.”
Instrument manufacturers, implant OEMs, and end-users alike constantly examine ways to cull both upfront and lifecycle costs. An increased mix of disposable instruments and kits in the inventory is one avenue that may be able to ease some costly inventory management woes.
“Single-procedure, or disposable, instruments and kits are becoming more advantageous, and are starting to garner more attention, in instances where it is logistically difficult or expensive to ship an entire reusable set,” commented Ryshkus. “All of a sudden, it becomes more economical to have a few disposable kits sitting on the shelf at a low volume user than it is to ship a case of instruments across the country. Typically, these sets are focused on specific procedures with instrumentation requirements that can be simplified down to a handful of key instruments.”
Single-use instruments eliminate some the challenges associated with complete sterilization. Reusable instruments may wear down over time due to repeated cleanings, and an infection risk is possible if the instrument has not been adequately prepared. According to a 2015 Centers for Disease Control and Prevention (CDC) study, surgical site infections (SSIs) account for 31 percent of all hospital-acquired infections (HAIs). The study also noted 3 percent (about 4,700) of these patients die and 75 percent of those deaths are directly attributed to the SSI. The cost of SSIs to hospitals averages over $4 billion annually. Disposable instruments help to prevent this unfortunate trend because they are sterilized and individually packaged to eliminate the risk of SSIs as well as HAIs and cross-contamination.
Further, single-use instruments are calibrated before they even enter the surgeon’s hands, which further reduces time spent in the OR by ensuring every orthopedic or spine implant has the means to be perfectly secured. It has the potential to save cost across the spectrum of those making, handling, or being operated on with the instrument as a result.
“Some advantages of single-use instruments are they are always pristine, sterile, calibrated, and ready,” offered Hale. They allow more efficient time management as well—sales reps can sell more implants, and OR staff can complete more surgeries. They also receive expanded coverage of ASCs and rural hospitals, and have quicker turnaround time in ORs (more surgeries per day) thanks to no reprocessing and re-sterilization. Further, this allows reduced infection risk and increased instrument utilization. Cost savings of $300 to $1,200 per surgery can also be achieved, depending on the procedure.”
“Single-procedure torque-limiting instruments are also receiving increased consideration due to the difficulties orthopedic OEMs have with calibration and ensuring units in the field are within their stated calibration,” noted Ryshkus. “A single-procedure torque-limiter helps eliminate the uncertainty associated with a torque-limiter that has been in the field for a period of time.”
However, the orthopedic industry separates itself somewhat from the single-use trend spreading throughout a number of surgical specialties. They may find increased use in more common reconstructive surgeries trending toward a minimally invasive approach. However, trauma cases and complex spine surgeries still use a wide range of specialized and robust tools that would be difficult to transfer to a single-use set.
“On the other side, we continue to see the dominance of reusable general instruments, and I believe this will prevail for a long time,” said Cabral. “Following this trend, I would envision the ortho instrument market to follow a similar pattern—especially given the higher level of complexity and projected lower volumes of particular patterns versus the general instruments. One other concern is the strength and longevity of ortho instruments in the harsher environment (impact, saw cutting, grinding, etc…).”
There is certainly a complex array of challenges to incorporating a larger supply of single-use instruments, but the roadblocks to the widespread adoption of single-use orthopedic and spine instrumentation are primarily two-fold. Orthopedic tools must be hardy because of the areas of the body they reach—bone, muscle, tendons and ligaments, etc. aren’t going to be easily manipulated. This type of robust construction can be challenging to justify a single-use model. Additionally, supply chain logistics transform with a single-use model. It’s important to develop a sales and marketing strategy that includes an increased mix of disposable instruments in the manufacturer’s portfolio.
“The obstacles of single-use adoption must also be addressed. The team is accustomed to selling and marketing with the traditional model of reusables, so a clear strategy needs to be put in place,” advised Hale. “It takes commitment from the top. It is a new approach for the sales team, so marketing and management need to support and clearly communicate the opportunities, tactics, and strategy. Rethink the supply chain and ensure all costs are accounted for when evaluating this approach. To realize the greatest savings and efficiencies, the more of the portfolio committed to single-use, the more you will save and convert accounts. Also, keep in mind that traditional manufacturing facilities are not built for plastics manufacturing.”
Finally, reimbursement for the OEM must always be a consideration about the economics of the single-use vs. reusable debate. Currently, there is no reimbursement model in place to govern reusable instrument sets—major changes would have to take place in this schema for savings to be realized.
“While it is possible to be reimbursed for a single-use instrument, making their use a potential advantage, conditioned by the DRG reimbursement definition, the real advantage with single use is in the area of cost removal on the individual instruments themselves,” explained Buck. “Reusable instrument set usage is never reimbursed. To remedy this, negotiating a per-use fee on the reusable instrumentation would extend some compensatory relief to the OEM, but in the world we live in, that can only manifest in reality if bundled payments somehow extend deference in the reimbursement protocol.”
Keep the End-User in Mind
It’s all well and good to discuss the sensitivity of economics with regard to making instruments, but no instrument of any kind is going to be worth much if surgeons aren’t happy with them. In fact, it can be argued that in the surgeon’s case, the design of the instrument or delivery system must have equal or greater consideration than the implant itself.
A user-centered strategy is integral to developing an effective orthopedic instrument or updating one already in use. “Surgeon ergonomic sensitivity is a big deal,” declared Buck.
“That’s what you should look for in your design for manufacturing (DFM). Start with the end in mind—how the instrument could look vs. what it is today. Examine what existing sets we could pursue set revision for (which happens frequently), but really do it right. Go at set revision to complement and enhance procedural efficacy with existing sets in the field.”
The ideal surgical instrument should essentially be an extension of the surgeon’s hand. Any new or updated instrument should make an orthopedic or spinal procedure easier to perform in some way. That sort of improvement could target ergonomics by boosting precision and control, increasing dexterity, limiting the amount of stress to the surgeon’s hand, or (ideally) all of the above.
Innovative materials, technology, or supply chain logistics don’t mean much if the needs and performance capability of the procedure aren’t adequately addressed. A worst-case scenario in this case would be releasing an instrument into the field and waiting until a patient is being operated on only to find it actually complicates the procedure.
“The complexity of the instruments must not be a hindrance to the surgeon’s technique,” warned Cabral. “The instrument must be somewhat intuitive and easily configured for clinician use. If the instrument is difficult to use and decipher, the surgeon will reach frustration and prefer his previous tried-and-true methodology. Instruments that are too complex to use may impact the procedural process and result in longer procedure times, lower factors of patient safety, or overall surgeon dissatisfaction with the new methodology.”
The irony seems to be the more complex a procedure becomes, the simpler its tools must be. That could mean less moving parts to confuse the surgeon, or blatantly obvious labeling to ensure no errors in operating the instrument.
“Keep it simple and intuitive to eliminate the fiddle factor that often comes with overly complex instruments,” advised Ryshkus. “One method to reduce confusion and error can be incorporating poka-yoke concepts where interfaces of mating items are designed to only work one way. Proper identification and markings for use that are clear and understandable are other simple solutions that can ensure ease-of-use.”
Manufacturing instruments with these factors in mind may have surgeons clamoring to use a particular instrument—always good for business and expanding the market.
“The likelihood of adoption is much greater if the instrument system offers a much more simplified technique or makes the procedure more efficient,” Ryshkus continued, but with a further caution: “Of course, if the implant does not have the efficacy of analogous or predicate systems, it could all be a moot point.”
A DFM strategy has many advantages beyond procedural efficacy for surgeons, as well. Continuously monitoring manufacturability throughout the development process comes with a cost, of course, both the literal extra spending on things like computer modeling and simulation and time spent executing these actions. But the payoff for the “end user”—in this context, the manufacturer—is a quicker path to market with a smoother approval process.
But for all of the industry’s talk of DFM becoming common practice, it’s not appearing to gain as much traction as potential DFM practitioners have been promising.
“The industry must ‘walk’ DFM, not simply talk about doing it and fail to follow through,” commented Buck. “If the industry truly embraces DFM practices, truly allows or demonstrates behavior that allows inclusion of their key suppliers to participate upstream, precedent to program launch, there is significant potential to both dramatically reduce cost while achieving the launch lead time objectives on a year over year basis, that frankly we all need to pursue with informed aggression.”
“Really focus on DFM actually being done long before the instrument sets are released into production,” he continued. “Instrument sets will by definition cost less to produce and there should be less of them in a given set, thereby reducing set cost to field. This should also lead to compression of recurring processing costs, whether in set refurbishment or sterile processing pre- and postoperatively.”
First used during the early 1600s in pre-modern Europe, the “trephine” was a hand drill used to perform brain surgery. A metal pin mounted at the center of the tool was used to make the initial hole in the skull. Once the hole was set, the surgeon would then twist the trephine and its serrated edge cut away at the bone until it bore a circular hole large enough to (relatively, for the time) safely reach the brain. These grotesque surgeries were performed in attempts to treat epileptic seizures, skull fractures, and miscellaneous mental illnesses.
Early dentistry was no less horrifying. As if the sound of a dentist’s drill doesn’t inspire enough fear, a late 1700s practice for tooth extraction involved something called a dental “key.”
At one end of this key was a claw and bolster. The claw was placed over the tooth, and the bolster along the tooth’s root. The dentist then twisted and turned the key until the tooth was (painfully) pulled out, root and all. According to a 2005 Journal of the History of Dentistry review, the dental key caused more accidents and injuries than any other extraction instrument. (It was only popular because it was the quickest way to remove a posterior tooth.)
Orthopedic instrumentation also used to employ hand drills to cut into bone, as well as a rather unsettling device called an osteoclast. Educated readers may know that moniker now represents the bone cell that is critical in maintenance, repair, and remodeling of bones in the vertebral skeleton. Its origin is pretty much the exact opposite; the instrument was used in the mid- to late-1800s to break the deformed bones of children between its three legs.
Cringe-worthy as these instruments were, they were remarkable given the manufacturing methods available at the time. They were both relatively small and contained moving parts despite that modern machining and additive manufacturing still had centuries before their introduction. As surgery developed, the trade of instrument makers developed in tandem. Believe it or not, there was actually evidence that metal craftsmen who specialized in the manufacture of medical instruments existed as far back as the 1700s when surgery came into its own as a discipline.
The instruments then demonstrated both good quality and elaborate ornamentation that also served the purpose of providing a better grip for surgeons. The Industrial Revolution rationalized production methods, advancing instrument manufacture further. It developed into the high level of precision crafting practiced today—and because progress is exponential, even the modern methods of instrument manufacture are being refined at breakneck speeds to address orthopedic market shifts and the market’s associated instrumentation or delivery systems.
“The accelerated, widespread use of 3D printed components, assemblies, and implants has really changed the way we look at instruments and systems,” noted David Cabral, president of Five Star Companies, a New Bedford, Mass.-based contract manufacturer of orthopedic implants and instrumentation. “The conventional manufacturing methods continue, but the integrated use of 3D manufacturing adds a new element to the overall product development process. These elements may be the material type, how the part configuration affects another assembly, the final 3D component application, and any downstream methodologies that must be addressed as part of the product development cycle.”
Surgical instrumentation and delivery trends tend to follow the orthopedic industry in general. As the implants themselves evolve, so too must the equipment required to put them in place. For example, robotic or computer-assisted surgeries are now able to assist a growing number of orthopedic and spine procedures. Previously only available to assist partial knee and hip replacements, in November of last year Smith & Nephew’s NAVIO robotics-assisted surgical system was able to perform a bi-cruciate total knee replacement—a milestone for orthopedic surgery. This trend is a boon for patients and clinicians as it ultimately leads to shorter recovery times and less time spent on the operating table, but represents a unique challenge for contract manufacturers tasked with making instrumentation compatible with a robotic-assisted procedure.
“The introduction of robotics into orthopedic and spine procedures has seen significant growth over the past few years,” commented Chad Ryshkus, director of marketing and product development for MedTorque Inc., an Elmhurst, Ill.-based contract manufacturer of customized orthopedic instrumentation and implants. “The robot-related programs we’re participating in require tolerances that are extremely tight when compared to traditional tolerances. These robotic systems need to be precise because the software expects the working end to be in an exact position. If the tolerance stack-up is too significant, the potential error could defeat the purpose of a robotic system.”
Instrumentation is also changing as a result of orthopedic procedures in general becoming less laborious and time-consuming. Thanks to advances in surgical technique, anesthesia, and pain management, some surgeons are migrating more of their total joint procedures from the hospital into outpatient procedures. These procedures are hosted in ambulatory surgical centers (ASCs), which could potentially send patients home after one night—some even within a few hours. OEM implant manufacturers are rushing to claim more of this fast-growing ASC/outpatient market, and instrument manufacturers are following suit.
“The growth in ambulatory surgical centers (ASCs) across the U.S. is the single most influential trend that will impact instrumentation and delivery systems,” offered Lane Hale, president and CEO of ECA Medical Instruments, a Thousand Oaks, Calif.-based designer and manufacturer of single-use torque-limiting surgical instruments, fixed drivers, and customized implant fixation kits. “Analysts project that by 2020, 60 percent of all eligible procedures will be performed in the outpatient setting. The traditional model of sales reps shuttling around cases and trays and the wasted costs of shipping heavy trays around to lower volume surgery centers is not a sustainable model. More efficient instrument set configurations and delivery systems will need to be developed and deployed.”
Orthopedic OEMs responding to these trends seek to trim the cost of instrumentation and delivery systems because they focus most of their efforts on developing the implants themselves. Hip and knee products also continue to become increasingly commoditized, driving pricing pressures in that segment. Coupled with OEMs’ increasing tendencies to focus on their core competencies, much of the instrumentation and delivery system work is sourced to a strategic supplier with requisite knowledge and processes already in place.
“Outsourcing of instrumentation is accelerating,” explained Tobias Buck, chairman, founder, president, and CEO of Paragon Medical Inc., a Pierceton, Ind.-based Tier 1 supplier of custom and standard surgical instrument cases, trays and instruments, implantable components, and design and development services to the medical device industry. “OEMs are doing all within their power to outsource instrumentation to preferred and strategic suppliers, primarily due to the fact they want and need to focus on their core competencies. Instrumentation is, simply put, more difficult to manufacture due to the high mix/low volume nature of most instrument applications post- system launch, along with the level of geometric complexity, multiple components, and attendant finish requirements as compared to implants.”
Partnership with such a supplier offers the OEM custom solutions, low price points, and quick turnaround times that comply with all necessary regulations. But saving money is also a strong consideration for both orthopedic contract manufacturers and for their OEM clients.
“Another trend affecting the industry is the absence of feature-based price sensitivity, which is not as present as it should be,” Buck continued. “The marketplace needs to get real about how instruments are used and prepared for re-use. OEMs need to pursue category and system-based sourcing in lieu of transactional sourcing events—sourcing one widget to one supplier is not economically wise. It actually amplifies cost within the very context where cost must be removed in the value stream.”
To Re-Use or Not to Re-Use?
Single-use instruments have been used in medical procedures involving cardiac rhythm management and neuromodulation—among others—for a number of years. They are becoming increasingly viable as a way to save cost as well as prevent the potentially expensive risks of infection. The market is definitely growing for single-use instruments as well—according to a Freedonia Industry Study, U.S. demand for single-use medical supplies will expand 4.1 percent annually to $49.3 billion in 2018.
“I have seen the deployment of single-use instruments in the general surgical market for several years, with success,” Cabral noted. “With the current focus on infection control, these instruments can play a significant role in eliminating the root causes of surgical site infections.”
Instrument manufacturers, implant OEMs, and end-users alike constantly examine ways to cull both upfront and lifecycle costs. An increased mix of disposable instruments and kits in the inventory is one avenue that may be able to ease some costly inventory management woes.
“Single-procedure, or disposable, instruments and kits are becoming more advantageous, and are starting to garner more attention, in instances where it is logistically difficult or expensive to ship an entire reusable set,” commented Ryshkus. “All of a sudden, it becomes more economical to have a few disposable kits sitting on the shelf at a low volume user than it is to ship a case of instruments across the country. Typically, these sets are focused on specific procedures with instrumentation requirements that can be simplified down to a handful of key instruments.”
Single-use instruments eliminate some the challenges associated with complete sterilization. Reusable instruments may wear down over time due to repeated cleanings, and an infection risk is possible if the instrument has not been adequately prepared. According to a 2015 Centers for Disease Control and Prevention (CDC) study, surgical site infections (SSIs) account for 31 percent of all hospital-acquired infections (HAIs). The study also noted 3 percent (about 4,700) of these patients die and 75 percent of those deaths are directly attributed to the SSI. The cost of SSIs to hospitals averages over $4 billion annually. Disposable instruments help to prevent this unfortunate trend because they are sterilized and individually packaged to eliminate the risk of SSIs as well as HAIs and cross-contamination.
Further, single-use instruments are calibrated before they even enter the surgeon’s hands, which further reduces time spent in the OR by ensuring every orthopedic or spine implant has the means to be perfectly secured. It has the potential to save cost across the spectrum of those making, handling, or being operated on with the instrument as a result.
“Some advantages of single-use instruments are they are always pristine, sterile, calibrated, and ready,” offered Hale. They allow more efficient time management as well—sales reps can sell more implants, and OR staff can complete more surgeries. They also receive expanded coverage of ASCs and rural hospitals, and have quicker turnaround time in ORs (more surgeries per day) thanks to no reprocessing and re-sterilization. Further, this allows reduced infection risk and increased instrument utilization. Cost savings of $300 to $1,200 per surgery can also be achieved, depending on the procedure.”
“Single-procedure torque-limiting instruments are also receiving increased consideration due to the difficulties orthopedic OEMs have with calibration and ensuring units in the field are within their stated calibration,” noted Ryshkus. “A single-procedure torque-limiter helps eliminate the uncertainty associated with a torque-limiter that has been in the field for a period of time.”
However, the orthopedic industry separates itself somewhat from the single-use trend spreading throughout a number of surgical specialties. They may find increased use in more common reconstructive surgeries trending toward a minimally invasive approach. However, trauma cases and complex spine surgeries still use a wide range of specialized and robust tools that would be difficult to transfer to a single-use set.
“On the other side, we continue to see the dominance of reusable general instruments, and I believe this will prevail for a long time,” said Cabral. “Following this trend, I would envision the ortho instrument market to follow a similar pattern—especially given the higher level of complexity and projected lower volumes of particular patterns versus the general instruments. One other concern is the strength and longevity of ortho instruments in the harsher environment (impact, saw cutting, grinding, etc…).”
There is certainly a complex array of challenges to incorporating a larger supply of single-use instruments, but the roadblocks to the widespread adoption of single-use orthopedic and spine instrumentation are primarily two-fold. Orthopedic tools must be hardy because of the areas of the body they reach—bone, muscle, tendons and ligaments, etc. aren’t going to be easily manipulated. This type of robust construction can be challenging to justify a single-use model. Additionally, supply chain logistics transform with a single-use model. It’s important to develop a sales and marketing strategy that includes an increased mix of disposable instruments in the manufacturer’s portfolio.
“The obstacles of single-use adoption must also be addressed. The team is accustomed to selling and marketing with the traditional model of reusables, so a clear strategy needs to be put in place,” advised Hale. “It takes commitment from the top. It is a new approach for the sales team, so marketing and management need to support and clearly communicate the opportunities, tactics, and strategy. Rethink the supply chain and ensure all costs are accounted for when evaluating this approach. To realize the greatest savings and efficiencies, the more of the portfolio committed to single-use, the more you will save and convert accounts. Also, keep in mind that traditional manufacturing facilities are not built for plastics manufacturing.”
Finally, reimbursement for the OEM must always be a consideration about the economics of the single-use vs. reusable debate. Currently, there is no reimbursement model in place to govern reusable instrument sets—major changes would have to take place in this schema for savings to be realized.
“While it is possible to be reimbursed for a single-use instrument, making their use a potential advantage, conditioned by the DRG reimbursement definition, the real advantage with single use is in the area of cost removal on the individual instruments themselves,” explained Buck. “Reusable instrument set usage is never reimbursed. To remedy this, negotiating a per-use fee on the reusable instrumentation would extend some compensatory relief to the OEM, but in the world we live in, that can only manifest in reality if bundled payments somehow extend deference in the reimbursement protocol.”
Keep the End-User in Mind
It’s all well and good to discuss the sensitivity of economics with regard to making instruments, but no instrument of any kind is going to be worth much if surgeons aren’t happy with them. In fact, it can be argued that in the surgeon’s case, the design of the instrument or delivery system must have equal or greater consideration than the implant itself.
A user-centered strategy is integral to developing an effective orthopedic instrument or updating one already in use. “Surgeon ergonomic sensitivity is a big deal,” declared Buck.
“That’s what you should look for in your design for manufacturing (DFM). Start with the end in mind—how the instrument could look vs. what it is today. Examine what existing sets we could pursue set revision for (which happens frequently), but really do it right. Go at set revision to complement and enhance procedural efficacy with existing sets in the field.”
The ideal surgical instrument should essentially be an extension of the surgeon’s hand. Any new or updated instrument should make an orthopedic or spinal procedure easier to perform in some way. That sort of improvement could target ergonomics by boosting precision and control, increasing dexterity, limiting the amount of stress to the surgeon’s hand, or (ideally) all of the above.
Innovative materials, technology, or supply chain logistics don’t mean much if the needs and performance capability of the procedure aren’t adequately addressed. A worst-case scenario in this case would be releasing an instrument into the field and waiting until a patient is being operated on only to find it actually complicates the procedure.
“The complexity of the instruments must not be a hindrance to the surgeon’s technique,” warned Cabral. “The instrument must be somewhat intuitive and easily configured for clinician use. If the instrument is difficult to use and decipher, the surgeon will reach frustration and prefer his previous tried-and-true methodology. Instruments that are too complex to use may impact the procedural process and result in longer procedure times, lower factors of patient safety, or overall surgeon dissatisfaction with the new methodology.”
The irony seems to be the more complex a procedure becomes, the simpler its tools must be. That could mean less moving parts to confuse the surgeon, or blatantly obvious labeling to ensure no errors in operating the instrument.
“Keep it simple and intuitive to eliminate the fiddle factor that often comes with overly complex instruments,” advised Ryshkus. “One method to reduce confusion and error can be incorporating poka-yoke concepts where interfaces of mating items are designed to only work one way. Proper identification and markings for use that are clear and understandable are other simple solutions that can ensure ease-of-use.”
Manufacturing instruments with these factors in mind may have surgeons clamoring to use a particular instrument—always good for business and expanding the market.
“The likelihood of adoption is much greater if the instrument system offers a much more simplified technique or makes the procedure more efficient,” Ryshkus continued, but with a further caution: “Of course, if the implant does not have the efficacy of analogous or predicate systems, it could all be a moot point.”
A DFM strategy has many advantages beyond procedural efficacy for surgeons, as well. Continuously monitoring manufacturability throughout the development process comes with a cost, of course, both the literal extra spending on things like computer modeling and simulation and time spent executing these actions. But the payoff for the “end user”—in this context, the manufacturer—is a quicker path to market with a smoother approval process.
But for all of the industry’s talk of DFM becoming common practice, it’s not appearing to gain as much traction as potential DFM practitioners have been promising.
“The industry must ‘walk’ DFM, not simply talk about doing it and fail to follow through,” commented Buck. “If the industry truly embraces DFM practices, truly allows or demonstrates behavior that allows inclusion of their key suppliers to participate upstream, precedent to program launch, there is significant potential to both dramatically reduce cost while achieving the launch lead time objectives on a year over year basis, that frankly we all need to pursue with informed aggression.”
“Really focus on DFM actually being done long before the instrument sets are released into production,” he continued. “Instrument sets will by definition cost less to produce and there should be less of them in a given set, thereby reducing set cost to field. This should also lead to compression of recurring processing costs, whether in set refurbishment or sterile processing pre- and postoperatively.”