Sam Brusco, Associate Editor02.18.20
The majority of adults in the U.S. suffer from low back pain at some point in their life. It’s one of the more common complaints—according to the National Institutes of Health, about 80 percent of adults experience it during their lifetimes.1 Spinal disc herniation—an injury to the cushioning and connecting tissue between spinal vertebrae—is a major contributor to low back pain. About 300,000 U.S. patients a year2 undergo a procedure called lumbar discectomy to treat the herniated discs in their lower backs. But these procedures can be costly and aren’t always effective because the spinal area is small and intricate, a significant space challenge for surgeons.
That’s why David Cappelleri, an associate professor of mechanical engineering at Purdue University’s College of Engineering, co-founded C2 Medical Robotics Inc., a University-affiliated startup aiming to improve the skills of surgeons with its new technology. The company is developing low-cost, articulated, robotic spinal surgical tools and devices for lumbar discectomy.
“With the help of multi-material 3D printing, we can shrink existing robotic systems to fit into the small workspace of the spine making it easier for surgeons to perform this delicate surgery,” Cappelleri told the press.
C2 Medical Robotics’ method replaces pin joints typically used in lumbar discectomy for compliant joints printed from a soft, rubber-like material. Rigid components are printed from hard plastic material. It all comes out of the printer as a unified mechanism, which is then connected to tendon wires to drive it. Surgeons can control the technology with joysticks and onboard actuators. The robotic system also boosts surgeons’ skills by allowing more dexterous movement and control of the tools in the surgical workspace. Surgeons who might not have been skilled enough to perform the procedure in the past may have the opportunity to operate as a result of C2’s system.
“The hope is we can help people and reduce their pain,” said Cappelleri, who has been working in the medical device industry for over a decade. “For surgeons, we want to make their job easier, and just make it a low-cost system that can be adopted by many hospitals and medical centers, so it becomes the standard for these types of procedures.”
Robotic and computer-assisted surgery has become so pervasive in orthopedic and spine procedures that seven of the top 10 global orthopedic device manufacturers have made major investments in these technologies:
• Stryker’s Mako (partial and total knee replacement, total hip replacement)
• DePuy Synthes’ Orthotaxy buy (expected to launch orthopedic surgery robot this year)
• Zimmer Biomet’s Rosa One (total knee replacement, spine, brain)
• Smith+Nephew’s Navio (partial and total knee replacement)
• Medtronic’s Mazor X Stealth Edition (spine)
• NuVasive’s Pulse navigation (spine)
• Globus Medical’s ExcelsiusGPS (spine)
Increased demand for robotic or computer-assisted procedures means firms manufacturing instruments for orthopedic and spine procedures must organize their business operations to account for this trend if they hope to grow. This is much easier said than done, however—the tolerances required to manufacture instruments used in robotic procedures require much tighter tolerances when compared to those for manual instruments. The robotic systems need to be precise because the software expects the working end to be in an exact position. With too significant of a tolerance stack-up, the possible error defeats the purpose of using a robotic system at all.
In addition to robotics, more complexity, multifunctionality, ease of use, and human factors engineering are driving orthopedic and spine surgery instrumentation innovation. The market for new instruments to improve the end-user experience for both surgeons and patients is growing. To accomplish this, OEMs collaborate closely with surgeons on instrument designs to improve ease of use and ergonomics.
All of these demands can really rack up cost, so orthopedic OEMs strive to trim the expense of instrumentation since they focus the majority of their efforts on developing implants. Hip and knee products continue to become increasingly commoditized, driving price pressures for those implants. OEMs continue to focus on their core competencies, so much of the work of instrument manufacturing is sourced to a strategic supplier with requisite knowledge and processes already in place. Partnership with instrument manufacturers can offer the OEM custom solutions, low price points, and quick turnaround times that comply with all necessary regulations.
To gain further insight on the trends and challenges affecting the orthopedic and spine instrument manufacturing sector, as well as how instrument manufacturers are responding to these challenges to provide the best solutions possible, Orthopedic Design & Technology spoke with the following industry experts.
Todd Andreoni, director, advanced operations at Stryker Corp., a Kalamazoo, Mich.-based global medical device and equipment manufacturer offering products and services in orthopedics, medical and surgical, and neurotechnology and spine.
Holger Gruenert, founder and president of Pacific Instruments Inc., a Honolulu, Hawaii-based contract manufacturer and procurement source for the development, design, and manufacturing of surgical instruments.
Rob Hall, president of Parmatech, an ATW Company. Based in Petaluma, Calif., Parmatech is a supplier of custom manufactured metal injection molding components.
David Hotter, director of corporate business development at ATW Companies. Based in Warwick, R.I., the ATW Companies are suppliers of precision tubing and fabricated metal components.
John Ruggieri, vice president of engineering and business development at ARCH Medical Solutions, a Seabrook, N.H.-based contract manufacturer of surgical instruments, implants, and medical devices for orthopedic and medical device companies.
Chad Ryshkus, director of marketing and product development at MedTorque, a Kenosha, Wis.-based manufacturer of orthopedic instruments and implants, including single-procedure torque-limiting drivers.
James Schultz, vice president of customer solutions at ECA Medical, a Thousand Oaks, Calif.-based manufacturer of single-use torque limiting and surgery-ready procedure kits.
Sam Brusco: How are trends in orthopedic/spinal surgical procedures and implants affecting instrumentation?
Holger Gruenert: Minimally invasive procedures and time-sensitive execution have influenced the shape and construction of surgical instruments. Due to these trends, OEM companies need technical and cost-efficient suppliers, like us, who can deliver high-quality, custom instrumentation reliably. Proudly, we can say in 2019, we experienced a 25 percent sales growth due to meeting these trends and our customers’ needs.
Rob Hall & David Hotter: Robotic-assisted surgery is the current focus for improvements to orthopedic/spinal surgical procedures and implants. Advancements in metal additive manufacturing may lead to better customization of orthopedic implants for future surgical procedures.
Chad Ryshkus: Ambulatory Surgical Centers (ASCs) will become a more significant factor in orthopedics and spine through this upcoming decade. We are already seeing commercial payer reimbursements for total joint replacements performed in ASCs. ASCs are a cost-effective alternative that have unique needs not typical of the traditional hospital setting. That’s where we’ll see their impact on instrumentation. Single-use instrument sets packaged specifically for the procedures will play a considerable role in addressing the limited space and resources associated with the overall management of the logistics of inventorying, cleaning, and processing of instruments.
James Schultz: As a designer and manufacturer of single- use instruments, we are seeing increased demand for sterile pack, surgery ready torque limiters and instrument kits across all segments of the market. Application is in both the hospital and ASC setting to reduce reprocessing costs, meet surgical demand, and improve OR efficiency and turnover. Lower cost, clinically robust instrumentation that reduces inventory levels and life cycle costs and offers increased sales of orthopedic implants is driving demand. Small and medium-sized implant OEMs want to use their cash wisely and investments in expensive cases and trays can be cost prohibitive and create a large and long logistics and support burden. Single-use sterile pack kits are always surgery ready and can be bundled with implants for reimbursement.
Brusco: What advances in manufacturing technology have most significantly impacted your instrument manufacturing business?
Todd Andreoni: Additive manufacturing is emerging as a commercially viable way to make instrumentation both quickly and now more cost-effectively. New materials, especially those used for surgical instrumentation, are being validated for use, giving both design and process engineers more options.
Gruenert: Advances such as 3D printing for prototypes and productions have entered the market for both polymers and metals. New advanced multi-axis machining centers and lathes coupled with smart machining software have also made a significant impact.
Hall & Hotter: Additive manufacturing and 3D printing are expanding the possibilities for design features and are augmenting traditional manufacturing methods for small, detailed parts with shorter development cycles.
John Ruggieri: Robotic and navigated instruments have changed the landscape of orthopedic manufacturing. The tolerance requirements and complex geometries add a higher level of complexity to almost every device.
Schultz: 3D printing and new materials are reducing costs, providing robust instrument solutions, and replacing many traditional stainless steel components with selected polymers. These polymers can mimic steel in many cases and have excellent gamma sterilization stability while reducing overall instrument and procedural kit costs.
Brusco: How is the push toward robotic and minimally invasive approaches affecting instrumentation?
Andreoni: Instrumentation to support robotic surgery is certainly at the core of any new procedure, and this could end up being a differentiating feature for customers when selecting a robotic platform. Minimally invasive approaches are here today. In order to have market adoption, it is critical to integrate customer inputs into instrument designs that help make procedures efficient and effective, while placing the highest priority on patient safety.
Hall & Hotter: Robotic and minimally invasive processes are pushing instrumentation toward small form factors and end effectors. End effector designs are migrating toward the ends of the utilization spectrum, with a need for high utilization designs that can perform multiple tasks, and specific designs to address an individual challenge.
Ryshkus: Robotics is pushing the envelope for precision instrumentation even further with the extremely tight tolerances required to ensure the robots can precisely position the instruments. The impact of these tolerances doesn’t just affect machine tolerance capabilities. The inspection methods and techniques are also required to adapt to the increased requirements. MedTorque has invested in both resources and capabilities to accommodate the unique inspections now required for the robotic instruments it manufactures.
Brusco: What are the most important considerations for a user-centered instrument design strategy?
Andreoni: Diverse opinions matter most, because this input can potentially best represent the user population as a whole. How to get a diverse set of opinions is the challenge we face when developing any new implant or instrument system. Whether it’s diversity of experience, surgical approach, country, etc.—getting the inputs from a diverse user population, and sometimes even from a non-user population (to understand why the non-user is opting out of utilizing the current product offerings), can make the difference in market adoption. Instruments that keep the patient safe, help keep surgical techniques efficient, and facilitate an effective spinal procedure are what drive this adoption.
Gruenert: A no-nonsense and direct connection to the engineers (designers), machinists, and craftsman is important. This was practiced in the 90’s a few times with huge success. I fondly recall the instruments that were developed like this are still frontrunners today! Now, the OEMs have become tighter and less flexible due to fear of the regulatory controls. We at Pacific Instruments have begun working with surgeons directly and have positively experienced this no-nonsense and direct connection and are very encouraged about the future.
Hall & Hotter: Minimizing time in design and feedback loops will be important considerations for user-centered design. The ability to take user feedback and quickly adjust the design to address this feedback will be critical. The use of additive manufacturing in the process will help reduce the design cycle times.
Brusco: What are some best practices for OEM customers looking to have a successful partnership with you?
Andreoni: Robust quality systems at the OEM can make a big difference. At Stryker, we want to distribute a product that has been fabricated and documented using a process similar to our own standards.
Gruenert: In today’s world, it’s important to be respectful, to pay on time, be transparent, and communicate directly to make any partnership successful. Avoid conflicts of interest. Also, as I previously mentioned, be sure to bring the craftsman and surgeon directly together when developing an instrument.
Hall & Hotter: By partnering with a parts manufacturer early in the design and development phase, customers can collaborate and benefit from design for manufacturing feedback. Collaboration with the manufacturing partner will lead to better understanding of design freedoms and technology advancements, such as 3D printed metal, and could lead to design improvements for functional and cost improvement. Too often, we receive requests to manufacture part designs that could be much more cost effective by slightly modifying the design.
Ruggieri: With respect to navigated instruments, the need for a cooperative relationship between the OEM and supplier becomes extremely important. These new technologies are pushing the need toward “zero” tolerance which, if not planned for, can lead to delays and difficulties during the process.
Ryshkus: As a partner, our experience and expertise are always available to our customers. We will gladly provide design for manufacturability (DFM) inputs to our customers’ designs. We even offer design assistance if our customers need it. The best advice is to get our team involved early and to provide as much information about the application as possible. Sometimes the initial product we’re approached to manufacture is not what eventually goes to market—it is often the result of collaborative design and development.
Schultz: A major value add we provide customers is turnkey solutions with off-the-shelf products like torque limiters that are fully validated, sterile pack, and dock to stock ready. We can have fully validated production products in our customers’ hands within 30 to 45 days of engagement. This is changing the paradigm for lead times and fulfillment to get critical instrument solutions to market quickly. For tailored instrument kits for extremity, trauma, sports medicine, hip and knee, and spine, it is the one-stop-shop ability to provide and manage all development, documentation, validations, machining, molding, packaging, and sterilization steps in the process. We also reduce their costs and accelerate time to market as we can leverage existing products, molds, and validations, simplifying the process and allowing implant OEMs to focus on their core competence of implant design, product marketing, and selling.
Brusco: What factors do you believe will most significantly impact orthopedic/spine instrumentation and its manufacture in the coming years?
Gruenert: We call it as it is. Price pressures have brought in many faulty and dishonest players, which has actually benefitted us. Customers recognize a hardworking, high quality, team that performs and cares—the proof, in 2019 our sales grew by 25 percent. Also, the time to the marketplace has slowed down due to additional regulatory regulations and has favored us, a company that has the technical expertise and focus, flexibility, and high-quality products.
Hall & Hotter: Advanced material technology and the growth of robotic and minimally invasive procedures is going to continue to drive advances in instrumentation. This will mean that instrumentation OEMs will be looking to make instruments smaller and task these devices with accomplishing more. Smaller and more detailed instruments could benefit from advanced manufacturing techniques such as metal injection molding and 3D printing. As new alloys and processes become available to additive manufacturing, there is potential for innovative design for implantable devices as well.
Ruggieri: Inspection and verification of difficult to measure features need to be considered at the front end of the product design cycle. Too often, there is a need to take a few steps backward once these inspection techniques are introduced. Inspection correlation studies are one of the most important steps that need to occur before manufacturing takes place. This is, unfortunately, rarely considered in project timelines.
Ryshkus: Effectively and efficiently incorporating additive manufacturing into instrument manufacturing has the potential to dramatically impact instrumentation design and manufacture.
Schultz: Low cost manufacturing including offshore options and automated lights out machining are critical. Reduced cost of goods sold, off-the-shelf solutions, dock to stock fulfillment, faster time to market, and personalized medicine solutions are the future.
Brusco: Is there anything else you’d like to say on the topic?
Ruggieri: Newer instruments require the use of better grades of materials and often need intermediate steps to assure the machined geometry and tight tolerances are maintained throughout the entire manufacturing process. Old and tired equipment won’t get the job done. If you’re not using the very best machinery and software available, chances are slim for producing compliant parts on a consistent basis.
References
That’s why David Cappelleri, an associate professor of mechanical engineering at Purdue University’s College of Engineering, co-founded C2 Medical Robotics Inc., a University-affiliated startup aiming to improve the skills of surgeons with its new technology. The company is developing low-cost, articulated, robotic spinal surgical tools and devices for lumbar discectomy.
“With the help of multi-material 3D printing, we can shrink existing robotic systems to fit into the small workspace of the spine making it easier for surgeons to perform this delicate surgery,” Cappelleri told the press.
C2 Medical Robotics’ method replaces pin joints typically used in lumbar discectomy for compliant joints printed from a soft, rubber-like material. Rigid components are printed from hard plastic material. It all comes out of the printer as a unified mechanism, which is then connected to tendon wires to drive it. Surgeons can control the technology with joysticks and onboard actuators. The robotic system also boosts surgeons’ skills by allowing more dexterous movement and control of the tools in the surgical workspace. Surgeons who might not have been skilled enough to perform the procedure in the past may have the opportunity to operate as a result of C2’s system.
“The hope is we can help people and reduce their pain,” said Cappelleri, who has been working in the medical device industry for over a decade. “For surgeons, we want to make their job easier, and just make it a low-cost system that can be adopted by many hospitals and medical centers, so it becomes the standard for these types of procedures.”
Robotic and computer-assisted surgery has become so pervasive in orthopedic and spine procedures that seven of the top 10 global orthopedic device manufacturers have made major investments in these technologies:
• Stryker’s Mako (partial and total knee replacement, total hip replacement)
• DePuy Synthes’ Orthotaxy buy (expected to launch orthopedic surgery robot this year)
• Zimmer Biomet’s Rosa One (total knee replacement, spine, brain)
• Smith+Nephew’s Navio (partial and total knee replacement)
• Medtronic’s Mazor X Stealth Edition (spine)
• NuVasive’s Pulse navigation (spine)
• Globus Medical’s ExcelsiusGPS (spine)
Increased demand for robotic or computer-assisted procedures means firms manufacturing instruments for orthopedic and spine procedures must organize their business operations to account for this trend if they hope to grow. This is much easier said than done, however—the tolerances required to manufacture instruments used in robotic procedures require much tighter tolerances when compared to those for manual instruments. The robotic systems need to be precise because the software expects the working end to be in an exact position. With too significant of a tolerance stack-up, the possible error defeats the purpose of using a robotic system at all.
In addition to robotics, more complexity, multifunctionality, ease of use, and human factors engineering are driving orthopedic and spine surgery instrumentation innovation. The market for new instruments to improve the end-user experience for both surgeons and patients is growing. To accomplish this, OEMs collaborate closely with surgeons on instrument designs to improve ease of use and ergonomics.
All of these demands can really rack up cost, so orthopedic OEMs strive to trim the expense of instrumentation since they focus the majority of their efforts on developing implants. Hip and knee products continue to become increasingly commoditized, driving price pressures for those implants. OEMs continue to focus on their core competencies, so much of the work of instrument manufacturing is sourced to a strategic supplier with requisite knowledge and processes already in place. Partnership with instrument manufacturers can offer the OEM custom solutions, low price points, and quick turnaround times that comply with all necessary regulations.
To gain further insight on the trends and challenges affecting the orthopedic and spine instrument manufacturing sector, as well as how instrument manufacturers are responding to these challenges to provide the best solutions possible, Orthopedic Design & Technology spoke with the following industry experts.
Todd Andreoni, director, advanced operations at Stryker Corp., a Kalamazoo, Mich.-based global medical device and equipment manufacturer offering products and services in orthopedics, medical and surgical, and neurotechnology and spine.
Holger Gruenert, founder and president of Pacific Instruments Inc., a Honolulu, Hawaii-based contract manufacturer and procurement source for the development, design, and manufacturing of surgical instruments.
Rob Hall, president of Parmatech, an ATW Company. Based in Petaluma, Calif., Parmatech is a supplier of custom manufactured metal injection molding components.
David Hotter, director of corporate business development at ATW Companies. Based in Warwick, R.I., the ATW Companies are suppliers of precision tubing and fabricated metal components.
John Ruggieri, vice president of engineering and business development at ARCH Medical Solutions, a Seabrook, N.H.-based contract manufacturer of surgical instruments, implants, and medical devices for orthopedic and medical device companies.
Chad Ryshkus, director of marketing and product development at MedTorque, a Kenosha, Wis.-based manufacturer of orthopedic instruments and implants, including single-procedure torque-limiting drivers.
James Schultz, vice president of customer solutions at ECA Medical, a Thousand Oaks, Calif.-based manufacturer of single-use torque limiting and surgery-ready procedure kits.
Sam Brusco: How are trends in orthopedic/spinal surgical procedures and implants affecting instrumentation?
Holger Gruenert: Minimally invasive procedures and time-sensitive execution have influenced the shape and construction of surgical instruments. Due to these trends, OEM companies need technical and cost-efficient suppliers, like us, who can deliver high-quality, custom instrumentation reliably. Proudly, we can say in 2019, we experienced a 25 percent sales growth due to meeting these trends and our customers’ needs.
Rob Hall & David Hotter: Robotic-assisted surgery is the current focus for improvements to orthopedic/spinal surgical procedures and implants. Advancements in metal additive manufacturing may lead to better customization of orthopedic implants for future surgical procedures.
Chad Ryshkus: Ambulatory Surgical Centers (ASCs) will become a more significant factor in orthopedics and spine through this upcoming decade. We are already seeing commercial payer reimbursements for total joint replacements performed in ASCs. ASCs are a cost-effective alternative that have unique needs not typical of the traditional hospital setting. That’s where we’ll see their impact on instrumentation. Single-use instrument sets packaged specifically for the procedures will play a considerable role in addressing the limited space and resources associated with the overall management of the logistics of inventorying, cleaning, and processing of instruments.
James Schultz: As a designer and manufacturer of single- use instruments, we are seeing increased demand for sterile pack, surgery ready torque limiters and instrument kits across all segments of the market. Application is in both the hospital and ASC setting to reduce reprocessing costs, meet surgical demand, and improve OR efficiency and turnover. Lower cost, clinically robust instrumentation that reduces inventory levels and life cycle costs and offers increased sales of orthopedic implants is driving demand. Small and medium-sized implant OEMs want to use their cash wisely and investments in expensive cases and trays can be cost prohibitive and create a large and long logistics and support burden. Single-use sterile pack kits are always surgery ready and can be bundled with implants for reimbursement.
Brusco: What advances in manufacturing technology have most significantly impacted your instrument manufacturing business?
Todd Andreoni: Additive manufacturing is emerging as a commercially viable way to make instrumentation both quickly and now more cost-effectively. New materials, especially those used for surgical instrumentation, are being validated for use, giving both design and process engineers more options.
Gruenert: Advances such as 3D printing for prototypes and productions have entered the market for both polymers and metals. New advanced multi-axis machining centers and lathes coupled with smart machining software have also made a significant impact.
Hall & Hotter: Additive manufacturing and 3D printing are expanding the possibilities for design features and are augmenting traditional manufacturing methods for small, detailed parts with shorter development cycles.
John Ruggieri: Robotic and navigated instruments have changed the landscape of orthopedic manufacturing. The tolerance requirements and complex geometries add a higher level of complexity to almost every device.
Schultz: 3D printing and new materials are reducing costs, providing robust instrument solutions, and replacing many traditional stainless steel components with selected polymers. These polymers can mimic steel in many cases and have excellent gamma sterilization stability while reducing overall instrument and procedural kit costs.
Brusco: How is the push toward robotic and minimally invasive approaches affecting instrumentation?
Andreoni: Instrumentation to support robotic surgery is certainly at the core of any new procedure, and this could end up being a differentiating feature for customers when selecting a robotic platform. Minimally invasive approaches are here today. In order to have market adoption, it is critical to integrate customer inputs into instrument designs that help make procedures efficient and effective, while placing the highest priority on patient safety.
Hall & Hotter: Robotic and minimally invasive processes are pushing instrumentation toward small form factors and end effectors. End effector designs are migrating toward the ends of the utilization spectrum, with a need for high utilization designs that can perform multiple tasks, and specific designs to address an individual challenge.
Ryshkus: Robotics is pushing the envelope for precision instrumentation even further with the extremely tight tolerances required to ensure the robots can precisely position the instruments. The impact of these tolerances doesn’t just affect machine tolerance capabilities. The inspection methods and techniques are also required to adapt to the increased requirements. MedTorque has invested in both resources and capabilities to accommodate the unique inspections now required for the robotic instruments it manufactures.
Brusco: What are the most important considerations for a user-centered instrument design strategy?
Andreoni: Diverse opinions matter most, because this input can potentially best represent the user population as a whole. How to get a diverse set of opinions is the challenge we face when developing any new implant or instrument system. Whether it’s diversity of experience, surgical approach, country, etc.—getting the inputs from a diverse user population, and sometimes even from a non-user population (to understand why the non-user is opting out of utilizing the current product offerings), can make the difference in market adoption. Instruments that keep the patient safe, help keep surgical techniques efficient, and facilitate an effective spinal procedure are what drive this adoption.
Gruenert: A no-nonsense and direct connection to the engineers (designers), machinists, and craftsman is important. This was practiced in the 90’s a few times with huge success. I fondly recall the instruments that were developed like this are still frontrunners today! Now, the OEMs have become tighter and less flexible due to fear of the regulatory controls. We at Pacific Instruments have begun working with surgeons directly and have positively experienced this no-nonsense and direct connection and are very encouraged about the future.
Hall & Hotter: Minimizing time in design and feedback loops will be important considerations for user-centered design. The ability to take user feedback and quickly adjust the design to address this feedback will be critical. The use of additive manufacturing in the process will help reduce the design cycle times.
Brusco: What are some best practices for OEM customers looking to have a successful partnership with you?
Andreoni: Robust quality systems at the OEM can make a big difference. At Stryker, we want to distribute a product that has been fabricated and documented using a process similar to our own standards.
Gruenert: In today’s world, it’s important to be respectful, to pay on time, be transparent, and communicate directly to make any partnership successful. Avoid conflicts of interest. Also, as I previously mentioned, be sure to bring the craftsman and surgeon directly together when developing an instrument.
Hall & Hotter: By partnering with a parts manufacturer early in the design and development phase, customers can collaborate and benefit from design for manufacturing feedback. Collaboration with the manufacturing partner will lead to better understanding of design freedoms and technology advancements, such as 3D printed metal, and could lead to design improvements for functional and cost improvement. Too often, we receive requests to manufacture part designs that could be much more cost effective by slightly modifying the design.
Ruggieri: With respect to navigated instruments, the need for a cooperative relationship between the OEM and supplier becomes extremely important. These new technologies are pushing the need toward “zero” tolerance which, if not planned for, can lead to delays and difficulties during the process.
Ryshkus: As a partner, our experience and expertise are always available to our customers. We will gladly provide design for manufacturability (DFM) inputs to our customers’ designs. We even offer design assistance if our customers need it. The best advice is to get our team involved early and to provide as much information about the application as possible. Sometimes the initial product we’re approached to manufacture is not what eventually goes to market—it is often the result of collaborative design and development.
Schultz: A major value add we provide customers is turnkey solutions with off-the-shelf products like torque limiters that are fully validated, sterile pack, and dock to stock ready. We can have fully validated production products in our customers’ hands within 30 to 45 days of engagement. This is changing the paradigm for lead times and fulfillment to get critical instrument solutions to market quickly. For tailored instrument kits for extremity, trauma, sports medicine, hip and knee, and spine, it is the one-stop-shop ability to provide and manage all development, documentation, validations, machining, molding, packaging, and sterilization steps in the process. We also reduce their costs and accelerate time to market as we can leverage existing products, molds, and validations, simplifying the process and allowing implant OEMs to focus on their core competence of implant design, product marketing, and selling.
Brusco: What factors do you believe will most significantly impact orthopedic/spine instrumentation and its manufacture in the coming years?
Gruenert: We call it as it is. Price pressures have brought in many faulty and dishonest players, which has actually benefitted us. Customers recognize a hardworking, high quality, team that performs and cares—the proof, in 2019 our sales grew by 25 percent. Also, the time to the marketplace has slowed down due to additional regulatory regulations and has favored us, a company that has the technical expertise and focus, flexibility, and high-quality products.
Hall & Hotter: Advanced material technology and the growth of robotic and minimally invasive procedures is going to continue to drive advances in instrumentation. This will mean that instrumentation OEMs will be looking to make instruments smaller and task these devices with accomplishing more. Smaller and more detailed instruments could benefit from advanced manufacturing techniques such as metal injection molding and 3D printing. As new alloys and processes become available to additive manufacturing, there is potential for innovative design for implantable devices as well.
Ruggieri: Inspection and verification of difficult to measure features need to be considered at the front end of the product design cycle. Too often, there is a need to take a few steps backward once these inspection techniques are introduced. Inspection correlation studies are one of the most important steps that need to occur before manufacturing takes place. This is, unfortunately, rarely considered in project timelines.
Ryshkus: Effectively and efficiently incorporating additive manufacturing into instrument manufacturing has the potential to dramatically impact instrumentation design and manufacture.
Schultz: Low cost manufacturing including offshore options and automated lights out machining are critical. Reduced cost of goods sold, off-the-shelf solutions, dock to stock fulfillment, faster time to market, and personalized medicine solutions are the future.
Brusco: Is there anything else you’d like to say on the topic?
Ruggieri: Newer instruments require the use of better grades of materials and often need intermediate steps to assure the machined geometry and tight tolerances are maintained throughout the entire manufacturing process. Old and tired equipment won’t get the job done. If you’re not using the very best machinery and software available, chances are slim for producing compliant parts on a consistent basis.
References