Mark Crawford, Contributing Writer05.17.21
After a slowdown in 2020 due to COVID-19, the implant manufacturing market is making a comeback. Elective surgeries are almost back in full swing. As a result, many medical device manufacturers (MDMs) and their contract manufacturers (CMs) are running at full capacity.
“With the improving state of the pandemic, we are seeing electable surgeries coming back into favor,” said John Ruggieri, senior vice president of business development for ARCH Medical Solutions, a multi-site U.S.-based provider of precision machining and contract manufacturing for the medical device industry. “The demand for implants is reaching pre-pandemic levels and, in some cases, it is even higher.”
Additive manufacturing (AM) continues to capture a lot of attention as new methods and materials enter the market on a steady basis.
“The shift toward additive manufacturing is even more prevalent now than it was five years ago,” said Nick Corcoran, vice president of division operations for Stryker, a Kalamazoo, Mich.-based medical technology company that specializes in orthopedic, neurotechnology, and spinal products. “Today, while more traditional subtractive manufacturing is still commonplace, additive manufacturing has become central to the implant manufacturing landscape.”
MDMs want to find AM partners that are experienced enough to expertly manufacture innovative designs that traditional methods cannot produce, as well as advise them on material selection, manufacturability, and regulatory processes.
“We have been speaking with many companies that continue to look for additional suppliers who have experience with AM for implants,” said Brian R. McLaughlin, president and founder of Amplify Additive, a Scarborough, Maine-based contract designer and manufacturer of additively manufactured titanium implants. “We see an unmet gap in the market for what companies are seeking. The manufacturing market for AM is still extremely fragmented, which is one reason this sector continues to grow.”
Even with the ever-expanding popularity of AM, MDMs prefer to use traditional “tried-and-true” methods whenever they can, such as casting, forging, and machining, for parts that do not require the unique structures or geometries that can only be created with AM. Improved capabilities in traditional machining, however, are keeping pace with AM, with better controls and higher precision. In addition to the actual material removal processes—grinding, milling, belting—these capabilities also include integration and automation of secondary operations to reduce the number of “touches” and the opportunities for error, all of which save time and reduce cost.
“Smaller implants that support less-invasive procedures and quicker patient recoveries are also in high demand,” added David Francis, general manager of Autocam Medical, a Plymouth, Mass., division of a global contract manufacturer of orthopedic implants, spinal implants, precision instruments, and orthopedic cutting tools. “These devices require more complex machining geometries and tighter tolerancing, which call for higher multi-axis spindle speeds and more precise machining capabilities.”
Latest Trends
There continues to be a strong focus on AM across the industry. In addition to 3D-printed lattice structures that provide an effective surface for osseointegration, MDMs are also interested in adding coatings to further enhance bone in-growth. Other popular coatings such as anodize, hard coat, chromium coating, tin coating, plasma spray, and chemical machining finishes improve functionality in several ways, including enhanced durability and color coding. Coatings have also been developed with antimicrobial properties as well as the ability to repel bacteria, viruses, or living cells.
Current methods such as titanium plasma spray (TPS) coatings only provide a pore size ranging from 100 to 300 microns. “Even though there is good data that shows adhesion of bone and some in-growth, there is also research that demonstrates the optimal pore size for vascularized bone in-growth is in the range of 650 microns,” said McLaughlin. “Currently, the only way to achieve those dimensions is through additive manufacturing, where we can essentially design a pore size and structure for optimized fusion. AM can also create a roughened surface that also aids biomedical fusion.”
Computer numerical control (CNC) machining is staying competitive with AM, especially by becoming more efficient through the reduction of steps. For example, Haas Multigrind, a Charlotte, N.C.- and Trossingen, Germany-based manufacturer of high-precision, multi-axis grinding centers, manufactures equipment that allows MDMs to perform multiple machining operations (e.g., grinding, milling, belting) in a single part clamping. “Rather than moving the part to multiple machines,” said David Drechsler, business development manager for Haas Multigrind, “where each handling creates an opportunity for error, the single clamping and combined operations means all features are produced from a single reference or clamping location.”
Machining improvements are often made in-house, such as specialized equipment and more efficient and longer-lasting tooling. Tools might be built for a particular project need but can then be utilized on future projects. “We have come to rely heavily on our tooling engineers from our ARCH Cutting Tool factories to help shorten cycle times, increase tool life, and increase accuracy from part to part,” said Ruggieri.
Conventional manufacturing techniques are often still needed to augment AM processes. Rarely is an implant ready to go right out of the laser or electron beam asset. The complex shapes of AM-made products often require finishing steps conducted with traditional machining methods. “The combination of maturation in additive manufacturing and precision machining is enabling a step change in the complexity of product offerings, including expandable devices,” said Corcoran.
What OEMs Want
Quality is paramount when producing a complex device that will be inserted into the body and expected to perform capably for decades. In addition, “more detailed questions are being asked by regulatory bodies regarding the safety of the implant as well as safety of manufacturing phases, which drives the manufacturers to carry out more tests and more validations,” said Serdar Omur Goren, vice general manager of Sayan Tibbi Aletler Limited, an Izmir, Turkey-based manufacturer of orthopedic, spinal, and dental instruments, instrument sets, and implants. “With the European Union Medical Device Regulation in place, implant manufacturers are now required to follow up on their implants and report their findings every year.”
“OEMs consistently ask for the same four key things: timely delivery, competitive pricing, inventory management programs, and increased quality requirements,” said John Phillips, president of the implants and instrumentation division of Phillips Precision Medicraft, an Elmwood Park, N.J.-based manufacturer of orthopedic implants, instrumentation, sterilization delivery systems, cases, and trays. “Quality requirements have been the most significant change for us in 2020. Things like process validations, capability studies, part production approval process activity, and gage R&R are all used to prove the process is sound, verifiable, and repeatable.”
MDMs want to work with CMs that understand their priorities and can comply with constantly changing regulatory requirements. They expect their partners to utilize design for manufacturability to achieve design intent, price targets, and shorter lead times. Careful cost management by the CMs is critical for helping MDMs meet the stringent cost requirements of their healthcare system customers—in fact, in some ways cost control is more important than the added or special functionality in the devices they seek.
“For example, single-use sterile implants that are designed to be supported with disposable instruments reduce OR time, eliminate reprocessing costs, and are safer for the patient,” said Adam Paltzer, vice president of operations for Able Medical Devices, a Marquette, Mich.-based designer and manufacturer of implants and instruments for the orthopedic market. “We have worked with OEMs on reducing complexity of implant design to achieve this, while also allowing expansion of distribution by reducing instrument capital investment.”
New Technologies
In parallel with the huge growth in 3D printing, casting technology has not been standing still. Manufacturers can produce castings that are much closer to near-net shape and with more features. The result is faster machining times and fewer down-stream manufacturing steps. For example, Haas Multigrind has recently introduced a cloud-based, pay-per-use, simulation tool called Styx. When engineers run the Styx software, 3D results of the CNC grinding program can be very precisely measured to verify accuracy of the program before committing to machine time and real parts. “This is a big benefit for complex 3D anatomically contoured implants and instruments,” said Drechsler. “It is especially beneficial for Tier-1 suppliers that produce a variety of different products for OEMs and are constantly developing new processes.”
Other machine improvements include 12-axis turning tools, more durable inserts, advanced thread-whirling machines (spindle speeds up to 30,000 rpm), and faster and more capable electrical discharge machining machines. More complex cutting tools combine multiple features into single tools, which improves efficiency and accuracy and saves time. This also reduces cycle time and eliminates many inspection challenges. More CMs are investing in customized and automated inspection technologies to balance the ever-expanding need for manufacturing data and process controls. Other Industry 4.0 technologies that improve efficiencies and production—for example, automation—allow companies to improve efficiencies and capabilities in the manufacturing process, from creation to inspection to packaging.
“For us, it’s all about automating the manufacturing process with accurate high-end equipment and great technicians,” said Phillips. “This strategy requires investment, but once implemented, the returns on flexibility and increased capacity in the same footprint are undeniable.”
Many complex designs require the ability to micro machine, using very small tools, high spindle speeds, and superior programming. Phillips Precision Medicraft has added a growing number of palletized 5-axis machining centers tended by robotic loading equipment. “These machines are extremely accurate and give us the ability to continue to run parts unattended when humans are not present, growing our lights-out manufacturing capabilities,” said Phillips. “These assets have improved the quality, repeatability, and new-found capacity for the manufacture of implants and other high-volume products.”
“We have invested heavily in automated material feeders and robot-fed machining centers in all of our factories across the U.S.,” added Ruggieri. “The flexibility of cobots allows them to achieve a variety of tasks, including several non-CNC functions. Creating semi-custom solutions to seamlessly capture inspection data allows our machinists to focus on constant throughput and high-efficiency operations and improve our quality metrics simultaneously.”
AM continues to play a huge role in the development of patient-specific implants (PSI). Medical-grade implants with complex structures continue to evolve, especially for spinal procedures. Polyetheretherketone (PEEK) is increasingly used to make 3D-printed implants, with surfaces or coatings that promote osseointegration; however, titanium is still the most popular material for PSI. Surgeons recently created a 3D-printed titanium talus bone for a patient with sickle cell disease.1 Instead of fusing the patient’s ankle to the hindfoot, which would have taken away her ability to move the foot, the surgical team replaced the entire talus bone, preserving her ability to walk. Researchers at Boston Micro Fabrication are exploring the possibility of making 3D-printed eye stents from a dissolvable polymer that could eliminate the follow-up surgery necessary to remove the titanium eye stents commonly used today.2
For some PSI projects, Haas Multigrind’s Horizon programming system allows users to create complex grinding and milling programs directly from a 3D model. In other cases, complex 5-axis tool paths can be imported to the Horizon programming system to create grinding and milling programs. “For even more complex parts like hip rasps and broaches, we have developed application-specific routines to generate programs that produce a variety of tooth patterns on 3D anatomically contoured blanks,” said Drechsler.
Additive manufacturing also creates new design opportunities for using an ever-increasing array of biocompatible materials. Nitinol can now be 3D-printed and still maintain its mechanical and shape memory/superelasticity properties.3 Magnesium alloys are promising materials for use in absorbable implants. Biodegradable magnesium materials offer significantly enhanced mechanical properties for orthopedic applications compared to their biodegradable plastic counterparts; however, the degradation rates of magnesium and magnesium alloys in the body must be carefully controlled. 3D-printed bioceramic implants, made using a digital light processing (DLP) technique, can now replace both cortical and cancellous bone.
Moving Forward
There is a large misconception that additive manufacturing is still too expensive to use for making implants—however, according to McLaughlin, it is cost-competitive with traditional machining when all the process steps and logistics are compared. “For example, to manufacture an acetabular cup using standard methods, you need to design your part, design your casting, manufacture your casting, manufacture your part, ship to machine shop, machine your part, ship to coating house for TPS (or other coating), and ship to packaging,” he said. “With AM, you design, print, ship to machine shop, machine, ship to packaging. As with any other manufacturing process, volume matters, so the more that shifts over to AM, the faster the cost will come down. That said, I believe we can be cost-competitive with traditional methods now.”
Once companies gain AM knowledge and experience, their opportunities for making innovative designs seem almost endless—especially for making complex, one-of-a-kind products, with far fewer steps and less material waste compared to traditional processes, and much more quickly. AM is rapidly gaining acceptance in the healthcare sector, going beyond making medical devices to creating 3D tools and models that assist surgeons in their procedures, such as 3D virtual surgical planning, fabrication of anatomical models, and patient-specific implants. For example, a surgical team at New England Baptist Hospital in Boston recently accomplished a healthcare first by using an augmented reality (AR) device during a total hip replacement.4 The device was cleared by the U.S. Food and Drug Administration (FDA) in January 2021.
“We’re going to a place in medicine that has just never existed before,” said Steve Murphy, an orthopedic surgeon at New England Baptist Hospital who not only performed the surgery, but also invented the intraoperative AR guidance platform for joint replacement.
“The technology takes all the critical three-dimensional information of that patient and puts it right where you want it, when you want it, in real time,“ Murphy said.
Before surgery, 3D images of the patient’s anatomy are loaded into special head-mounted lenses. A tracker is placed on the patient. Once the lenses lock onto the tracker, the person’s anatomical information is projected inside the body, in real time. This allows the surgeon to see a patient’s exact, unique anatomy in detail to perfectly place a new implant through a very small incision.
“Little differences turn out to be big differences for the patient,” Murphy added. “Being able to lock in and be sure that everything you’re doing is exactly what you planned, and that you’re accomplishing exactly what you set out to do, is a difference-maker for surgery.”
In another innovative milestone, the Hospital for Special Surgery (HSS) in New York City and LimaCorporate, a global provider of 3D design and printing of personalized orthopedic components, have teamed up to open the “3D Design and Printing Center for Complex Joint Reconstruction Surgery,” the first provider-based center of its kind.5 The FDA-regulated commercial facility at the HSS main campus was established to create faster access to patient-specific implants for highly complex orthopedic conditions.
“This partnership reflects our sense of responsibility to innovate better possibilities, not only for our patients but also for other providers,” said Louis A. Shapiro, president and CEO of HSS. “We hope to further accelerate complex musculoskeletal solutions by expanding our ecosystem and providing surgeons with best-in-class patient care technology, on site.”
Patient-specific custom implant solutions will be designed and additively manufactured using LimaCorporate’s proprietary “Trabecular Titanium Technology.” Patients will be scanned on site, where their custom implants will be designed and fabricated. “Trabecular Titanium” is a biomaterial that creates a unique geometric structure with an interconnected design that is built using electron beam melting (EBM) technology. The material is lightweight and corrosion-resistant, with high biocompatibility and mechanical performance.
“While the majority of joint replacement patients have a similar treatment pattern, these custom 3D-printed solutions will provide relief to complex patients, who have often been living with joint problems for decades, and expedite what was once an international production process,” said Leonard Achan, president of the HSS Innovation Institute. “With this new level of access to LimaCorporate’s custom 3D printing, we also hope to foster and accelerate innovation in complex orthopedic joint care across the U.S.”
Although this is an exciting development, McLaughlin cautions that a key issue will be finding the right people to work directly with the surgeons and help them bridge the gap from clinical to design/manufacturing. “Ultimately, I don’t see a lot of hospitals doing this same thing,” he said. “I think it is more likely that organizations will set up advanced manufacturing sites, closer to the markets they serve, that offer a more vertically integrated solution.”
References
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
“With the improving state of the pandemic, we are seeing electable surgeries coming back into favor,” said John Ruggieri, senior vice president of business development for ARCH Medical Solutions, a multi-site U.S.-based provider of precision machining and contract manufacturing for the medical device industry. “The demand for implants is reaching pre-pandemic levels and, in some cases, it is even higher.”
Additive manufacturing (AM) continues to capture a lot of attention as new methods and materials enter the market on a steady basis.
“The shift toward additive manufacturing is even more prevalent now than it was five years ago,” said Nick Corcoran, vice president of division operations for Stryker, a Kalamazoo, Mich.-based medical technology company that specializes in orthopedic, neurotechnology, and spinal products. “Today, while more traditional subtractive manufacturing is still commonplace, additive manufacturing has become central to the implant manufacturing landscape.”
MDMs want to find AM partners that are experienced enough to expertly manufacture innovative designs that traditional methods cannot produce, as well as advise them on material selection, manufacturability, and regulatory processes.
“We have been speaking with many companies that continue to look for additional suppliers who have experience with AM for implants,” said Brian R. McLaughlin, president and founder of Amplify Additive, a Scarborough, Maine-based contract designer and manufacturer of additively manufactured titanium implants. “We see an unmet gap in the market for what companies are seeking. The manufacturing market for AM is still extremely fragmented, which is one reason this sector continues to grow.”
Even with the ever-expanding popularity of AM, MDMs prefer to use traditional “tried-and-true” methods whenever they can, such as casting, forging, and machining, for parts that do not require the unique structures or geometries that can only be created with AM. Improved capabilities in traditional machining, however, are keeping pace with AM, with better controls and higher precision. In addition to the actual material removal processes—grinding, milling, belting—these capabilities also include integration and automation of secondary operations to reduce the number of “touches” and the opportunities for error, all of which save time and reduce cost.
“Smaller implants that support less-invasive procedures and quicker patient recoveries are also in high demand,” added David Francis, general manager of Autocam Medical, a Plymouth, Mass., division of a global contract manufacturer of orthopedic implants, spinal implants, precision instruments, and orthopedic cutting tools. “These devices require more complex machining geometries and tighter tolerancing, which call for higher multi-axis spindle speeds and more precise machining capabilities.”
Latest Trends
There continues to be a strong focus on AM across the industry. In addition to 3D-printed lattice structures that provide an effective surface for osseointegration, MDMs are also interested in adding coatings to further enhance bone in-growth. Other popular coatings such as anodize, hard coat, chromium coating, tin coating, plasma spray, and chemical machining finishes improve functionality in several ways, including enhanced durability and color coding. Coatings have also been developed with antimicrobial properties as well as the ability to repel bacteria, viruses, or living cells.
Current methods such as titanium plasma spray (TPS) coatings only provide a pore size ranging from 100 to 300 microns. “Even though there is good data that shows adhesion of bone and some in-growth, there is also research that demonstrates the optimal pore size for vascularized bone in-growth is in the range of 650 microns,” said McLaughlin. “Currently, the only way to achieve those dimensions is through additive manufacturing, where we can essentially design a pore size and structure for optimized fusion. AM can also create a roughened surface that also aids biomedical fusion.”
Computer numerical control (CNC) machining is staying competitive with AM, especially by becoming more efficient through the reduction of steps. For example, Haas Multigrind, a Charlotte, N.C.- and Trossingen, Germany-based manufacturer of high-precision, multi-axis grinding centers, manufactures equipment that allows MDMs to perform multiple machining operations (e.g., grinding, milling, belting) in a single part clamping. “Rather than moving the part to multiple machines,” said David Drechsler, business development manager for Haas Multigrind, “where each handling creates an opportunity for error, the single clamping and combined operations means all features are produced from a single reference or clamping location.”
Machining improvements are often made in-house, such as specialized equipment and more efficient and longer-lasting tooling. Tools might be built for a particular project need but can then be utilized on future projects. “We have come to rely heavily on our tooling engineers from our ARCH Cutting Tool factories to help shorten cycle times, increase tool life, and increase accuracy from part to part,” said Ruggieri.
Conventional manufacturing techniques are often still needed to augment AM processes. Rarely is an implant ready to go right out of the laser or electron beam asset. The complex shapes of AM-made products often require finishing steps conducted with traditional machining methods. “The combination of maturation in additive manufacturing and precision machining is enabling a step change in the complexity of product offerings, including expandable devices,” said Corcoran.
What OEMs Want
Quality is paramount when producing a complex device that will be inserted into the body and expected to perform capably for decades. In addition, “more detailed questions are being asked by regulatory bodies regarding the safety of the implant as well as safety of manufacturing phases, which drives the manufacturers to carry out more tests and more validations,” said Serdar Omur Goren, vice general manager of Sayan Tibbi Aletler Limited, an Izmir, Turkey-based manufacturer of orthopedic, spinal, and dental instruments, instrument sets, and implants. “With the European Union Medical Device Regulation in place, implant manufacturers are now required to follow up on their implants and report their findings every year.”
“OEMs consistently ask for the same four key things: timely delivery, competitive pricing, inventory management programs, and increased quality requirements,” said John Phillips, president of the implants and instrumentation division of Phillips Precision Medicraft, an Elmwood Park, N.J.-based manufacturer of orthopedic implants, instrumentation, sterilization delivery systems, cases, and trays. “Quality requirements have been the most significant change for us in 2020. Things like process validations, capability studies, part production approval process activity, and gage R&R are all used to prove the process is sound, verifiable, and repeatable.”
MDMs want to work with CMs that understand their priorities and can comply with constantly changing regulatory requirements. They expect their partners to utilize design for manufacturability to achieve design intent, price targets, and shorter lead times. Careful cost management by the CMs is critical for helping MDMs meet the stringent cost requirements of their healthcare system customers—in fact, in some ways cost control is more important than the added or special functionality in the devices they seek.
“For example, single-use sterile implants that are designed to be supported with disposable instruments reduce OR time, eliminate reprocessing costs, and are safer for the patient,” said Adam Paltzer, vice president of operations for Able Medical Devices, a Marquette, Mich.-based designer and manufacturer of implants and instruments for the orthopedic market. “We have worked with OEMs on reducing complexity of implant design to achieve this, while also allowing expansion of distribution by reducing instrument capital investment.”
New Technologies
In parallel with the huge growth in 3D printing, casting technology has not been standing still. Manufacturers can produce castings that are much closer to near-net shape and with more features. The result is faster machining times and fewer down-stream manufacturing steps. For example, Haas Multigrind has recently introduced a cloud-based, pay-per-use, simulation tool called Styx. When engineers run the Styx software, 3D results of the CNC grinding program can be very precisely measured to verify accuracy of the program before committing to machine time and real parts. “This is a big benefit for complex 3D anatomically contoured implants and instruments,” said Drechsler. “It is especially beneficial for Tier-1 suppliers that produce a variety of different products for OEMs and are constantly developing new processes.”
Other machine improvements include 12-axis turning tools, more durable inserts, advanced thread-whirling machines (spindle speeds up to 30,000 rpm), and faster and more capable electrical discharge machining machines. More complex cutting tools combine multiple features into single tools, which improves efficiency and accuracy and saves time. This also reduces cycle time and eliminates many inspection challenges. More CMs are investing in customized and automated inspection technologies to balance the ever-expanding need for manufacturing data and process controls. Other Industry 4.0 technologies that improve efficiencies and production—for example, automation—allow companies to improve efficiencies and capabilities in the manufacturing process, from creation to inspection to packaging.
“For us, it’s all about automating the manufacturing process with accurate high-end equipment and great technicians,” said Phillips. “This strategy requires investment, but once implemented, the returns on flexibility and increased capacity in the same footprint are undeniable.”
Many complex designs require the ability to micro machine, using very small tools, high spindle speeds, and superior programming. Phillips Precision Medicraft has added a growing number of palletized 5-axis machining centers tended by robotic loading equipment. “These machines are extremely accurate and give us the ability to continue to run parts unattended when humans are not present, growing our lights-out manufacturing capabilities,” said Phillips. “These assets have improved the quality, repeatability, and new-found capacity for the manufacture of implants and other high-volume products.”
“We have invested heavily in automated material feeders and robot-fed machining centers in all of our factories across the U.S.,” added Ruggieri. “The flexibility of cobots allows them to achieve a variety of tasks, including several non-CNC functions. Creating semi-custom solutions to seamlessly capture inspection data allows our machinists to focus on constant throughput and high-efficiency operations and improve our quality metrics simultaneously.”
AM continues to play a huge role in the development of patient-specific implants (PSI). Medical-grade implants with complex structures continue to evolve, especially for spinal procedures. Polyetheretherketone (PEEK) is increasingly used to make 3D-printed implants, with surfaces or coatings that promote osseointegration; however, titanium is still the most popular material for PSI. Surgeons recently created a 3D-printed titanium talus bone for a patient with sickle cell disease.1 Instead of fusing the patient’s ankle to the hindfoot, which would have taken away her ability to move the foot, the surgical team replaced the entire talus bone, preserving her ability to walk. Researchers at Boston Micro Fabrication are exploring the possibility of making 3D-printed eye stents from a dissolvable polymer that could eliminate the follow-up surgery necessary to remove the titanium eye stents commonly used today.2
For some PSI projects, Haas Multigrind’s Horizon programming system allows users to create complex grinding and milling programs directly from a 3D model. In other cases, complex 5-axis tool paths can be imported to the Horizon programming system to create grinding and milling programs. “For even more complex parts like hip rasps and broaches, we have developed application-specific routines to generate programs that produce a variety of tooth patterns on 3D anatomically contoured blanks,” said Drechsler.
Additive manufacturing also creates new design opportunities for using an ever-increasing array of biocompatible materials. Nitinol can now be 3D-printed and still maintain its mechanical and shape memory/superelasticity properties.3 Magnesium alloys are promising materials for use in absorbable implants. Biodegradable magnesium materials offer significantly enhanced mechanical properties for orthopedic applications compared to their biodegradable plastic counterparts; however, the degradation rates of magnesium and magnesium alloys in the body must be carefully controlled. 3D-printed bioceramic implants, made using a digital light processing (DLP) technique, can now replace both cortical and cancellous bone.
Moving Forward
There is a large misconception that additive manufacturing is still too expensive to use for making implants—however, according to McLaughlin, it is cost-competitive with traditional machining when all the process steps and logistics are compared. “For example, to manufacture an acetabular cup using standard methods, you need to design your part, design your casting, manufacture your casting, manufacture your part, ship to machine shop, machine your part, ship to coating house for TPS (or other coating), and ship to packaging,” he said. “With AM, you design, print, ship to machine shop, machine, ship to packaging. As with any other manufacturing process, volume matters, so the more that shifts over to AM, the faster the cost will come down. That said, I believe we can be cost-competitive with traditional methods now.”
Once companies gain AM knowledge and experience, their opportunities for making innovative designs seem almost endless—especially for making complex, one-of-a-kind products, with far fewer steps and less material waste compared to traditional processes, and much more quickly. AM is rapidly gaining acceptance in the healthcare sector, going beyond making medical devices to creating 3D tools and models that assist surgeons in their procedures, such as 3D virtual surgical planning, fabrication of anatomical models, and patient-specific implants. For example, a surgical team at New England Baptist Hospital in Boston recently accomplished a healthcare first by using an augmented reality (AR) device during a total hip replacement.4 The device was cleared by the U.S. Food and Drug Administration (FDA) in January 2021.
“We’re going to a place in medicine that has just never existed before,” said Steve Murphy, an orthopedic surgeon at New England Baptist Hospital who not only performed the surgery, but also invented the intraoperative AR guidance platform for joint replacement.
“The technology takes all the critical three-dimensional information of that patient and puts it right where you want it, when you want it, in real time,“ Murphy said.
Before surgery, 3D images of the patient’s anatomy are loaded into special head-mounted lenses. A tracker is placed on the patient. Once the lenses lock onto the tracker, the person’s anatomical information is projected inside the body, in real time. This allows the surgeon to see a patient’s exact, unique anatomy in detail to perfectly place a new implant through a very small incision.
“Little differences turn out to be big differences for the patient,” Murphy added. “Being able to lock in and be sure that everything you’re doing is exactly what you planned, and that you’re accomplishing exactly what you set out to do, is a difference-maker for surgery.”
In another innovative milestone, the Hospital for Special Surgery (HSS) in New York City and LimaCorporate, a global provider of 3D design and printing of personalized orthopedic components, have teamed up to open the “3D Design and Printing Center for Complex Joint Reconstruction Surgery,” the first provider-based center of its kind.5 The FDA-regulated commercial facility at the HSS main campus was established to create faster access to patient-specific implants for highly complex orthopedic conditions.
“This partnership reflects our sense of responsibility to innovate better possibilities, not only for our patients but also for other providers,” said Louis A. Shapiro, president and CEO of HSS. “We hope to further accelerate complex musculoskeletal solutions by expanding our ecosystem and providing surgeons with best-in-class patient care technology, on site.”
Patient-specific custom implant solutions will be designed and additively manufactured using LimaCorporate’s proprietary “Trabecular Titanium Technology.” Patients will be scanned on site, where their custom implants will be designed and fabricated. “Trabecular Titanium” is a biomaterial that creates a unique geometric structure with an interconnected design that is built using electron beam melting (EBM) technology. The material is lightweight and corrosion-resistant, with high biocompatibility and mechanical performance.
“While the majority of joint replacement patients have a similar treatment pattern, these custom 3D-printed solutions will provide relief to complex patients, who have often been living with joint problems for decades, and expedite what was once an international production process,” said Leonard Achan, president of the HSS Innovation Institute. “With this new level of access to LimaCorporate’s custom 3D printing, we also hope to foster and accelerate innovation in complex orthopedic joint care across the U.S.”
Although this is an exciting development, McLaughlin cautions that a key issue will be finding the right people to work directly with the surgeons and help them bridge the gap from clinical to design/manufacturing. “Ultimately, I don’t see a lot of hospitals doing this same thing,” he said. “I think it is more likely that organizations will set up advanced manufacturing sites, closer to the markets they serve, that offer a more vertically integrated solution.”
References
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.
