Mark Crawford, Contributing Writer05.23.16
Implant manufacturing, at the global scale, is growing at an annual rate of 3 to 5 percent. Even though there are tantalizing possibilities with disruptive technologies such as additive manufacturing and 3D printing (especially as products become smaller, more complex, and costly), many OEMs still feel more comfortable staying with proven and validated processes and materials. The challenge then becomes finding new ways to improve efficiency and save time and money.
Some of these ideas come from other industries—for example, some medical device manufacturers (MDMs) are using the product part approval process, a quality-control method that has already been proven in the automotive and aerospace industries. MDMs are also paying more attention to test method development, process characterization, and gage repeatability and reproducibility—and generally the earlier, the better. Doing this during the design stage means fewer mistakes, iterations, restarts, and other changes further down the line. This, of course, saves manufacturing time and speeds up delivery into the market, which is one way of offsetting the higher costs of manufacturing more complex devices, and meeting more stringent OEM demands.
The rapid growth of minimally invasive procedures, as well as new product innovations that support combination products and biologic applications, “often make it challenging to manufacture products that are less invasive and safer, yet still affordable,” commented D. Lindsay Conner, president of Tracer Orthopedics, an Oakland, N.J.-based manufacturer of orthopedic implants and instrumentation.
One way to gain access to needed technological prowess and also shorten the supply chain is through consolidation. The mergers and acquisitions within the implant manufacturing market have resulted in larger device companies gaining increased leverage in price negotiations, which has cascaded both up and down the value stream, resulting in both increased insourcing and outsourcing.
“The insourcing has been seen via vertical integration in strategic areas by our partners through acquisitions,” said Carola Hansen, director of biomedical polyethylenes for DSM Biomedical, an Exton, Pa.-based medical device materials developer and manufacturer. “The outsourcing has created an opportunity for implant manufacturers to forge stronger strategic alliances with their partners to assist in optimizing operational costs—for example, logistics, inventory levels, etc. There are also smaller start-up companies leading innovation, but they are finding it increasingly difficult to maintain funding due to long regulatory approval cycles.”
Keeping Costs Down
Cost is a constant factor in any major implant design or manufacturing decision—especially for more complex designs, new materials, or more challenging processes.
“Medical device OEMs are under tremendous pressure to minimize inventories and reduce pricing due to the outcomes-based healthcare model mandated by the Affordable Care Act,” stated Terry Webster, sales manager for Medical Devices & Implants LLC, a Lancaster, Pa.-based contract manufacturer specializing in spinal and extremity implants. “These expectations are then passed on to the contract manufacturer in the same respect.” Conner agreed.
“Our customers are implementing ‘just-in-time’ principles to minimize their financial responsibility for holding inventory,” he said. “Smaller controlled orders are becoming the norm to minimize inventories and maximize cash flow. Therefore, shortened lead times and flexibility are keys for a successful relationship.”
Many MDMs are laser focused on data analytics, looking for new ways to improve functionality and performance, and reduce cost.
“Our OEM partners are crunching the numbers on patient outcomes and efficacy of new technologies to drive acceptance with healthcare systems,” said Philip Allen, director of sales and marketing for Lowell Inc., a Minneapolis, Minn.-based contract manufacturer of complex implants for the orthopedic and cardiovascular markets. “As a result, data is driving our world, too.
For example, we can perform critical feature analysis using Minitab statistical software and demonstrate that we have a competency with a machined feature down to a specific Cpk. This enables us to measure three critical features instead of the original 10, saving a great deal of inspection time, and shortening lead times and time to market.”
Selecting the Right Process
OEMs make no secret about what they want—more precision, tighter tolerances, improved finishes, and shorter cycle times—all at a lower cost. The intriguing capabilities of 3D printing are forcing medical device companies to take a closer look at this rapidly evolving technology. This, however, often takes them out of their comfort zone, which is traditional machining.
For orthopedic implant manufacturers, the biggest advantage of 3D printing is prototyping—being able to get a functional prototype into the hands of the design team in a matter of hours, instead of days or weeks, in high-demand materials such as metal and polyether ether ketone (PEEK). A few orthopedic companies have already used 3D printing to build implants that have received 510(k) approval from the U.S. Food and Drug Administration (FDA).
“Additive manufacturing (AM) is a good choice for implants with low surface-to-volume ratios and implants that have complex geometries [that] are difficult to achieve with traditional forging, casting, and machining techniques,” Parimal Bapat, a research engineer with Orchid Orthopedics Solutions, a Holt, Mich.-based provider of medical device outsourcing services, said in a blog on the company’s website. “In addition, since a variety of materials such as titanium and stainless steel can be used in the AM process, functional prototypes can be made out of the same material as production components. This enables more rigorous testing of prototypes while decreasing the development time for new products.”
In some cases, 3D printing is being used to build complete orthopedic implants in a single process. The method is ideal for low runs, and especially beneficial for one-run, customized, patient-specific products.
“The benefits of customizable implants for trauma and craniomaxillofacial needs have been acknowledged,” said Chander Chawla, director of biomedical polyurethanes for DSM Biomedical. “For example, FDA 510(k)-cleared 3D-printed devices include Oxford Performance Materials’ OsteoFab patient-specific polymeric facial implants for its cranial prostheses line and Medshape’s FDA-approved, 3D printed device to correct bunions.”
Three-dimensional printing also saves time and money by eliminating secondary steps, reducing material waste, and speeding time to market. “Not only does AM save considerable time and money compared to standard machining, it also gives design engineers greater freedom for designing innovative parts with unique or challenging geometries,” added Bapat. For example, researchers at the University of Sydney in Australia have utilized 3D printing to design and fabricate scaffolds with a mechanical strength comparable to cortical bone, which offers huge potential for repairing large bone defects.
Despite the incredible potential that additive manufacturing and 3D printing hold, there is definitely comfort in using already acquired, tried-and-true, traditional equipment—for example, computer numerical control (CNC) machines. “There have been no huge steps in CNC technology for machining components—just steady improvements in tooling and machine software capabilities,” said Neil Anderton, technical manager for Orthoplastics, a Bacup, U.K.-based processor of orthopedic-grade ultra-high-molecular-weight polyethylene (UHMWPE) in sheets and rods.
CNC machines can be combined with other equipment, such as lasers for cutting, welding, or etching. Five-axis machining centers can use data from medical scanning of patients to create a range of patient-specific implantable components, especially for skeletal requirements, such as bone, jaw, or skull. These types of projects are a good fit for sophisticated 5-axis machines.
To meet challenging OEM requests for custom/patient specific components, Orthoplastics has created its New Product Introduction Group, which brings the best science and control technology to bear on the development of patient-specific products, from design through production and documentation. Patient measurements are used to create a 3D model of the component required. Tolerance for the UHMW material is typically ±0.1mm, but can be as low as ±0.05mm, depending on the type of component.
“In addition to custom devices, there are also unique composite device constructions that pose particular challenges with respect to component fixation and the required production
controls to achieve the high tolerances,” added Anderton. “We have invested in innovative fixation and top specification-controlled environments in the necessary production areas to achieve these customer requirements.”
Although many industry experts have predicted that additive manufacturing will be the death of traditional machining, Allen isn’t convinced.
“We actually think the opposite may be true,” he said. “For example, we’ve developed an advanced process with a leading implant manufacturer to take a near net shape additive manufactured component with tolerances of ±0.01 inches and machine the final tolerances of ±0.001 inches they need for the device. This involves very sophisticated work holdings and machine probing, along with conventional multi-axis machining, to achieve the final design intent. We see this being an increasing part of our business.”
Advanced Materials
Material selection is both a science and an art—especially for those engineered materials with unique characteristics that require more control during production, or a more sophisticated process. High-performance plastics can provide the same level of strength, rigidity, and heat resistance as metals. PEEK, for example, a common material in the aerospace industry, is being used more in medical devices because of its strength, light weight, chemical inertness, and easy colorability—a big plus for making devices that can be color-coded for easy identification in the operating room.
Because PEEK provides an alternative load-bearing material to metal for joint implants, with a modulus similar to human bone, it is often the material of choice for spine, hip, knee, and shoulder implants. PEEK implants can also be coated with hydroxyapatite or titanium to improve bone upgrowth or osseointegration.
The downside to PEEK is that it is expensive. So, in every effort to control costs, manufacturers that use PEEK want to waste as little of it as possible.
“Our customers that use PEEK in their orthopedic implants are increasingly interested in getting the maximum yield for this expensive polymer,” said Webster. “To do this, we have designed proprietary tooling for milling applications that significantly reduces waste.”
UHMWPE is a popular biomaterial for implants that has been around for decades. The newest variations of UHMWPE are highly cross-linked with gamma or electron beam radiation and then thermally processed to improve their oxidation resistance. Over the last several years, manufacturers have disseminated antioxidants such as vitamin E into UHMWPE implants. The vitamin E is intended to neutralize the free radicals that are introduced during the irradiation process, which improves the oxidation resistance of the UHMWPE without the need for additional thermal treatment. Using UHMWPE highly cross-linked and vitamin-E variants, however, can make it more difficult for contract manufacturers to maintain tight tolerances and improve surface finishes.
“Orthoplastics is combining different irradiation dose rates with vitamin E variants with variations in annealing in order to provide solutions mainly for acetabular liners and tibial inserts,” said Anderton. “The variations in the cross-linking and annealing cycles have required many characterization studies to maintain customer tolerance requirements during machining, especially for tolerance bands and surface finish requirements.”
The biggest challenges for new/advanced materials remains regulatory approval, which is often a lengthy and uncertain process. This is a challenge for both OEMs and their customers, especially when active materials are involved—for example, antimicrobial materials, biodegradable materials, etc. As a result, “medical device companies prefer to use existing biomaterials with proven clinical history, and focus more on design to mimic the biomechanics of the spine, knee, and other joints,” indicated Chawla.
Into the Future
The first thing OEMs look for in a supply-chain partner is product quality. Not only must the component meet the print, there must also be equipment and process validation, ironclad traceability, and 100-percent accurate paperwork.
Medical device OEMs also want fewer supply chain partners who can do more. OEMs continue to demand more internal services and controls from their vendors, including fully documented validations of equipment and processes.
“The ultimate goal,” said Conner, “is to reduce the cost of maintaining a large vendor base and maximize utilization of key performing suppliers. Vendors must be able to provide a wide range of in-house capabilities to ensure that delivery schedules are consistently met. This allows the vendor to control all associated manufacturing costs, as well as shorten our lead times.”
Technical expertise is, of course, required. Contract manufacturers must be thoroughly familiar with the latest manufacturing processes and inspection equipment, and know how to use it. This is critical because, with the deep cutbacks in many OEM design departments, contract manufacturers are expected to step into the roles of designer and engineer, and share their material and production expertise. They can therefore bridge the skills gap, assist the overall development team, and provide validated manufacturing and full documentation procedures to ensure a smooth approval process.
Overall, implant manufacturing is a relatively conservative market that is controlled by a large number of powerful stakeholders. These stakeholders, such as patients and surgeons, define the product needs, while payers and regulators set boundary conditions. “Breakthrough” advances are rare because change typically comes incrementally in this market, as determined by stakeholder needs. Contract manufacturers, therefore, also often assume the role of educator when it comes to introducing and developing new technologies and materials—such as additive manufacturing, which can be used for prototypes, actual implants, and customized implants, as well as be viable for larger implants.
Anti-infection around implants is a hot research topic. For example, hydroxyapatite films coated with ionic silver are being developed to prevent implant-associated infections. At Stevens Institute of Technology in New Jersey, a research team led by Dr. Matthew Libera has developed a new anti-infection technology that repels bacteria and promotes the growth of bone cells around an implant. In addition to the repellent and adhesive properties of the surface, the technology also releases antimicrobial compounds to fight bacteria. So, instead of the patient taking antibiotics systemically by mouth, the medicine is localized at the surfaces of the implant, which can also release growth factors to promote better implant-bone interaction.
Bacterial infections at implant sites can be thousands of times more resistant to antibiotics. “Usually the only way to resolve a biomaterials-associated infection is to remove the device, treat the infected tissue, and later implant a second device,” said Libera. “Not only does this bring really significant cost to the healthcare system, it forces the patient to undergo a lengthy and challenging surgical and rehabilitation process over a long period of time. We hope to eliminate that risk.”
A team of Massachusetts Institute of Technology (MIT) researchers has come up with still another way to reduce immune-system rejection of implants. In a recent issue of Nature Materials, they report that the geometry of implantable devices has a significant impact on how well the body tolerates them. The researchers originally thought that it might be easier for smaller devices to evade the immune system; they discovered, however, that larger, spherical devices actually do a better job of maintaining their function and minimizing the development of scar tissue.
“We were surprised by how much the size and shape of an implant can affect its triggering an immune response,” said Daniel Anderson, an associate professor of chemical engineering at MIT and senior author of the article. “What it’s made of is still an important piece of the puzzle, but it turns out if you really want to have the least amount of scar tissue, you need to pick the right size and shape.”
As devices and implants become smaller and more complex, it is increasingly important to conduct design for manufacturability and finite element analysis studies, not only to ensure the safety of the design, but also to maximize the prototyping stage by identifying ways to maintain design specifications and still reduce cost and accelerate production. Being able to model and simulate mechanical behavior is essential for minimizing the number of design iterations and speeding up delivery to market.
Allen is optimistic about the future, including the increased competitiveness of the U.S. as a place to manufacture orthopedic products. The advantages of domestic manufacturing are clear—shorter lead times, lower regulatory and intellectual property risk, faster time to market, and less inventory all improve quality and reduce cost. In addition, technological advances, as well as the addition of robotics for assembly and inspection, have further reduced costs and raised productivity, whittling away at the labor advantages that low-cost countries enjoy. However, these are also rapidly diminishing.
“The labor cost playing field is leveling out, as wage inflation of over 15 percent a year raises the cost of operating in China, India, and Southeast Asia,” said Allen. “Closer to home, Puerto Rico is facing a debt crisis that could impact the 70 medical device companies operating there as their government seeks new sources of revenue. I think that for an increasing number of OEMs, when they consider the total cost of operating offshore, including the communication and travel burden on support staff, manufacturing in the U.S. is looking better and better.”
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. Contact him at mark.crawford@charter.net.
Some of these ideas come from other industries—for example, some medical device manufacturers (MDMs) are using the product part approval process, a quality-control method that has already been proven in the automotive and aerospace industries. MDMs are also paying more attention to test method development, process characterization, and gage repeatability and reproducibility—and generally the earlier, the better. Doing this during the design stage means fewer mistakes, iterations, restarts, and other changes further down the line. This, of course, saves manufacturing time and speeds up delivery into the market, which is one way of offsetting the higher costs of manufacturing more complex devices, and meeting more stringent OEM demands.
The rapid growth of minimally invasive procedures, as well as new product innovations that support combination products and biologic applications, “often make it challenging to manufacture products that are less invasive and safer, yet still affordable,” commented D. Lindsay Conner, president of Tracer Orthopedics, an Oakland, N.J.-based manufacturer of orthopedic implants and instrumentation.
One way to gain access to needed technological prowess and also shorten the supply chain is through consolidation. The mergers and acquisitions within the implant manufacturing market have resulted in larger device companies gaining increased leverage in price negotiations, which has cascaded both up and down the value stream, resulting in both increased insourcing and outsourcing.
“The insourcing has been seen via vertical integration in strategic areas by our partners through acquisitions,” said Carola Hansen, director of biomedical polyethylenes for DSM Biomedical, an Exton, Pa.-based medical device materials developer and manufacturer. “The outsourcing has created an opportunity for implant manufacturers to forge stronger strategic alliances with their partners to assist in optimizing operational costs—for example, logistics, inventory levels, etc. There are also smaller start-up companies leading innovation, but they are finding it increasingly difficult to maintain funding due to long regulatory approval cycles.”
Keeping Costs Down
Cost is a constant factor in any major implant design or manufacturing decision—especially for more complex designs, new materials, or more challenging processes.
“Medical device OEMs are under tremendous pressure to minimize inventories and reduce pricing due to the outcomes-based healthcare model mandated by the Affordable Care Act,” stated Terry Webster, sales manager for Medical Devices & Implants LLC, a Lancaster, Pa.-based contract manufacturer specializing in spinal and extremity implants. “These expectations are then passed on to the contract manufacturer in the same respect.” Conner agreed.
“Our customers are implementing ‘just-in-time’ principles to minimize their financial responsibility for holding inventory,” he said. “Smaller controlled orders are becoming the norm to minimize inventories and maximize cash flow. Therefore, shortened lead times and flexibility are keys for a successful relationship.”
Many MDMs are laser focused on data analytics, looking for new ways to improve functionality and performance, and reduce cost.
“Our OEM partners are crunching the numbers on patient outcomes and efficacy of new technologies to drive acceptance with healthcare systems,” said Philip Allen, director of sales and marketing for Lowell Inc., a Minneapolis, Minn.-based contract manufacturer of complex implants for the orthopedic and cardiovascular markets. “As a result, data is driving our world, too.
For example, we can perform critical feature analysis using Minitab statistical software and demonstrate that we have a competency with a machined feature down to a specific Cpk. This enables us to measure three critical features instead of the original 10, saving a great deal of inspection time, and shortening lead times and time to market.”
Selecting the Right Process
OEMs make no secret about what they want—more precision, tighter tolerances, improved finishes, and shorter cycle times—all at a lower cost. The intriguing capabilities of 3D printing are forcing medical device companies to take a closer look at this rapidly evolving technology. This, however, often takes them out of their comfort zone, which is traditional machining.
For orthopedic implant manufacturers, the biggest advantage of 3D printing is prototyping—being able to get a functional prototype into the hands of the design team in a matter of hours, instead of days or weeks, in high-demand materials such as metal and polyether ether ketone (PEEK). A few orthopedic companies have already used 3D printing to build implants that have received 510(k) approval from the U.S. Food and Drug Administration (FDA).
“Additive manufacturing (AM) is a good choice for implants with low surface-to-volume ratios and implants that have complex geometries [that] are difficult to achieve with traditional forging, casting, and machining techniques,” Parimal Bapat, a research engineer with Orchid Orthopedics Solutions, a Holt, Mich.-based provider of medical device outsourcing services, said in a blog on the company’s website. “In addition, since a variety of materials such as titanium and stainless steel can be used in the AM process, functional prototypes can be made out of the same material as production components. This enables more rigorous testing of prototypes while decreasing the development time for new products.”
In some cases, 3D printing is being used to build complete orthopedic implants in a single process. The method is ideal for low runs, and especially beneficial for one-run, customized, patient-specific products.
“The benefits of customizable implants for trauma and craniomaxillofacial needs have been acknowledged,” said Chander Chawla, director of biomedical polyurethanes for DSM Biomedical. “For example, FDA 510(k)-cleared 3D-printed devices include Oxford Performance Materials’ OsteoFab patient-specific polymeric facial implants for its cranial prostheses line and Medshape’s FDA-approved, 3D printed device to correct bunions.”
Three-dimensional printing also saves time and money by eliminating secondary steps, reducing material waste, and speeding time to market. “Not only does AM save considerable time and money compared to standard machining, it also gives design engineers greater freedom for designing innovative parts with unique or challenging geometries,” added Bapat. For example, researchers at the University of Sydney in Australia have utilized 3D printing to design and fabricate scaffolds with a mechanical strength comparable to cortical bone, which offers huge potential for repairing large bone defects.
Despite the incredible potential that additive manufacturing and 3D printing hold, there is definitely comfort in using already acquired, tried-and-true, traditional equipment—for example, computer numerical control (CNC) machines. “There have been no huge steps in CNC technology for machining components—just steady improvements in tooling and machine software capabilities,” said Neil Anderton, technical manager for Orthoplastics, a Bacup, U.K.-based processor of orthopedic-grade ultra-high-molecular-weight polyethylene (UHMWPE) in sheets and rods.
CNC machines can be combined with other equipment, such as lasers for cutting, welding, or etching. Five-axis machining centers can use data from medical scanning of patients to create a range of patient-specific implantable components, especially for skeletal requirements, such as bone, jaw, or skull. These types of projects are a good fit for sophisticated 5-axis machines.
To meet challenging OEM requests for custom/patient specific components, Orthoplastics has created its New Product Introduction Group, which brings the best science and control technology to bear on the development of patient-specific products, from design through production and documentation. Patient measurements are used to create a 3D model of the component required. Tolerance for the UHMW material is typically ±0.1mm, but can be as low as ±0.05mm, depending on the type of component.
“In addition to custom devices, there are also unique composite device constructions that pose particular challenges with respect to component fixation and the required production
controls to achieve the high tolerances,” added Anderton. “We have invested in innovative fixation and top specification-controlled environments in the necessary production areas to achieve these customer requirements.”
Although many industry experts have predicted that additive manufacturing will be the death of traditional machining, Allen isn’t convinced.
“We actually think the opposite may be true,” he said. “For example, we’ve developed an advanced process with a leading implant manufacturer to take a near net shape additive manufactured component with tolerances of ±0.01 inches and machine the final tolerances of ±0.001 inches they need for the device. This involves very sophisticated work holdings and machine probing, along with conventional multi-axis machining, to achieve the final design intent. We see this being an increasing part of our business.”
Advanced Materials
Material selection is both a science and an art—especially for those engineered materials with unique characteristics that require more control during production, or a more sophisticated process. High-performance plastics can provide the same level of strength, rigidity, and heat resistance as metals. PEEK, for example, a common material in the aerospace industry, is being used more in medical devices because of its strength, light weight, chemical inertness, and easy colorability—a big plus for making devices that can be color-coded for easy identification in the operating room.
Because PEEK provides an alternative load-bearing material to metal for joint implants, with a modulus similar to human bone, it is often the material of choice for spine, hip, knee, and shoulder implants. PEEK implants can also be coated with hydroxyapatite or titanium to improve bone upgrowth or osseointegration.
The downside to PEEK is that it is expensive. So, in every effort to control costs, manufacturers that use PEEK want to waste as little of it as possible.
“Our customers that use PEEK in their orthopedic implants are increasingly interested in getting the maximum yield for this expensive polymer,” said Webster. “To do this, we have designed proprietary tooling for milling applications that significantly reduces waste.”
UHMWPE is a popular biomaterial for implants that has been around for decades. The newest variations of UHMWPE are highly cross-linked with gamma or electron beam radiation and then thermally processed to improve their oxidation resistance. Over the last several years, manufacturers have disseminated antioxidants such as vitamin E into UHMWPE implants. The vitamin E is intended to neutralize the free radicals that are introduced during the irradiation process, which improves the oxidation resistance of the UHMWPE without the need for additional thermal treatment. Using UHMWPE highly cross-linked and vitamin-E variants, however, can make it more difficult for contract manufacturers to maintain tight tolerances and improve surface finishes.
“Orthoplastics is combining different irradiation dose rates with vitamin E variants with variations in annealing in order to provide solutions mainly for acetabular liners and tibial inserts,” said Anderton. “The variations in the cross-linking and annealing cycles have required many characterization studies to maintain customer tolerance requirements during machining, especially for tolerance bands and surface finish requirements.”
The biggest challenges for new/advanced materials remains regulatory approval, which is often a lengthy and uncertain process. This is a challenge for both OEMs and their customers, especially when active materials are involved—for example, antimicrobial materials, biodegradable materials, etc. As a result, “medical device companies prefer to use existing biomaterials with proven clinical history, and focus more on design to mimic the biomechanics of the spine, knee, and other joints,” indicated Chawla.
Into the Future
The first thing OEMs look for in a supply-chain partner is product quality. Not only must the component meet the print, there must also be equipment and process validation, ironclad traceability, and 100-percent accurate paperwork.
Medical device OEMs also want fewer supply chain partners who can do more. OEMs continue to demand more internal services and controls from their vendors, including fully documented validations of equipment and processes.
“The ultimate goal,” said Conner, “is to reduce the cost of maintaining a large vendor base and maximize utilization of key performing suppliers. Vendors must be able to provide a wide range of in-house capabilities to ensure that delivery schedules are consistently met. This allows the vendor to control all associated manufacturing costs, as well as shorten our lead times.”
Technical expertise is, of course, required. Contract manufacturers must be thoroughly familiar with the latest manufacturing processes and inspection equipment, and know how to use it. This is critical because, with the deep cutbacks in many OEM design departments, contract manufacturers are expected to step into the roles of designer and engineer, and share their material and production expertise. They can therefore bridge the skills gap, assist the overall development team, and provide validated manufacturing and full documentation procedures to ensure a smooth approval process.
Overall, implant manufacturing is a relatively conservative market that is controlled by a large number of powerful stakeholders. These stakeholders, such as patients and surgeons, define the product needs, while payers and regulators set boundary conditions. “Breakthrough” advances are rare because change typically comes incrementally in this market, as determined by stakeholder needs. Contract manufacturers, therefore, also often assume the role of educator when it comes to introducing and developing new technologies and materials—such as additive manufacturing, which can be used for prototypes, actual implants, and customized implants, as well as be viable for larger implants.
Anti-infection around implants is a hot research topic. For example, hydroxyapatite films coated with ionic silver are being developed to prevent implant-associated infections. At Stevens Institute of Technology in New Jersey, a research team led by Dr. Matthew Libera has developed a new anti-infection technology that repels bacteria and promotes the growth of bone cells around an implant. In addition to the repellent and adhesive properties of the surface, the technology also releases antimicrobial compounds to fight bacteria. So, instead of the patient taking antibiotics systemically by mouth, the medicine is localized at the surfaces of the implant, which can also release growth factors to promote better implant-bone interaction.
Bacterial infections at implant sites can be thousands of times more resistant to antibiotics. “Usually the only way to resolve a biomaterials-associated infection is to remove the device, treat the infected tissue, and later implant a second device,” said Libera. “Not only does this bring really significant cost to the healthcare system, it forces the patient to undergo a lengthy and challenging surgical and rehabilitation process over a long period of time. We hope to eliminate that risk.”
A team of Massachusetts Institute of Technology (MIT) researchers has come up with still another way to reduce immune-system rejection of implants. In a recent issue of Nature Materials, they report that the geometry of implantable devices has a significant impact on how well the body tolerates them. The researchers originally thought that it might be easier for smaller devices to evade the immune system; they discovered, however, that larger, spherical devices actually do a better job of maintaining their function and minimizing the development of scar tissue.
“We were surprised by how much the size and shape of an implant can affect its triggering an immune response,” said Daniel Anderson, an associate professor of chemical engineering at MIT and senior author of the article. “What it’s made of is still an important piece of the puzzle, but it turns out if you really want to have the least amount of scar tissue, you need to pick the right size and shape.”
As devices and implants become smaller and more complex, it is increasingly important to conduct design for manufacturability and finite element analysis studies, not only to ensure the safety of the design, but also to maximize the prototyping stage by identifying ways to maintain design specifications and still reduce cost and accelerate production. Being able to model and simulate mechanical behavior is essential for minimizing the number of design iterations and speeding up delivery to market.
Allen is optimistic about the future, including the increased competitiveness of the U.S. as a place to manufacture orthopedic products. The advantages of domestic manufacturing are clear—shorter lead times, lower regulatory and intellectual property risk, faster time to market, and less inventory all improve quality and reduce cost. In addition, technological advances, as well as the addition of robotics for assembly and inspection, have further reduced costs and raised productivity, whittling away at the labor advantages that low-cost countries enjoy. However, these are also rapidly diminishing.
“The labor cost playing field is leveling out, as wage inflation of over 15 percent a year raises the cost of operating in China, India, and Southeast Asia,” said Allen. “Closer to home, Puerto Rico is facing a debt crisis that could impact the 70 medical device companies operating there as their government seeks new sources of revenue. I think that for an increasing number of OEMs, when they consider the total cost of operating offshore, including the communication and travel burden on support staff, manufacturing in the U.S. is looking better and better.”
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. Contact him at mark.crawford@charter.net.