Mark Crawford, Contributing Writer09.15.15
New designs for orthopedic devices continue to push the boundaries of manufacturing and materials science. Even as devices get more complex and harder to manufacture, OEMs are intently focused on reducing total product costs and shortening lead times for shipment. To address these expectations, contract manufacturers and supply chain partners must meet these challenges head on with creativity and innovation.
Product complexity, miniaturization and advanced materials all challenge the limits of machining and tooling. Equipment manufacturers are releasing new versions of 5-axis machining that increase functionality and produce devices directly from scans or models. Swiss machines also are being equipped with high-pressure coolant, making it easier to machine harder engineered materials such as high-temperature alloys, stainless steels, glass-filled plastics and other challenging materials such as polyether ether ketone (PEEK) and ultra-high molecular weight polyethylene (UHMWPE). Rapid prototyping also is of keen interest for making patient-specific components and production-equivalent instruments.
The use of 3-D laser sintering is gaining increased acceptance in the medical marketplace as an additive manufacturing process. The wide variety of powered metal compounds, combined with U.S. Food and Drug Administration (FDA) approval of the additive process, make 3-D laser sintering an increasingly viable manufacturing method for OEM customers.
“As a machining contract manufacturer, we add value by being able to create secondary finishes or precision-made part geometries in order for the laser-sintered device to be used in assembly,” said Jack Neenan, vice president of sales and business development for Phillips Precision Medicraft, an Elmwood Park, N.J.-based manufacturer of orthopedic implants, instrumentation and delivery systems.
Modern tool grinding technology also is advancing, resulting in the development of complex profile tooling that enables faster machining. New models offer improved metal removal rates, better use of high-speed tool paths and more mill/turn capabilities. Many tooling suppliers are using leading-edge technology to provide tooling and grinding techniques that provide exceptional edge preparation, especially for the bearing surfaces of implantable components.
OEMs want consistency, reliability and faster deliveries from their supply chain partners. Proactive machining and tooling companies are investing in the technology, manpower and training they need to meet these demands.
Recently, France-based In’Tech Medical, a designer and manufacturer of surgical instruments for the orthopedic industry, acquired Athens, Ala.-based Turner Medical Inc. to increase its global contract manufacturing capacity. Turner Medical then purchased more advanced equipment, hired more employees and added a third shift to keep up with customer demands.
“We are also cross-training employees to allow us to be more fluid in times of need,” said David Brackeen, vice president of operations for Turner Medical.
Enhanced Capabilities
Improving machining technology and automation is an ongoing process, as is evidenced by the steady stream of announcements from equipment manufacturers about new machines that extend tool life, reduce costs and improve the manufacturing process. These enhanced machines/tooling capabilities have enabled contract manufacturers to offer the latest machine tool innovations, expanding their range of services for various design and production stages, from concept evaluation through full-scale production.
“Many machine tool manufacturers are now providing full 5-axis CNC (computer numerical control) machines specifically aimed at the orthopedic component manufacturing and the requirements these components pose for their production,” said Mark Allen, managing director for Orthoplastics in Lancashire, England, a global processor of implantable grade UHMWPE and polymers in semi-finished and finished forms. “Providing large tool capacity while maintaining a small footprint is key, as well as providing component probing, particularly with the complex geometry of bearing surfaces taken from scans.”
Turner Medical continues to invest in its machine line to provide clients with the latest manufacturing and engineering solutions. This includes new Mazak CNC multi-axis machining centers to streamline the turning and milling process. Robot feeders will be used to simultaneously feed two CNC 5-axis milling centers.
“This allows us to improve efficiency and eliminate down time,” noted Brackeen. “We actually gain time because the machines can run unattended during off hours.”
There is growing demand for special tooling that can produce double- and triple-lead bone screws. These types of bone screw designs are preferred by surgeons because they reduce the time patients spend in the operating room.
NTK Cutting Tools, headquartered in Nagoya, Japan, with an office in Wixom, Mich., offers a dedicated line of tooling for Swiss-type lathes. These systems have an innovative and precise insert design, based on customer specifications. Each insert has a sharp cutting edge that provides better surface finishes and longer tool life. Multi-lead threads are produced in a single pass—providing faster cycle times with increased productivity. The company also manufactures a series of coolant-through tool-holders that “keep the cutting edges cool, sharp and free from chip packing,” said Steve Easterday, an NTK Swiss product specialist. “These features improve part tolerances and lead to longer tool life. We also provide quick-change coolant line components, which reduce machine down time and increase overall efficiency.”
Orthoplastics uses direct compression molding (DCM) to process ultra-high molecular weight polyethylene, which is a popular material for the bearing surfaces of most joint replacements. UHMWPE actually represents a range of materials with differing physical properties and performance attributes. For example, because of its extreme molecular weight, when UHMWPE is heated above its crystalline melting point, instead of transforming to a liquid phase it becomes a translucent amorphous rubbery material. Because of these challenging properties, UHMWPE is best processed using DCM, where near net shape components with a mold-finished articulating surface can be produced from a small compression press. DCM also is very effective for manufacturing a composite monoblock structure.
The use of highly cross-linked and vitamin E variants of UHMWPE also has created processing challenges, especially maintaining customer requirements in tolerances/surface finish.
“The advancements in materials and the wide range of variants for these material—for example, dose rates in cross-linked and varying annealing cycles—mean there is a constant challenge to characterize the material in relation to the component and its dimensional requirements,” said Allen.
Oberg Medical, a Freeport, Pa.-based manufacturer of precision components and tooling for the medical industry, offers a proprietary process known as molecular decomposition processing (MDP). This advanced grinding technology provides highly efficient removal or cutting of any conductive material using an electrochemical action with an abrasive assist. MDP can easily achieve precision tolerances held to ±0.0005 inches, creating highly polished weight-bearing and articulating surfaces that are free of micro cracks and fissures. It also works well on dissimilar material combinations.
During MDP, an electric current flows between the negatively charged abrasive wheel and the positively charged work piece through an electrolyte (saline) solution. A decomposing action occurs causing the material surface to oxidize. This oxidized surface then is removed by the specially formulated abrasives in the wheel, exposing more material and repeating the cycle. The process is suitable for many applications that require a burr-free, heat-free surface at sub-micron tolerances, according to the company.
“MDP is able to cut any conductive material 80 percent faster than conventional methods and is especially effective on super-alloys and exotic metals such as nitinol,” said Jim Hoffman, director of manufacturing for milling for Oberg Medical. “It is also gentle enough to grind thin-walled components without damage or distortion and works well with tubing, rapid cut-off needs or precision grinding of complex features. The electrolyte is a simple salt compound that easily mixes with tap water. When used with our filtration methods, electrolyte life is extended with the omission of hexavalent chrome.”
Minimally invasive procedures, with smaller and more complex devices and products, are growing in popularity. That means manufacturers must provide even more intricate assemblies with tight geometries that require snug assemblies with implants or instruments. To achieve this, In’Tech Medical and Turner Medical have invested in what they call “The Prototype Garage.”
This standalone rapid prototyping cell has the ability to combine the rapid manufacturing of prototypes with proven expertise in verification and validation processes, thereby speeding up the regulatory approval process for new technologies with production-equivalent prototypes. State-of-the-art equipment includes CNC 5-axis turning and milling centers and wire and RAM electrical discharge machining (EDM).
“The idea was to isolate the prototype cell from our standard production tool so as not to affect our day-to-day larger-scale manufacturing,” said Brackeen. “The Prototype Garage is still embedded within a larger quality-focused environment to ensure our ability to provide our customers with full-traceability on prototypes that are often developed with the intent of use in surgery.”
Regulatory Expectations
An evolving regulatory climate continues to challenge orthopedic device manufacturers.
Machining and tooling suppliers that want to keep their OEM customers must put procedures and robust training in place to reduce risk for product non-conformance—in fact, OEMs often count on their key suppliers to know the answers to their regulatory questions.
“These non-conformances are more than just dimensional issues,” said Hoffman. “Suppliers need to ensure that raw materials meet specifications, cutting fluids can be cleaned from parts, machine tools are able to produce repeatable results and certification documents are correct. The paperwork is just as important as the parts and must have the same scrutiny of the product dimensions before they ship to the customer.”
To meet the FDA’s increasingly stringent expectations, Turner Medical captures, validates and continuously monitors its equipment and specialized processes (cleaning, welding, epoxy paint, etc.) through its validation master plan. “From an inspection standpoint, we are regularly investing in new vision systems for inspection on the floor and in the lab,” said Brackeen. “These systems fit well with the growing and ever-changing dimensioning schemes we are seeing in our customers’ designs. Our vision equipment is also becoming more programmable and user-friendly, which allows more efficient in-process measurements.”
Not only are increasingly complex devices more expensive to manufacture, they also can be more difficult for FDA reviewers to understand. More complexity also can mean an increased probability for variability—which can make validation and verification more challenging. In general, the fewer steps a manufacturing process has, the better. This is where applying lean manufacturing principles can simplify the process, improve quality, increase efficiency and throughput and make verification and validation easier.
“Phillips Precision Medicraft implements and executes lean principles on a daily basis,” said Neenan. “Using lean techniques to eliminate wasteful steps in manufacturing adds value to our OEM partners by reducing overall manufacturing cycle times, which equates to lower-cost products.”
Savings related to the implementation of lean manufacturing principles are highly product-dependent. What drives savings is the ability to reduce steps and consolidate machining operations. A good example is taking a product that may have been processed in the past by milling, turning and wire EDM and moving it to a mill/turn-machining platform.
“In this kind of situation,” said Neenan, “we would have the opportunity through programming, tooling and fixtures to load a material blank into a single machine and unload a finished product, compared to multiple machining platforms, programs, set-ups, fixtures and tooling strategies. The fewer times you have to re-fixture something in the manufacturing process, the more accurate, repeatable and efficient your process will be.”
Future Challenges
OEM requests for custom-designed, patient-specific components continue to push the technical boundaries of machining/tooling.
“In addition to the custom device, unique composite device constructions pose particular challenges with respect to component fixation and production controls to achieve the high tolerances required,” said Allen. “Success requires in-depth planning prior to actual manufacturing with the aim of 100 percent right the first time—not just for the product, but the documented best practices as well.”
OEMs are very uncertain regarding the use of new technology on legacy products. A process change can often trigger the need for a new validation and a complete round of new testing for the product. An example of this would be a situation where a device may have been processed on a lathe and then sent to a mill for secondary operations. To take advantage of current technology, the same part could be completed in one operation on a mill turn. Using a mill turn to finish a part could eliminate as many as five or six operations from previous processes—but also could prompt the FDA to call for more testing and validation.
“There is a common misconception that a process change like this could have some radical change on the parts properties, when in actuality the forces are the same and the only change is the product can be manufactured more efficiently,” said Neenan.
Additive manufacturing (AM) is a disruptive technology that is rapidly transforming medical manufacturing. AM processes such as laser sintering and 3-D printing are providing design engineers with new ways to design and create more innovative products—in plastic or metal. AM methods can save OEMs up to 25 percent in development costs. They also can save weeks worth of manufacturing time, producing components in a matter of hours, helping companies launch products more quickly.
“We want to embrace innovations that will help us find solutions to today’s difficult engineering challenges, maximize capacity and ensure top quality,” said Brackeen. “We have found that 3-D printers and the latest computer-aided manufacturing software precisely serve that purpose. The use of 3-D printing allows simple fixtures, such as laser etch and inspection, to be produced much faster and require far less resources to produce.”
In some cases, production-ready parts can be manufactured with 3-D printing, which is ideal for low-volume runs or products that are customized for individual patients.
“Additive manufacturing is especially useful in the expanding field of personalized medicine,” said Justin Conway, a product development engineer with Orchid Orthopedic Solutions in Memphis, Tenn. “A good example is customized, one-of-a-kind, patient-specific implants that are very time-consuming and expensive to make using traditional machining methods, but that can be manufactured quickly and at less cost with additive manufacturing.”
Partner Up
The best customer relationships are built around mutual respect, trust and collaboration—the essence of a true partnership.
“When we are able to work towards a common goal, whether it is a new spinal implant with a cutting-edge material or a complex surgical instrument, then we have the best chance for success when we are communicating and listening to each other throughout the project,” said Frank D. Noone, vice president of advanced surgical sales for Five Star Companies, a New Bedford, Mass.-based contract manufacturer of orthopedic implants and instrumentation.
As the OEM-contract manufacturer relationship gains trust, OEMs increasingly will ask for help with cost-effective manufacturing, design for manufacturability, engineering and quality input. “Our value add as a manufacturing partner is practical machining knowledge and the ability to analyze designs and offer refinement suggestions in areas of manufacturing, quality and function,” said Neenan. “Partnering with a knowledgeable supplier can circumvent hidden problems that are only discovered as they are manufactured. This is expensive for both the supplier and OEM and significantly slows the time to market for such designs.”
Working with trusted, full-service partners shortens the supply chain for OEMs because these partners are vertically integrated and do more in-house and communicate effectively. Suppliers become masters of risk mitigation for OEMs by building quality into the process with the ability to scale up or down quickly. Oberg Medical, for example, offers design for manufacturability; a low-cost country location; installation qualification, operational qualification and performance qualification validation protocols; ISO certifications; project and supply chain management; manufacturing; and quality engineering.
“OEMs are looking for the one-stop-shop that can handle everything from start to finish,” said Hoffman. “Suppliers no longer get ‘extra credit’ for having excellent quality, on-time delivery or competitive on cost—these are expected in today’s business climate. The process has become much more than just manufacturing a part to print. OEMs are looking for partnerships that can grow with their ever-changing business needs, which means the supplier must become a trusted extension of the OEM’s business.”
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
Product complexity, miniaturization and advanced materials all challenge the limits of machining and tooling. Equipment manufacturers are releasing new versions of 5-axis machining that increase functionality and produce devices directly from scans or models. Swiss machines also are being equipped with high-pressure coolant, making it easier to machine harder engineered materials such as high-temperature alloys, stainless steels, glass-filled plastics and other challenging materials such as polyether ether ketone (PEEK) and ultra-high molecular weight polyethylene (UHMWPE). Rapid prototyping also is of keen interest for making patient-specific components and production-equivalent instruments.
The use of 3-D laser sintering is gaining increased acceptance in the medical marketplace as an additive manufacturing process. The wide variety of powered metal compounds, combined with U.S. Food and Drug Administration (FDA) approval of the additive process, make 3-D laser sintering an increasingly viable manufacturing method for OEM customers.
“As a machining contract manufacturer, we add value by being able to create secondary finishes or precision-made part geometries in order for the laser-sintered device to be used in assembly,” said Jack Neenan, vice president of sales and business development for Phillips Precision Medicraft, an Elmwood Park, N.J.-based manufacturer of orthopedic implants, instrumentation and delivery systems.
Modern tool grinding technology also is advancing, resulting in the development of complex profile tooling that enables faster machining. New models offer improved metal removal rates, better use of high-speed tool paths and more mill/turn capabilities. Many tooling suppliers are using leading-edge technology to provide tooling and grinding techniques that provide exceptional edge preparation, especially for the bearing surfaces of implantable components.
OEMs want consistency, reliability and faster deliveries from their supply chain partners. Proactive machining and tooling companies are investing in the technology, manpower and training they need to meet these demands.
Recently, France-based In’Tech Medical, a designer and manufacturer of surgical instruments for the orthopedic industry, acquired Athens, Ala.-based Turner Medical Inc. to increase its global contract manufacturing capacity. Turner Medical then purchased more advanced equipment, hired more employees and added a third shift to keep up with customer demands.
“We are also cross-training employees to allow us to be more fluid in times of need,” said David Brackeen, vice president of operations for Turner Medical.
Enhanced Capabilities
Improving machining technology and automation is an ongoing process, as is evidenced by the steady stream of announcements from equipment manufacturers about new machines that extend tool life, reduce costs and improve the manufacturing process. These enhanced machines/tooling capabilities have enabled contract manufacturers to offer the latest machine tool innovations, expanding their range of services for various design and production stages, from concept evaluation through full-scale production.
“Many machine tool manufacturers are now providing full 5-axis CNC (computer numerical control) machines specifically aimed at the orthopedic component manufacturing and the requirements these components pose for their production,” said Mark Allen, managing director for Orthoplastics in Lancashire, England, a global processor of implantable grade UHMWPE and polymers in semi-finished and finished forms. “Providing large tool capacity while maintaining a small footprint is key, as well as providing component probing, particularly with the complex geometry of bearing surfaces taken from scans.”
Turner Medical continues to invest in its machine line to provide clients with the latest manufacturing and engineering solutions. This includes new Mazak CNC multi-axis machining centers to streamline the turning and milling process. Robot feeders will be used to simultaneously feed two CNC 5-axis milling centers.
“This allows us to improve efficiency and eliminate down time,” noted Brackeen. “We actually gain time because the machines can run unattended during off hours.”
There is growing demand for special tooling that can produce double- and triple-lead bone screws. These types of bone screw designs are preferred by surgeons because they reduce the time patients spend in the operating room.
NTK Cutting Tools, headquartered in Nagoya, Japan, with an office in Wixom, Mich., offers a dedicated line of tooling for Swiss-type lathes. These systems have an innovative and precise insert design, based on customer specifications. Each insert has a sharp cutting edge that provides better surface finishes and longer tool life. Multi-lead threads are produced in a single pass—providing faster cycle times with increased productivity. The company also manufactures a series of coolant-through tool-holders that “keep the cutting edges cool, sharp and free from chip packing,” said Steve Easterday, an NTK Swiss product specialist. “These features improve part tolerances and lead to longer tool life. We also provide quick-change coolant line components, which reduce machine down time and increase overall efficiency.”
Orthoplastics uses direct compression molding (DCM) to process ultra-high molecular weight polyethylene, which is a popular material for the bearing surfaces of most joint replacements. UHMWPE actually represents a range of materials with differing physical properties and performance attributes. For example, because of its extreme molecular weight, when UHMWPE is heated above its crystalline melting point, instead of transforming to a liquid phase it becomes a translucent amorphous rubbery material. Because of these challenging properties, UHMWPE is best processed using DCM, where near net shape components with a mold-finished articulating surface can be produced from a small compression press. DCM also is very effective for manufacturing a composite monoblock structure.
The use of highly cross-linked and vitamin E variants of UHMWPE also has created processing challenges, especially maintaining customer requirements in tolerances/surface finish.
“The advancements in materials and the wide range of variants for these material—for example, dose rates in cross-linked and varying annealing cycles—mean there is a constant challenge to characterize the material in relation to the component and its dimensional requirements,” said Allen.
Oberg Medical, a Freeport, Pa.-based manufacturer of precision components and tooling for the medical industry, offers a proprietary process known as molecular decomposition processing (MDP). This advanced grinding technology provides highly efficient removal or cutting of any conductive material using an electrochemical action with an abrasive assist. MDP can easily achieve precision tolerances held to ±0.0005 inches, creating highly polished weight-bearing and articulating surfaces that are free of micro cracks and fissures. It also works well on dissimilar material combinations.
During MDP, an electric current flows between the negatively charged abrasive wheel and the positively charged work piece through an electrolyte (saline) solution. A decomposing action occurs causing the material surface to oxidize. This oxidized surface then is removed by the specially formulated abrasives in the wheel, exposing more material and repeating the cycle. The process is suitable for many applications that require a burr-free, heat-free surface at sub-micron tolerances, according to the company.
“MDP is able to cut any conductive material 80 percent faster than conventional methods and is especially effective on super-alloys and exotic metals such as nitinol,” said Jim Hoffman, director of manufacturing for milling for Oberg Medical. “It is also gentle enough to grind thin-walled components without damage or distortion and works well with tubing, rapid cut-off needs or precision grinding of complex features. The electrolyte is a simple salt compound that easily mixes with tap water. When used with our filtration methods, electrolyte life is extended with the omission of hexavalent chrome.”
Minimally invasive procedures, with smaller and more complex devices and products, are growing in popularity. That means manufacturers must provide even more intricate assemblies with tight geometries that require snug assemblies with implants or instruments. To achieve this, In’Tech Medical and Turner Medical have invested in what they call “The Prototype Garage.”
This standalone rapid prototyping cell has the ability to combine the rapid manufacturing of prototypes with proven expertise in verification and validation processes, thereby speeding up the regulatory approval process for new technologies with production-equivalent prototypes. State-of-the-art equipment includes CNC 5-axis turning and milling centers and wire and RAM electrical discharge machining (EDM).
“The idea was to isolate the prototype cell from our standard production tool so as not to affect our day-to-day larger-scale manufacturing,” said Brackeen. “The Prototype Garage is still embedded within a larger quality-focused environment to ensure our ability to provide our customers with full-traceability on prototypes that are often developed with the intent of use in surgery.”
Regulatory Expectations
An evolving regulatory climate continues to challenge orthopedic device manufacturers.
Machining and tooling suppliers that want to keep their OEM customers must put procedures and robust training in place to reduce risk for product non-conformance—in fact, OEMs often count on their key suppliers to know the answers to their regulatory questions.
“These non-conformances are more than just dimensional issues,” said Hoffman. “Suppliers need to ensure that raw materials meet specifications, cutting fluids can be cleaned from parts, machine tools are able to produce repeatable results and certification documents are correct. The paperwork is just as important as the parts and must have the same scrutiny of the product dimensions before they ship to the customer.”
To meet the FDA’s increasingly stringent expectations, Turner Medical captures, validates and continuously monitors its equipment and specialized processes (cleaning, welding, epoxy paint, etc.) through its validation master plan. “From an inspection standpoint, we are regularly investing in new vision systems for inspection on the floor and in the lab,” said Brackeen. “These systems fit well with the growing and ever-changing dimensioning schemes we are seeing in our customers’ designs. Our vision equipment is also becoming more programmable and user-friendly, which allows more efficient in-process measurements.”
Not only are increasingly complex devices more expensive to manufacture, they also can be more difficult for FDA reviewers to understand. More complexity also can mean an increased probability for variability—which can make validation and verification more challenging. In general, the fewer steps a manufacturing process has, the better. This is where applying lean manufacturing principles can simplify the process, improve quality, increase efficiency and throughput and make verification and validation easier.
“Phillips Precision Medicraft implements and executes lean principles on a daily basis,” said Neenan. “Using lean techniques to eliminate wasteful steps in manufacturing adds value to our OEM partners by reducing overall manufacturing cycle times, which equates to lower-cost products.”
Savings related to the implementation of lean manufacturing principles are highly product-dependent. What drives savings is the ability to reduce steps and consolidate machining operations. A good example is taking a product that may have been processed in the past by milling, turning and wire EDM and moving it to a mill/turn-machining platform.
“In this kind of situation,” said Neenan, “we would have the opportunity through programming, tooling and fixtures to load a material blank into a single machine and unload a finished product, compared to multiple machining platforms, programs, set-ups, fixtures and tooling strategies. The fewer times you have to re-fixture something in the manufacturing process, the more accurate, repeatable and efficient your process will be.”
Future Challenges
OEM requests for custom-designed, patient-specific components continue to push the technical boundaries of machining/tooling.
“In addition to the custom device, unique composite device constructions pose particular challenges with respect to component fixation and production controls to achieve the high tolerances required,” said Allen. “Success requires in-depth planning prior to actual manufacturing with the aim of 100 percent right the first time—not just for the product, but the documented best practices as well.”
OEMs are very uncertain regarding the use of new technology on legacy products. A process change can often trigger the need for a new validation and a complete round of new testing for the product. An example of this would be a situation where a device may have been processed on a lathe and then sent to a mill for secondary operations. To take advantage of current technology, the same part could be completed in one operation on a mill turn. Using a mill turn to finish a part could eliminate as many as five or six operations from previous processes—but also could prompt the FDA to call for more testing and validation.
“There is a common misconception that a process change like this could have some radical change on the parts properties, when in actuality the forces are the same and the only change is the product can be manufactured more efficiently,” said Neenan.
Additive manufacturing (AM) is a disruptive technology that is rapidly transforming medical manufacturing. AM processes such as laser sintering and 3-D printing are providing design engineers with new ways to design and create more innovative products—in plastic or metal. AM methods can save OEMs up to 25 percent in development costs. They also can save weeks worth of manufacturing time, producing components in a matter of hours, helping companies launch products more quickly.
“We want to embrace innovations that will help us find solutions to today’s difficult engineering challenges, maximize capacity and ensure top quality,” said Brackeen. “We have found that 3-D printers and the latest computer-aided manufacturing software precisely serve that purpose. The use of 3-D printing allows simple fixtures, such as laser etch and inspection, to be produced much faster and require far less resources to produce.”
In some cases, production-ready parts can be manufactured with 3-D printing, which is ideal for low-volume runs or products that are customized for individual patients.
“Additive manufacturing is especially useful in the expanding field of personalized medicine,” said Justin Conway, a product development engineer with Orchid Orthopedic Solutions in Memphis, Tenn. “A good example is customized, one-of-a-kind, patient-specific implants that are very time-consuming and expensive to make using traditional machining methods, but that can be manufactured quickly and at less cost with additive manufacturing.”
Partner Up
The best customer relationships are built around mutual respect, trust and collaboration—the essence of a true partnership.
“When we are able to work towards a common goal, whether it is a new spinal implant with a cutting-edge material or a complex surgical instrument, then we have the best chance for success when we are communicating and listening to each other throughout the project,” said Frank D. Noone, vice president of advanced surgical sales for Five Star Companies, a New Bedford, Mass.-based contract manufacturer of orthopedic implants and instrumentation.
As the OEM-contract manufacturer relationship gains trust, OEMs increasingly will ask for help with cost-effective manufacturing, design for manufacturability, engineering and quality input. “Our value add as a manufacturing partner is practical machining knowledge and the ability to analyze designs and offer refinement suggestions in areas of manufacturing, quality and function,” said Neenan. “Partnering with a knowledgeable supplier can circumvent hidden problems that are only discovered as they are manufactured. This is expensive for both the supplier and OEM and significantly slows the time to market for such designs.”
Working with trusted, full-service partners shortens the supply chain for OEMs because these partners are vertically integrated and do more in-house and communicate effectively. Suppliers become masters of risk mitigation for OEMs by building quality into the process with the ability to scale up or down quickly. Oberg Medical, for example, offers design for manufacturability; a low-cost country location; installation qualification, operational qualification and performance qualification validation protocols; ISO certifications; project and supply chain management; manufacturing; and quality engineering.
“OEMs are looking for the one-stop-shop that can handle everything from start to finish,” said Hoffman. “Suppliers no longer get ‘extra credit’ for having excellent quality, on-time delivery or competitive on cost—these are expected in today’s business climate. The process has become much more than just manufacturing a part to print. OEMs are looking for partnerships that can grow with their ever-changing business needs, which means the supplier must become a trusted extension of the OEM’s business.”
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