Sam Brusco, Associate Editor03.10.23
When we think of orthopedic devices, metal implants largely manufactured via machining processes typically come to mind. However, a great deal of injection molding technologies are also used to manufacture implants, surgical instruments, and other related products.
Molders for the orthopedic device industry are challenged by the industry environment of smaller devices, more complex designs, and high-performance polymers designed to offer enhanced physical properties like stiffness, chemical resistance, and temperature resistance. The flavor of molding technology to make an orthopedic component or product depends on the end use/area of operation, chosen materials, design of the product, aesthetic considerations, budget, and size of the production run.
Some common methods to mold orthopedic technologies include two-shot molding, thermoplastic injection molding, insert molding, overmolding, high-temperature molding, and gas-assisted injection molding. Plastic is the most common molded material, but liquid silicone rubber (LSR) and metal can also be injection molded. Orthopedic products made these ways include surgical instruments, spinal implants, disposables, bone anchors and staples, surgical handles, surgical cutting guides, and case/tray components.
In order to further examine the orthopedic device molding industry, Orthopedic Design & Technology spoke to eight experts in the field:
Time to market is a critical market force in the orthopedic market. New product launches need to hit the targets announced because OEMs, doctors, and hospitals are planning well in advance for these launches. The supply chain disruptions and labor shortages over the past two to three years have been challenging and required more communication and monitoring throughout the supply chains to ensure product is available within the agreed to time lines. There’s also the continued trend to make things smaller. Smaller devices are less invasive and can reach areas in the body that couldn’t be reached in the past. The ability to manufacture these devices and components is a key growth area moving forward.
Patrick Haney: I think contract manufacturers (CMs) can be involved with a product’s development process in a lot more intimate ways than most people might think. In many cases, R&D teams from both companies may create a “hybrid” development team that can pull in better and more diverse expertise and capabilities, which may bring a product to market faster.
Lindsay Mann: Fully assembled devices with fast speed-to-market, controlled by one trusted supplier. Continuing to streamline the manufacturing process and be more engaged with suppliers throughout R&D, development, and validation to get the highest quality finished device. Relationships are key to streamline these processes. For miniaturized assemblies and implants, there’s a need to move away from less precise and repeatable tipping or encapsulation processes and investigate better options, like precision overmolding and molding encapsulation.
Forest Rose: The state of the world’s supply chain continues to be challenging for manufacturers. Though delays are easing in some sectors, Flambeau’s demand for certain components are facing a year or more of lead time. This can cause scheduling difficulties and affect the response time our customers are accustomed to.
Russ Roy: The last few years have presented some unprecedented challenges for the injection molding industry. Supply chain problems and inconsistencies with resin pricing created issues in all markets, including the medical industry, which was seeing demand at record highs. Labor rates have changed dramatically as well—for instance in Mexico, where they recently received a healthy increase to catch up with the United States. These factors all created challenges with maintaining competitive pricing and meeting expected deliveries. We have worked closely with strategic supply partners to come up with creative solutions to address these issues, leveraging our buying power of raw materials across multiple plant locations. We also created new and unique programs in our plants to develop new capabilities that would help us meet demands.
James Schultz: There is growing, pent-up demand for instrument and implant delivery systems for surgeries conducted in the outpatient setting. With ambulatory surgical centers (ASCs) making up more than 68% of all surgeries and for orthopedics to remain the most profitable, the paradigm shift is to single-use, sterile pack instrumentation coupled with sterile implants that are optimized and tailored for the procedure and facility operational flow. This requires a holistic approach to creating an efficient and scalable model for surgeons and OR teams to conduct multiple surgeries throughout the day in a seamless, sustainable, and cost-effective manner. OEM implant firms want to deliver advanced sterile pack solutions with lower cost of sales and manage inventory to grow sales and margins. The ASC wants surgery-ready instruments and implants to maximize time and OR turnover to meet patient needs and manage costs. We are seeing broad adoption across trauma, extremity, CMF, and spine implant OEMs. The pace is rapidly accelerating.
Chris Thatcher: Next-generation materials that provides comparable clinical utility without any changes in operative technique. If you can take a power driver and drive a metal ACL screw into bone, the next-gen bioabsorbable material must be able to do the same thing. While this seems simple enough, as there are current material formulations available that can achieve this goal with excellent clinical results, the twist comes that clients want a material that’s new and provides market differentiation. This drives the question, how do you define clinically relevant and efficacious results with good science, not just the same material with something new added in that might present marketing appeal but doesn’t provide a significantly relevant clinical benefit?
Further complicating this quest for a next-generation material is both process development and the regulatory pathway. A new material may involve both new tooling and significant processing changes that affect direct costs and regulatory submissions. We also see a trend where device designers who have been working with metal or bio-durable polymers like PEEK are unaccustomed to designing with materials bespoke to a specific indication and solicited healing response. Sometimes they’re looking for a one-size (one material) fits-all approach, which may not be readily possible with a more complex next-generation bioabsorbable material.
John Woodhouse: The orthopedic business has traditionally been supported by machining technologies, but we see more opportunities for injection molding. To transition into molding from machining, the tolerances need to align to allow for molding. A second challenge is the lower volumes in the orthopedic industry. Up-front capital investments as well as setup costs can drive higher molding prices for ultra-low volume molding opportunities.
We have several years of experience and expertise in leveraging the use of multiple analytical tools, to develop and optimize tooling and molding processes. These include predictive MoldFlow Analysis, process mapping design of experiments, knowledge-based molding methodologies—including scientific injection molding and process monitoring with documentation, using cavity pressure and temperature sensors.
Haney: For many of the materials we use, there is very little published data available, so we must gather our own. Even more common materials rarely behave the way they are “supposed to” when they’re micro injection molded.
Mann: We offer R&D support, materials expertise, prototyping options, DFM (design for manufacturing), micro injection molding, as well as metrology services including CT scanning, validation, and scalable production.
Rose: We excel at the key molding capabilities that manufacturers of orthopedic and spinal devices count on, mainly injection and blow molding. In addition to conventional clean room injection molding, we also perform insert molding, over molding, encapsulation, and other needed services.
Roy: We are specialty molders and take pride in our success with demanding projects where tight tolerance, complicated geometry, or highly engineered materials are the norm. Our capabilities range from macro to micro-sized parts, insert molding, overmolding, and two-shot molding. Some of the exotic materials we work with are bioresorbables, implantables, glass-filled, and high temperature such as PEEK and PLLA. We also offer a full range of secondary and value-added operations and assembly for molded parts. Each of our facilities are controlled environments with several thousand square feet of cleanroom molding.
Schultz: We are a one-stop shop, or turnkey single-use instrument and procedural system provider to the orthopedic industry. We help implant OEMs create optimal surgery solutions using both polymers and metal materials to create clinically robust instrumentation that provides economic value. To meet our customers’ needs, we develop our own molds in the U.S. and selected overseas locations and have multiple in-house machines for injection molding of plastics. This allows us to manage schedules, control costs, and meet demanding tolerances.
Thatcher: While we are and have actively explored various manufacturing techniques for the orthopedic field, injection molding still is one of the most predominant and effective methods for manufacturing.
Woodhouse: We have been a provider of molded products to the orthopedic and spinal OEMs for years. We have provided engineering and design support to our customers to ease the transitioning from machining to injection molding. We provide a wide range of molding services, including micro molding, insert molding, and assembly to support product needs. We have learned how to be adaptable and agile to support their needs while solving the most challenging issues.
Haney: Understanding that some R&D stages of the product development process are nonlinear is important. Many times with R&D work, the project plan and initial work are exploratory. It’s very difficult to guarantee success for projects in their infancy and crucial to have open dialogue with the customer to ensure there’s an understanding that R&D steps are necessary to reach more stable process development phases.
Mann: A successful molding partnership starts with a clear understanding of client goals and supplier capabilities. We encourage clients to visit the facility early on to see the equipment and services in action, as well as meet the team they would be working with closely. Relationships and customer service is critical for our team and ensuring all expectations are understood early is imperative. Problem-solving and troubleshooting are innate to advanced micro molding and assembly processes, and strong relationships between supplier and client helps move through process checkpoints quickly and efficiently.
Rose: Our high-level engineering support is a strong factor in helping form successful partnerships with our clients. We are made up of manufacturing engineers and quality engineers who are accustomed to solving challenges as a team with our customers.
Roy: Experience has taught us the best way to guarantee a successful molding partnership is to get involved as early as possible in a project, as well as establish dedicated lines of communication. Getting involved early helps our engineers identify and get ahead of any issues like DFM concerns that can cause time delays or increase costs as tools come online. For every project, we set up dedicated program managers to provide a single point of contact, and utilize weekly/monthly drumbeat meetings that ensure the teams are in sync with one another. This establishes accountability to team members to keep projects moving forward on time.
Schultz: Key is a keen understanding of the tolerances and inspection criteria needed to produce an acceptable part. Dialing in the mold design and development is critical to time to market while reducing cost and waste that occurs when multiple mold spins or changes are required to create a stable, scalable part. World-class injection molding of plastics takes experience and lots of knowhow, including understanding the behavior of various types of resins and for engineering design teams to select the right polymer for the application.
Thatcher: Partnership is a great word to use, because that’s what it is. We have found that one of the most crucial aspects of a creating a successful partnership with clients is clear, open, and honest communications. Don’t try and hide issues. Discuss and address them head-on before it becomes an issue in the marketplace, or before you’re so far into the project it will cost the client more time and money.
Moreover, being knowledgeable in all aspects of the client's project is equally as important. Your role cannot just be the manufacturer—your role is to support and create successful projects and relationships by understanding as many aspects as possible. Understand the medical procedure the device will be used for, insurance reimbursement schedules, marketing, price points, and markets being looked at. Provide input and support on the regulatory side. All of these help to create a partnership and trust between the manufacturer and client, as well as help determine various aspects and directions of projects.
Woodhouse: We have a culture of quality and patient safety. We understand the products we manufacture could be used on a loved one or even ourselves, and therefore, quality is our number one goal. We are an engineering-driven company that helps working through the design with customers in the early stages of product development. We can help save money and improve manufacturability, ensuring success of a project with the early interaction. Open and honest communication is critical to all parties being successful in the relationship.
Roy: We recently completed an extensive $7.2 million renovation to our Molding Center of Excellence in Minneapolis. This project included a full revamp of everything from our front offices, to molding space with new presses, as well as adding 6,000 square feet of new cleanroom space to our manufacturing floor.
Schultz: Injection molding of plastic components is both an art and science. We make over 3 million injection-molded instruments per year for the cardio, neuro, ortho, and spine markets.
Experienced mold makers and machine operators can create very accurate cGMP parts for medical devices to meet schedule and minimize waste/scrap. Injection molding is one of the most complex manufacturing processes. Molders inject hot, molten fluid of various blends and additives into a cold mold, where it’s simultaneously flowing and hardening. There is a complex interaction of the plastic, mold design, part design, and process that combine to control the mechanical properties, shrinkage, residual stresses, and warpage of the final molded part. Know-how and experience are vital to a successful outcome.
Molders for the orthopedic device industry are challenged by the industry environment of smaller devices, more complex designs, and high-performance polymers designed to offer enhanced physical properties like stiffness, chemical resistance, and temperature resistance. The flavor of molding technology to make an orthopedic component or product depends on the end use/area of operation, chosen materials, design of the product, aesthetic considerations, budget, and size of the production run.
Some common methods to mold orthopedic technologies include two-shot molding, thermoplastic injection molding, insert molding, overmolding, high-temperature molding, and gas-assisted injection molding. Plastic is the most common molded material, but liquid silicone rubber (LSR) and metal can also be injection molded. Orthopedic products made these ways include surgical instruments, spinal implants, disposables, bone anchors and staples, surgical handles, surgical cutting guides, and case/tray components.
In order to further examine the orthopedic device molding industry, Orthopedic Design & Technology spoke to eight experts in the field:
- Mike Kaiser, VP of business operations at Donatelle.
- Patrick Haney, R&D engineer at MTD Micro Molding.
- Lindsay Mann, director of sales and marketing at MTD Micro Molding.
- Forest Rose, plant manager of Flambeau’s facilities in Phoenix.
- Russ Roy, sales manager—specialty molding at Spectrum Plastics Group.
- James Schultz, VP of customer solutions at ECA Medical.
- Chris Thatcher, VP of TESco Associates.
- John Woodhouse, director of sales and marketing at Medbio.
Sam Brusco: What are the market forces at play in your corner of the orthopedic/spinal device market?
Mike Kaiser: More end customer OEMs are coming to us looking for full device manufacturing capabilities to manufacture most of the products in-house, kit the various parts together into a final medically sealed package, and manage sterilization. Needs have been for machined plastic and metal parts, along with other injection-molded implant delivery and surgical instruments made of combinations of overmolded metal and plastic components. This allows a more cost-effective approach for many single-use instruments. The need for very robust and proven quality systems are a key part of being successful, as there are many combinations of instruments that need comprehensive lot control tracking, as well as multi-part manufacturing traceability control.Time to market is a critical market force in the orthopedic market. New product launches need to hit the targets announced because OEMs, doctors, and hospitals are planning well in advance for these launches. The supply chain disruptions and labor shortages over the past two to three years have been challenging and required more communication and monitoring throughout the supply chains to ensure product is available within the agreed to time lines. There’s also the continued trend to make things smaller. Smaller devices are less invasive and can reach areas in the body that couldn’t be reached in the past. The ability to manufacture these devices and components is a key growth area moving forward.
Patrick Haney: I think contract manufacturers (CMs) can be involved with a product’s development process in a lot more intimate ways than most people might think. In many cases, R&D teams from both companies may create a “hybrid” development team that can pull in better and more diverse expertise and capabilities, which may bring a product to market faster.
Lindsay Mann: Fully assembled devices with fast speed-to-market, controlled by one trusted supplier. Continuing to streamline the manufacturing process and be more engaged with suppliers throughout R&D, development, and validation to get the highest quality finished device. Relationships are key to streamline these processes. For miniaturized assemblies and implants, there’s a need to move away from less precise and repeatable tipping or encapsulation processes and investigate better options, like precision overmolding and molding encapsulation.
Forest Rose: The state of the world’s supply chain continues to be challenging for manufacturers. Though delays are easing in some sectors, Flambeau’s demand for certain components are facing a year or more of lead time. This can cause scheduling difficulties and affect the response time our customers are accustomed to.
Russ Roy: The last few years have presented some unprecedented challenges for the injection molding industry. Supply chain problems and inconsistencies with resin pricing created issues in all markets, including the medical industry, which was seeing demand at record highs. Labor rates have changed dramatically as well—for instance in Mexico, where they recently received a healthy increase to catch up with the United States. These factors all created challenges with maintaining competitive pricing and meeting expected deliveries. We have worked closely with strategic supply partners to come up with creative solutions to address these issues, leveraging our buying power of raw materials across multiple plant locations. We also created new and unique programs in our plants to develop new capabilities that would help us meet demands.
James Schultz: There is growing, pent-up demand for instrument and implant delivery systems for surgeries conducted in the outpatient setting. With ambulatory surgical centers (ASCs) making up more than 68% of all surgeries and for orthopedics to remain the most profitable, the paradigm shift is to single-use, sterile pack instrumentation coupled with sterile implants that are optimized and tailored for the procedure and facility operational flow. This requires a holistic approach to creating an efficient and scalable model for surgeons and OR teams to conduct multiple surgeries throughout the day in a seamless, sustainable, and cost-effective manner. OEM implant firms want to deliver advanced sterile pack solutions with lower cost of sales and manage inventory to grow sales and margins. The ASC wants surgery-ready instruments and implants to maximize time and OR turnover to meet patient needs and manage costs. We are seeing broad adoption across trauma, extremity, CMF, and spine implant OEMs. The pace is rapidly accelerating.
Chris Thatcher: Next-generation materials that provides comparable clinical utility without any changes in operative technique. If you can take a power driver and drive a metal ACL screw into bone, the next-gen bioabsorbable material must be able to do the same thing. While this seems simple enough, as there are current material formulations available that can achieve this goal with excellent clinical results, the twist comes that clients want a material that’s new and provides market differentiation. This drives the question, how do you define clinically relevant and efficacious results with good science, not just the same material with something new added in that might present marketing appeal but doesn’t provide a significantly relevant clinical benefit?
Further complicating this quest for a next-generation material is both process development and the regulatory pathway. A new material may involve both new tooling and significant processing changes that affect direct costs and regulatory submissions. We also see a trend where device designers who have been working with metal or bio-durable polymers like PEEK are unaccustomed to designing with materials bespoke to a specific indication and solicited healing response. Sometimes they’re looking for a one-size (one material) fits-all approach, which may not be readily possible with a more complex next-generation bioabsorbable material.
John Woodhouse: The orthopedic business has traditionally been supported by machining technologies, but we see more opportunities for injection molding. To transition into molding from machining, the tolerances need to align to allow for molding. A second challenge is the lower volumes in the orthopedic industry. Up-front capital investments as well as setup costs can drive higher molding prices for ultra-low volume molding opportunities.
Brusco: What sorts of molding technologies/services do you offer orthopedic/spinal device makers?
Kaiser: We are a vertically integrated contract manufacturer offering 3D printing, prototyping, in-house toolmaking, molding for 5- to 300-ton capacity, insert molding, over molding, liquid silicone molding, micro molding, micro metal injection molding, and molding of bioresorbable materials. Services can be provided in both clean room and white room environments. Over the past several years, the equipment capabilities and processing expertise have been evolving to allow for more complexity and more repeatability around smaller features.We have several years of experience and expertise in leveraging the use of multiple analytical tools, to develop and optimize tooling and molding processes. These include predictive MoldFlow Analysis, process mapping design of experiments, knowledge-based molding methodologies—including scientific injection molding and process monitoring with documentation, using cavity pressure and temperature sensors.
Haney: For many of the materials we use, there is very little published data available, so we must gather our own. Even more common materials rarely behave the way they are “supposed to” when they’re micro injection molded.
Mann: We offer R&D support, materials expertise, prototyping options, DFM (design for manufacturing), micro injection molding, as well as metrology services including CT scanning, validation, and scalable production.
Rose: We excel at the key molding capabilities that manufacturers of orthopedic and spinal devices count on, mainly injection and blow molding. In addition to conventional clean room injection molding, we also perform insert molding, over molding, encapsulation, and other needed services.
Roy: We are specialty molders and take pride in our success with demanding projects where tight tolerance, complicated geometry, or highly engineered materials are the norm. Our capabilities range from macro to micro-sized parts, insert molding, overmolding, and two-shot molding. Some of the exotic materials we work with are bioresorbables, implantables, glass-filled, and high temperature such as PEEK and PLLA. We also offer a full range of secondary and value-added operations and assembly for molded parts. Each of our facilities are controlled environments with several thousand square feet of cleanroom molding.
Schultz: We are a one-stop shop, or turnkey single-use instrument and procedural system provider to the orthopedic industry. We help implant OEMs create optimal surgery solutions using both polymers and metal materials to create clinically robust instrumentation that provides economic value. To meet our customers’ needs, we develop our own molds in the U.S. and selected overseas locations and have multiple in-house machines for injection molding of plastics. This allows us to manage schedules, control costs, and meet demanding tolerances.
Thatcher: While we are and have actively explored various manufacturing techniques for the orthopedic field, injection molding still is one of the most predominant and effective methods for manufacturing.
Woodhouse: We have been a provider of molded products to the orthopedic and spinal OEMs for years. We have provided engineering and design support to our customers to ease the transitioning from machining to injection molding. We provide a wide range of molding services, including micro molding, insert molding, and assembly to support product needs. We have learned how to be adaptable and agile to support their needs while solving the most challenging issues.
Brusco: How do you ensure a successful molding partnership with your orthopedic clients?
Kaiser: OEMs must get contract manufacturers involved early in a new program, before the design has been finalized. This could involve prototyping, design iterations, and early build phases. Early involvement allows for design for manufacturing input into the design for long-term mold design, assembly, kitting, packaging/labeling, and advanced quality planning solutions that minimize production manufacturing issues downstream as production is ramping up. If issues come up when product is ramping, the cost to correct at that time is exponentially greater than early on in the process. In order to get to a successful OEM/supplier partnership, there must be an open and trusting relationship between the companies as soon as possible and up front, where the groups are able to rely on and utilize each other’s expertise toward the common development goal.Haney: Understanding that some R&D stages of the product development process are nonlinear is important. Many times with R&D work, the project plan and initial work are exploratory. It’s very difficult to guarantee success for projects in their infancy and crucial to have open dialogue with the customer to ensure there’s an understanding that R&D steps are necessary to reach more stable process development phases.
Mann: A successful molding partnership starts with a clear understanding of client goals and supplier capabilities. We encourage clients to visit the facility early on to see the equipment and services in action, as well as meet the team they would be working with closely. Relationships and customer service is critical for our team and ensuring all expectations are understood early is imperative. Problem-solving and troubleshooting are innate to advanced micro molding and assembly processes, and strong relationships between supplier and client helps move through process checkpoints quickly and efficiently.
Rose: Our high-level engineering support is a strong factor in helping form successful partnerships with our clients. We are made up of manufacturing engineers and quality engineers who are accustomed to solving challenges as a team with our customers.
Roy: Experience has taught us the best way to guarantee a successful molding partnership is to get involved as early as possible in a project, as well as establish dedicated lines of communication. Getting involved early helps our engineers identify and get ahead of any issues like DFM concerns that can cause time delays or increase costs as tools come online. For every project, we set up dedicated program managers to provide a single point of contact, and utilize weekly/monthly drumbeat meetings that ensure the teams are in sync with one another. This establishes accountability to team members to keep projects moving forward on time.
Schultz: Key is a keen understanding of the tolerances and inspection criteria needed to produce an acceptable part. Dialing in the mold design and development is critical to time to market while reducing cost and waste that occurs when multiple mold spins or changes are required to create a stable, scalable part. World-class injection molding of plastics takes experience and lots of knowhow, including understanding the behavior of various types of resins and for engineering design teams to select the right polymer for the application.
Thatcher: Partnership is a great word to use, because that’s what it is. We have found that one of the most crucial aspects of a creating a successful partnership with clients is clear, open, and honest communications. Don’t try and hide issues. Discuss and address them head-on before it becomes an issue in the marketplace, or before you’re so far into the project it will cost the client more time and money.
Moreover, being knowledgeable in all aspects of the client's project is equally as important. Your role cannot just be the manufacturer—your role is to support and create successful projects and relationships by understanding as many aspects as possible. Understand the medical procedure the device will be used for, insurance reimbursement schedules, marketing, price points, and markets being looked at. Provide input and support on the regulatory side. All of these help to create a partnership and trust between the manufacturer and client, as well as help determine various aspects and directions of projects.
Woodhouse: We have a culture of quality and patient safety. We understand the products we manufacture could be used on a loved one or even ourselves, and therefore, quality is our number one goal. We are an engineering-driven company that helps working through the design with customers in the early stages of product development. We can help save money and improve manufacturability, ensuring success of a project with the early interaction. Open and honest communication is critical to all parties being successful in the relationship.
Brusco: Anything else you’d like to say regarding molding equipment/services for orthopedic device manufacturing?
Kaiser: If the product is of a molded implantable grade material, which is quite expensive, OEMs need a molding process designed to optimally minimize the manufacturing cost and variation in the product. For an extremely efficient and streamlined program, OEMs need a contract manufacturer that offers a vertically integrated, in-house approach in the design and manufacturing of their products. Technical bandwidth from a longstanding, single-source supplier with a proven quality system, built around the medical industry, will bring the most success.Roy: We recently completed an extensive $7.2 million renovation to our Molding Center of Excellence in Minneapolis. This project included a full revamp of everything from our front offices, to molding space with new presses, as well as adding 6,000 square feet of new cleanroom space to our manufacturing floor.
Schultz: Injection molding of plastic components is both an art and science. We make over 3 million injection-molded instruments per year for the cardio, neuro, ortho, and spine markets.
Experienced mold makers and machine operators can create very accurate cGMP parts for medical devices to meet schedule and minimize waste/scrap. Injection molding is one of the most complex manufacturing processes. Molders inject hot, molten fluid of various blends and additives into a cold mold, where it’s simultaneously flowing and hardening. There is a complex interaction of the plastic, mold design, part design, and process that combine to control the mechanical properties, shrinkage, residual stresses, and warpage of the final molded part. Know-how and experience are vital to a successful outcome.
