The orthopedic device industry combines advanced molding techniques in innovative ways to meet the demand for smaller, more complex, and high-performance medical components. Molding technologies are advancing with higher precision, enhanced materials, and increased automation. With miniaturization driving device design, micro-molding, which enables ultra-small components with sub-micron tolerances, is in high demand. Overmolding integrates multiple materials for improved durability. Two-shot molding, thermoplastic injection molding, insert molding, high-temperature molding, and gas-assisted injection molding allow medical device manufacturers (MDMs) to make a variety of products, including surgical instruments, spinal implants, disposables, bone anchors, surgical handles, cutting guides, and case/tray components. Real-time process monitoring, Internet of Things (IoT) sensors, and AI-driven analytics are optimizing quality, reducing waste, and enhancing efficiency. Closed-loop control systems further enable precision by making automatic adjustments. 

“A significant trend in the industry is the miniaturization of devices, which has led molders to develop innovative micro-scale methods, techniques, and tools,” said Joelle Faught, vice president of marketing and business development for Plastic Design Company, a Scottdale, Ariz.-based contract manufacturer specializing in precision micro injection molding and value-added assembly. “This evolution is driven by the need for precision and the use of high-performance polymers that offer enhanced properties like stiffness, chemical resistance, and temperature resistance.”

In addition, the industry is witnessing a shift toward domestic production, with more molding operations returning to the U.S. This trend is accompanied by increased outsourcing of molding tasks from OEMs to specialized molding shops. “The progression of ISO 80369 standards, which introduce dimensional and functional changes to components, is also influencing the industry,” said Faught. These standards necessitate rigorous testing and traceability, compelling molders to comply with stringent requirements.”

“Ultimately,” said Raghu Vadlamudi, chief research and technology director at Donatelle, a DuPont Business, “the integration of advanced molding technologies, bioresorbable materials, and smart manufacturing is driving innovation in orthopedic device design and efficiency.”

Latest Molding Trends

Innovation in the orthopedic design field is steady, including advancements in materials and how these materials are being used in unique ways. “For example, bioabsorbable materials have been a mainstay in orthopedic use, but we are seeing combination uses in hybrid fixation devices, where a bioabsorbable part and an implantable polyetheretherketone (PEEK) part are used in combination,” said Henri Asselin, vice president of engineering and technology for Beacon MedTech Solutions, a Leominster, Mass.-based vertically integrated contract manufacturing provider of injection molding for thermoplastic and liquid silicone rubber components. 

Although PEEK, carbon fiber, and glass fiber-reinforced PEEK are well-established material choices for implants and reusable surgical instruments and components, new and stronger materials such as IXEF have also become very common in recent years. These materials have high strength and are also compatible with gamma or EO (ethylene oxide) sterilization.

Although projected growth for orthopedic design and innovation appears to be strong, “some companies have taken a more cautious approach regarding development, being very selective as to which project they may choose to develop,” said Scott Herbert, president of Rapidwerks, a Pleasanton, Calif.-based provider of micro injection molded components for the medical device industry.

With strong growth comes increased competition, which is forcing MDMs to aggressively consolidate their supply chains, and/or vertically integrate with their contract manufacturers (CMs). Cretex Medical | CDT, for example, “has already established sophisticated vertical integration for orthopedic subcomponents,” said Kyle Klein, technical sales engineer for Cretex Medical | CDT, a Minneapolis, Minn.-based privately-owned contract manufacturer and engineering service provider for the medical device industry.

Greater verticalization within an injection molder reduces time, risks, and costs—for both the molder and the MDM. “We’re often approached by other suppliers looking for us to help them with their specialized component and to offer shared verticalization,” said Asselin.

What MDMs Want

Of course, MDMs want smaller components, but with more functionality and less cost. They approach their injection molder hoping to fit more capabilities into a smaller and very defined envelope. In addition, MDMs are asking for rapid prototypes, tight tolerances, and thin walls and small sprues due to the high cost of the implantable PEEK materials used in implant-grade materials. 

MDM needs vary according to their unique strategies for each product they are developing. “Generally, what we hear from them falls into five main categories,” said Klein:

• Upfront and early-in-the-process engineering support
• Design for manufacturing for steel shut-offs, adding ribs for reducing wall sections while maintaining strength, and draft recommendations for long core pulls
• Mold design competency
• The ability to mold a variety of medical-grade and medical-implant-grade materials
• A proven quality management system (QMS) process 

Production processes that can achieve these goals include high-precision molding processes with real-time monitoring and automation as well as bioresorbable materials, while also prioritizing regulatory compliance. Suppliers that offer smart, data-driven molding solutions with advanced materials and multi-material capabilities will gain a strong competitive edge. 

OEMs also expect the highest cleanliness standards.

For example, to ensure the highest quality and prevent contamination, “Gsell employs separate extrusion units for each implantable material,” said Patrick Fässler, member of the management for Gsell Switzerland and CEO of Gsell USA, a Swiss contract manufacturer for CNC machining, thermoforming, injection molding, and compression molding, with sales and engineering offices in Maryland. Gsell also specializes in PEEK molding and cleanroom molding of custom single-use instruments for various minimally invasive surgical procedures.

As the medical-device industry becomes more complex and competitive, OEMs want molders who can support new product introductions while also delivering the capacity to scale production as demand grows. 

“Today’s OEMs don’t just need a molder—they need a partner for DFM [design for manufacturing], tooling, materials, quality, assembly, and beyond,” said Asselin. “Being able to deliver this expertise under one roof gives customers better control over timelines, simplifies supply chain management, increases accountability, and reduces costs.”

How Small Can Molding Go?

“Of course, one of the first questions molders typically hear from MDMs is ‘How small can you make this feature?’” said Herbert. “‘How fast? We need this feature to move forward—what will it take?’”

“Micromolding in orthopedics is achieving extreme precision, with sub-millimeter components and tolerances as tight as 5 to 10 µm or smaller, depending on the material,” said Vadlamudi. “Success hinges on careful material selection, advanced tooling, and real-time process control.”

The tightest tolerances are really the limiting factors, rather than just the part dimensions. “Implantable devices for neurostimulation have been in the microns for decades, but it is really the critical dimensions and aspect ratios for the part dimensions, combined with the mechanical strength of the implant, that makes these devices special,” said Faught. “Companies that understand tool design and difficult-to-mold materials, such as PEEK, can achieve sub-micron tolerances consistently.”

Asselin shared that Beacon MedTech Solutions was able to get down to 0.4 inches with a recent implantable PEEK program. “We have parts that are 0.5 inch x 0.13 inch x 0.3 inch with tolerances of 0.005 inches,” he said. “Tolerances are more based in tooling for these programs, rather than material. However, we can manage ‘softer’ materials like liquid silicone rubber that are much more difficult to control.”

Small implantable parts (such as bone screws or micro implants) are typically 0.005 inches or smaller. However, not all materials can produce such small dimensions. For example, in general, Cretex Medical | CDT has the capability to produce orthopedic implant parts with the following specifications:

• Part weight: 0.005 grams
• Wall thickness: 0.003 inches
• Outside diameter: ~0.04 inches to ~0.06 inches
• Tolerance: ±0.0003 inches to 0.0005 inches

These specifications are fully dependent on and limited by material type, which dictates factors such as melt flow and viscosity. Material properties determine multiple factors including the flow length of the material forming the part geometry, minimum wall thickness capability, and overall geometry, in addition to the gate design approach. 

“Short flow lengths [0.03 to 0.07 inches] with simple part geometry lend themselves to a variety of medical material options, including PEEK, IXEF, and PCABS [polycarbonate/acrylonitrile butadiene styrene]” said Klein. “Longer flow lengths require higher melt flow materials, as per material specifications dictated on material supplier technical data sheets.”

Advanced Tools and Technologies 

Recent technological advancements in molding include IoT-enabled injection molding machines with pressure and temperature sensors for real-time process control, enhancing quality and reducing defects. Predictive maintenance algorithms monitor conditions like pressure and temperature, preventing downtime. AI and machine learning optimize parameters, reduce waste, and improve yields by detecting trends and defects early. AI can also be used during the manufacturing process to add traceability to a product’s design history file and work history record for long-term tracking of the product’s fabrication history.

“Additive manufacturing enables 3D-printed mold inserts with cooling channels that improve cycle times and part quality,” said Vadlamudi. “Smart robotics and automation, including collaborative robots and AI-driven handling, optimize finishing and inspection, improving consistency and reducing labor costs. These advancements are transforming orthopedic device production by improving efficiency, quality, and cost-effectiveness.”

As parts get smaller and harder to make, CMs continually seek new ways to shorten lead times and reduce costs for their MDMs, often pushing the boundaries of molding science. For example, Gsell’s latest innovations include the injection molding of PEEK tube-like geometries for complex radiology instruments. Additionally, Gsell is exploring new opportunities in overmolding continuous carbon fiber-reinforced 3D-printed components. “One of the key challenges in contract manufacturing with highly innovative and unique processing methods is being able to effectively match these technologies to the right applications,” said Fässler.

Manufacturers are integrating molding with secondary processes, automation, and in-line inspection to improve efficiency. For example, in-mold assembly combines multiple components inside the mold, reducing post-molding assembly steps and enhancing structural integrity. “In-line metrology systems, including AI-driven defect detection, enable real-time verification and reduce errors,” said Vadlamudi. “Automated post-processing, such as pad printing and ultrasonic welding, improves consistency and throughput. These innovations help eliminate secondary processes, reduce cycle times, and improve regulatory compliance, making the manufacturing of orthopedic devices faster, more cost-effective, and consistent.”

Gsell offers a broad range of manufacturing technologies for processing thermoplastics, all under a single, sophisticated, and dedicated quality management system. “A key highlight is our integration of molding and machining, where molded blanks or semi-finished parts can be further processed to incorporate complex features or produce various sizes from standardized blanks for a product platform,” said Fässler. “Gsell will soon offer continuous carbon fiber 3D printing of PEEK components using our proprietary process. These components can be overmolded with functional or protective features, unlocking exciting new possibilities, especially for metal-free implant solutions.”

The next generation of implant fabrication is rapid prototyping of the injection mold cavity. High-temperature materials, such as PEEK, have not yet yielded successful cavity development with 3D-printed cavities, and this is the next frontier of rapid prototyping. “I would recommend that injection molding teams work to add other areas of fast-track to their tool production, such as modular designs to existing single-cavity prototype tools, and minimal runner systems, to ensure that OEMs can more quickly iterate in PEEK and obtain faster prototype parts,” said Faught. “Currently, they wait eight to 10 weeks for parts, which rivals the time for a production tool, which is too long for some development teams.”

Cretex Medical | CDT uses a variety of robotics for automation in molding manufacturing cells. Operators use integrated computer numerical control (CNC) technology with programmed controlled coordinates within very tight tolerances, typically with a three-axis robotic movement. “This allows us to enhance the manufacturing process by controlling process repeatability, greatly reducing cycle time and decreasing operator intervention,” said Klein. “When an operator is required, we use this technology to reduce potential safety and ergonomic risks for the operator.”

Micro to Nano

Micromolding will be very dominant in the next few years. “There is no way conventional injection molding can supply small intricate details to a part, within the envelope that is required by most device makers,” said Herbert. “Thus, device makers are pushing to learn more about micro injection molding, or going one step further by trying to acquire the market leaders.”

The future of nano molding will be self-assembling materials. “Once PEEK can assemble on a scaffold, we will hit the winner,” said Faught. “The trick will be to find the right framework.” Recent advancements have focused on the development of self-assembling PEEK nanotubes, which aim to enhance the material’s properties by creating nanostructured configurations. These nanotubes are engineered to spontaneously form through molecular self-assembly processes, resulting in structures with high surface area and unique mechanical characteristics.

“The self-assembly of PEEK nanotubes involves the organization of polymer chains into tubular formations without external guidance, driven by non-covalent interactions such as hydrogen bonding and π–π stacking,” Faught continued. 

This process can be influenced by factors like solvent conditions, temperature, and the presence of specific molecular templates. The resulting nanotubular structures have potential applications in various fields, including drug delivery systems, “where their high surface area can facilitate efficient loading and controlled release of therapeutic agents,” said Faught. “The enhanced mechanical properties of PEEK nanotubes make them suitable for reinforcing composite materials used in aerospace and automotive industries.”

An Ever-Shifting Landscape

Many of the challenges in the regulatory space are in the new product introduction process. When a new product is launched, the cycle of development, testing, and FDA submission can be time-consuming and expensive. FDA requirements for medical devices and other human intervention products have become more stringent. More emphasis is being placed on regulating material biocompatibility for the components and elements necessary to ensure device safety and effectiveness. Typical materials include medical- and medical-implant-grade polymers, metals, and silicones. 

“We are also staying on top of evolving quality standards, specifically the FDA’s final rule on amending current good manufacturing practice requirements of the Quality System Regulation—21 CFR 820—to more closely align with other regulatory QMS standards,” said Asselin.

Sometimes, it’s not a new technology that does the trick, but the combination of existing processes in innovative ways. These can result in efficiencies in production, reduced costs, and faster project delivery. For example, Cretex Medical | CDT was recently tasked with designing a surgical instrument that had one commonly designed handle with over 40 different shafts for the different surgeries that could be performed with a single instrument. The different shafts included features such as various sized reamers, screwdriver shafts, and drills. “All these SKUs were to be manufactured out of IXEF (a 50% glass filled material for strength) and have inserted pieces for the various sizes,” said Klein. “We were able to produce one mold with 19 changeover inserts to manufacture all the different configurations. We then automated the process so a robot loads the shaft in the mold, which removes the need for an operator.”

Time to market is often the driving force for design changes. “We recently created a single tool to fabricate over nine different and unique parts,” said Herbert. “Saving our MDM time and money while also moving fast to create variations of a part is a big differentiator in the market.”

As the orthopedic device industry advances, AI, micromolding, hybrid manufacturing, automation, and sensor technologies are transforming molding, making it faster and more efficient, and capable of producing highly complex, precise devices. “These innovations reduce lead times and enable consistent biomechanical properties and regulatory compliance,” said Vadlamudi. “As they evolve, molding will play an even greater role in the supply chain, driving cost-effective, high-quality manufacturing.”

Sensitive materials like bioabsorbables can certainly be used successfully in orthopedic devices, though they present different challenges compared to traditional thermoplastic resins. “However, there is an increase in demand for PEEK components due to its strength, biocompatibility, and performance. This material can be challenging to injection mold due to stringent molding conditions required to successfully be injection molded, but it offers many advantages in orthopedic devices,” said Asselin.

On the Horizon

The combination of advanced materials, AI, real-time monitoring, and hybrid manufacturing is revolutionizing molding, making it more precise, intelligent, and efficient than ever. From intelligent molding systems to bioresorbable implants that integrate seamlessly with the body and micro-features (possible by advancements in machine tools) that enhance functionality, these innovations are pushing boundaries. The advancements will elevate device quality, shorten patient recovery times, reduce surgical risks, and make personalized, cost-effective orthopedic solutions the new standard. 

New technologies are on the horizon for AI-driven closed-loop systems for production monitoring and adjustment. Advancements in process control, including eDART and CoPilots, facilitate de-coupled molding for process monitoring.

“Despite significant advancements in molding technologies for orthopedic devices, challenges such as material complexities, regulatory delays, high costs, and lack of standardization limit widespread adoption,” said Vadlamudi. While the potential for more efficient, precise, and customizable devices is immense, addressing these barriers is crucial to fully leveraging molding innovations. 

Advanced materials like bioresorbables, antimicrobial additives, and nanomaterials are enhancing orthopedic device performance and safety. Material additives allow precise tailoring of mechanical properties for specific needs. “Innovations in molding now support sensitive materials like bioresorbable polymers, enabling bioresorbable implants that eliminate additional surgeries,” said Vadlamudi. 

Balancing cutting-edge innovations with practical scalability in injection molding requires a strategic approach. Manufacturers must weigh cost, feasibility, and availability while maintaining quality and regulatory compliance. Advanced materials, real-time monitoring, and smart technologies offer great potential, but their adoption must consider long-term scalability, sustainability, and efficiency. “Success depends on ongoing collaboration among technology developers, regulatory bodies, OEMs, and suppliers to enable innovations that are both practical and commercially viable,” said Vadlamudi.

Engineers often lack a community to share ideas and best practices. “It’s a niche industry and can be difficult to find answers to these tough questions,” said Faught. “We are trying our best to provide solutions that share design principles to enable the best practices we developed over the past 40 years.”

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.