Polyetheretherketone (PEEK) is among the newer thermoplastic engineering plastics and has demonstrated biological, mechanical, and chemical properties as a biomaterial for orthopedics. Historically, PEEK’s availability arrived when there was a rising need to build isoelastic hip and fracture implants with a modulus similar to bone.

PEEK’s elastic modulus lowers the stress shielding effect that’s seen in metals used for arthroplasty or fracture fixation like stainless steel. It also avoids the side effects of releasing metal ions in the body, which can cause osteolysis and immune reactions. It’s also more compatible with radiological techniques like CT and MRI used for treatment monitoring and follow-up.

Due to these properties, PEEK has become a material of choice for orthopedic devices. In the 1990s, it saw use in spinal fusion cages, which has become one of its most popular applications. Arthoscopic PEEK anchors have also begun to overtake metal and bioabsorbable anchors used in anterior cruciate ligament (ACL) and meniscus repairs and reconstructions.

Because of its biological properties, there’s also been research interest in using PEEK in 3D printing models, where they can realize economical, personalized, and sophisticated orthopedic implant design and development. Research has also begun to explore PEEK and its composite’s tribology as bearing surfaces and flexible components for joint arthroplasty.

For example, high-performance thermoplastics, composites, seals, and engineered components manufacturer Greene Tweed’s Orthtek is a thermoplastic composite material that is intended for orthopedic and surgical device applications. It’s made of a bi-directional, woven carbon fiber combined with a PEEK matrix. The preimpregnated fabric material is then stacked, heated, and compression molded for final consolidation.

“Orthtek offers high-strength capability via its continuous fiber fabric reinforcement and durable PEEK matrix,” said Travis Mease, product manager—structural components for Greene Tweed. “These strength and stiffness properties ensure instruments perform reliably in surgical environments, while the reduced weight comparatively to metal decreases physical fatigue during lengthy surgical procedures. Coupled with this strength-to-weight ratio, Orthtek materials also offer radiolucent capability, enabling real-time procedural X-rays and scans. The low water absorption and high thermal stability allows for repeated autoclave sterilization cycles without form or physical property degradation.”

Products using the material have applications in nail guides, targeting devices, fixation components, and universal screw guides. 

“Orthtek plates can be machined into a wide variety of custom shapes. We are happy to provide guidance on machining parameters, but our specialty is offering the market and device manufactures consolidated Orthtek plates and blanks,” said Mease. “We focus on processing the raw material into a high-quality, machinable plate form instead of creating the final end-user device ourselves.”

PEEK is just one of the many materials used in orthopedic device manufacturing. In order to glean further insights on material trends impacting the orthopedic device manufacturing industry, Orthopedic Design & Technology spoke to several experts in the field over the past few weeks:

Josh Ackernecht, Commercial Manager—Consumer, Medical, & Distribution Partners, KRAIBURG TPE Americas
Mark Heatherley, VP of Sales, ACNIS International
Chris Hester, CEO, Grover Precision. (Grover Precision was recently acquired by Forecreu and makes a very similar product.)
Travis Mease, Product Manager—Structural Components, Greene Tweed
Dennis Rahill, Business Development Manager, United Performance Metals
Corey Seacrist, Ph.D., MBA, Manager, Sales & Marketing, Poly-Med
Stephen Smith, Director, Market Development, A.M. Castle & Co.

Sam Brusco: What are the chief trends you’re seeing in medical-grade materials at present?

Josh Ackernecht: Sustainability is an emerging trend in the medical market, particularly in diagnostics, pharma, and medical devices. There’s a shift away from less sustainable materials, with TPE being considered a viable alternative—depending on the end use, application needs, material properties, testing, and resistance requirements. Further evaluation of TPE is needed, as existing medical industry standards limit the use of materials that are otherwise acceptable in other markets. On the positive side, this perception is slowly evolving in the right way, allowing for more possibilities in the future.

Mark Heatherley: There are several key trends our teams are closely monitoring.

Titanium alloys and high-performance polymers like PEEK and UHMWPE are now favored for their biocompatibility and optimized mechanical properties. We ensure that we offer certified materials that comply with applicable regulations, ensuring their use in medical devices.

Additive manufacturing is revolutionizing the design of implants and prostheses. This requires new expertise to provide specific metallic powders suitable for different manufacturing processes, and also to technically support customers in selecting the most effective materials for their applications, considering both mechanical and biological constraints. Powder characterization, process optimization, heat treatment protocols, machine park knowledge, powder customization, research, and development—additive manufacturing is driving significant technical advancements to guarantee the best results.

The evolution of standards, particularly in Europe with the MDR (Medical Device Regulation), is forcing manufacturers to have perfectly traceable and compliant materials. With our expertise in sourcing and logistics, we help partners secure their supplies of materials that meet, in particular, ISO 13485 standards.

With tensions surrounding certain metals like titanium and cobalt-chrome, securing stock is becoming strategic. We have extensive storage capacity (700 tons, over 3,000 references) and optimized logistics to ensure a continuous supply to our customers while anticipating market shifts.

The search for recyclable and low-carbon-footprint materials is a major challenge for the future. We are part of this transition with initiatives such as the “Green Titanium” offering, made from recycled materials, ensuring the same quality as virgin alloys while minimizing environmental impact.

Chris Hester: After a long period of stability, we have seen dramatic swings in material availability and inventory levels in the post-COVID era. After peaking in 2023, inventory levels and material lead times have fallen, putting pressure on ordering patterns as players throughout the supply chain adjust to new realities. While end-use surgeries have continued apace, there has been overall reduction in demand throughout the supply chain as inventory levels adjust to post-COVID availability of material.

Dennis Rahill: Many significant trends are evolving in the medical device and implants industry, but the most relevant ones seem to be the tremendous growth of additive technology, doctor-owned ambulatory service centers (ASCs), robotics, surgical navigation tools, and of course AI. All raw material suppliers must learn how to accept and quickly adapt to these trends to survive and thrive.

Corey Seacrist: We specialize in manufacturing high-performance, next-generation absorbable block copolymers and converting these materials into components or finished medical devices on behalf of our customers. Our orthopedic customers are increasingly requesting high-strength, absorbable knitted, woven, and braided textile constructions for augmenting tendon repairs with biocompatible polymers. Our Lactoprene 8812 (for use in multifilament constructs) and Lactoprene 8411 (for use in monofilament constructions) both have a 10+ year clinical history in long-term absorbable medical devices, offering biocompatible alternatives to PLLA-based medical devices with a history of exhibiting late-stage acid release issues.

Stephen Smith: The major issue now is the lingering effect of extended mill lead times from 2022/2023. Coming out of COVID, OEMs saw a surge in demand for orthopedic surgeries, many of which had been postponed in 2020. As a result, they placed additional orders for raw materials with the mills and for components with CMOs—in some cases, more than double normal projections. This led to mill lead times of over 52 weeks, and as much as 90 weeks on some grades, especially cobalt-chrome. Faced with such extended deliveries, the mills looked to distributors and bought whatever they could for immediate shipment from stock. The CMOs, under pressure from the OEMs to produce finished components above and beyond previous levels, were also looking to secure as much material as they could from the distributors. By the beginning of 2024, the OEMs had more metal than they needed for their production and more components than they could physically turn into finished product. With interest rates also increasing, finance departments took control and orders for material and components were pushed back or cancelled.

This drastically reduced demand for raw materials at the mill and distributor level for all of 2024 and into 2025. All this despite the fact there had continued to be a 5%-6% year-on-year growth in surgeries. The oversupply will dwindle down, more likely on certain items rather than across the board as 2025 progresses.

Brusco: Which specific orthopedic device trends are most significantly impacting your business?

Ackernecht: We’ve successfully used TPE in orthopedic products such as boots, support braces, orthoses, and shoe insoles for rehabilitation and injury recovery. Since many of these products are custom-made for individual patients, additive manufacturing presents an exciting opportunity to enhance both product quality and cost efficiency. It’s worth noting that THERMOLAST® M—even the super-soft grades—can be easily processed in 3D printers with granule feeding systems.

Heatherley: We observe several major trends directly impacting the business.

3D printing allows for increased customization of orthopedic implants, with lighter structures optimized for osseointegration. We offer a full range of certified titanium and cobalt-chrome powders specially adapted for laser fusion and EBM printing technologies.

The improvement of implant longevity relies on the use of materials with very high mechanical resistance and low wear, such as reinforced PEEK or grade 23 titanium. We ensure these materials comply with the highest standards in the industry.

Minimally invasive and robotic-assisted surgical techniques require extremely precise instruments and implants, often made from lightweight and durable alloys such as titanium or medical-grade stainless steel. Our cutting and machining equipment enables us to offer “near to shape” parts, facilitating processing and reducing material waste.

With growing demand in regions like India and Latin America, cost optimization is becoming a key challenge. Thanks to our international presence and expertise in stock management, we know how essential it is to support clients wherever they are to secure their supply chains and enhance their competitiveness.

Hester: Over the past several years, we’ve witnessed a dramatic increase in the percentage of orthopedic implants, cutting tools, and instruments manufactured with cannulation, due primarily to the ongoing increase in minimally invasive surgical therapies that use the K-wire. This has forced many OEMs and CMOs to invest in gundrill and other machine-tool capacity to install cannulation. This has created significant opportunities for companies like ours to provide pre-cannulated raw materials that allow OEMs and CMOs to manufacture cannulated parts more efficiently and without adding separate gundrill processing time. 

As inventories stabilize and end-use demand begins to flow throughout the supply chain again, we believe this availability of high-quality pre-cannulated bars will allow OEMs and CMOs to satisfy increasing demand more efficiently and quickly than in the past. This trend is likely to accelerate as medical device designers continue to respond to demands for even more minimally invasive therapies utilizing smaller devices with smaller cannulation that is difficult to install with gundrill or other machining techniques but is well-suited for pre-cannulated bar.

Rahill: Change, constant change within the supply chain at all levels, because we still live in a very chaotic global environment. Each medical device OEM, Tier One, and subcontract machine shop have many different unique initiatives driving their business and if you’re not ready to come up with tailor-made solutions for them, you’ll likely be left out of many opportunities.

Seacrist: As orthopedic medical device manufacturers continue to push the boundaries for regenerative medicine applications, patients continue to desire solutions that facilitate healing but go away after they’re no longer needed. Although synthetic polymers do not illicit the same biological effects as collagen and hyaluronic acid, they facilitate long-term reinforcement throughout the healing process. The combination of synthetic and biological-based polymers are in the their infancy, although are already having an impact as seen through products including Zimmer Biomet’s Tapestry electrospun collagen & synthetic implant (acquired from Embody) and ConMed’s BioBrace collagen/PLLA fiber containing implant (acquired from Biorez).

Smith: Mergers and acquisitions have been a key factor in the growth and development of medical device OEMs and CMOs, particularly over the last decade. CMOs can no longer specialize in one product in the supply chain. OEMs expect CMOs to provide a broader range of components and services, e.g., further processing of forged and machined parts, coatings, etc. This means their purchasing requirements expand; they need a wider range of grades and more value-add capabilities. Distributors must adapt to this scenario to keep pace.

Although the growth of additive manufacturing/3D printing in medical devices seems to indicate a shift away from the more traditional reductive machining process, it’s helping expand development of new, more intricate components and growing the overall market without reducing demand for basic raw materials. Opportunities are now opening for distributors to be involved in the AM supply chain from stocking and selling powder to supplying a full processing service for baseplates used in 3D printers.

One major trend we see at most of the OEMs is development and expansion in the production and use of robotics for orthopedic and spine surgery. Robots are particularly appealing at ASCs, where the focus is on consistency, repeatability, and where patients feel more comfortable than being exposed to the negative aspects of a traditional hospital setting. The expansion of robotic surgeries can only be good news for the CMOs and the metal distributors, as they should increase the overall number of surgeries, thereby requiring more metals and components.

Brusco: What are the largest pain points in the supply chain for medical-grade materials at present?

Ackernecht: It’s difficult to say as medical additives and raw material supply chains are some of the most secure in the world. We are managing this very well, in our humble opinion.

Heatherley: The supply of titanium and cobalt-chrome remains subject to geopolitical and economic tensions. Thanks to our storage capacity and a diversified supplier network, we ensure continuous supply for our clients. Compliance with regulations such as MDR in Europe or FDA standards complicates access to materials. Our teams ensure continuous monitoring and technical support to guarantee certified and compliant materials to our clients.

The increase in transport costs and congestion in supply chains requires optimized flow management. Our logistics platform network enables us to ship materials quickly, reducing delivery times for our clients. Medical device manufacturers are increasingly looking for materials from responsible supply chains. Our “Green Titanium” offering and commitment to more sustainable logistics address these expectations. These initiatives are part of a larger, ambitious project aimed at achieving B-Corp certification.

Certain critical medical materials are produced by a small number of players, increasing the risk of disruption. It’s crucial to diversify sources of supply and offer alternatives to secure clients’ stock. Quality communication with clients and continuous contact with teams on all continents allows us to identify the right solutions while respecting all specifications.

Hester: As inventories stabilize and end-use demand begins to flow throughout the supply chain again, we believe manufacturing capacity constraints will begin to manifest in the market, increasing the benefit of working with pre-cannulated bar that doesn’t require specialized gundrill machine capacity.

Rahill: Trying to manage the cost reduction goals of the market in an inflationary market, with many customers still in an excess inventory situation. The implementation of the section 232 tariffs for stainless steel grade implants and instruments only creates more fear, confusion, and anxiety for our customer base.

Brusco: Anything else you’d like to say regarding materials used in orthopedic device manufacturing?

Ackernecht: The fit, form, and function of a medical device determine the material requirements—ranging from super-soft grades for impact absorption, comfort, flexibility, and protection, to higher-hardness materials for added durability and structural support. A broad hardness range allows for a tailored solution to meet each patient’s unique needs. Beyond performance, critical factors include safety, purity, consistency, availability, and traceability, with compliance to ISO 10993 Parts 4, 5, 10, 11, USP Class VI, and more. Our THERMOLAST^® M grades meet these demands and are free from nitrosamines, PFAS, and latex allergens. Additionally, they feature a smooth-touch, low-friction surface ensuring a comfortable skin feel—an important consideration for skin-contact medical devices.

Mease: For our Orthtek material, we leveraged decades of thermoplastic composites manufacturing and process optimization skills to provide Tier 1 device manufacturers and machine shops the ideal plate and blank forms. These plates are absent of voids and porosity, with the usable area extending practically to the very edges of the plate. Using novel processing approaches and analytical optimization, we have recently increased the plate’s thickness capability up to 2.5 inches.

Smith: The most encouraging aspect of the medical device market is it’s somewhat impervious to economic conditions. As the population ages, the current baby-boom generation wants to stay active as long as possible and they’re showing the way to subsequent generations. This all augurs well for continued growth in orthopedics. Distributors of medical grade materials have a bright future—they must keep up to date with industry trends and have the right material in stock when the OEM or CMO needs it.