The medical extrusion industry is extremely robust, driven by demand for ultra-precision extrusions for single-use devices used in complex anatomy and life-saving procedures, especially in fast-growing sectors such as electrophysiology, structural heart, and neurovascular devices. Medical device manufacturers (MDMs) rely on extrusion technology extensively for manufacturing catheters, tubing, and implantable components. Multi-lumen extrusion has become increasingly sophisticated, enabling complex cross-sectional profiles for drug delivery systems and minimally invasive surgical tools. Other key trends include co-extrusion techniques for combining multiple materials in single components, integration of radiopaque markers during the extrusion process, and development of antimicrobial surface treatments applied in-line.

“There is also an advanced focus on micro-extrusion capabilities, biocompatible polymer processing including bioresorbable materials, and tight tolerance control for meeting FDA regulatory requirements,” said Jean Paul Jiron, a global AI senior process engineer for Utah-based ATL Technology, a global, full-service, vertically integrated engineering and manufacturing partner to the medical device industry.

MDMs and their contract manufacturers (CMs) also seek greater control over supply chains and customization through more in-sourcing for high-volume fluid management, such as IV lines and dialysis-circuit tubing. “Overall, the industry is evolving toward smaller diameters, multi-layer constructions, and enhanced material properties to meet the needs of minimally invasive procedures, with equipment advancements enabling tighter tolerances, higher CPKs [capability process index], and faster changeovers,” said Steve Maxson, director of innovation and business development at US Extruders, a Westerly, R.I.-based manufacturer of extrusion equipment, especially medical extruders and systems designed for high-precision applications.

Today’s medical devices require precision tubing that supports miniaturization, while also maintaining performance and reliability. This requires tighter tolerances, thinner walls, and increasingly complex catheter designs. “MDMs are pushing beyond traditional braiding and coiling toward new approaches—such as pairing extrusions with laser-cut hypotube backbones—to achieve better flexibility, articulation, and mechanical properties,” said Patrick Daly, director of global extrusion for Tempe, Ariz.-based Aptyx, a global design and manufacturing partner that offers a broad range of services to MDMs, including extrusion, molding, coating solutions, and assembly. “At the same time, extrusion partners must deliver not only innovation, but also scalability and cost efficiency.”

A challenge for MDMs in any hot market is the entrance of more players that are eager to take advantage of the increased demand, but may not have the appropriate skills or depth of knowledge to meet strict MDM expectations. 

“In my opinion, extrusion in the medical device industry is becoming diluted because too many companies are trying to vertically integrate extrusion by simply buying and implementing equipment without taking the next step to invest in the people and training required to master the fundamental basics of the process,” said Ben Ebert, extrusion engineering director for LightningCATH, a Brooklyn Park, Minn.-based rapid-turn medical device contract manufacturer and extruded component supplier. 

Latest Extrusion Trends 

Plenty of innovation is happening in the extrusion market.

“New formulations are turning heads everywhere you look,” said Todd Dickson, president of Santa Clara, Calif.-based Lumenous Device Technologies, which laser-processes medical device components/subassemblies and nitinol materials. “Today’s materials are rocket fuel. Laser-cut shafts are making their way into more and more segments. The design space is really popping—old, unavoidable trade-offs are now starting to pass away.”

Tighter tolerances, single and multilayer tubing in large and small diameters, and complex profiles are in high demand. “Complex extrusions for structural heart applications are where we are seeing significant demand and need for complexity,” said Mihir Goradia, engineering manager, catheters and extrusions, for Teleflex Medical OEM, a Limerick, Ireland-based provider of complex extrusions, diagnostic and interventional catheters, precision fluoropolymer and polyimide extrusions, and custom suture assemblies. “Customers also want very thin wall, ultra-low durometer extrusions (e.g., 40-70A) in polyurethane that can be fused to other more conventional materials. These are used in a wide range of complex composite catheter assemblies in the neurovascular space.”

Another innovative segment is ultra-soft micro-bore tubing for neurovascular applications, where diameters as small as 0.01 inches outer diameter (OD) with wall thicknesses under 0.002 inches are common, enabling delicate navigation in brain vasculature. Large-bore tubing (up to 24 French or ~8.0-mm OD) is popular for structural heart interventions, such as transcatheter aortic valve replacements (TAVR), requiring robust yet flexible profiles for delivery systems. “These segments are fueled by growth in minimally invasive cardiology and neurology procedures, with extrusion playing a pivotal role in enabling device miniaturization and performance,” said Maxson. 

Multi-lumen flexible tubing and paratubing are both expanding markets with abundant development opportunities in the pipeline. Sustainability is yet another goal. “Currently, we are having discussions with several MDMs regarding our help in developing products or methods where they can either use post-industrial recycled materials or reuse their own material to support sustainability efforts in the medical device market,” said Christian Herrild, director of growth strategies for Teel Plastics, a Baraboo, Wis.-based diversified extruder and molder serving a variety of end markets, including medical device components. “We have several parts on test with an MDM right now.”

Other key trends that are shaping the extrusion market include:

• Miniaturization and complexity—“Multi-lumen extrusions with ultra-thin septum walls are now common, requiring tight stack-up tolerances to avoid cross-talk,” said Daly.
• Integration with advanced designs—“New extrusions are being developed to complement laser-cut hypotubes and other next-generation delivery systems,” indicated Brian Walsh, director of development for Aptyx.
• As surgical robotics become more common across the board, development teams are pushing the envelope on tolerances for both large bore and micro extrusions with extremely tight tolerances and unique additives to ensure minimal wear and resistance.
• Cost and yield optimization—Since MDMs face cost pressures, design solutions that improve process yields without sacrificing precision, such as optimized core mandrels, are gaining attention.

What MDMs Want

“How thin can you go and how consistent can you make it?”

“This is what we are often asked first,” said Daly. “Customers want thinner walls, more lumens, and the ability to push catheter performance limits without compromising yield. Maintaining lumen separation [avoiding cross-talk] is a frequent challenge.” 

MDMs also want high precision, with tolerances in the ±0.0005-inch range or better. Large diameter extrusions, sub 1F size tubings, and repeatable mechanical properties such as tensile strength and elongation are in high demand. Sometimes MDMs and their CMs must be creative with co-extrusion to achieve novel performance requirements in complex catheter assemblies. “For example, steerable catheters may have different durometer sections in the desired steering plane to facilitate low deflection forces, but still must have a robust catheter structure,” said Goradia.

Complex multi-lumen configurations, such as asymmetric lumen arrangements, are often requested, including “custom multi-layer extrusions that combine lubricious inner layers with durable outer jackets for bonding integrity,” said Maxson. 

MDMs are always looking for advanced material processing capabilities, including polyether ether ketone (PEEK), bioresorbable polymers, and materials meeting USP Class VI requirements. There is heavy demand for radiopaque materials integrated during extrusion for better visibility under fluoroscopy, especially in electrophysiology and vascular applications. OEMs want faster prototyping turnaround with tighter tolerances and materials that support secondary processes, such as laser welding or balloon forming. 

The adoption of automation and other Internet of Things (IoT) technologies continues to accelerate the pace of creative design and development in extrusion. Automation is seen as a way to improve quality, efficiency, productivity, and speed to market. When automation is combined with artificial intelligence (AI) and IoT, “lights out” manufacturing can be achieved for certain products. Automation enables precise and consistent production, reducing human error. IoT technologies, especially advanced data analytics, facilitate real-time monitoring and control over the extrusion process. This leads to improved quality, faster production times, and the ability to create more complex and customized extruded products. “Medical device manufacturers are looking to reduce time to market by utilizing highly automated processes that have a fast return on investment on the cost of that automation,” said Walter Tarca, president of Forefront Medical Technologies, a Singapore-based medical device contract manufacturer.

Advanced Tools, Tech, and Materials

The extrusion industry is growing exponentially, pushing technology to limits that have not been seen before. Dimensions continue to get smaller: micro-extrusions now routinely achieve 0.008- to 0.01-inch OD with walls as thin as 0.0015 inches.

Teel Plastics has developed several products with combined dimensions that are impressive—for example, parts that are 0.25 inches OD with a wall that is 0.005 inches, a 0.002-inch inner diameter in a part with a 0.08-inch OD, and several items with inner or outer layers that are 0.001 inches in a 0.01-wall. “These are dimensions that customers may not think are possible, but with the right process, we can make them happen,” said Herrild. 

Micro-lumen tubing allows multiple therapies to be safely administered through a single access point. “We have also added a thermally bonded multi-tubing extrusion process with different colors,” said Tarca. “Inspection is done using in-line high precision contactless measurement equipment.”

AI-powered in-line inspection systems can detect flaws as small as 0.0002 inches. Advanced data capture and analytics help reduce post-extrusion batch inspections, which speeds up time to market and reduces costs. Quality inspection has advanced with in-line laser gauging providing closed-loop feedback for real-time OD, wall thickness, and eccentricity control, integrating with downstream cutters to auto-reject off-spec parts.

“Inline and post-process inspection methods—such as tensile testing, surface finish analysis, and CPK/PPK [process capability indices] data collection—ensure repeatability and compliance,” said Daly. “Advanced vision systems are increasingly applied to detect micro-defects earlier.”

Material science continues to advance. “For bonding and materials, tie-layer resins enable strong interlayer adhesion in multi-layer co-extrusions of dissimilar polymers—for example, high-density polyethylene inner with nylon outer—preventing delamination,” said Maxson.

Originally introduced as an alternative to traditional polytetrafluoroethylene (PTFE) with e-beam compatibility, Dynaflex’s EverGlide+ delivers PTFE-like lubricity. Instead of locking into a single stiffness, this material offers durometer control from 20D to 60D. “This means the flexible distal tip you designed won’t be canceled out by stiff PTFE,” said Dickson. Often used as a liner, the nylon-based material easily bonds with Pebax. 

“The nylon-based extrusion also adheres to metal, so the ever-present delamination concerns are passing away,” added Dickson. “Bonding to metal means that laser-cut shafts are finally setting designers free from the limitations of braid construction, including build time, scalability of challenging transitions, bulky profile, and insufficient payload space. EverGlide+ creates the opportunity to dial in the optimum interaction of metal and extrusion, harnessing the metal and polymers as a single team,” said Dixon. 

Advanced extrusion methods, such as coextrusion, also expand bonding flexibility. Tight tolerances and dimensionally stable extrusions directly improve bonding by minimizing variation and reducing cumulative stack-up across components. This consistency not only enhances process repeatability and reduces scrap rates; it also enables engineers to optimize designs and select bonding methods based on performance, rather than having to compensate for variability. “In the same way that precision extrusion supports device miniaturization and yield, it also provides a more reliable foundation for downstream assembly,” said Walsh.

For extrusion equipment, recent advancements include US Extruders’ Med-Ex Reflow single-screw extruder, which uses a versatile screw design to process diverse materials like Pebax, nylon 12, and polyurethanes without frequent changeovers, reducing downtime by up to 50% and improving efficiency for contract manufacturers handling varied runs. “The direct-drive system eliminates gearboxes and belts, minimizing particulates and oil contamination—critical for cleanroom medical extrusion,” said Maxson. 

Teel Plastics is doing interesting development work with extrusion-on-extrusion. This involves running and fully cooling the first part and lining it up with a second extruder to extrude the second feature, as part of a continuous process. “I’ve never seen anyone doing anything quite like it,” said Herrild. “Back-to-back extrusions allow you to layer things that normally will not extrude together. And you can have them bond or not, depending on how you set your second extruder.” 

Regulatory Challenges

The FDA is still sharply focused on concentrations of PFAS and other emerging contaminants in medical devices and their impacts on environmental and human health. 

“MDMs have largely been on the outskirts of the issue so far, with the FDA still approving medications that are PFAS and devices with fluoropolymers,” said Herrild. 

However, a potential ban on the manufacture and use of PFAS in medical devices “has led to significant interest in evaluation of melt-processible, non-fluoropolymer alternatives,” said Goradia.

New materials to date that include PFAS-free low-friction compounds include Foster’s ProPell.

MDMs are still discussing replacement materials, but in most cases, no material can meet all the performance characteristics of PFAS. Therefore, it should not be surprising, given the cost and challenge of working with these materials, they are only used when they are really needed. “Working without them will lead to changes in either device design or function or both, and MDMs are still working through these considerations,” said Herrild. 

As more materials are added to restricted substances lists, developing replacement materials is high on the MDM wish list. Staying current with the different material types and how to process them can be challenging.

“Other FDA challenges regarding extrusion center on biocompatibility [ISO 10993], process validation under 21 CFR 820, and extractables/leachables testing for tubing in contact with bodily fluids or drugs,” said Maxson. Cleanroom validation (ISO 7/8) is critical, with particulates from gearboxes now mitigated by direct drives. Supply chain transparency for resin sourcing is scrutinized under unique device identification (UDI) rules. Extrusion firms must document dimensional stability post-sterilization to avoid failures. Breakthroughs such as virtual sensing help meet these requirements without compromising safety, but MDMs often underestimate validation timelines for novel materials.

Innovation Drives Discovery

Equipment technology continues to improve. For example, advanced servo drives and motors are improving extrusion machine control and measurement. This improves both the speed and precision of the extrusion process. AI-driven autonomous extrusion leverages machine learning to self-adjust process parameters such as temperature, screw RPM, and line speed. These advancements reduce time to market and the need for a highly skilled workforce. New developments in polymer science enable the ability to control materials and drive process improvements—for example, the multi-material integration of five or more materials in a single tube, such as metals, ceramics, and electronics, all embedded within polymer structures to create concepts such as “smart catheters” that have built-in sensors.

AI is emerging in extrusion through machine learning algorithms for anomaly detection in process data, thereby optimizing screw speeds or die gaps to minimize defects. For instance, AI-driven analytics can predict material inconsistencies from sensor feeds, improving first-pass yields. “While not yet fully implemented in our base systems, we are exploring AI for adaptive control in multi-layer runs, where it could auto-adjust for viscosity variations, making processes more efficient and less operator-dependent,” said Maxson. “This aligns with broader Industry 4.0 trends in medtech, where AI helps scale from R&D to production.”

One of the most transformative developments on the horizon is the mainstream adoption of variable durometer extrusion technology. “For example, an AI and microprocessor-controlled process that joins distal, intermediate, and proximal catheter sections using two or three polymers with varying durometers,” said Maxson. “This allows for a seamless transition between hard and soft segments—such as a 72D Pebax proximal section for pushability and a 35D distal tip for flexibility—within a single extrusion run.” 

A complementary technology to extrusion is filmcast (or dipping) of ultra-thin polyimide and PTFE liners combined with advanced tie-layer coatings. Filmcast processes can build polyimide and PTFE liners with walls as thin as 0.0005 inches, far beyond what single screw extrusion can reliably achieve. IDs are defined by precision mandrels, which make this ideal for micro-catheters and neurovascular devices.

“Film-cast processes are consistently producing sub-thousandth-inch walls, while still maintaining lubricity and mechanical strength,” said Maxson. “That combination is indispensable for next-generation neurovascular and structural heart devices, where every micron of wall reduction translates to better deliverability.”

Daly noted the volume and sheer complexity of requests for quotes coming from R&D groups
is remarkable. 

“Designs that once seemed unextrudable are now routinely expected,” he said. “We’re also excited by the surface finish we can achieve on our core mandrel. Under 200X magnification, surfaces remain smooth and consistent across long runs, ensuring low-friction release and preserving lumen geometry. This is the kind of incremental innovation that quietly enables breakthrough devices.”

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.