Extrusion is an essential manufacturing process in the medical device industry that continues to evolve, driven by the growing demand for complex designs, miniaturization, and advanced materials. This, in turn, leads to more innovation in equipment and systems manufacturing, such as automated processes and high-precision digital machine controls.
A key role of medical plastic extrusion is producing customized extruded tubing and complex profiles for various medical applications.

“Medical plastic extrusion has revolutionized the medical device industry,” stated Varun Venoor, Ph.D., senior extrusion engineer for Teleflex Medical OEM, a Jaffrey, N.H.-based global provider of specialty medical devices used in a range of procedures for critical care and surgery markets. “By altering the properties of unmodified base resins, extrusion can create customized tubing and profiles with unique properties, utilizing advanced polymeric resins and incorporating additives as required.”

Medical plastic extrusion is a preferred method for making cost-effective and disposable medical products, as well as many of the components and devices that support minimally invasive surgeries (MIS), thereby improving patient outcomes. As these procedures become more prevalent, with a broader range of applications, so does the demand for customized/more complex extrusion configurations.

“Requests by medical device manufacturers for devices that are utilized in MIS [minimally invasive surgery] inevitably flow downhill to medical extrusion companies, who are tasked with producing components that offer tolerances in increasingly small diameters,” said Gary Mizenko, global head of technical operations, medical devices, for TekniPlex Healthcare, a Wayne, Pa.-based company that provides innovative solutions through materials science and manufacturing technologies. “These factors place a heightened emphasis on the extrusion process.”

Although the medical extrusion market is robust, COVID-19-related supply chain shortages and concurrent destocking obstacles still linger; there are also cost pressures on extruders to produce more sophisticated, tighter-tolerance tubing solutions at a more commoditized price. “The need for more efficient, expedient collaboration is paramount to meeting these challenges,” noted Mizenko.

Latest Trends

The growing demand for precision medicine is pushing extruders to produce unique medical extrusions, especially complex profiles with tight tolerances and specific characteristics. Extruders are busy developing innovative solutions and/or processes for these challenging applications—for example, making catheter navigation to internal organs easier by adding low-friction additives to the tubing. “Thin-walled extrusion with tighter tolerances is in high demand, with larger sizes [inner diameter] employed in structural heart applications, such as catheter builds, while smaller inner-diameter tubing finds use in neurovascular interventions,” said Dr. Venoor.

Multi-layer extrusion and coextrusion techniques continue to gain momentum in medical applications. These processes enable the combination of different materials with varying properties, such as flexibility, strength, and barrier properties, all within a single extruded component. Such versatility promotes the design of tailored products that meet specific medical requirements, such as enhanced performance, improved drug delivery, and superior infection control.

All of these developments play a critical role in improving patient care, enhancing device performance, and addressing environmental concerns associated with traditional medical device materials.

The adoption of automation and other Industry 4.0 technologies continues to accelerate the pace of creative design and development in extrusion. Automation enables precise and consistent production, reducing human error and increasing efficiency. Industry 4.0 incorporates technologies such as the Internet of Things (IoT), AI, and advanced data analytics, all of which 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,” said Martin Forrester, R&D technical manager for Aptyx, a global provider of specialized engineering and manufacturing services for the medical device industry, including extrusion, injection molding, coatings, and medical device assembly.

Miniaturization is driving many innovative and next-generation advancements in extrusion for medical devices. Medical device manufacturers (MDMs) increasingly demand smaller-diameter tubing with thinner walls, pushing the boundaries of extrusion science. “There is also a strong emphasis on optimizing designs for better performance, such as improving torque response in braided catheters,” said Tim Finn, manufacturing and process manager for New England Tubing Technologies, a Lisbon, N.H.-based provider of custom medical braid, spiral- and braid-reinforced tubing, lubricious lined catheter shafts, and multi-lumen and multi-durometer tubing.

Greg Smith, manufacturing engineer for NewAge Industries, a Southampton, Pa.-based manufacturer of fluid transfer tubing and hoses for industrial and biopharmaceutical markets, sees the extrusion industry shifting toward more data-driven and simulation-based approaches. “There seems to be a growing emphasis on optimizing the extrusion process from the screw to the die,” he said. “Advancements in flow simulation software have also revolutionized tooling design, enabling more efficient and precise product creation.”

What MDMs Want

MDMs and their design houses are keenly focused on integrating miniaturization and improved process controls into their products. There is also constant pressure from MDMs for top quality, accuracy, consistency, and shorter lead times—all of which improve speed to market.

They also expect their extrusion partners to respond quickly to meet their evolving needs, including tolerances, drawings, and specification requirements—at an agreeable price point and with speed and accuracy. Innovation is the key to keeping pace with these demands. For example, TekniPlex Healthcare has developed a virtual new production introduction (NPI) process that utilizes the company’s combined global engineering knowledge. NPI engineers from each global facility meet virtually on a routine basis to discuss NPI challenges and plan out prototype runs with the goal of decreasing the cycle time from prototype to solution. “This expansion of brain power within the extrusion expertise at TekniPlex has enabled us to meet the ever-demanding needs of MDM customers,” said Mizenko.

Other MDM requests include improved control systems for automation, real-time process monitoring, and data logging to enhance precision and traceability as well as to minimize human error. MDMs that support minimally invasive and robotic surgical procedures are especially interested in finding smaller-diameter tubing with tighter tolerances at or below ±0.001” in a variety of materials.

Ultimately, while quality and safety are still the top demands, “cost-effective product manufacturing remains a customer priority, whereby the selection of extrusion technology strikes a balance between performance, reliability, and affordability,” said Dr. Venoor.

Extrusion Innovation

There have been notable advancements in extrusion technology in recent years, especially in the areas of energy efficiency, data acquisition, and process monitoring. These improvements have enhanced the efficiency and sustainability of the extrusion process. Equipment manufacturers are focusing on developing extrusion systems that consume less energy and minimize environmental impact. “In addition, the integration of advanced sensors, automation systems, and data acquisition technologies has allowed for real-time monitoring and control of critical process parameters,” said Dr. Venoor. “This ensures greater precision, consistency, and quality control throughout the extrusion process.”

Industry 4.0 technologies have helped extrusion technology achieve smaller and narrower profiles. With precise control over die design and advanced cooling methods, extruders can produce profiles with extremely tight tolerances and intricate geometries. “This enables the creation of micro-extrusions or thin-walled structures that were previously challenging to achieve,” said Dr. Venoor. “Such advancements open up new possibilities in various segments within the medical device industry.”

For example, TekniPlex has designed extrusion equipment capable of achieving 0.0005-inch tolerances for both outer diameter (OD) and inner diameter (ID) for various materials such as polyvinyl chloride, thermoplastic polyurethane, and nylons. “We have been able to develop these processes to not only maintain these tolerances during the extrusion process, but also after any growth or shrinkage without the need for post-annealing,” said Mizenko.

The medical industry is experiencing a shift toward biocompatible and bioresorbable polymeric materials for medical extrusion. These materials offer advantages such as reduced risk of adverse reactions, compatibility with physiological environments, and the ability to degrade naturally over time, eliminating the need for subsequent interventions. Resin manufacturers are working hard to develop biobased resins that will offer comparable performance and function to traditional fluoropolymers. This shift will not only enhance patient safety, but also address growing environmental concerns regarding perfluoroalkyl and polyfluoroalkyl substances [PFAS].

Tool designers continue to improve the precision, efficiency, and process controls of their equipment. Advanced manufacturing execution systems (MES) with real-time data analytics can enhance precision for tight-tolerance processes and improve manufacturing efficiency. “Real-time data analysis and machine learning algorithms are improving product consistency and reducing defects,” said Finn. “Advances in tooling design and manufacturing enable tighter tolerances and improved surface finishes.”

Advanced extrusion equipment plays a pivotal role in achieving optimal results by providing precise control over crucial process parameters. This enables the efficient production of intricate profiles from a variety of materials. “The utilization of versatile polymer resins allows catering to diverse product designs and specifications without significant reconfigurations,” said Dr. Venoor. “Meanwhile, the need for process optimization is crucial, as it enables continuously enhancing extrusion techniques by fine-tuning parameters such as melt temperature, die design, and screw speed. This not only ensures consistency, but also emphasizes the need for ensuring quality at source by continuously monitoring critical-to-quality specifications.”

Loren Bridges, principal manufacturing engineer for Confluent Medical, a medical device manufacturer that specializes in the design, development, and large-scale manufacturing of interventional catheter-based devices and implants, agreed.

“There are many excellent products on the market that help bond dissimilar materials during multilayer extrusion processes, both from larger polymer manufacturers and from smaller compounding houses,” he said. “These innovations open up the ability to marry different polymers to get unique shaft properties—for example, using a polyolefin grafted with maleic anhydride as a bonding layer between high-density polyethylene and polyamide or polyamide co-polymer layers.”

Advancements in quality inspection techniques have also enhanced the reliability and efficiency of extrusion. Non-destructive testing methods such as inline vision systems, ultrasonic testing, and optical inspection systems allow for continuous quality monitoring during production. “These technologies ensure the detection of defects, wall thickness variations, or surface imperfections, enabling manufacturers to address issues promptly and maintain high-quality standards,” said Dr. Venoor.

Smart inspection systems, powered by machine learning, are making it easier to identify defects such as foreign material, gels, and surface imperfections. “This advanced equipment allows us to go back and improve our extrusion process based on the found defects,” said Finn.

LaserLinc recently introduced FlawSense, a high-speed inline inspection and measurement system that detects surface flaws and takes accurate OD and ovality measurements.¹ The system uses multiple laser beams that pass through optics to project a linear array of light; a CMOS (complementary metal-oxide-semiconductor) array sensor then collects the reflected light, providing multipoint measurements of triangulation across the field of view of the laser, allowing a profile to be computed using algorithms and point cloud data manipulation. The high-resolution laser technology can detect flaws as small as 0.0002 inches. The resultant 3D image is then used to identify and correct the process problems causing the defect. This process is more accurate than laser micrometer systems and camera vision technology.

Although AI is the hot topic these days, high-quality specialty extrusion still requires experienced personnel on the line, who have logged many hours of iterations during the development process. Iterations require human interaction and knowledge—human intelligence rather than artificial intelligence. “Due to the variation of the incoming raw materials for each production run, it is difficult to manage all of the fluctuations in the subsequent extrusion process,” said Mizenko. “We utilize real-time data gathered from the process, allowing experienced technicians to make well-informed immediate decisions to compensate for any variations.”

Regulatory Implications

Earlier in the year, the FDA finalized a rule to incorporate ISO 13485 into the new Quality Management System Regulation (QMSR). Starting in February 2026, this ISO 13485 integration will require process validation for the production of medical device products, with the FDA mandating process validation to ensure specifications are consistently met. Both the FDA and ISO 13485 provide general regulatory requirements; however, neither offers substantive guidance on how to specifically conduct the actual validations.

To aid its MDMs in meeting FDA validation requirements, TekniPlex Healthcare has developed a Master Validation Questionnaire (MVP) to ensure the customer validation quality requirements match the TekniPlex Healthcare validation quality protocol. The MVP is a semi-automated spreadsheet that allows customers to develop the validation plan in a manner that meets their requirements. “It encompasses items such as critical dimensions, properties, measurement techniques, operational qualification/performance qualification [OQ/PQ], gauge repeatability and reproducibility [R&R], and all report requirements necessary to complete an extrusion validation per ISO 13485, as well as per the FDA,” said Mizenko. “This approach has streamlined the validation process, reducing its timeframe by 40% to 50%.”

Also, increased regulatory focus on PFAS and other emerging contaminants presents significant challenges for the medical device industry. MDMs are increasingly scrutinized regarding the environmental and health impacts of their products, with demands for greater transparency and assurance.

PFAS regulations will likely have an impact on fluoropolymer tubing at some point in the near future. “As more materials are added to the restricted substances lists, replacement materials have to be found or invented with similar properties,” said Amin Ghasemian, product development extrusion engineer at Confluent Medical’s Orange County, Calif., facility. “Staying current with the different material types and how to process them can be difficult.”

Finn agreed.

“It is a complex task, identifying suitable alternatives to PFAS-containing materials, while still maintaining product performance and biocompatibility,” he said. “This, coupled with the need to navigate a rapidly evolving regulatory landscape, requires substantial resources and expertise.”

Innovation at the Forefront

Extrusion technology continues to advance at a rapid pace. For example, X-ray inline wall measurement is getting serious attention as a replacement for ultrasonic gauges because it has the potential to detect some of the smallest diameters and wall thicknesses, without needing the tuning that is required for ultrasonic measurements. “A few more innovations in that technology, or a new process, will help make online wall thickness measurement simpler, more consistent, and faster,” said Ghasemian.

Extruders and extrusion equipment manufacturers continue to innovate to meet increasingly challenging MDM requests. For example, Aptyx has developed proprietary hybrid lines for the internal production of tubing designed for surgical smoke evacuation. The automated process produces differentiated tubing inline, eliminating the need for secondary processes and ensuring consistent quality and reliability, including optimal stretch. “The result is extruded tubing that offers enhanced elasticity at the device end, improving the surgeon’s experience without raising costs,” said Forrester.

One of the most innovative technologies is an alternative to extrusion. Spectrum Plastics Group, A DuPont Business, developed a proprietary additive manufacturing process that creates tubing, without the need for extrusion. Spectrum can 3D-print single- and multi-lumen tubing configurations in multiple materials with turnaround times ranging from hours to days—”a first in the industry,” said Tyler Stark, innovation hub leader for Spectrum.

Innovations do not have to be disruptive to have a major impact on the extrusion process. Design changes often aim to increase efficiency, reduce steps, and save time. For example, in July 2024 US Extruders announced its Med-Ex Reflow process, a single-screw extruder for medical tubing. In the past, it has been a challenge to design a single screw that can handle a variety of materials—Med-Ex Reflow is unique in that it can process Pebax, nylon 12, and PU equally well. “This machine allows those contract manufacturers that are doing a lot of changeovers the ability to run all of those materials with one screw design,” said Steve Maxson, US Extruders’ innovation and business development manager.²

“The versatility of this screw design simplifies the extrusion process, making it adaptable to different materials without the need for multiple screws, ultimately enhancing operational efficiency and enabling high-quality production of medical devices,” added Dr. Venoor.

OEMs often push the boundaries of what is possible. However, medical device designers do not always understand the capabilities of extrusion and request tolerances and designs that do not lend themselves well to design for manufacturing (DFM). Also, they often do not fully understand the critical role of individual extrusion process parameters in achieving desired part performance—for example, that uniform crystallinity in PEEK requires precise control over temperature, pressure, and cooling rates.

“By collaborating closely with MDMs early in the design phase, we can identify potential challenges and optimize the extrusion process to meet product requirements,” said Finn.

AI, IoT, and Industry 4.0 are evolving quickly, creating the potential for real-time sensing and analysis of what seems like an endless number of process variables. Keeping up with rapid developments in materials and technologies can seem daunting at times for extruders.

“The challenge is understanding how those variables impact the final extruded product, and determining what to change in the production process itself to produce a higher-quality product, said Mizenko. “Extrusion is definitely a combination of art and science, and the human element cannot be dismissed. Perhaps the most prominent opportunity to improve extrusion rests with larger-scale crowd-sourcing environments, which have the potential to accelerate innovation and drive more unique innovations in the near future.” 

Reference

1. tinyurl.com/mpo241081
2. tinyurl.com/mpo241091

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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.