Wall to Wall: The Future of Medical Device Extrusion

From catheters and tubing to multilayer structures and specialty components, extrusion remains a foundational process for producing medical devices and components. That said, evolving requirements are driving advances in equipment, materials, automation and quality control.

At the same time, manufacturers face persistent challenges, including material variability, increasingly demanding specifications, regulatory requirements, and pressure to improve efficiency without compromising quality. These factors are prompting extruders and device manufacturers to refine processes and adopt new technologies throughout the production cycle.

To explore where medical device extrusion is headed, MPO spoke with 10 industry experts about the technologies, materials, and manufacturing trends shaping the market. Their insights highlight how extrusion suppliers are addressing tighter specifications, emerging applications, and the growing need for scalable, reliable, and cost-effective production.

• Luke Allen, process engineer at New England Tubing Technologies
• Larry Alpert, medical extrusion support specialist at Graham Engineering Company
• Jason DiChristofaro, strategic market manager, extrusion at Graham Engineering Company
• Brian Frechette, operational strategist at Medical Extrusion Technologies (MET)
• Christian Herrild, director of growth strategies at Teel Plastics
• Paul Mazelin, president and CEO of SiMEDEx Inc.
• Stephanie McGee, VP of sales operations at Command Medical Products
• Suresh Sainath, chief technology officer at Zeus
• Dave Schroeder, president and CEO at Graham Engineering Company
• Tim Steele, founder and CEO at Microspec Corporation

Brusco: What applications are driving demand for increasingly complex, multi-lumen designs? How has tooling evolved to support these products?

Luke Allen: I see miniaturization driving a lot of the demand. We continue to try to fit more in less space, leading to ultra-thin walls and complex arrangements. To keep pace, we’ve had to use a combination of additive and subtractive manufacturing in our tool design: Additive to achieve the complex shapes, and subtractive to improve surface finish and tolerances. However, I foresee improvements in additive manufacturing continuing to erode the line between machined and printed finishes.

Larry Alpert: As various electronic sensors become miniaturized, catheter designs try to leverage adding them to devices. Devices that require passage of sensors as well as having working channels for various tools have been around for a while, especially in laparoscopy, endoscopy, robotics, and other larger French sizes, but are starting to take hold in cardiology, neurovascular, and other applications. These require another level of precision and smaller extruders with screw and feed throat customization to ensure consistent solids conveyance and to minimize residence time to ensure there’s no material degradation.

Brian Frechette: Demand is being driven primarily by advanced catheter and delivery systems—particularly in cardiovascular, neurovascular, electrophysiology, and structural heart applications. These devices increasingly require multiple independent pathways within a single shaft for guidewire access, fluid delivery or aspiration, balloon inflation, sensor integration, or steering mechanisms, all while maintaining a low overall profile.

Modern extrusion tooling is designed and fabricated in-house with much tighter precision, enabling complex multi-lumen geometries, thinner walls, and tighter tolerances that were difficult or impossible to achieve reliably a decade ago. Advances in die design, mandrel technology, and process monitoring allow consistent production of intricate cross-sections while preserving lumen integrity and dimensional stability from prototype through production scale-up.

Christian Herrild: These can broadly be split into two categories. One is enhanced function through more lumens and more complex designs allow a device to do more with a single shaft. The second is cost savings, where parts that used to be multi-tubing lay-ups or assemblies are being made into a single tube through a more advanced extrusion process. 

Tooling needs to keep pace with these designs, obviously. We’re doing more flow modeling and more advanced designs on pins to get tooling closer on the first try. This also helps the process be more consistent. The target should be to have tooling that can make a part 24/7 at high quality, as opposed to things that need engineering support to maintain tolerance.

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Paul Mazelin: Cardiac rhythm (pacemaker leads) and neurostimulation applications top the list for the multi-lumen applications with greater complexity. With these applications being the primary electrical insulation for the device, minimum wall thickness requirements between lumens, as well as to the outer diameter, make these configurations extremely challenging. It’s not uncommon for these cross sections to have greater than 10 dimensions that must be held with tolerances tighter than +/-0.001”. Other device manufacturers look for catheters to perform multiple functions simultaneously. This is driving additional lumens in cross sections for functions such as balloon inflation, irrigation, aspiration, and device deployment.

Tooling has become increasingly smaller as a result. Unlike thermoplastic extrusion that uses pressurized air to maintain patency during extrusion, silicone extrusion typically uses ambient air. Mandrels require sufficient air flow to maintain patency and this at times limits how small of a pin you can use to create a lumen.

Stephanie McGee: Demand is being driven primarily by minimally invasive and catheter-based procedures, including cardiovascular, electrophysiology, structural heart, neurovascular, endoscopic, drug-delivery, and other interventional applications. These devices increasingly need to transport fluids, accommodate guidewires, deliver therapy, manage pressure, and provide pathways for sensors, electrical conductors, or optical fibers; all within a smaller overall profile.

Multi-lumen extrusion allows several functions to be incorporated into a single component, but it also creates significant challenges involving flow balance, concentricity, lumen geometry, wall uniformity, and material behavior.

Tooling development has consequently become much more engineering-driven. Advanced flow simulation, precision machining, modular tooling components, material characterization, and metal additive manufacturing are helping engineers develop complex internal geometries while reducing the number of tooling iterations. The industry is moving away from traditional trial-and-error development toward simulation-supported tooling and faster, data-driven prototyping.

Suresh Sainath: The push toward minimally invasive and neurovascular procedures is a major driver. As devices are asked to navigate smaller, more tortuous anatomy while delivering more function, designers must fit more into less space, multiple lumens for fluids, wires, and sensors, all within a tighter overall profile. Structural heart, electrophysiology, and complex interventional applications are all pulling in the same direction: more capability, smaller footprint, tighter tolerances.

Holding precise geometry across multiple lumens at very thin walls leaves little margin for error, so the die design, process controls, and material behavior all must work together. A lot of the advancement is upstream of the line itself, using process modeling and simulation to anticipate how a material will flow and behave before we cut tooling. That lets us design for a complex geometry with far less trial and error, which matters enormously when tolerances are measured in thousandths of an inch and the cost of remaking tooling is high.

Dave Schroeder: The demand for more complex multi-lumen designs reflects a broader trend toward minimally invasive therapies, smaller devices, and more functionalities being built into the catheter or delivery system. This creates a need for development partners who can help connect the product concept to a manufacturable, scalable process. The earlier we are engaged, the more value we can provide in helping customers manage complexity before it becomes a cost, quality, or timeline issue.

Tim Steele: Devices increasingly need to perform multiple functions through a single, sometimes extremely small, flexible, or rigid shaft or catheter tube. These functions include but aren’t limited to drug delivery, drainage, guidewire access, pressure monitoring, infusion, suction, irrigation, balloon inflation, aspiration, sensing, and electrical conductors. 

There’s been much progress in heart valve replacement and the tube used for this procedure, a transcatheter. It has nine or as many as 13 lumens with an outside diameter of only about .050”. This tube is not only a challenge to extrude, but building an extrusion tool to extrude this tube was even a bigger problem and development of making the tube risk free is unending.

I’ve always said to make a high-quality, complex multi-lumen tube, you must start with high quality, complex extrusion tools. Forty years ago, two- and three-lumen tubes were state of the art, but with the continuous advancements in medical technologies and procedures, the technical complexity and technical functionality of extruded medical tubing also advanced. The machines needed to make tools for the increasingly smaller and more complex parts had to advance to stay abreast of the new requirements. 

We extrude using a custom crosshead designed specifically for small-bore medical tubing and profiles. Our crosshead design has been revised seven times over the years to address new emerging technologies. Our standard die and tip design have evolved similarly, and our tooling technology is a result of collaborative efforts by our engineering team, extrusion technicians, and machine shop. We design and fabricate all our extrusion tools and have complete control of the quality and the availability of our tooling. With this, we can respond faster to customer changes or improvements to the tools we feel will make the extrusion better. 

Finally, extrusion tools today aren’t just more complex because of the complex designs we extrude, but we also extrude many more custom materials than many years ago. One tool design doesn’t work for all the materials, or even the same material but in different durometers.

Brusco: Are customers asking for more data collection and process monitoring? If so, how are you meeting the demand?

Allen: I haven’t seen a lot of direct demand for additional data and process monitoring from customers, yet. However, our internal focus on data collection and monitoring related to quality leaves us well positioned when such requests are made.

Jason DiChristofaro: Yes, customers are increasingly requesting more robust data collection, process monitoring, and production analytics capabilities. This demand is being driven by quality traceability, labor challenges, process consistency required for tighter tolerance devices, predictive maintenance, and the need to leverage manufacturing data to improve overall equipment effectiveness (OEE).

We meet this demand through our Navigator Control Platform, which provides real-time monitoring and centralized control of the entire extrusion line. It captures all critical process parameters vs. actual set points, alarms, trends, recipes, and production data, allowing operators and management teams to quickly identify process deviations and maintain consistent product quality. It also enables advanced quality reporting for each batch of products produced on our systems.

Frechette: Yes. OEMs are increasingly requiring greater process visibility and data transparency—driven by tighter regulatory expectations, risk management requirements, and the need for robust process validation and ongoing capability monitoring.

We meet this demand by continuously monitoring critical process parameters in real time, including melt temperature and pressure, line speed, vacuum levels, and dimensional measurements via in-line laser micrometers. This level of monitoring supports process capability studies and the documentation needed for regulatory submissions, while enabling faster root-cause analysis when issues arise.

Herrild: Yes, more process monitoring has been an ongoing theme in medical for some time now. We use a variety of in-line and on-line gauges for OD, ID, Wall, specs, and surface finish. It requires constant investment in measurement technologies to meet OEM needs. Automating the data capture is really the only way to keep pace.

Mazelin: Yes, absolutely! The dreaded “V” word for validation is now commonplace in our industry ever since the FDA stressed risk mitigation as a fundamental requirement for manufacturing processes. That said, all our extrusion lines are equipped with 3-axis laser micrometers that monitor the outer diameter 100% of the time and can calculate process capabilities (CpKs) if required.

Interestingly, most companies don’t have a specific script to follow, nor do they have protocols prepared. We’re meeting this demand by offering services such as developing protocols suited to the products being produced. If multiple set-ups and multiple raw material lots are required, this can add substantial time to a project. We can perform a condensed version of these to aid in moving a project along.

McGee: Yes. Clients seek more insight from their CMOs for lot-to-lot detail than previously. This includes supplemental data to normal C of C requirements in some cases, including raw material lot detail, temperatures, pressures, line speeds, dimensional measurements, and production history. We support this by integrating the extrusion line, so critical process parameters and inspection data are captured electronically whenever possible. The objective is to demonstrate process stability, simplify investigations, and reduce operator-dependent record keeping.

Sainath: Yes, and the expectation keeps rising. Customers want confidence that the part they qualified is the same part they will receive a year from now, at higher volume, run after run. In regulated device manufacturing, consistency is not a nice-to-have; it’s critical for our medical device customers. That’s driving real demand for process data, not just a pass-fail at the end, but visibility into the process itself.

We treat process monitoring as part of the design, not an afterthought. The goal is a process that’s measured, understood, and repeatable, so we can demonstrate control rather than simply assert it. That data does double duty; it protects quality as a program scales, and it gives our customers something concrete to show their regulators and quality teams. As programs move from development into higher-volume production, that kind of documented, repeatable control is what lets a customer scale with confidence.

Steele: Customers increasingly ask for more data collection, process monitoring, and traceability. The main drivers are tighter tolerances, regulatory expectations, more complex designs, and that extrusion quality, many times, cannot be verified at final inspection to meet critical device performance requirements. 

Customers want confidence that the extrusion process was stable throughout the run; key, validated parameters were being met; and the tooling, materials, line settings, in-process inspection results, and lot history can be traced in case future questions arise. This is especially important in complex multi-lumen, tight tolerance, and custom material applications, where the extrusion process must be verifiably controlled. 

We meet that demand by focusing on strict process control, documentation, and repeatability. We track critical process information, maintain lot and material traceability, document inspection results, and use our experience with tooling and process development to interpret what variables matter most for a given part. The goal is to collect useful data that helps prove that the process is capable, supports validation, and gives our customer confidence the part they receive today can be reproduced repeatedly in the future.

Brusco: What supply chain risks still concern you?

Allen: Lead times and raw material costs. Tariffs and shipping delays are affecting nearly everyone right now.

Frechette: The most persistent risks center on specialty medical-grade resins and additives. Certain high-performance polymers and fluoropolymers remain single-sourced or constrained, and any disruption—whether from production issues, geopolitical factors, or allocation decisions—can cascade quickly into longer lead times and qualification challenges for OEMs.

We also watch resin lot-to-lot consistency closely, because even minor variations can affect extrusion process stability and dimensional performance. Mitigating these risks requires proactive dual-sourcing strategies with feasible, deeper supplier relationships, strategic inventory positioning, and early engagement with customers on material qualification pathways. While overall supply chain resilience has improved since the pandemic, these material-specific vulnerabilities remain a key focus.

Herrild: Resins made domestically often have additives that come from overseas. Compounded materials often use products from more than one supplier. There are a lot of situations where a domestically made resin could still have potential supply upsets or shocks in the current global trade environment, but OEMs think getting a domestically made resin allows them to ignore global issues.

Mazelin: Lead times on raw materials continue to be a struggle in the industry. If we have a blanket order for a product, we can stock materials to properly meet demand. To simply have multiple raw materials on hand to be responsive comes at an extremely high cost since all raw materials have a limited shelf life. We cannot properly certify a raw material for a medical device (implantable or non-implantable) if the raw material has passed its expiration date. 

Other supply chain concerns come from external vendors. There’s a tremendous amount of education required in teaching vendors the quality expectations that exist in our marketplace.

McGee: Our greatest concern is the number of hidden single-source dependencies within the medical device supply chain. These can include a specific medical-grade resin, custom compound, additive, colorant, or legacy components that may only be available from one qualified source.

Material discontinuations, unannounced formulation changes, extended lead times, supplier minimum-order requirements, geopolitical instability, tariffs, freight interruptions, and force majeure events can all threaten continuity. The challenge is magnified in medical devices because changing a material or supplier may require extensive technical evaluation, biocompatibility work, sterilization assessment, revalidation, and potentially regulatory review. The FDA and industry organizations continue to emphasize the patient and manufacturing risks created by medical device supply disruptions.

Risk mitigation must begin during product development. Wherever practical, manufacturers should qualify alternate materials or suppliers, obtain appropriate supplier-change notifications, maintain strategic inventory, avoid unnecessary sole-source specifications, and consider regional or nearshore manufacturing options. Resilience cannot be added after a disruption occurs; it must be designed into the supply chain.

Sainath: Material availability and qualification remain the ones I watch most closely. In this industry, you cannot swap one material for another when something becomes scarce; a change in resin or supplier can mean requalifying the whole process—which takes time that a customer’s program may not have. The lesson of the last several years is that resilience must be designed in early, not bolted on when there’s a problem.

We address it through capacity, consistency, and being close to customers. Building manufacturing capacity in more than one location, keeping a consistent quality system across sites, planning for volume before a customer needs it, and maintaining a high level of raw material inventory all help reduce the risk that a single disruption stalls a program.

Schroeder: Supply chain risk in medical extrusion is less about finding available components and more about maintaining validated performance, documentation, and long-term reliability. Many of the systems we build rely on highly specified components, specialty materials, and supplier capabilities that cannot be changed casually once a process is defined. The best way to manage that risk is through early engagement, disciplined supplier qualification, careful planning around longer-lead items, and designing systems with supportability in mind. Customers increasingly value partners who can anticipate those risks early and help them avoid surprises later in the project.

Steele: The biggest supply chain concern in medical extrusion (and most industries) is the uncertainty of price and availability in the materials markets caused by political leadership. The medical device industry is global; thus, the unpredictable use of tariffs affects us all. Long-term supply agreements are more difficult to negotiate and manage, increasing the complexity of serving our customers. 

Everything is more expensive: raw materials, machines, labor, insurance, freight, energy—you name it! Geopolitics and political leadership are serious problems that small businesses must deal with, and we have little or no control over the situation. If the global geopolitical situation around the world were more stable, we all would be happier.

Brusco: Where do you expect the next major innovation in medical extrusion to come from?

Allen: The advancement and application of computer simulations to various extrusion processes will push boundaries for what’s possible. For example, accurate characterization of polymer flow through the extruder and tooling gives insight into hidden phenomena. These insights promote better understanding and more complete control.

Alpert: First, the next major innovation may be from the materials side, such as biomaterials, more long-term implants, and specialty grades that target specific applications instead of general use. These will most likely require special processing hardware to minimize the risk of degradation and enhance material performance for the application. Manufacturers will need to answer the call for more customized design offerings such as varying LD ratios, feed throats, and feed screws, as applications could rival pharmaceutical requirements. Controls and data collection to verify that components were manufactured to validation parameters will also be important.

Secondly, as important as multi-lumen configurations are, measuring them still requires manually cutting a sample, and physically measuring is still the only viable method to measure multi-lumen components in process. Vendors of in-process metrology are working on various ways to better and more quickly measure these through various new technologies combined with high-speed multicore processing technologies (external geometry measurements of profiles are already commercially available).

Frechette: I expect the next meaningful advances to come from the convergence of process intelligence and tooling precision, rather than a single breakthrough material. Real-time data analytics, closed-loop process control, and AI-assisted monitoring will enable tighter dimensional consistency and faster process optimization on increasingly complex multi-lumen and multi-layer designs.

At the same time, continued refinement of in-house tooling and die technology will push the boundaries of lumen count, wall thickness, and geometric complexity while maintaining the process stability required for regulated medical devices. Together, these developments will allow OEMs to design more sophisticated catheter and delivery systems without sacrificing manufacturability or quality.

Herrild: This is a tough question, given that a lot of major innovations seem to come out of the blue. I think there’s more to be done on tooling design, where you can get more consistent parts faster by better understanding exactly how material flows in the die and as it exits. I think consistency and speed here could lead to development of parts that were previously unobtainable.

Mazelin: On the silicone side, I expect to see more innovation coming out of the UV-cured silicone raw material. By limiting the heat required for standard vulcanized rubbers, I see many co-extrusion applications that combine silicones with thermoplastic materials, as well as drug-eluting applications where the efficacy of the active pharmaceutical ingredients isn’t hindered by exposure to the standard processing temperatures used with silicone processing.

McGee: The next major innovation in medical extrusion will come less from entirely new extrusion equipment and more from the continued integration of smart manufacturing technologies. Future extrusion lines will combine real-time process monitoring, automated process adjustments, predictive maintenance, and comprehensive electronic production records into a single connected manufacturing platform.

As inline measurement technologies, artificial intelligence, machine learning, and digital manufacturing continue to mature, extrusion processes will become increasingly predictive rather than reactive. Advanced systems will be capable of identifying process variation in real time, automatically adjusting critical parameters, and maintaining tighter dimensional control with significantly less operator intervention.

We believe the greatest opportunity extends beyond simply producing tubing faster. The future of medical extrusion lies in delivering greater process capability, tighter repeatability, complete manufacturing traceability, and seamless integration with downstream assembly, packaging, and finished-device manufacturing. As medical devices become more complex and regulatory expectations continue to increase, manufacturers that combine advanced extrusion technology with intelligent process control and vertically integrated manufacturing will be best positioned to accelerate commercialization while improving quality, reliability, and overall supply-chain resilience.

Sainath: I expect the next wave to come from materials. For decades, certain fluoropolymers were the default answer because nothing else matched their performance, but the industry is now actively looking beyond them, driven by sustainability, regulatory scrutiny around PFAS, and the search for new sterilization pathways. The opportunity is to deliver the performance engineers have relied on for years in new material forms that open possibilities the old ones could not. That’s a genuinely exciting problem to work on, and it’s where a lot of our R&D energy is focused.

The second area is the marriage of materials science with smarter process design, using modeling, simulation, and tighter process control to make geometries and tolerances possible that weren’t practical before. Innovation in extrusion is not only about what the material is; it’s about how precisely and repeatably we can shape it. When you advance both together, you can expand what device designers are able to attempt.

Schroeder: I expect the next wave of innovation to come from the intersection of materials, process control, and measurement. Medical device companies are pushing toward smaller, more complex, and more application-specific products, which means extrusion partners will need to help customers solve problems across the full process, not just at one piece of equipment. 

“Equipment can be bought; know-how has to be earned.” The companies that bring application knowledge, integrated systems, and disciplined execution together will be best positioned to help customers move from development to reliable production.

Steele: Technology is increasingly being driven by AI, and it won’t be long before basic single lumen extrusions will not need a human operator. The future use of AI in medical extrusion is just beginning, and I embrace the integration of it into our process!