The Petite Passageways of Medical Device Tubing

In recent years, the medical tubing market has enjoyed steady and continuous year-over-year growth in the 5% to 10% range. Valued at about $12.5 billion in 2025, the global tubing market is expected to grow at an 8% compound annual growth rate to reach a total value of $18.5 billion by 2030.¹ Growth factors include an aging population, treatments for diabetes and cardiovascular diseases, and advances in minimally invasive treatment technologies, such as electrophysiology.

Although medical tubing is technically a mature market, it is under pressure from medical device manufacturers (MDMs) to constantly innovate and meet new material and performance expectations. “Device profiles continue to shrink, while mechanical requirements—burst strength, torque transmission, kink resistance, and pushability—continue to rise,” said Patrick Daly, director of global extrusion for Aptyx, a global medical device contract development and manufacturing organization that provides precision extrusion, molding, and integrated manufacturing services. “MDMs are asking for tighter tolerances, more complex lumen geometries, and thinner walls, all within compressed development timelines.”

“Extrusion is a critical process in the medical device industry that is always being pushed to find new capabilities,” added Tim Finn, manufacturing and process manager for Lisbon, N.H.-based New England Tubing Technologies, a provider of custom products including medical braid, lubricious-lined catheter shafts, and multi-durometer tubing. “What we provide today are thinner walls, smaller outside diameters, and more complex geometries than we would have considered before, even just a few years ago.”

A key driver for medical tubing is the shift toward minimally invasive procedures and more complex catheter systems. “Across the market, growth is fueled by demand for smaller profiles, tighter tolerances, more functional layers, with improved integration of manufacturing controls and inspection,” said Kyle Walker, development engineering manager for Teleflex Medical OEM, a Trenton, Ga.-based developer and manufacturer of micro-diameter specialty tubing used in minimally invasive devices.

As medical devices get smaller and more complex, tubing becomes an increasingly important, performance-critical component that directly impacts device deliverability, reliability, and patient outcomes.

“Tubing is no longer a secondary component,” said Daly. “In many advanced delivery systems, extrusion architecture directly determines device deliverability, deployment accuracy, and clinical reliability. MDMs therefore prioritize partners with deep material expertise, robust process control, and the ability to scale without redesign.”

Latest Trends 

Innovative designs continue to shape the tubing market, leading to higher precision and smaller sizes. For example, MDMs seek ultra-thin walls with higher performance requirements. “They want thinner walls to maximize internal lumen space, while still maintaining strength and kink resistance,” said Daly. “This pushes material science, process control, and inspection capability to new limits.”

MDMs are also developing more challenging multi-lumen tubing profiles. Intricate lumen geometries can accommodate guidewires, fluid delivery, sensors, pull wires, and implant deployment systems—all within a single shaft. Hybrid material constructions use various materials and engineered additives to achieve differential stiffness profiles and controlled lubricity along the catheter length. 

“The momentum in multi-lumen designs for complex device functions, such as delivery, aspiration, and sensing, drives higher expectations on concentricity and dimensional stability,” said Walker.

For many designs, secondary operations such as bonding, reflow, or tip forming can partially occlude lumens if not accounted for early in the design stage. Maintaining lumen integrity through downstream processing requires tight dimensional control and careful tolerance stack-up management. “Another persistent challenge,” said Daly, “is preventing lumen cross-communication and preserving septum wall integrity, particularly in ultra-thin multi-lumen configurations.”

In addition to the ongoing trend toward minimally invasive procedures, new treatments such as pulse field ablation for cardiac arrhythmia have spurred growth in complex tubing designs for multi-lumen catheters—often lined with polytetrafluoroethylene (PTFE) for lubricity or polyimide for electrical insulation and ultrathin robustness. “These complex designs enable multiple functions within a single catheter, such as tip articulation with pull wires, imaging and mapping, and electrical transmission over insulated wiring,” said Gordon Brooks, senior principal product line manager for Nordson MEDICAL, a provider of medical tubing design, development, and high-volume manufacturing, including thermoplastic extrusions, heat shrink tubing, and biomaterial delivery systems. 

There is growing interest in low-friction surfaces, selective bonding zones, and coatings that support device assembly and clinical performance. Advances include new formulations for base polymers and improved surface treatments that tubing will accept. “Extrusions can be formulated with a mix of base materials to optimize features such as flexibility, porosity, microbial resistance, or hydrophilic/hydrophobic features,” said David Pascutti, vice president of business development for Robling Medical, a Raleigh, N.C.-based developer and manufacturer of tubing assemblies as finished devices. 

Six years after the onset of COVID-19, MDMs are still making operational adjustments based on their experiences during the pandemic. For example, the industry is experiencing fast-paced regionalization initiatives to shorten supply chains and minimize the impacts of tariffs. “These factors drive increased demand for outsourced tubing solutions,” said Ravi Narayanan, commercial vice president of fluid management and flexibles for DuPont Healthcare Solutions (DHCS), which provides scalable, full-service tubing solutions in a wide range of materials suitable for medical therapies and biopharma applications.

What MDMs Want

Top requests from MDMs are thinner walls, tighter tolerances, improved torque transmission, laser-cut hypotubes, faster iteration cycles, and overall greater predictability. They also want tighter validation packages, stronger process windows, and clearer evidence of robustness, which also means consistent performance from lot to lot.

“MDMs want confidence that their tubing will perform consistently across all development builds and into commercial volumes,” said Daly. “This requires strong process controls, in-line inspection, and tight collaboration between extrusion engineers and downstream assembly teams.”

There is increasing demand for ultra-thin, multi-purpose tubing with precise tolerances for specific material characteristics, such as reinforced polyimide for electrical insulation, durability, kink resistance, columnar strength, and polyether ether ketone (PEEK) for catheter robustness. 

“Because of these complex catheter designs, MDMs want tubing partners that provide a broad range of integrated capabilities, including multi-lumen and layered extrusions, film-cast polyimide tubing and PTFE liners, ram-extruded PTFE, heat shrink tubing, and secondary processing such as hole punching, tipping, over-molding, and printing,” said Brooks.

MDMs are also intent on locking in shorter development cycles with faster iterations. “They seek partners that can prototype quickly, then scale into stable production,” said Walker. “They also want assembly-friendly designs that show consistent bonding behavior, predictable surface interaction, and stable dimensions that reduce downstream assembly variability. This is best accomplished during early design for manufacturability [DFM].”

Better Precision, Higher Performance

Advancements in polymer engineering, in-line metrology, and process monitoring allow tubing companies to keep up with the latest designs coming in from their MDMs, including miniaturization. “Improved resin quality and compounding techniques enable higher strength-to-thickness ratios,” said Daly. “Radiopaque additives and multi-material layering are also becoming more refined.”

For in-line metrology and process monitoring, laser-based diameter measurement and real-time wall monitoring enable tighter control of outer diameter (OD), inner diameter (ID), wall thickness, and concentricity. “Data-driven process adjustments reduce variation and improve lot-to-lot repeatability,” Daly added.

Processing technologies—both “in-line” and “post”—allow for tight control monitoring and evaluation of specifications. Real-time data analysis and machine learning algorithms improve product consistency and reduce defects. “Lasers that measure ID/OD/length and are integrated with the extrusion equipment improve a vendor’s abilities to meet tight tolerance specifications and other critical dimensions,” said Pascutti.

Almost all extruded thermoplastic tubing requires secondary processing to perform as intended. Depending on the application, MDMs may need value-added features such as hole punching, skiving, tipping, and over molding. Precision cutting to achieve tight-tolerance lengths is often required to ensure a high-yield catheter assembly process.

MDMs are also expanding their use of ultra-thin-walled polyethylene terephthalate (PET) heat shrink tubing for manufacturing aid applications, such as masking, bundling, and wrapping. Wall thicknesses range from 0.0001 inches to 0.001 inches with a shrink ratio up to 4:1. It is easily removed in process with end-to-end peelability. “This speeds up processes, increases throughput, reduces costs, and eliminates the risk of damage to substrate tubing due to skiving,” said Brooks.

Additive manufacturing (AM)/3D printing is an increasingly important process in tube manufacturing. For example, DHCS has developed in-house, proprietary AM technology that produces high-precision, single and multi-lumen tubing, “enabling rapid low-cost prototyping of solutions that allow us to experiment quickly and iterate as needed,” said Narayanan. “This reduces design iteration time from weeks to days.”

DHCS can 3D-print both the tubing and the needed tooling for both single and complex multi-lumen and profiles. “We usually 3D-print tubing for complex profile tubing and small batch runs to determine feasibility of design and materials,” said Narayanan. “3D-printed tooling is largely used for quick-turn large volume tubing, or non-complex tubing, depending on the design.”

Regulatory Challenges

Current regulatory issues are largely centered on how to deal with popular, accepted materials that are now known to pose human health risks. For example, di(2-ethylhexyl)phthalate (DEHP) is a common plasticizer that may be carcinogenic and linked to reproductive issues; in response, many MDMs are on the hunt for DEHP-free alternative materials. 

Regulatory concerns are also growing over the use of per- and polyfluoroalkyl substances (PFAS) and their potential environmental and health risks. While the PFAS materials found in medical tubing (most commonly PTFE and FEP) have not yet been proven to be dangerous, MDMs are nonetheless seeking non-PFAS materials in response to this concern. “Nordson MEDICAL has extensively researched alternative materials for both heat shrink tubing and liners and published an in-depth study of lubricious additives in 2023, which was followed by a second study in 2025 that focused on alternatives to PTFE liners,” said Brooks. “We are also actively partnering with MDMs to provide this technical support.” 

Importantly, the use of FEP heat shrink during the reflow lamination of multi-layer catheters is a very common and accepted practice in the tubing industry. However, FEP is a PFAS material. An effective PFAS-free alternative to FEP heat shrink is Nordson MEDICAL’s PET heat shrink, “which laminates catheters as well as FEP heat shrink, is easily removed, and is PFAS-free,” said Brooks. “In addition to these benefits, the 0.003-inch wall thickness of our PET reflow heat shrink tubing can speed up the lamination process, increase throughput, and reduce processing costs.”

Although PFAS concerns are still a top regulatory concern, especially for next-generation devices, there are also increased discussions around endotoxins and how to mitigate their risks. “While neither are currently directly targeted by the FDA,” said Finn, “it would not surprise me if guidance from the FDA trickles down to manufacturers over the next few years.”

Yet another regulatory target is polyvinyl chloride (PVC). 

“Many high-volume therapeutic sets such as IV and drug delivery and blood management sets use PVC in their fluid management tubing,” said Narayanan. PVC is very popular due to its cost effectiveness and functionality; however, because it contains toxic additives such as phthalates, it is under pressure from regulatory initiatives aiming to eliminate toxic substances from healthcare. Europe also typically incinerates its medical waste, and burning PVC increases the spread of contaminants. “Other recent regulatory developments include the European Chemicals Agency move to restrict phthalates, particularly DEHP, which is used to make PVC flexible,” added Narayanan. “The deadline for authorization of DEHP in medical devices has been extended to Jan. 1, 2029, with a prohibition date of July 1, 2030, unless specific authorization is granted.” 

Creative Solutions

Finding solutions to complex tubing requirements relies on creative thinking and deep tubing knowledge, often resulting in hybrid construction development. When a single material cannot meet all performance needs (for example, deliverability versus kink resistance vs. lubricity vs. bondability), a layered/hybrid approach is often the solution, where each layer is designed around a specific function. “For example, we have incorporated materials such as nitinol to enhance stability and shape control in insulated wires that must be navigated through complex device pathways,” said Walker.

Tapered catheters are increasingly designed for specialized clinical applications such as neurovascular, where a larger-OD, more robust proximal catheter with push and torque narrows down to a much smaller, trackable, atraumatic microcatheter. The challenge is assembling these tapered catheters, which typically requires multiple and sequentially layered tubing that adds manufacturing costs and slows down production. Nordson MEDICAL is developing a unique solution casting process that enables a single Pebax layer to be applied to a tapered mandrel. “This innovation can produce the desired catheter design in one pass, simplifying and accelerating the process, saving cost and increasing production throughput,” said Brooks. “This capability is available now for MDMs interested in exploring these benefits.”

Aptyx recently developed a complex, multi-lumen gastrointestinal therapy tube.

The customer required a long, small-diameter feeding tube incorporating numerous secondary lumens integrated along the sidewall to support sensing and stimulation functions. The engineering challenge involved maintaining lumen integrity and positional accuracy while enabling downstream integration of functional components along the tube length. “Aptyx developed a removable-core extrusion approach that enabled complex lumen architecture without compromising dimensional stability,” said Daly. “The solution allowed advanced functionality to be incorporated into a compact therapeutic device platform.”

On the Horizon 

Steady improvements are being made for the combination of real-time inspection and feedback loops, moving toward closed-loop control that prevents defects, rather than catching them after they have been made. Material providers and tubing companies often work together to improve properties such as bondability, lubricity, and durability—especially for MDMs that want multiple properties without adding wall thickness.

A key manufacturing capability that enables surgical innovations is the laser cutting of metal hypotubes, which must be precision-engineered to meet tight tolerances. Ultra-fast femtosecond lasers (light pulses in the 250-femtosecond range) vaporize material instantly, often reducing or eliminating post-processing steps. The main advantage of laser cutting is reducing cycle times and producing tiny features that cannot be made using any other method, such as interlocking spirals or hinged patterns. New hybrid systems can switch between different laser types on the same hypotube, optimizing speed and functionality. 

For their next-generation devices, MDMs demand rapid time to market, tubing materials that withstand the fluids and high pressures within, tighter tolerances, contamination reduction, toxic substances check through environmental and drug substances compatibility, and optimum fluid management. “These require a comprehensive set of process capabilities, strict adherence to quality management systems, a clean [Class 8] manufacturing environment, and, most importantly, talent,” said Narayanan. “In a manufacturing industry, innovation is key, whether it be process- or product-oriented. This requires a lot of talent and tools, such as additive manufacturing, to experiment and fail faster, iterate to success, and capital expenditure to act quickly.”

Miniaturization—as amazing as it can be—also challenges innovation. 

“As OD shrinks, every micron has to do more work,” said Walker. “It then becomes a balancing act. For example, stacking functionality—strength plus flexibility plus lubricity plus bonding plus radiopacity plus reinforcement—is harder to achieve without giving up something else. Variation also becomes more expensive—tiny drift can turn into yield loss, performance variability, or assembly headaches.”

Material performance limits and shortened development timelines also constrain innovation. The primary challenge is repeatability due to lot-to-lot variation in resins and raw material properties. “Advancements have been made to control this variation; however, it is still not where it needs to be,” said Daly. “Successful programs require early collaboration between extrusion engineers and system designers.”

Moving Forward

“Rarely a week goes by that a customer doesn’t bring us a design that will push the limits of the compound, as well as our equipment capabilities,” said Finn. “These devices are normally used in unique applications that benefit and advance a broad range of medical applications.”

Walker agreed.

“The rapid pace of miniaturization and feature integration is amazing,” he said. “For example, tubing and catheter components are being asked to behave like engineered systems, rather than basic polymer parts.”

The role that extrusion plays in enabling therapies that were previously unattainable—especially in neurovascular and structural heart applications where device precision and deliverability are critical—will continue to expand. The level of geometric and material control now achievable in catheter shaft design is significantly more advanced than even five to 10 years ago.

AI will be in high demand for making the extrusion process even more automated and efficient. “Reactive and predictive control modules using inline sensors to monitor pressures, temperatures, and speeds potentially reducing scrap rates to near zero, reducing dependency on operator control,” said Pascutti.

“In micro-diameter and layered constructions, performance challenges—wall allocation, bondability, dimensional control, and mechanical balance—cannot be solved in isolation,” said Walker. “They require alignment between design intent, material selection, process capability, and inspection strategy from the start. At Teleflex Medical OEM, early collaboration allows us to help define specifications that are not only technically achievable, but repeatable and scalable—reducing risk and shortening development timelines.”

“Medical tubing should be approached as engineered architecture, not commodity supply,” Daly added. “When extrusion expertise is integrated early in the DFM process, MDMs gain both performance confidence and manufacturing scalability. The most successful programs will integrate extrusion expertise early in development, align dimensional control with functional requirements, and design for both performance and scale from the outset.”

References

¹ tinyurl.com/mpo260421

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.