Medical tubing is a critical component in healthcare applications. It plays a crucial role in diagnostics, fluid management, and medication delivery systems, spanning procedures like intravenous therapy, catheterization, oxygen delivery, and much more.

Advancements in manufacturing processes have led to development of minimally invasive and micro-tubing designs to enable precision in surgeries and diagnostic procedures. Smart medical tubing embedded with sensors for real-time monitoring of fluid delivery to patients is also gaining ground.

High-performance materials like silicone, polyurethane, and thermoplastic elastomers are also being increasingly used because of their flexibility, durability, and chemical resistance. There are also efforts underway to integrate antimicrobial properties into tubing in order to reduce infection risks. Demand for tailored medical tubing solutions are causing manufacturers to invest in customized polymers to meet healthcare’s evolving needs.

The type of material used to manufacture medical tubing is important because the incompatibility of material can lead to chemical alteration of medicines or drugs, binding of chemical or drug delivery to the patient, or other serious issues. Medical tubing has become one of the most supportive technologies in the modern medical and healthcare industries.

Rising cases of respiratory diseases, cardiovascular diseases, digestive disorders, and others are also fueling the demand for medical tubing because they require complex surgeries.

In addition, the market faces challenges due to the significant investments and delays in regulatory approvals for medical tubing. Required high investment for manufacturing and intensive research and development process, along with stringent regulation of tubing and delay in approvals are constantly challenging manufacturers.

To gain perspective on key trends impacting the medical tubing and extrusion markets, MPO asked two questions to several experts in the industry:

1. How are material concerns (e.g., elimination of PFAS) and sustainability trends affecting the development and manufacture of tubing?
2. What types of devices and/or delivery systems are having the greatest impact on tubing design and what kinds of innovations are being fabricated as a result?

The experts’ responses are featured in the following presentations, each offering a unique voice about material concerns and the impact of devices and/or delivery systems in the world of medical tubing and extrusion.

Dean Burke
Business Development Director
Confluent Medical Technologies

Shane Wood
Director of Technology, Polymers
Confluent Medical Technologies

Material Concerns: There’s been greater regulatory scrutiny on potential materials that have an adverse effect on human health and the environment. PFAS is a big topic for materials like PTFE, where lubricity is key. In a similar manner, REACH compliance has been a common topic for polyimide where strength and electrical insulation are important. Both materials are used extensively in the medical device industry. 

Our approach to these concerns have been to partner with regulatory agencies and our suppliers to better understand the landscape and continue to innovate and offer solutions that would mitigate the material concerns.

We have been ahead of the curve with the recent launch of our REACH-Compliant Polyimide and Tecoflex offerings. The EPA has targeted the solvent used in the traditional manufacturing method for polyimide tubing. Our REACH offerings leverage a solvent that isn’t on the EU’s restricted materials list and eliminates this concern for OEMs. We’re also investigating new lubricious materials without PFAS that could potentially replace as the liner of choice for several delivery systems.

Impact: OEMs continue to push the envelope, needing more performance in a smaller package. The neurovascular space is at the forefront, where delivery systems are trying to get further into the vasculature to prevent ischemic strokes. Our customers need products that are thinner and more flexible in order to tackle the tortuous anatomy encountered. In addition, the pulsed field ablation (PFA) market has exploded and will continue to transform the electrophysiology market for years to come. 

We’ve responded to both challenges and have announced new material innovations for our filmcast PTFE and polyimide lines in Q1 2025. We’re also providing several types of product offerings (e.g., spooled PTFE) that allow manufacturers efficiency improvements that help to improve COGs, which is extremely important in a cost-competitive environment.

Patrick Daly
Director, Global Extrusion
Aptyx

Material Concerns: As we become more aware of the negative environmental impacts of PFAS, particularly for single- to limited-use tubing applications, there’s a collective shift in the industry. This awareness is prompting us to seek out safer, more sustainable alternatives that still meet our rigorous performance standards.

On a personal level, this isn’t just about compliance; it’s about doing what’s right for patients and the planet. It’s inspiring to see so many in our field embracing this change by looking into biopolymers and recyclable materials that can limit waste and reduce our ecological footprint. We’re not only focusing on creating effective medical products but also ensuring we’re making a positive impact on the environment we all share.

As we navigate these trends, we’re fostering a culture of innovation in material science, which is an exciting endeavor. By rethinking our production processes, we’re aiming for methods that reduce harmful waste in manufacturing, while developing new materials to replace PTFE liners in catheter assembly. Utilizing novel coating solutions is another avenue while material compounding companies are now breaking new ground on developing lubricious additives for medical-grade polymers to begin a new era in catheter manufacturing. Together, we can lead the charge toward a future where medical tubing is both safe and sustainable.

Impact: The major area of impact lies in minimally invasive applications. As healthcare moves toward less invasive procedures at an increasing rate, there’s a growing need for flexible, durable tubing that can navigate the body without compromising performance or the device’s integrity. Developments in endoscopy and catheterization underscore the demand for innovative materials that enhance visibility and reduce friction. 

Infusion pumps demand precision fluid delivery. Advances to support enhanced precision include multi-lumen designs that allow for simultaneous delivery of multiple infusions while minimizing the risk of kinking or blockages. Similarly, drug delivery systems are evolving to incorporate smart tubing with integrated sensors that monitor real-time delivery rates, enhancing patient care and management. These sensors are constantly evolving to keep up with the market demands. 

Wearable health devices like insulin pumps require compact and lightweight tubing solutions that prioritize biocompatibility and comfort for extended use. Dialysis machines further emphasize the need for non-thrombogenic materials that ensure patient safety over prolonged periods.

The ongoing advancement in medical devices is reshaping tubing design, leading to enhanced material selection, configurations, and functionality that prioritize both efficacy and patient well-being. Tighter tolerances and more process challenging materials are becoming more common requests. These innovations are crucial for improving healthcare outcomes in a rapidly evolving medical device landscape.

Timothy Finn
Manufacturing & Process Engineer
New England Tubing Technologies

Material Concerns: Material concerns, especially the focus on eliminating PFAS, are a common topic during the design of new tubing systems. While these discussions are active and ongoing, there hasn’t yet been a notable shift away from the use of well-established, high-performance fluoropolymers in applications that demand exceptional performance. 

A significant challenge facing the industry is the uncertainty surrounding which specific fluorinated substances will be classified under evolving PFAS regulations. This ambiguity has prompted a cautious yet practical approach, as manufacturers and designers aim to balance compliance with the need for reliable materials. In many critical applications, the unparalleled properties of fluoropolymers—such as chemical resistance, lubricity, and durability—remain indispensable. Consequently, despite regulatory pressures, these materials continue to be specified where their performance is essential. 

Until regulatory guidelines are clarified and viable alternatives are developed, fluoropolymers will likely remain the material of choice for demanding applications. This situation highlights the broader tension between advancing environmental goals and maintaining the high standards required in industrial and medical settings. The industry’s adaptability and innovation will ultimately determine how these challenges are addressed over the coming years.

Impact: Minimally invasive procedures are significantly impacting tubing design. Customers push for smaller, more complex, and higher-performing tubing. Catheters, endoscopes, and other interventional devices require tubing with increasingly tight tolerances, thinner walls, and improved flexibility for navigation through intricate anatomies. This has led to expanded use of multi-lumen, variable durometer, and specialty braiding use. 

Multi-lumen tubing is where multiple channels are within a single tube for simultaneous delivery of fluids, gases, and guidewires. While this increases cost and complexity of the tube, it can reduce overall manufacturing costs of subsequent processes. The use of higher performing plastics such as PEEK are commonly being utilized to allow for robust and as thin of walls as possible. In addition, the increase of multi-lumen designs has led to improvements in measuring equipment due to the precision and complexity of designs. 

Variable durometer tubing consists of combining materials with different stiffnesses along the length of the tube to optimize pushability, trackability, and flexibility. Some of these tubes can have a continuous low friction liner and continuous braid with just variation in the topcoat. 

Novel braiding patterns and materials are being used to enhance torque transmission, kink resistance, tensile strength, and burst pressure. The braid pick count can be increased or decreased for a set length to reach specific performance parameters. Material and processing advancements allow use of specialty polymer-based reinforcement, as well. These can be used in applications involving MRI or RF without the fear of metal-based alloys interfering. 

However, the need for tighter tolerances, specialized materials, and intricate extrusion techniques can increase manufacturing complexity and material costs. This challenges manufacturers to balance the need for advanced performance with cost-effectiveness. Close collaboration with material suppliers and careful consideration of design for manufacturability are crucial to optimize performance and cost in these demanding applications.

Brian Frechette
Operational Strategist
Medical Extrusion Technologies

Material Concerns: Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are widely used in medical tubing due to their chemical resistance and durability; however, they’re increasingly recognized as persistent environmental pollutants with potential health risks. Because of this, regulatory pressure and growing public awareness are leading device manufacturers to find alternatives. We see greater focus on customers conducting comprehensive lifecycle assessments to evaluate the environmental impact of different tubing materials and manufacturing processes.

Many customers are exploring materials like thermoplastic elastomers (TPEs) and bio-based polymers as potential replacements for PFAS-containing materials. Secondarily, many raw material manufacturers and compounders are developing innovative surface treatments that provide similar properties to PFAS without their environmental drawbacks. Finding alternative materials that meet the stringent performance requirements of medical applications (biocompatibility, durability, flexibility) can be challenging. Sustainable materials and manufacturing processes may sometimes incur higher costs, which must be balanced with the environmental and social benefits. Material concerns and sustainability trends are driving significant innovation in medical tubing design and manufacturing. By embracing these challenges, the industry can develop more environmentally-friendly and sustainable solutions that meet healthcare’s evolving needs.

Impact: Many customers are developing products that continue to stretch the limits of current market capabilities. The areas of focus tend to be minimally invasive surgeries, cardiovascular devices, and neurological devices. Many of the impacts are similar, with a focus on smaller overall size as well as novel designs to improve device controllability in complex anatomical pathways. Some of these trends’ requirements are micro-tubing, multi-lumen tubing, and less common raw materials that allow for more flexibility, lubricity, and other more cutting-edge traits. To meet market needs, we’ve focused on expanding in-house tooling capabilities by adding additional dedicated space for tooling equipment, tool design, and development. This allows for fast tooling development and iteration capability to improve speed to market. Continual improvement to extrusion processes is also required, to meet the often more precise needs of newer designs.

Vanessa Gagnon
Director, Medical Tubing & Filtration
Saint-Gobain

Material Concerns: Material selection plays a crucial, yet sometimes overlooked role in determining a medical device’s environmental impact, particularly regarding carbon emissions. Material concerns are especially pertinent in medical tubing development and manufacture, where sustainability considerations can significantly influence material selection. For instance, fluoropolymer-based materials like PTFE (polytetrafluoroethylene) and FEP (fluorinated ethylene propylene) are widely used due to their excellent chemical resistance and high-performance characteristics. However, these materials come with substantial environmental costs. The production of PTFE can involve energy-intensive processes and aggressive chemicals, such as hydrofluoric acid, leading to the release of perfluorinated compounds (PFCs). These compounds have a high global warming potential (GWP) and a long atmospheric lifespan, making fluoropolymers significant contributors to greenhouse gas emissions despite their relatively lower usage volumes in the medical tubing industry.

On the other hand, polyolefin-based materials like polyethylene (PE) and polypropylene (PP) present a more sustainable alternative. Their production processes are simpler, require less energy, and emit fewer potent greenhouse gases compared to fluoropolymers. Polyolefins are easier to recycle and generate fewer toxic byproducts, which aligns with the growing emphasis on circular economy principles in the medical device sector.

While precise data on the GWP of specific medical tubing materials can be challenging to obtain due to variability in additives, polymer grades, and processing conditions, general trends indicate material selection has a profound impact on emissions. By conducting detailed Life Cycle Analyses (LCAs) and comparing the GWP of different materials, manufacturers can make informed decisions to minimize environmental impact without compromising product performance.

As sustainability trends continue to shape the medical device industry, material considerations will play a pivotal role in driving innovation. While regulatory requirements surrounding substances like PFAS are still evolving, the environmental implications of fluoropolymer production are prompting a shift toward more sustainable materials. This transition, supported by robust data and thoughtful material selection, could significantly reduce the carbon footprint of medical tubing manufacturing while maintaining high standards of quality and performance. 

By leveraging our material expertise, we started working with customers to propose alternative tubing solutions that don’t contain fluoropolymer materials yet perform adequately in the application. We’re also investing in R&D to develop new tubing formulations to help the industry address the evolving regulatory requirements.

Impact: Advanced delivery systems are revolutionizing medical tubing design, necessitating innovative features to stay ahead of healthcare’s evolving trends. These systems require steerable shafts for precise navigation, radiopaque materials for enhanced imaging visibility, and significant advancements in miniaturization and sensor integration. Additionally, the increasing integration of robotization into medical devices enhances precision and control, aligning seamlessly with the modern demands of healthcare applications.

Christian Herrild
Director of Growth Strategies
Teel Plastics

Material Concerns: Sustainability is becoming a larger and larger part of the developments we do. We have customers pushing to increase the sustainability of the products they already have on the market and new products under development. 

This is an area where we have worked for a long time and have had some pretty good success. We have one customer in particular that we qualified regrind for use in one component of their device. It took some rigorous work defining device requirements and ascetic needs in terms that could be measured. We needed understanding of failure modes in the end device to allow us to develop a testing battery as well. Once we had critical to quality attributes and device failure modes, we were able to qualify regrind use. This generated a significant reduction in material to landfill for them, and we were able to generate some cost savings. 

We’ve had recent conversations with both current and new customers looking for the same kind of advancement. We’ve reviewed materials with a lower carbon footprint based on LCA. We’re starting an evaluation of incorporating regrind into a non-patient contact device component for one customer. We have another customer looking for sustainable materials—whether those are bioplastics or bio-sourced conventional materials—that can meet device requirements. Finally, we’ve had a few customers reviewing more regulatory aligned materials. That includes both non-DEHP PVC, which has been around for a long time, and in some cases PFAS-free materials. 

The “PFAS-free” issue is an interesting one. Where we have customers with fluoropolymers present, they have focused on the materials currently EPA regulated and looked for assurances they aren’t present. We have customers asking very detailed questions on other materials, like PE and PP, where fluorinated materials may be present as a processing aide or surface modification additive. Those customers are taking a harder stance, and we’re working with them to satisfy their obligations. My concern is the parts-per-trillion levels they’re able to detect the material at are so small, it’s hard to comprehend. It would be roughly one ounce of material in 260,000 railcars. We don’t know where we will find it because we haven’t looked everywhere with that fine of a microscope. Added to that complexity are things like dexamethasone, ciprofloxacin, and some anesthesia that are PFAS and they are being used with some of these same devices. 

Daniel Lazas
VP, Sales and Marketing
Nordson Medical

Material Concerns: As a global supplier of medical tubing and components for interventional devices, we are significantly impacted by materials regulations, which can influence the solutions we offer customers. For example, anticipated regulations that may restrict the use of per- and polyfluoroalkyl substances (PFAS) could affect interventional catheter components made from fluoropolymers. These include PTFE tubing, commonly used for catheter liners, sheaths, and other components, as well as FEP, which is used in heat-shrink form for reflow welding of catheter shafts and in extruded form for vascular access and other components.

These regulations present substantial challenges for interventional devices. PTFE is well-known for its low-friction properties, enabling wires, balloon catheters, and other devices to pass smoothly through the inside of a guide catheter. Similarly, FEP heat-shrink has long been the industry standard for securing the components of complex catheter shafts during reflow welding. While PFAS-free polymers show promise as alternatives, they may involve trade-offs. A supplier’s ability to provide components for both existing devices and regulatory-compliant alternatives requires a broad range of material and processing capabilities.

We have built an organization capable of delivering a wide range of polymer tubing and related components using multiple manufacturing processes. These include melt extrusion, ram extrusion, film casting, and solution coating. Additionally, we provide heat-shrink tubing, balloon manufacturing, braid-reinforced tubing, and more.

This broad expertise allows us to adapt alongside customers to address regulatory challenges. For instance, a melt-extruded polyolefin liner that’s PFAS-free may be a viable alternative to a ram-extruded PTFE liner. Likewise, a PFAS-free PET heat-shrink may serve as a suitable replacement for some FEP heat-shrink applications.

Santiago Medina
Global Product Manager
TekniPlex Healthcare

Material Concerns: Unsurprisingly, PVC compounds remain by far the most common materials utilized in medical tubing applications. And while PVC’s functionality is exemplary, its eco-friendliness has been called into question.

Considering this, materials science companies like us are well-advised to be proactive in improving the sustainability profiles of their PVC-derived products. For example, the technology now exists to utilize bio-based compounds for medical plastics applications whose performance and compositional properties are equivalent to conventional PVC resins.

It’s also necessary to explore viable alternatives to PVC technologies, including polyolefin and thermoplastic elastomers. Always, the top priority must remain uncompromising device performance, meaning specific polymer chemistries must be developed with the utmost care and thorough testing. But even within these strict guardrails innovation is indeed possible, with the recent advent of solvent-bondable PFC alternatives a prime example.

Regarding PFAS, it’s encouraging to note the dynamics of tubing design are trending toward fluoropolymer elimination from early-stage design. Promising strides have been made in doing away with fluoropolymers such as PTFE, FEP, and EPTFE from catheter-based devices, largely through substitutes like Pebax, with additives for increased lubricity. Often, these alternatives can be integrated seamlessly into initial concepting and prototyping—both key to streamlined regulatory approval.

Impact: Medical devices and delivery systems, including an ever-broadening range of catheter-based devices and implants, are having enormous impact in the design cycles of tubing solutions.

Stents and catheter-based heart valves both push the limits of current technologies. Stents are a strong example of this dynamic. Here, myriad factors are at play; for starters, the right catheter will meet its stent’s needs for column strength without an overabundance of compliance, because if it stretches too much or too unpredictably, the procedure becomes more complicated and less informed. Deployment accuracy also is critical; for instance, a particularly springy stent will need a custom-designed catheter mechanism to prevent premature deployment.

With catheters and stents everything must be synergized. Notably, there are typically several design tradeoffs when holistically considering the tortuous path, stent radial force, and catheter compliance. Striking the right balance among these attributes will yield an optimized stent-catheter combo whose procedural application is repeatable and whose ultimate effects are positive and enduring. 

Such intricacies apply not only to stent-catheter combos but also a wide array of adjacent and next-generation solutions. It’s becoming increasingly common for complex catheter systems to include stent-like devices like “stentrievers” and other devices for thrombectomy. Unsurprisingly, such sophisticated constructions also benefit greatly from extensive experience in traditional stents, catheters, and other interventional medical devices.

Sonia Schwantes
Product Management and Applied Technologies Director
NewAge Industries

Material Concerns: Being a tubing manufacturer requires that we make quality tubing in the most responsible way possible. To do so, we continue educating ourselves about trends and concerns that can be turned into actions. Because all actions aren’t created equal, we also do our due diligence, so our actions produce a positive impact, rather than more issues. This belief has led us to take a hard look at our materials, our processes, and our goals to see where we can make a strong impact the right way and incorporate appropriate changes throughout the organization, not just in the products. We believe sustainability should be treated like quality—built into every step of production.

Impact: Anything that will touch the body requires careful thought to the material and design. As more is learned about the body and as regulators require more testing or enact restrictions, manufacturers must reconsider how and when materials are used. There are a lot of options out there but change in this industry is difficult until forced. Perhaps, this opens doors for not just new materials, but new technologies as well.