Medical tubing is used for a variety of medical- or pharmaceutical-related applications—fluid management, drainage, anesthesiology and respiratory equipment, IVs, catheters, peristaltic pumps, dialysis, feeding tubes, and biopharmaceutical laboratory equipment, just to name a few.

The two most common types of medical tubing used for the medical device market are, arguably, urinary catheters and vascular catheters. Urinary catheters are used to drain and collect urine from the bladder. They can also be used to monitor urine output, diagnose disorders in the lower urinary tract, and introduce medication.

Vascular catheters are used to gain access to blood vessels for a variety of therapeutic and diagnostic purposes, depending on the kind of device. They can be used to give intravenous fluids, blood transfusions, chemotherapy, and other drugs, as well as to deliver stents, balloons, heart valves, and the list goes on.

There are a broad range of materials used to manufacture medical tubing, as well. The type of material determines crucial performance properties for medical tubes, like abrasion resistance, hardness, flexibility, and durability. Most medical tubes are made of a certain type of plastic or rubber material, though some applications require metal tubes.

The material of choice is important for medical applications because incompatible materials can cause a variety of issues. One such example: Incompatible tube materials can chemically change drugs or medicines, causing them to bind to the tube and bring about failed delivery to the patient. Further, tubes that are radiopaque can’t be in or on patients that are receiving medical imaging because it would result in an inadequate image.

Sizing for medical tubing is based on the outside diameter (OD), which defines the span of the tubing cross-section. Inner diameter (ID) defines the measurement of the open area of the tube. Wall thickness defines the width or thickness of the tube itself. Tubes come in standard lengths, which measure the continuous span of the tube from end to end. Dimensions for tubing are specified in both inches and millimeters (or smaller). Correct sizing is paramount to fit tubes into proper connections and equipment, and influences the tube’s performance properties.

Real-time monitoring of various parameters using sensors and other technologies is also an emerging trend for medical tubing. “Smart” tubing can provide continuous vital signs data or other relevant metrics to enhance patient care.

With all these ideas in mind, over the past few weeks, MPO reached out to more than a dozen tubing and extrusion specialists to get their perspectives on the following questions.

1. Which tubing and extrusion technologies and/or requests from OEM manufacturing partners have been in-demand or impactful to your business recently, and why do you think that is?
2. What offerings and/or capabilities are available from tubing and extrusion partners that medical device manufacturers do not yet fully embrace or realize?

The experts’ responses are featured in the following presentations, each offering a unique voice about medical device OEM requests and untapped potential in the complex, multifaceted world of medical tubing and extrusion.

Christian Herrild
Director of Growth Strategies,
Teel Plastics

OEM Requests: We’ve had two that we have seen more of recently. The first is paratubing. We have seen more requests for paratubing that have a narrow and targeted range of peel force and very specific frost requirements. It is different than we saw in the past with just basic configurations. We understand that is related to some automation equipment being used now. To really get speeds up and dial the equipment in, they need those factors to be very consistent and just “right” to save on scrap or downtime with their equipment. We also see some interest in tubes with a very large ID to OD ratio. These are parts with 0.06-0.08 OD and an ID that is down to a couple of thousandths. The customers are using them for very specific, but unrelated applications. It seems more a result of them engineering a part with niche requirements, then going to market and looking for a production partner.

Untapped Potential: We still see some OEMs have a lack of understanding of the information available from online measurement systems. We can put equipment inline that will measure every inch or less of a part and we can then sort and review that data. This is effectively 100% inspection, and we know when parts are packed if they are in spec or not. However, we still have OEMs demanding secondary inspection or getting into dialog about Cpk levels or distribution data. Those don’t really make sense when we have already done all the measurements for parts we saved. I still think some OEMs either have a hard time understanding what the data tells you or what the implications are, and still design acceptance criteria as if we’re measuring 30 or 50 pieces to accept a lot of tubing. Some get it, but some are forcing product be scrapped because the Cpk shows you expect some parts out, but the actual measurements say everything is good.

Tim Finn
Product Development Engineer,
New England Tubing Technologies

OEM Requests: Across our entire product range, the most impactful trend we see is a relentless push for tighter tolerances and miniaturization. This demand from OEM manufacturing partners reflects the evolving landscape of the medical device industry, where advancements in minimally invasive surgery and microfluidics are driving the need for ever-smaller, more precise components.

As minimally invasive surgery techniques become increasingly sophisticated, surgeons require intricate instruments and catheters that can navigate delicate anatomy with minimal disruption. Miniaturized tubing facilitates smaller incisions, reduced patient recovery time, and improved cosmetic outcomes. The rise of microfluidic devices for diagnostics and drug delivery demands micro-scale tubing with ultra-precise dimensions and surface properties to ensure accurate fluid flow and efficient drug distribution. This shift toward tighter tolerances and miniaturization isn’t just a passing trend—it’s shaping the future of medical devices.

Unrealized Offerings: While medical device manufacturers leverage various capabilities from tubing and extrusion partners, one area with immense potential yet to be fully embraced is our eTubing technology. Many manufacturers might not be fully aware of eTubing’s capabilities and potential applications. eTubing eliminates the need for separate wires, reducing device size and complexity. Electrical functionalities like stimulation, sensing, or data transmission can be directly integrated within the tubing.

Streamlined design with no external wires offers a sleeker, more discreet look, something we prioritize for patient comfort and device appeal. Fewer components simplify assembly and potentially lower manufacturing costs, contributing to overall device efficiency. As miniaturization and multifunctionality become increasingly important trends, eTubing’s potential will continue to grow.

Tim Steele
Founder and CEO,
Microspec

OEM Requests: The four extrusion technologies we continue to focus on—multi-lumen tubing, co-extruded tubing, thin wall tubing, and bump tubing—are still vibrant and growing, although thin wall tubing appears to be growing faster than the others. The thin wall industry tends to be somewhat secretive, so we often do not know the tube’s function. Endoscopy applications are obvious to us, but if a customer is reflowing the tube, we typically are not told why or how. What we are told is the thin wall is necessary because of a lack of space in the device and the wall thickness is critical to function.

Measuring these walls can be a challenge. Customary inspection equipment is often inadequate for walls less than .001 inches (25 microns) and multiple measurements of the same wall are required to determine the most reliable value. The chief reason for the ultra-thin walls is almost always the need to save on space in new devices being manufactured. This shift in the marketplace is driving extruders of thin wall tubing to innovate through tool and process design to meet customers’ advancing requirements.

Untapped Potential: Creative extrusion companies possess knowledge and technology the industry may not be aware of, and open communication is the way new extrusion technologies will get launched and integrated into new and innovative devices. For example, creating extrusion tools for today’s minimally invasive devices is often more of a challenge than extruding the part. A “state of the art” machine shop enables manufacture of extrusion tools I could only dream about 15 years ago. An innovative engineering team fully involved with the customer promotes discussions and problem solving as the extrusion team and customer collaboratively explore options and sometimes even the identification of unspecified aspects of a part can provide opportunities to meet dimensions the customer requires. Extrusion technology today is what it is, but the technology is always advancing and anyone looking for advanced extruded parts should keep this in mind and ask questions of what is possible.

Casey Brennan
VP of Business Development,
Cirtec Medical

OEM Requests: We have experienced a notable surge in demand for several specific tubing and extrusion technologies. One prominent trend driving this demand is the increasing preference for platinum-cured silicone tubing. The demand for platinum-cured silicone tubing over peroxide-cured alternatives is spurred by heightened awareness of the health risks associated with byproducts generated from the peroxide-cured tubing. Additionally, platinum-cured silicone tubing offers superior purity, transparency, and biocompatibility; sterilizability by autoclave, EtO and Gamma; minimizes the risk of leachables and extractables; resistance to extreme temperatures; exceptional resilience, and durability.

Untapped Potential: As devices shrink in size and become more intricate in design, there’s a growing demand for specialized tubing components. For instance, tubing components to have extremely tight tolerance (which exceeds RMA standard), single-layer, multi-lumen, and micro-tubing, online auto-cutting, cut-to-length tubing and spooling, transitional (profile change) extrusion, ultra-low particulate spallation biologically compatible peristaltic pump tubing, as well as co-extruded strip tubing with radiopaque properties, thin-tape/film and intricate profiles with online measuring device coupled with color printing/labeling and color matching capabilities, per FDA guidelines.

There’s also untapped potential in collaborative partnerships with tubing and extrusion partners. For instance, materials selection assistance and custom blending to meet or match performance.

Brett Blanchard
Commercial Manager,
Advanced Components,
Spectrum Plastics Group, a DuPont company

OEM Requests: OEMs are finding more need for partners that provide a full-service solution for their medical device and component design, development, and manufacturing. We’re seeing an increase in unrelated projects due to OEMs looking for a full-service supplier to condense their supply chain and minimize production risk in bringing their next-generation products to market. With a one-stop-partner, OEMs can be rest assured their full-service medical device needs are addressed and handled by reputable and seasoned experts.

Untapped Potential: Customers are finding value in choosing a full-service partner of choice for a variety of their component and medical device projects, not just a select few. They turn to full-service partners for current and future projects because they trust them to make their products and see how they are invested in their success by forecasting the advancing medical device market. They like the ease of collaboration and communication and trust the efficiency, dependability, and convenience of having a single-source provider. They entrust their projects to partners like Spectrum, in part, due to decades of experience serving a wide range of markets, manufacturing a variety of finished devices and assemblies, with the convenience of value-added services like assembling and packaging.

Mike Winterling
COO,
Junkosha USA

OEM Requests: Catheter delivery systems for applications including structural heart interventions, abdominal aortic aneurysm (AAA) repair and transcatheter aortic valve replacement (TAVR) rely on increasingly complex shapes and constructs to deliver their intended treatment. Consequently, manufacturers find themselves compelled to produce tailored and customized catheters to meet individual patient needs with precision and efficiency. As TAVR becomes the standard of care for more patients with severe aortic stenosis, it’s crucial to have larger vessel catheter delivery systems available that keep up with the evolution of the therapy. The precise control of various parameters such as wall thickness, diameter, length, flexibility, strength, and stiffness are necessary to achieve the desired form and function for these new tools. This level of control provided by peelable heat shrink tubing (PHST) can enhance reliability and increase yields in the assembly process.

Untapped Potential: Many medical device manufacturers think it is difficult to use heat shrink tubing for micro-catheters, due to the challenge of using razor blades to skive and remove the tubing after the reflow process. The process of catheter construction requires absolute precision, leaving no room for error. The final step, which involves removing the recovered FEP heat shrink from the outer shaft, is often the most laborious and critical. PHST solutions simplify this step by requiring a single slit to start the peeling process, making it effortless to remove the tubing from the catheter and reducing risk of damage to the underlying construct, resulting in higher yields.

Ragan Finnegan
Product Line Manager, Medical Tubing,
Nordson Medical

Carmel Cullen
Senior Manager, Engineering,
Nordson Medical

OEM Requests: The demand for reduced lead times and costs in supply and speed to market for new designs has been a lead driver of requests. Fast tracked deliveries, dualled with reduced lead times, is an aspect of support that manufacturing partners are continuing to deliver to customers. The reduction in lead times coupled with prototype line availability for quick-turn trials provides a fast track, one-stop-shop for partners. Recent demand in dual sourcing to drive risk mitigation has also been a strong focus in the market from OEM manufacturers. Design requirements like lubricious additives and PFAS-free material requests are also changing the way OEMs design medical devices.

We’re also working with OEMs toward low NMP polyimide and non-Phthalate PVC. Low NMP polyimide complies with REACH and EU MDR guidelines regarding SVHC/CMR restrictions. Responses to non-DEHP PVC offerings due to regulatory requirements have prompted the development of DEHP-free PVC material.

Untapped Potential: The ability to complete additional processing (tipping, over-modeling, hole punching, printing, laser marking, welding, etc.) to the tubing is an area of focus for us. We see ourselves as a center of excellence for these activities. With a big focus on automating these processes, a cost-efficient option can be ensured. It’s important to offer early engagement and collaboration between tubing and extrusion suppliers and medical device manufacturers and it’s a critical component in the success through design processes. Front-end design activities start the vertical integration process, streamlining the successes and operations to the composed finished device of the customer. Vertical integration, accompanied with value-add technologies driving performance and design enhancements, results in a streamlined production and design.

Brian Frechette
Operational Strategist,
Medical Extrusion Technologies

OEM Requests: We still see the impact of supply chain disruptions on the FEP heat-shrink market. We have been able to assist many existing and new customers in keeping production lines running through the use of FEP heat-shrink. MET has been manufacturing FEP heat-shrink since 2006 and market demand has grown tremendously since its introduction. We have found OEM customers appreciate the quality of the FEP heat-shrink product we manufacture. Our product is very consistent from lot to lot, and we achieve low longitudinal growth in the 0-5% range. We have continued to add capacity across all three of our manufacturing locations, but specific focus has been paid to our Texas facility and the manufacturing capacity of FEP heat-shrink.

Untapped Potential: Customers often assume they have constraints due to limited options of “off the shelf” products and sizes from suppliers, specifically in the development phase. With a manufacturer of custom tubing, this is simply not the case. Custom tubing makers work closely with customers to understand the unique attributes required to meet product performance goals and challenge ourselves to come up with solutions in the manufacturing process to achieve these goals. Many of the resin manufacturers and compounders have designed products to achieve specific desirable attributes, and we have worked with many customers and compounders to produce extrusions utilizing these newer options to help them achieve their goals.

Scott Nicora
Vice President,
NDH Medical

OEM Requests: We see more requests for a couple of technologies. The first is incorporating metal into tubing design, which could be for reasons like torsional strength, burst strength, and electrical applications. The second is trying to make lower cost materials perform better by incorporating different additives. These applications could be for lubricity, laser marking, and a host of other possibilities. The third area is for bump and taper tubing capability, where the tubing diameters can be changed along the length of the tube (e.g., one end has a small diameter and the other end has a larger diameter). This tubing can be used to facilitate assembly operations and eliminate the need for some connectors. I believe we are seeing these trends as OEMs design for smaller, lower-cost devices with fewer components. Another trend is OEMs wanting more manufacturing operations performed by a single vendor to simplify their supply chain.

Untapped Potential: I believe there are two capabilities that more device manufactures could take advantage of. The first is to include the component and/or contract manufacturers in initial design talks. The earlier we are included, the more direction we can give on whether or not a design is manufacturable and if it will be repeatable. Second is incorporating multiple sources of raw materials into initial product validations. We have seen companies that specified a single raw material grade in an application run into issues over the last couple of years due to changes in the marketplace. Whether it was due to mergers and acquisitions or supply chain disruptions, it may lead to unacceptable lead times. Alternate suppliers were determined, sourced, and validated to alleviate the issue.

Alex Kakad
Global Product Manager,
TekniPlex Healthcare

OEM Requests: With the trend toward more minimally invasive and robotic surgical procedures, medical device manufacturers are being challenged with the need for smaller diameter tubing with tighter tolerances. We have seen a substantial increase in requests for extremely small tubing diameters with tolerances at or below ±0.001” in a variety of materials. We have also seen more interest in its paratubing for application solutions both with and without an embedded wire in one or multiple tube lumens.

We’ve also seen increasing demand for some more novel multilayer extrusion solutions. One example is three-layer configurations that utilize a proprietary tie layer that helps limit tubing delamination, as well as a unique configuration that offers a chemically resistant fluid path for solvent suspensions. This technology has seen a lot of interest in dual hormone therapy as well as newer cell and gene therapies.

There’s also renewed interest in UV light-blocking tubing used primarily for oncology treatments. Having precise distribution of the colorant throughout the tubing is paramount to blocking the targeted UV wavelengths in order to maintain the drug’s efficacy.

Untapped Potential: In general, we believe medical device manufacturers aren’t always aware of the breadth of materials available for their tubing solution. Correct material selection is of the utmost importance, whether it’s related to the right tie layer to mitigate the risk of delamination, the right fluid contact layer to mitigate preservative absorption or the optimal material selection for a given peristaltic pumping application. These are a few examples that highlight the need for not only extrusion expertise in a tubing supplier, but also one that understands the universe of medical grade material options for a specific application.

Crew Feighery
VP of Sales, Catheter Technologies,
Medical Manufacturing Technologies (MMT)

OEM Requests: The minimally invasive medical device industry is constantly looking for tubing with thinner walls, lower durometer, and tighter tolerances. These three primary requests are in an effort to improve performance of the finished devices and/or offer a marketable difference in their product when compared to the competition. The challenge the customers have with these thinner, softer, tighter tolerance materials is how to process them reliably and repeatably. Those issues can be solved with manufacturing equipment purpose built for tasks such as precision cut to length, flashless tip forming, automated handling, and hole drilling.

Untapped Potential: With the recent challenges in the PTFE supply chain, there is an increased demand for catheter liner alternatives. There are several polymers available with similar characteristics of PTFE (lubricity topping that list) that have added benefits of manufacture traditional extrusion processes, not requiring etching, and being overall more manufacturing friendly. The challenge is most devices were originally designed with PTFE liners and the general thought in the industry is it’s the only suitable material for the application. However, there are some industry leaders looking to move away from PTFE as their inner liner, which will allow them to have lower costs on their catheter shafts due to more efficient manufacturing and lower cost than very pricey PTFE liners. This will be an interesting trend to follow as it propagates, as it will invariably lead to finished cost reduction and more competition in the market.

Danielle Arcuri
Product Segment Manager,
Qosina

OEM Requests: We typically see a variety of tubing-related requests. This includes continuous demands for DEHP-free PVC tubing due to regulatory requirements and the material being commonly used in the medical device industry. However, we have noticed that more companies are transitioning to silicone tubing. We also see requests for tubing that are cut-to-length based on a defined specification to minimize the need for this step in the customers’ manufacturing process, and to help them streamline their operations. It also helps prevent any tubing set from tubing being previously coiled prior to being cut.

Untapped Potential: There are applications in which tight tubing tolerances may be required, related to inner diameter (ID), outer diameter (OD), or overall length (OAL). We have partnerships with vendors who could provide liquid silicone injected tubing which would provide these tighter tolerances to customer specifications. We are currently evaluating where these tubing components could provide the most benefit to customers, who may not be aware of this technology today.

Barry Schnur
Interim CEO,
Cobalt Polymers

OEM Requests: There’s been a lot of disruption in the heat shrink tubing market since the pandemic. Some companies have been making popular products less available and decreasing product support, so we’ve definitely seen interest from those who had been using other solutions. In fact, it was that demand that motivated development of the 74D version of 2:1 and 4:1 ratio Pebax heat shrink tubing. We’ve responded to this shortage by increasing the number part numbers in stock, amplifying our online marketplace presence, and boosting our capacity with a new facility in Northern California that’s nearly triple the size of our previous space.

Untapped Potential: Interventional device design is trending away from braided shafts towards laser-cut hypotubes. Now, a single jacket of Pebax heat shrink tubing over a laser-cut hypotube can streamline the process and provide flexibility, thin walls and strong adhesion. Based on feedback, we introduced several sizes of larger-diameter 4:1 ratio Pebax heat shrink tubing designed for structural heart and other applications. Another newer product is the 70D version of the 2:1 ratio Pebax heat shrink tubing. It provides more flexibility than 72D Pebax tubing with superior kink resistance.