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.
- 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?
- What offerings and/or capabilities are available from tubing and extrusion partners that medical device manufacturers do not yet fully embrace or realize?
Christian Herrild
Director of Growth Strategies,
Teel Plastics
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
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
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
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
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
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
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
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
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
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)
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
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
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.