Beyond the Tube: Application Expertise Is the Most Valuable Part of Extrusion—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

Tubing is synonymous with many healthcare applications. As such, it’s a common component in medical devices. It also comes in various forms, sizes, and lengths; each with its own set of requirements and specifications. The number of variables associated with medical tubing is virtually infinite, which makes its manufacture challenging.

Fortunately, extrusion experts have established best practices, techniques, and technologies to ensure they’re able to meet the demanding requests from medtech customers. These supply partners can achieve the tight tolerances often associated with healthcare applications. In addition, many often focus on the medical device sector, building up their application expertise in the industry.

To help further explain why application expertise can be so important for extrusion supply partners, two representatives from Graham Engineering participated in the following Q&A. In this interview, Dave Schroeder, President & CEO, and Larry Alpert, Medical Extrusion Support Specialist, tackle questions about design factors, when to engage the extruder, and common missteps OEMs make.

Sean Fenske: We’re discussing application expertise with medical extrusion. Can you please explain the applications we’re talking about in terms of Graham Engineering’s expertise?

Dave Schroeder: Graham Engineering’s expertise spans the full range of medical tubing and catheter applications—from conventional single-lumen tubing to multi-lumen; multi-layer; micro, bump, and taper; fluoropolymer; and braided or spiral-reinforced constructions. We also bring deep experience in demanding materials, precision tooling, process controls, and integrated downstream equipment. The real value is our ability to understand how the finished component must perform in the device and then translate those requirements into a stable, repeatable extrusion process and a complete production system.

Fenske: Why is it valuable to work with a medical extruder that is an expert in your specific device application area?

Larry Alpert: Partnering with a team experienced in medical applications will add value for the customer. The team can guide the catheter designers in specifications that make sense, material selections, and more robust/repeatable designs that could mean the difference in validation activities.

In addition, these efficiencies can be achieved while reducing cost. What may seem to be more complex can cost less than the original design.

Fenske: Can you expand on how the extruder helps with design decisions? Are these determined by the needs of the application or another factor?

Alpert: The needs of the application will always trump any other consideration, but some drivers will impact the project in time and money.

Your vendor should be an extension of your project team; they can advise/guide your group from early design considerations all the way through validation and into production for the lifecycle of the product. If your vendor is not familiar with every aspect of the medical device needs across all activities, it can make things much more difficult in the long run.

Fenske: Is there an optimal starting point to bring in the extrusion partner? When and why?

Schroeder: The optimal time is as early as possible—ideally while the device requirements are still being translated into component specifications. Early engagement allows the extrusion partner to evaluate geometry, tolerances, materials, tooling, process capability, downstream operations, and scale-up together, rather than treating them as separate decisions. That collaboration can identify risks before the design is locked, reduce unnecessary complexity and cost, shorten development and validation, and create a more reliable path from prototype to production.

Fenske: Can you share an example of a success story where benefits were achieved that would not have been enjoyed with a standard extruder?

Alpert: One of my personal experiences was for a cardiovascular application. The customer needed four lumens on the inner portion of the braid construction—two at 0.03 inches and two at 0.024 inches—and they needed these to fit inside a tube that was less than 2.0 mm in diameter. The precision needed was to the ten-thousandth of an inch to meet the full specification and to be able to go through two more processes. The tooling design needed to be manufacturable as well as usable for the technician on the floor.

Fenske: When it comes to extrusion, what should OEMs keep in mind? What factors are most important? Where do the common missteps take place?

Schroeder: OEMs should begin with a clear understanding of the component’s function and distinguish true critical requirements from preferences. Material behavior, dimensions and tolerances, concentricity, surface quality, downstream processing, inspection strategy, expected production volume, and regulatory requirements all need to be considered as one system.

Common missteps include specifying tolerances tighter than the application requires, selecting a material without fully considering processing and secondary operations, and waiting too long to involve the extrusion partner. The goal should not simply be to produce acceptable tubing once; it should be to establish a robust, repeatable, and scalable process that consistently produces the required result.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Schroeder: I would add that the best extrusion partner contributes value well beyond the initial equipment purchase or product launch. Medical manufacturers should look for a team that combines application and processing expertise with testing, training, technical support, service, and continuous improvement throughout the product’s lifecycle. That long-term partnership helps protect the original process intent, sustain quality and productivity, and adapt as requirements, materials, and production demands evolve.

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