Film & Tubing Extrusion in Medical Devices: Balancing Flexibility, Barrier Properties, Strength, and Biocompatibility
In the world of medical devices, film and tubing extrusion may seem like a small piece of the puzzle — but it plays an essential role in ensuring the reliability, safety, and performance of critical healthcare products. From IV lines to flexible bags and catheters, extrusion determines how these components function under pressure, interact with biological materials, and maintain integrity through sterilization, use, and shelf life.
At PiSA USA, we understand the balance required to achieve flexibility, strength, and biocompatibility in every extruded component. While our internal extrusion capabilities focus primarily on single-lumen tubing and PVC-based materials, our unique advantage lies in how extrusion fits within our vertically integrated manufacturing ecosystem.
The Role of Extrusion in Medical Devices
Extrusion is the process of shaping raw thermoplastic material — such as PE, PVC, EVA, TPE, or polyurethane — by forcing it through a precision die to create a continuous form like tubing or film. In medical applications, extrusion is used in everything from IV sets and drainage systems to the flexible films that make up medical solution bags.
What makes extrusion particularly complex in the MedTech field is the need for tight tolerances, biocompatibility, and consistent performance. Variability in wall thickness or clarity can impact flow rates, structural strength, and even the sterility and stability of the final product.
Balancing the Four Core Material Properties
1. Flexibility
The right amount of flexibility allows tubing to move with patients or fit into device assemblies without kinking or collapsing. PVC remains a preferred choice for many general applications due to its predictable performance and ease of processing.
2. Strength
Medical tubing and film must withstand pressure, stretching, and sterilization cycles without losing form or function. Controlling extrusion parameters ensures dimensional stability and structural reliability across every batch.
3. Biocompatibility
Materials must meet strict FDA and ISO biocompatibility standards. PVC has a long history of proven performance, though newer materials like TPEs and polyurethanes are emerging for specialized applications requiring reduced plasticizer content or enhanced chemical resistance.
4. Barrier Properties
Materials must ensure and protect product stability and efficacy during the complete product shelf life. Oxygen-gas interaction, UV light, and other factors may impact product performance and potential degradation, potentially decreasing product efficacy for the final user. Therefore, selecting an appropriate Polymer and a suitable wall thickness for the film tube will help ensure optimal primary container performance, taking into account the active ingredient(s), storage conditions, and final application.
Why Vertical Integration Matters
While many large device companies outsource their extrusion and film production, PiSA USA offers something distinct: the ability to integrate extrusion directly within a full assembly and sterilization process.
Rather than selling film or tubing as standalone commodities, PiSA’s extrusion capabilities are part of a complete, vertically integrated solution — encompassing film extrusion, tubing, welding, assembly, and ethylene oxide (ETO) sterilization under one roof.
This approach ensures:
Streamlined quality control across all manufacturing stages
Reduced supplier complexity and logistical coordination
Faster time-to-market for finished, validated medical devices
Enhanced regulatory traceability, with a single accountable manufacturing partner
As Ryan McCormick, PiSA USA’s VP of Business Development, summarized, “It’s not just about having extrusion — it’s about how that capability fits into a larger ecosystem. We can produce the tubing, the clamp, the film, and the welded assembly — all within one integrated process.”
The Future of Medical Extrusion
The medical device industry continues to evolve toward more advanced materials, sustainable manufacturing, and multi-functional tubing and films. Yet even as innovation accelerates, the fundamentals remain constant: the need to balance flexibility, strength, and biocompatibility and barrier properties through precision and process control.
At PiSA USA, we’re proud to bring those fundamentals together — not just through extrusion, but through a vertically integrated platform that supports the entire product lifecycle from concept to sterilized, ready-to-market device.
About PiSA USA
PiSA USA provides vertically integrated contract manufacturing and sterilization services for the medical device industry. From extrusion and welding to assembly and ETO sterilization, PiSA delivers a streamlined, end-to-end manufacturing solution designed to ensure precision, compliance, and reliability.
