Understanding tubing’s critical role in medical device design

Medical devices are smaller, more specialized and more complex than ever. In device design, tubing is a supporting yet critical component, as its impact on performance, reliability and compliance is significant. In many cases, the type of tube a designer selects directly affects functionality, patient safety and market success, so getting it right is key.
Because optimal device performance depends on the sum of its parts, designers can avoid costly mistakes and create products that meet the needs of clinicians and patients by understanding the role tubing plays, its technical demands and material options available early in the development process.

Evaluating characteristics in medical tubing
Specifying a tube for a specific application begins with defining what it must do, and form should always follow function.
Designers should ask themselves: Will the tube be exposed to skin or internal tissues? Will it carry reactive fluids or drugs? Does it need to flex repeatedly without kinking? Is it part of a disposable or reusable device?

Performance factors for consideration include flexibility, tensile strength, elongation, chemical and heat resistance, surface finish, biocompatibility, leachables and extractables performance, miniaturization and compatibility with cleaning agents and drugs. For example, tubing for a portable infusion pump must combine softness for comfort with structural integrity to resist collapse under pressure.

Regulatory compliance is essential. Tubing suppliers should meet quality management system standards such as ISO 13485 to ensure quality and consistency. Depending on the application, materials may also need to meet ISO 10993 or USP Class VI for biocompatibility and safety. Selecting a supply partner with documented quality systems ensures the tubing meets both mechanical and regulatory requirements.

Aligning material behaviors with desired device performance
The material medical tubing is comprised of affects its functionality. Common options include polyvinyl chloride, thermoplastic elastomers and latex.
Polyvinyl chloride (PVC) is a low-cost, versatile material widely used for fluid transfer in IV lines, oxygen tubing and respiratory circuits. It’s lightweight, durable and lends itself to solvent bonding, and PVC is a strong choice for applications requiring stability and resistance to tears and corrosion. Because flexible PVC relies on plasticizers (some with potentially significant safety concerns) it’s not suitable for implants or long-term patient contact.

Thermoplastic elastomers (TPEs) combine the flexibility of rubber with plastic processability, without plasticizers. They offer excellent biocompatibility, sterilization and chemical resistance. TPEs are well-suited for catheters, dialysis lines and miniature diagnostic channels. High-grade TPEs can withstand aggressive cleaning agents or elevated heat, and offer good tensile strength and tear resistance.

Latex delivers high elasticity and tear resistance, and is ideal for catheter balloons or tourniquets that require reliability and durability. However, allergy concerns have led many applications to synthetic alternatives.

A primary goal for device designers is to match tubing material properties to the device’s performance requirements and operating environment, whether it’s bioprocessing tubing that survives repeated sterilization or wearable diagnostic lines that prioritize comfort and light weight.

Meeting technical and regulatory demands
Medical tubing faces increasing performance and safety requirements:

• Biocompatibility to prevent adverse reactions;
• Leachables and extractables to avoid chemical migration;
• Miniaturization to maintain flow precision and stability in smaller diameters;
• And chemical compatibility to resist breakdown from cleaning agents or drugs.

Consider a chest drainage system, with tubing that must remain flexible for mobility, maintain a seal under varying pressures and resist chemical degradation. Missing any of these can cause device failure, regulatory rejection or patient harm. That’s why device designers should prioritize involving experienced tubing supply partners from the earliest design stages.

Improving marketability
Performance and safety are nonnegotiable, but specifying specific tubing can also influence market success.

The right choice can improve ease-of-use to boost adoption, streamline manufacturing and reduce lead times (especially with domestic suppliers), and support faster regulatory clearance by eliminating material-related risks.

In infusion systems, for example, a well-designed tubing set can enhance pump accuracy, reduce maintenance and improve patient satisfaction, benefits that strengthen market position.

Consider tubing early in design
Medical tubing may be “just a component,” but its impact is substantial. Choosing the right tube early in development improves performance, ensures compliance and enhances market potential. For medical device designers, treating tubing as a core design element can mean the difference between a product that simply works and one that excels. Medical Design and Outsourcing