For OEMs, the right partner isn’t just a vendor — it’s a competitive advantage.
When it comes to catheter component assembly and other high-performance medical applications, FEP heat shrink tubing plays a crucial role in device performance and reliability. But choosing the right supplier isn’t just about price or availability. It’s about finding a manufacturing partner who understands your product, your compliance requirements, and your go-to-market strategy.
Whether you’re developing components for a next-generation catheter or scaling production, these five questions (and follow ups) will help you identify the right FEP heat shrink supplier and avoid costly delays or quality issues later in the process.
Need FEP heat shrink for your project today? We have available FEP heat shrink stock, take a look.
1. Do You Manufacture In-House or Source from Distributors?
Not all heat shrink tubing suppliers are created equal. Many act as distributors, simply reselling stock tubing without insight into how it’s made or control over its dimensions, shrink ratio, or performance characteristics.
Why it matters:
Distributors often can’t offer custom sizes, shrink ratios, or material traceability. This introduces risk during assembly, especially when tight tolerances are critical to performance or compliance.
Follow up questions to ask:
- Do you extrude FEP tubing in-house?
- Can you provide shrink sleeves customized to our spec?
- How do you control consistency across production runs?
Why OEMs choose MET:
Medical Extrusion Technologies is a U.S.-based manufacturer. We produce heat shrink tubing in-house and offer customized dimensions, shrink profiles, and post-processing support tailored to OEM applications.
2. Is the Supplier Quality Certified?
In regulated industries, quality isn’t optional. Whether you’re building Class II devices or scaling a novel delivery system, your tubing supplier needs to demonstrate robust quality systems.
Follow up questions to ask:
- Are your facilities ISO certified (e.g., ISO 9001:2015)?
- Do you comply with USP Class VI, RoHS, or REACH?
- Can you provide Certificates of Compliance and lot traceability?
Why it matters:
Subpar quality systems result in variability, batch failures, or noncompliance that can derail your launch or compromise patient safety.
At MET:
We operate under robust quality protocols and ISO 9001:2015 certification, provide full traceability, and support your documentation requirements throughout design, validation, and production. Learn more about how we approach tensile testing in medical manufacturing.
3. Can You Meet the Dimensional and Functional Requirements of My Device?
FEP heat shrink tubing must perform consistently under thermal load and integrate seamlessly with complex assemblies. This is especially true for multi-durometer shafts, catheter sheathing, or strain relief applications.
Follow up questions to ask:
- What are your tolerances for inner diameter, wall thickness, and concentricity?
- Can you customize shrink ratios to match our form factor?
- Do you support prototypes with engineering input?
Why it matters:
Off-the-shelf tubing often lacks the precision needed for medical device manufacturing. Misaligned tolerances or uneven shrinkage can lead to poor fit-up or rework downstream.
MET’s advantage:
We specialize in tight-tolerance, custom catheter manufacturing and provide application-specific engineering support.
4. What Are Your Lead Times, MOQs, and Development Options?
In today’s medtech environment, speed-to-market and supply chain agility are non-negotiable. Whether you’re in early-stage development or preparing for commercial scale-up, your supplier must be able to move at your pace.
Follow up questions to ask:
- What are your typical lead times?
- Do you offer low-MOQ options for development?
- Can you scale production as we grow?
Why it matters:
Suppliers who can’t meet your timelines or require large upfront orders may limit your ability to respond to changing market or clinical needs. Understanding minimum order quantities (MOQs) upfront is essential to budgeting and planning.
With MET:
We offer short lead times, low-MOQ development runs, and the ability to scale with your program. Whether you’re building a single prototype or launching a high-volume product, our team adjusts to meet your milestones.
5. How Will You Protect My Design, Data, and Commercial Roadmap?
When working with a supplier on critical components, protecting your intellectual property and product plans is essential. This applies whether you’re refining a proprietary catheter shaft or preparing a novel delivery device for submission.
Follow up questions to ask:
- Do you use NDAs and confidentiality protocols with OEMs?
- How are my design files and commercial information secured?
- Will my team have direct communication with your engineers?
Why it matters:
OEMs need to know that their device designs, CAD files, and timelines are secure. According to WIPO, protecting your IP in a manufacturing context is key to reducing knockoffs and maintaining regulatory advantage.
At MET:
We treat confidentiality with the same seriousness as performance. Your project is governed by mutual NDAs, and our engineering team communicates directly with yours to ensure alignment from design through production.
Choose a Partner Who Builds More Than Tubing
FEP heat shrink tubing may be one small part of your device, but your supplier’s performance shapes your product’s reliability, regulatory compliance, and commercial success.
At MET, we don’t just deliver tubing. We build partnerships with medical device OEMs who demand precision, collaboration, and long-term value.
Looking for a heat shrink manufacturer who understands your product and process?
Contact Medical Extrusion Technologies to start your project.
