Medical Coils FAQ

For more details and information on our Medical Coils products and capabilities, visit our product catalog on te.com or download our brochure. You can also request a quote, or connect with our experts to learn more, get samples and design support.

Q: What coil geometries can you support (e.g., helical, solenoid, toroidal)?

A: We can manufacture helical, solenoidal, and custom-shaped coils depending on the application. We also support complex geometries such as multi-layer windings or bifilar windings when needed for redundancy or field uniformity.

Q: Can you customize wire diameter, pitch, turn count, or length?

A:  Yes, our coil winding process is highly configurable. We support wire diameters from ~0.0127 mm (0.0005”) up to ~0.2 mm (0.008”), with precise control over turn count, pitch, and coil length. We work closely with you to match electrical and mechanical specs exactly.

Q:  How small can you make the coil (inner/outer diameter, length)?

A:  We can produce micro coils with outer diameters under 0.5 mm, depending on the material and application. These are often used in neurovascular or
intravascular devices.

Q:  Can you integrate the coil into a catheter shaft, hypotube, or guidewire
assembly?

A:  Yes, we frequently integrate coils into catheter shafts, hypotubes, and hybrid
subassemblies with strain reliefs, terminations, and connectors. We’re also experienced in overmolding and joining to other components.

Q:  What wire materials are available (e.g., MP35N, Nitinol, Platinum-Iridium)?

A:  We typically work with MP35N, stainless steel, platinum-iridium, and Nitinol,
among others. Material selection depends on your electrical conductivity,
fatigue, and biocompatibility requirements.

Q:  Are the materials MRI-safe or radiopaque?

A:  Yes — for MRI compatibility, we often use non-ferromagnetic alloys like
platinum-iridium. For radiopacity, materials such as gold and platinum are
available.

Q:  What coating or insulation options do you offer (e.g., Parylene, PTFE, polyimide)?

A:  We offer polyimide, Parylene, PTFE, and other thin-film coatings. Insulation
type and thickness are tailored to electrical requirements and processing
needs.

Q:  Is the coil biocompatible or implant-grade?

A:  Yes, we select medical-grade materials and coatings that comply with ISO 10993 and are suitable for contact with bodily fluids or tissues, including
implantable-grade materials.

Q:  How do your coils perform under repeated flexing or torque?

A:  We test for mechanical durability under repeated bending and torsion. Our coils are designed to maintain electrical performance even under dynamic loading — especially important in steerable or active catheters.

Q:  Can they transmit electrical signals, mechanical motion, or both?

A:  Both. We support low-resistance winding for signal fidelity (e.g., in IVUS or
neurostimulation) as well as robust actuation coils for electromagnetic
movement or thermal activation.

Q:  What frequency ranges or signal integrity can the coil support?

A:  This depends on wire gauge, winding geometry, and insulation. We work with customers to model inductance, resistance, and self-resonance to meet specific signal performance targets — typically from kHz to low MHz ranges.

Q:  What’s the pull strength / tensile strength of your bonded joints?

A:  We design for high mechanical integrity. Our terminations and welds undergo pull testing per IPC and customer-specific protocols. We can support >5 lb pull strength depending on configuration.

Q: Do you manufacture in a cleanroom environment?

A:  Yes — we manufacture in ISO 7 and ISO 8 cleanroom environments where needed, particularly for implantable or interventional devices.

Q:  What tolerances can you hold on dimensions and resistance?

A:  Dimensional tolerances down to ±10 µm and electrical tolerances within ±5% resistance are common. Specific tolerances depend on coil size, wire type, and application.

Q:  What kind of in-process inspection or quality control do you perform?

A:  We use high-resolution vision systems, resistance checks, mechanical gauges, and optical comparators throughout the winding and finishing processes.

Q:  Are your processes ISO 13485 certified or FDA audited?

A:  Yes. TE Connectivity operates under ISO 13485:2016 and FDA-audited quality systems for medical manufacturing.

Q:  Can you provide assembled subcomponents (e.g., coil + connector + strain relief)?

A:  Yes — we can provide plug-and-play assemblies with electrical connections, strain reliefs, or integration into full catheter shafts, depending on your BOM.

Q:  Do you support rapid prototyping?

A:  Yes. We have fast-track engineering teams to support early-stage development and feasibility builds, with short lead times and iterative design feedback.

Q:  What are your lead times for custom designs?

A:  2-3  weeks if RM is on hand

Q:  Can you scale to volume production?

A:  Absolutely. We support seamless transfer from prototyping to validated production, including tooling, process validation (IQ/OQ/PQ), and supply chain planning.

Q:  Can you provide traceability for materials and process steps?

A:  Yes — we track raw materials, lot numbers, process steps, and inspection data. Full Device History Records (DHR) are available when required.

Q:  Do you offer design history files, PPAP, or validation documentation?

A:  We provide IQ/OQ/PQ protocols, FMEA inputs, PPAP documentation, and help with Design History Files (DHF) as part of regulated development processes.

Q:  Have your coils been used in FDA- or CE-approved devices?

A:  Yes. Our coils are already deployed in class II and class III devices across
neurovascular, cardiac rhythm management, and electrophysiology applications.

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