Medical Device Component Reliability
Client: Medical Equipment Manufacturer
The Challenge
Develop corrosion-resistant, biocompatible components for long-term implantable devices
Our Solution
Utilized precision-engineered nickel clad copper (NCC) for critical components
Results
100% pass rate in accelerated lifetime testing, approved for clinical implantable use
Project Timeline
Material Selection
NCC wire with 27% nickel for biocompatibility barrier
Testing
Passed ISO 10993 biocompatibility & 10-year accelerated life
Approval
Approved for clinical implantable device use
Background
Long-term implantable medical devices — from cardiac pacemakers to neurostimulators — demand conductor materials that remain reliable for a decade or more inside the human body. A leading Medical Equipment Manufacturer developing next-generation neurostimulation systems needed a wire that combined excellent conductivity with superior corrosion resistance and biocompatibility, while being drawable to ultra-fine diameters for minimally invasive leads.
The Challenge
The device manufacturer required a conductor material that would:
- Maintain stable electrical performance over a 10+ year implant duration in a corrosive physiological environment
- Pass ISO 10993 biocompatibility testing for direct tissue contact
- Be drawn to 0.05 mm diameter for ultra-fine lead assemblies
- Resist nickel-ion release at the surface to prevent allergic reactions in sensitive patients
The Solution: Raytron NCC Wire
We supplied our Nickel Clad Copper (NCC) Wire with a 27% nickel ratio, engineered for medical-grade performance:
- Construction: Oxygen-free copper core clad with 27% nickel by volume, providing a continuous nickel barrier against body-fluid corrosion
- Biocompatibility: Nickel surface fully compliant with ISO 10993-1 (cytotoxicity, sensitization, irritation), with verified low nickel-ion release rates
- Drawability: Successfully drawn to 0.05 mm ultra-fine wire — enabling the smallest lead diameters for minimally invasive implants
- Metallurgical bond: Cladding bonded at the atomic level, ensuring no delamination during drawing, coiling, or long-term implantation
Results
- Accelerated Life Testing: 100% pass rate across all samples in simulated 10-year accelerated life tests
- Simulated Lifespan: Successfully completed 10-year equivalent corrosion cycling with no measurable resistance increase
- Biocompatibility: Full ISO 10993 compliance confirmed, approved for direct tissue contact
- Ultra-Fine Capability: Wire drawn to 0.05 mm diameter — the thinnest in class — enabling next-generation micro-lead designs
Interested in Similar Solutions?
Contact our engineering team to learn how our bimetallic materials can benefit your projects.