Challenge

A medical device manufacturer producing a delivery system faced a critical supply chain and cost issue with their lubricious coating vendor. The coating, based on PTFE (polytetrafluoroethylene), had become increasingly expensive and subject to availability limitations due to global material shortages, PTFE regulatory constraints, and long lead times. The existing formulation was also proprietary, with little flexibility in sourcing or customization, creating a single-source dependency and design constraints.

The sponsor reached out to Chemva seeking an alternative coating formulation that would:

• Maintain or improve lubricity and durability,
• Eliminate PTFE to avoid regulatory and sourcing challenges,
• Be ambient curing, to simplify manufacturing and reduce energy and equipment needs,
• Be durable and adhering to a polymeric substrate, and
• Comply with biocompatibility and ISO 10993 standards for short-term intravascular use.

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Chemva’s Solution

Leveraging our deep expertise in biocompatible coatings and polymer systems, Chemva led a coating reformulation and optimization program tailored to the device’s surface, application method, and clinical use.

1. Needs Assessment & Surface Characterization:
   • Conducted surface energy and adhesion profile of the substrate material to ensure proper bonding.
   • Identified challenges with current processing workflow that could be optimized through formulation chemistry.
2. Formulation of a Custom Non-PTFE Coating:
   • In close collaboration with the sponsor, we rented a lab space and developed a hydrophilic, additive-free, ambient-curing coating system, optimized for balance between flexibility and wear resistance.
3. Performance & Process Validation:
   • Performed coefficient of friction (CoF) testing, showing a 15% improvement over the existing PTFE-based coating.
   • Verified curing under ambient conditions, eliminating the need for thermal ovens or UV curing systems.
   • Ensured chemical resistance and adhesion durability across radiation sterilization methods.
4. Biocompatibility Alignment & Scalability:
   • Screened all ingredients for ISO 10993 compatibility, selecting excipients and binders with existing regulatory precedence.
   • Supported the sponsor with small-scale batch production and guidance for in-house scale-up and application parameters.

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Impact Delivered

Chemva delivered a custom, non-PTFE lubricious coating solution that:

• Eliminated vendor lock-in, giving the sponsor full ownership of the formulation and freedom to scale or transfer manufacturing.
• Reduced material cost by 87% and removed PTFE from the device, streamlining regulatory submissions.
• Improved performance, achieving lower friction values and enhanced coating stability across multiple sterilization cycles.

The reformulated coating is now in use across multiple SKUs, and the client has expanded its in-house coating capabilities using Chemva’s validated process.