case studies
MDA Registered Wound Care Product
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Building on its expertise in silicone processing, FVG set out to create a wound care product that would demonstrate both material capability and medical precision.
The goal was clear: develop a safe, effective, and reusable silicone patch that helps flatten hypertrophic and keloid scars while maintaining comfort for long-term wear. The challenge lay in balancing softness, adhesion, and durability within strict medical standards without compromising patient comfort or product reusability.
This initiative became an internal benchmark project, designed to showcase FVG’s ability to transition medical-grade silicone from concept to fully compliant, market-ready form.
FVG’s engineering and process teams collaborated to design and validate a multi-layer system combining soft silicone gel with a breathable silicone film.
Every layer was developed with intent; to maintain gentle adhesion, allow skin breathability, and retain form after repeated use.
Manufacturing Process:
Silicone Casting and Material Formulation: Custom blended medical-grade silicone compounds were developed to achieve the right balance of elasticity, softness, and skin compatibility.
Precision Lamination: The silicone gel and breathable film were laminated using tightly controlled processes to ensure even bonding and smooth surface integrity.
Controlled Curing and Cutting: High-precision curing and die-cutting ensured dimensional accuracy and repeatable quality across production runs.
Medical Compliance and Traceability: The product was fully registered with Malaysia’s Medical Device Authority (MDA # GA7620221-71414), meeting key safety and regulatory requirements for medical use.
FVG’s own silicone wound care patch that supports natural skin rejuvenation and scar recovery.
Soft, self-adhesive, and reusable, the patch maintains consistent adhesion over multiple applications without causing irritation. Designed for both flat and jointed skin surfaces, it provides a breathable barrier that helps flatten and soften scars over time.
More than a product, it represents FVG’s technical depth in medical-grade silicone processing, from casting to lamination and assembly. It stands as proof of how precision manufacturing and materials science can directly translate into patient comfort and recovery outcomes.
Registered Device: Malaysia Medical Device Authority (MDA # GA7620221-71414)
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