From Concept to Compliant Mass Production – EXNAN’s One‑Stop Custom Implantable Silicone Components Service

One‑Stop: A Shorter Path from Idea to Implantable Silicone Part

Bringing an implantable silicone component from concept to a compliant marketable product typically involves material selection, structural design, tooling fabrication, process validation, biocompatibility assessment, aging studies, sterilization packaging, and batch release. EXNAN integrates these steps into a clear, controllable service chain – you simply provide the clinical need and intended implant duration, and we deliver finished silicone components meeting the corresponding standards.

Duration‑Specific Design to Avoid One‑Size‑Fits‑All Risks

Different implantation periods impose opposite failure requirements: short‑term devices require “easy removal, no residue”; medium‑term demands a balance between durability and retrievability; long‑term requires “lifetime stability, minimal change”. Based on EXNAN’s clear classification – short (≤29 days), medium (29–365 days), long (>365 days) – we provide:

• Short‑term: moderate cross‑linking, smooth surface, pre‑cut tear lines or temporary anchoring features for low‑trauma explant.
  
• Medium‑term: medium cross‑link density, hydrolysis/oxidation‑resistant formulation, passing aging tests up to 12 months.
  
• Long‑term: high‑purity platinum‑cured silicone, ultra‑low leachables, vacuum molding with post‑curing, passing ≥5‑year simulated aging and full biocompatibility.
  

From Prototyping to Production, Shortening Iteration Cycles

We understand that implant device development often requires multiple rounds of sampling and validation. EXNAN offers rapid prototype tooling (soft molds or simple steel molds), small‑batch engineering samples, and full performance test reports (including dimensional, mechanical, and preliminary extractables screening). After approval, we seamlessly transfer to production tooling and volume manufacturing, avoiding quality drift caused by supplier changes. Complex features such as radiopaque markers, overmolding, and multi‑layer composites are supported.

Compliance Documentation Support for Global Registration

Whether for NMPA, FDA, or MDR submissions, EXNAN provides complete manufacturing and validation documentation: material batch certificates, process validation reports, ISO 10993 testing (via third‑party partner labs), accelerated aging studies, packaging integrity validation, and sterilization compatibility assessment. We clarify documentation requirements at the proposal stage to prevent delays from missing studies.

Quality at Every Step

Production is carried out in a Class 10,000 cleanroom under ISO 13485. From raw material incoming, compounding, molding, post‑curing, to packaging, we establish critical control points and lot‑unique traceability. EXNAN – one‑stop service for more reliable, more accessible implantable components.

Visit us: www.exnan.com