How Did STIC Achieve Full Industrialization of Advanced Medical Silicone Gel?

National Major Project Milestone Reached

From independent material R&D to finished medical dressing development, our proprietary silicone gel technology passes stringent ChP 2020 validation and international benchmarking. We are proud to announce the successful conclusion of the national key special research project, "Research, Development and Industrialization of Advanced New Medical Organic Silicone Gel and Products." This milestone firmly establishes our independent and controllable capabilities across the entire value chain, from core silicone gel synthesis to finished medical device manufacturing, significantly strengthening our competitive position in the global medical materials market.

Validated Material Superiority

Our in-house developed medical silicone gel demonstrates outstanding resistance to light, high temperatures, high humidity, and aging. Even under complex environmental conditions, it maintains stable physicochemical properties, fully meeting the stringent long-term safety and durability requirements for skin-contact medical applications.

Full-Spectrum Quality Assurance Under ChP 2020

In strict accordance with the Chinese Pharmacopoeia (ChP) 2020 Edition, we have systematically tested ten independent production batches. Key indicators, including viscosity, molecular weight distribution, glass transition temperature, particle size, moisture, volatiles, and elemental impurities, have all been rigorously characterized. As a result, we have officially established a proprietary, complete quality standard system that ensures consistent, reproducible batch-to-batch quality.

Performance on Par with Global Market Leaders

We conducted a comprehensive head-to-head benchmark against mainstream imported medical silicone products. Across both macroscopic performance, including appearance, curing kinetics, and adhesion, and microscopic characterization, including FTIR, crosslinking density, thermal stability, and contact angle, our silicone gel not only matches the performance of premium foreign counterparts but also demonstrates superior stability in certain key indicators, underscoring its strong market competitiveness.

Established Microbial Safety Framework

Following ChP 2020 guidelines under sections 1105, 1106, and 1107, we have developed and fully validated a dedicated microbial limit testing method for silicone gel. Batch verifications confirm excellent biological safety, fully satisfying the strictest non-sterile medical device safety standards.

Pioneering a More Accurate Adhesion Testing Model

To address the limitations of traditional steel plate testing, which poorly simulates actual human skin adhesion, we adopted polyurethane (PU) leather as an alternative test carrier. Validated against the Bama miniature pig skin model, our PU-based testing data shows a strong correlation with real-skin adhesion performance. This innovation significantly improves the accuracy and clinical relevance of our holding power and peel strength evaluations.

Full-Series Medical Silicone Dressings in the Pipeline

Leveraging our in-house developed core silicone gel foundation, we are accelerating the development of three key product candidates.

• Baby Navel Waterproof Patch: completed full medical device registration technical dossiers and systematic compliance research, ready for regulatory submission
• Pressure Sore (Bedsore) Dressing: optimized formulations and process parameters using orthogonal experimental designs to maximize fluid absorption and conformability
• Scar Management Patch: refined the silicone formulation and processing technology to enhance skin friendliness, breathability, and overall scar repair efficacy

Looking Ahead: From R&D to Global Supply

Our immediate roadmap is centered around digital-enabled industrialization, including AI-driven process scale-up, real-time stability monitoring via advanced analytics, and parallel regulatory submissions across major global markets to accelerate time-to-market. We are fully committed to delivering reliable, high-performance silicone gel solutions to medical customers worldwide, setting a new standard for innovation and quality in advanced wound care.

About STIC

We are a pioneering researcher and professional manufacturer dedicated to the R&D and production of high-performance medical silicone adhesives and advanced wound care dressings. Driven by independent innovation and rigorous medical-grade quality control, we provide both standardized and customized material solutions to global partners. Contact our team to learn more about our silicone gel technology and products or request a sample.