In 2023, Lujian Technology invested in and established a new R&D incubation platform in Chengdu, Sichuan—Sichuan Innovation. This platform is an independent third-party R&D innovation incubation platform, focused on the development, production, and service of medical device materials and products. It is the “first in Western China” CDMO platform for Class III medical devices that complies with both US FDA and Chinese GMP regulations, built around the medical device registrant system. The platform provides a complete solution from “concept to compliant market release,” achieving a breakthrough from 0 to N in medical device development.

The platform offers full-chain consulting and technical services, including regulatory consultation, process design, verification and confirmation, R&D transformation, registration filing, mass production, and product iteration. It assists research institutions, clinical organizations, and domestic and international medical companies in reducing R&D and production costs, planning product registration pathways, shortening time-to-market, mitigating regulatory risks, and improving project conversion success rates.

Currently, the platform holds over twenty independent R&D patents and has been recognized as a national “Technology-Based SME” and a provincial “Innovative SME” in 2024. It is expected to complete the “High-tech Enterprise” and “Concept Verification Center” certifications by 2025. The platform has already undertaken the R&D transformation of several high-value surgical consumables, both domestic and international.

Lujian Technology & Sichuan Innovation CDMO platform boasts over a thousand square meters of medical device transformation infrastructure with a class 100,000 cleanroom:

1. Clean Production System

Equipped with a 1,000 square meter, Class 7 (ISO) / Class C (FDA) cleanroom, the production area is designed and constructed in strict compliance with China GMP, US FDA, and EU CE international regulatory standards. The modular layout supports the R&D and production of high-value products, including Class III sterile medical devices and implantable devices. An independent air conditioning and purification system ensures that critical parameters such as pressure differential, air exchanges, and particle concentration continuously meet regulatory requirements, providing a clean environment for high-end medical device R&D and production.

2. Sterilization Assurance Center

The sterilization center is equipped with independent sterilization equipment and has passed ISO 11135:2024 international certification, meeting FDA standards. The platform offers sterilization verification, confirmation, and contracted sterilization services for the entire process, covering the terminal sterilization needs of sterile medical devices and implants.

3. Inspection and Testing Laboratory

The platform has a comprehensive inspection and testing system covering:

·Microbiology Laboratory: With a Class 10,000 cleanroom, equipped with microbial counters, vertical steam sterilizers, and laser dust particle counters, conducting sterility testing, microbial limit tests, and bacterial endotoxin detection;

·Physicochemical Laboratory: Equipped with UV-visible spectrophotometers, computer-controlled dual-column tensile testers, and Luer lock testers, performing material mechanical, chemical, and physical property tests;

·Precision Instrument Room: Equipped with environmental testing instruments and airflow meters to meet ISO 13485/GMP compliance requirements.

4. R&D and Process Center

The center is equipped with 3D printing, injection molding, and machining capabilities, supporting product structure optimization, material selection, and rapid prototyping of engineering samples. It also has ultrasonic welding machines and multi-temperature inspection devices, providing hardware support for product design verification and process validation.