Announcement of the Results:

As a core supplier of high-end consumables in the field of interventional radiology, we have redefined our role in the industrial value chain - we are not only the producer of Kiyama needles, but also the provider of infrastructure for "precision and safety" in interventional surgeries. Through the establishment of a fully integrated manufacturing system of "materials - manufacturing - quality control" and a collaborative platform of "demand - design - verification" with rapid response capabilities, we provide customized Kiyama needle solutions that exceed standards in performance and guarantee absolute quality to global imaging equipment manufacturers, biopsy gun manufacturers, and drainage kit brands. We have become an invisible pillar supporting the innovation and high-quality development of the entire interventional consumables industry.

Research and Development Background Pain Points:

Interventional radiology is a rapidly evolving ecosystem that encompasses imaging equipment (ultrasound, CT), navigation systems, energy platforms (ablation), and a large number of disposable consumables (needle tips, catheters, embolic materials, etc.). The core competitiveness of consumable brand manufacturers (especially innovative startups with innovative ideas) lies in system integration, market channels, and clinical education, rather than precise metal processing. However, core puncture components like the Chiba needle directly determine the performance, reputation, and safety of the entire set of equipment (such as biopsy guns, drainage kits). Brand manufacturers face a dilemma: building their own production lines is costly and unprofessional; outsourcing processing is difficult to find a partner that can meet medical compliance, precise manufacturing, cost control, and be able to adapt to rapid iterations. The industry chain needs a top manufacturing partner that can provide "medical-grade trust".

Core Technological Innovation:

Our core competitiveness lies in the establishment of an "open and robust precision manufacturing platform":

Vertical integration's deep manufacturing capability: We control the entire chain from the procurement of medical-grade stainless steel raw materials, the drawing of precise tubes, the shaping of complex needle tips, surface modification treatment to the final cleaning packaging. This integration ensures the continuity of the process, the traceability of quality, and the ability to respond quickly. When brand manufacturers have special material (such as nickel-titanium alloy) or coating requirements, we can quickly mobilize internal resources for process development and verification.

Collaborative design based on customer needs: We establish a "front-end embedded" cooperation model with brand manufacturers. When brand manufacturers plan new products (such as a new type of manual biopsy gun), our engineers participate in the process. Based on a deep understanding of puncture mechanics and manufacturing processes, they provide design suggestions for needle specifications (length, diameter, rigidity), optimize their compatibility with the gun mechanism, and improve the performance and reliability of the entire product from the source.

Beyond standard's extreme quality control system: Our quality system not only meets ISO 13485, but also incorporates many "super-standard" control points. For example, 100% laser detection of the straightness of each batch of syringes; optical projector inspection of the needle tip's inclined angle; functional tests of the finished products (such as suction/injection smoothness tests). We establish independent quality archives and product traceability codes for each major customer. Each needle can be traced back to the corresponding raw material batch number, production machine, operator, and inspection report. This provides brand manufacturers with a powerful supply chain quality endorsement.

Agile supply chain and customized services: We have a "multiple batches, small batches, fast delivery" flexible production capacity. A new design from a brand manufacturer can be compressed to a few weeks from receiving the drawings to providing the first batch of clinically verifiable samples. We also offer one-stop services from simple laser marking to complex assembly, sterilization, etc., greatly reducing the operational complexity of brand manufacturers.

Mechanism of Action:

Our role mechanism in the industrial chain is that of a "capability enhancer" and a "risk resolver". For brand manufacturers, we are their "capability enhancer". They internalize our profound precision manufacturing and quality control capabilities as their core advantage in the supply chain, thereby being able to focus more on product definition, clinical registration, and market expansion, and accelerate the launch of innovative products. For the entire intervention industry, we are the "risk resolver". Through specialization and scale effects, we steadily output top manufacturing processes and nearly stringent quality standards to the downstream of the industrial chain. This ensures that regardless of the terminal brand, the performance and safety lower limit of the core puncture components are firmly locked at an extremely high level, enhancing the product safety benchmark of the entire industry. Our existence lowers the threshold for innovation, allowing more companies with ideas to focus on the creation of clinical value.

Efficacy Verification:

We are the long-term exclusive or main needle supplier for many of the world's top biopsy instrument brands and drainage kit manufacturers, with a partnership lasting for over ten years. We have previously assisted a European startup company in developing a magnetically compatible enhanced Chiba needle for its revolutionary soft tissue navigation biopsy system. From concept to obtaining the EU CE certification, it took only 9 months, and we were hailed as "a fantastic partner". Our production quality performance has consistently maintained a single-digit complaint rate (PPM) for clients, and we have been awarded "Supplier of the Year" or "Zero Defect Quality Award" by clients multiple times. During multiple client spot checks and FDA third-party audits, our quality system and production site received outstanding evaluations for having no defects.

Research and Development Strategy and Philosophy:

Our strategic positioning is "the manufacturing cornerstone of precision medical devices in interventional radiology worldwide". We firmly believe that in the highly specialized medical industry, achieving deep focus and excellence can create irreplaceable value. We do not aim to build an end-consumer brand, but are committed to becoming the "most reliable innovation support behind all companies dedicated to improving interventional treatment levels". Our mission is to become the most solid and trustworthy "infrastructure" in the global advancement wave of interventional medicine by ensuring that the Chiba needles and their related precision components reach the world's top quality standards.

Future Outlook:

In the future, we will upgrade from "manufacturing partners" to "technology co-creation partners" and "industry data nodes". We will actively collaborate with leading research institutions to pre-examine disruptive technologies such as next-generation intelligent puncture materials and degradable needle bodies. We plan to utilize the massive quality data accumulated in production to establish a "puncture instrument performance prediction model", providing data insights for industry design. At the same time, we will explore remote collaborative manufacturing based on the industrial internet and supply chain transparency, providing customers with real-time order and quality status dashboards. Our vision is to build a more open, collaborative, and efficient global interventional device innovation manufacturing network, becoming the core hub connecting clinical intelligence, industrial innovation, and cutting-edge manufacturing, and jointly promoting interventional medicine towards a more precise and minimally invasive future.