Dachuan Fluid Control Solves Reagent Needle Hanging and Corrosion Resistance Challenges Through Sino-Japanese Collaboration, Empowering IVD Industry Cost Reduction and Efficiency Gains
In-Vitro Diagnostics (IVD), hailed as the “eyes of physicians,” is an indispensable component of modern laboratory medicine. It permeates the entire continuum of disease management, including prevention, initial diagnosis, selection of treatment regimens, and evaluation of therapeutic efficacy, with over 80% of medical tests relying on IVD technologies.
In vitro diagnostic (IVD) systems primarily consist of diagnostic instruments and reagents, with their performance significantly influenced by the quality of upstream raw materials such as antigens and antibodies, enzymes and coenzymes, and core components. Particularly amid the current complex international economic landscape, the industrial significance and attention devoted to these upstream raw materials have increased substantially compared to the past. Ensuring the quality and performance of these raw materials is therefore critical to safeguarding the accuracy and reliability of IVD instruments.
Driven by the pandemic, China’s in vitro diagnostics (IVD) industry has experienced rapid development, leading to a corresponding surge in market demand for upstream IVD raw materials. According to data from Huajing Industry Research Institute, the market size grew from RMB 3.3 billion in 2015 to RMB 8.2 billion in 2019, representing a compound annual growth rate (CAGR) of 25.8% during this period. The market size is projected to reach RMB 20 billion by 2024, with a CAGR of 19.4% from 2019 to 2024.
In this era and industry context,Shenzhen Dachuan Fluid Control Technology Co., Ltd. (hereinafter referred to as “Shenzhen Dachuan Fluid”), a company specializing in precision microfluidic control technology, was established in Guangming District, Shenzhen. Leveraging nearly 40 years of expertise in the development of high-end components by its Japanese headquarters, Shenzhen Dachuan Fluid has addressed a critical industry challenge in China: the reliance on international imports for key components used in IVD equipment, including micro-sampling probes, reagent probes, heating probes, piercing needles, sheath flow cells, flow cells, and high-precision syringes.
Xiang Jun, General Manager of Shenzhen Dachuan Fluid, stated, “The key core technologies for precision components in IVD equipment require substantial investment, present extremely high technical barriers, and involve lengthy R&D cycles. They demand long-term accumulation and expertise, and for a considerable period, the input costs of these products are difficult to justify against their output value.”
In response, Dachuan Fluidics, with decades of deep expertise in precision medical manufacturing, has successfully developed a range of fluidic products, including IVD micro-sampling probes, reagent probes, heating probes, piercing needles, sheath flow cells, flow cells, and syringes. The company has resolved key technical challenges such as mirror-polishing the inner surfaces of metallic capillaries in sampling probes, addressing operational stuttering in high-precision syringes, and preventing clogging in rotary valves.
Dachuan Fluidics Needle Products
In addition to the Japanese headquarters mentioned earlier, the technical team members of Shenzhen Dachuan Fluid also possess sixteen years of professional experience in the research and development of medical components. Leveraging the accumulated expertise of its Chinese and Japanese R&D teams, the company has achieved breakthroughs in the performance and quality of multiple core components, reaching a globally leading level.
During the detection process, the biopsy needle, as a highly customized precision device, serves as the core component in the preparatory phase. The biopsy needle is used toSample aspiration, dispensing, and probe washing actions，Accurately perform sample transfer and liquid level detection tasks to ensure the smooth execution of subsequent testing procedures.
Dachuan Fluid's Independently DevelopedMP35Nis a type ofHigh DuctilityandHigh Corrosion ResistanceSexualNon-magnetic alloy，KangkeHydrogen sulfide, saline, and other chloride solutionsofCorrosion, and can also withstand2100MpaofTensile Strength，The puncture needle can self-recover even after being bent and deformed under force.
MP35N Features
According to the introduction,MP35NThe maximum service life of the biopsy needle can reach30tens of thousands of times, approximately that of conventional biopsy needles on the market (310,000 times) ten times. Moreover, due to its excellent corrosion resistance and high strength characteristics,MP35NThe alloy material can also be used for cardiac stents, cerebral aneurysm clips, and the roots of dental implants.
MP35N Applications in Dental Implantology
Next, taking gene sequencing as an example, as one of the key technologies in the IVD field, a single gene sequencing run typically takes more than ten days. Therefore, there is a high demand for the service life of autosampler syringes.The automated sampling syringes developed by Dachuan Fluidics have a service life of 500,000 to 1,000,000 cycles, whereas similar products from typical manufacturers on the market generally last for around 300,000 cycles. Furthermore, the company’s syringes are compatible with single-channel or multi-channel syringe pumps and are available in various sizes ranging from 250 μL to 2.5 mL.
Ookawa Fluidics Auto-Sampler Syringe
Secondly,The micro-sampling needles developed by Dachuan Fluidics also employ innovative manufacturing processes to resolve issues of liquid carryover and sample cross-contamination during IVD equipment sampling.Specifically, micro-sampling serves as the "hands" of fully automated IVD instruments such as biochemical analyzers. Since both samples and reagents for IVD testing are handled by sampling probes, there are extremely stringent requirements for the inner wall roughness and internal dimensions of these probes. Manufacturers must achieve a mirror-like finish on the inner walls of sampling probes with an inner diameter of approximately 0.1 mm.
Dachuan Fluid uses a magnetic abrasive finishing system for suspensions to polish the inner walls of the capillary tubes in sampling needles, reducing the average inner wall roughness (Ra) to below 0.01 μm and preventing test result interference caused by liquid retention on the sampling needles.
Comparison of the Application Effects of Suspension Magnetic Abrasive Finishing Systems
“High-end sampling needles required by domestic IVD equipment manufacturers generally need to be procured through cross-border purchases from countries such as Japan and the United States. Due to barriers in geography, language, and culture, imported sampling needles are not only expensive but also have long lead times. Often, it takes more than a month just to communicate requirements, while processing time can extend up to six months... This has a significant impact on the time-to-market for overall IVD devices. Furthermore, after-sales service for overseas products is difficult to guarantee in a timely manner due to objective constraints,” Xiang Jun told VCBeat.
In response, Shenzhen Dachuan Fluidics has established comprehensive hardware facilities, including an 800-square-meter standardized office and production plant, a 150-square-meter corporate product showroom, and an independent laboratory, while strictly adhering to the ISO 13485 quality assurance system for medical devices.
Dachuan Fluid Office and Production Plant
Xiang Jun stated: By establishing localized production and service capabilities, Shenzhen Dachuan Fluid can complete the entire process from requirements communication to sample manufacturing within one month. Furthermore, Japanese experts provide on-site guidance for production and R&D, and the laboratory can supply customers with various test reports for precision sampling needles.
More importantly, leveraging Shenzhen’s manufacturing and labor advantages, the company’s products are priced approximately one-third lower than imported alternatives, thereby reducing equipment manufacturing costs while shortening customers’ time-to-market.
As highly customized products, sampling needles and other needle-based components require “one-to-one” design to match different customers and various types of IVD instruments.In this regard, Dachuan Fluid not only offers a wide variety of sampling probes, reagent probes, heating probes, and piercing needles in multiple specifications, but also provides personalized customization based on customer drawings. By engaging in product design from the early stages of R&D, it helps customers address challenges encountered during development and accelerates time-to-market for their products.
According to reports, a globally innovative medical device and solutions provider from China contacted Shenzhen Dachuan Fluidics through online channels, seeking assistance in resolving the issue of liquid retention on reagent needles. Even with imported products, it has been difficult to completely address the challenges of crystallization-induced liquid retention and inadequate cleaning of reagent needles. In response, Dachuan Fluidics leveraged its newly developed high-temperature coating technology to thoroughly resolve the problem of liquid retention at the needle tip, earning customer recognition for the product’s performance.
To date, Dachuan Fluid’s various products have been successfully exported to developed countries and regions in Europe, the United States, Japan, South Korea, as well as the Middle East, with high-end precision components widely applied across multiple sectors globally.In the domestic market, Shenzhen Dachuan Fluid has established solid partnerships with numerous industry-leading enterprises, including dozens of well-known companies such as BGI Genomics, Autobio Diagnostics, YHLO Biotech, and Maccura Biotechnology.。
Regarding Shenzhen Dachuan Fluid's next steps in its development plan, Xiang Jun stated that he had worked at Japanese companies for over ten years, and the craftsmanship spirit of Japanese manufacturing has deeply influenced him.This spirit of craftsmanship emphasizes an uncompromising commitment to quality and focus, fostering a meticulous work ethic alongside continuous technological innovation and improvement. The company also maintains long-term technical exchanges and collaborations with industry leaders such as TOSOH CORPORATION.
At the end of the interview, Xiang Jun said,“Shenzhen Dachuan Fluid has maintained a low profile in the past, focusing on the research and development of fluidic products. However, regarding our future development direction, we will not only dedicate ourselves to advancing the development of raw materials such as novel alloys but also actively participate in offline exhibitions to promote industry-wide exchange of our products. Through these initiatives, we aim to further enhance our brand influence and gradually evolve into a key platform enterprise in the upstream segment of the IVD industry.”