Sailing Medical's Fully Automated Thromboelastography: Efficiency Gains Through Root-Cause Precision

Thromboelastography Is Entering the Era of Automation!

Thromboelastography is a critical test in the field of thrombosis and hemostasis, capable of providing a comprehensive assessment of coagulation function, with wide application across various clinical departments. However, traditional thromboelastography involves semi-automated operations requiring 18 manual steps, making test results susceptible to human interference, entailing high costs, and demanding highly skilled operators; thus, there is an urgent need for automation upgrades. Automated thromboelastography can significantly enhance the accuracy and coverage of coagulation screening, representing an emerging growth point in the industry.

However, the development of automated thromboelastography is no easy task, as factors such as vibration environments, steel needle sampling, and sample mixing can all affect detection accuracy.High-accuracy automated thromboelastography remains a scarce product, resulting in limited adoption of automated thromboelastography in healthcare institutions.

Addressing the challenges of automating thromboelastography, Sailing Medical has introduced a novel solution. Without altering the classic “hanging wire” method of thromboelastography, the company has overcome internal vibration issues and resolved problems associated with steel-needle sample loading and specimen mixing, thereby effectively ensuring the accuracy of test results. Currently,The company has launched a new round of financing.

The partners of Sailing Medical were among the earliest entrepreneurs in China to develop semi-automatic thromboelastography systems. With a profound understanding of thromboelastography, they firmly believed in 2016 that fully automated thromboelastography represented the future trend and swiftly developed a fully automated thromboelastography analyzer. This instrument is now referred to internally at Sailing Medical as the first-generation device.

In 2018, Sailing Medical was established. At the exhibition, investors and enterprises paid close attention to automated thromboelastography, and Sailing Medical’s first-generation device garnered strong interest. The company then began preparing for product registration and commercialization.

However, the company soon discovered issues with the first-generation instrument. Because the detection channels and sample loading components were not separated, vibrations caused by mechanical actions such as sample loading posed a risk of random deviations in test results.

Does the product need to be reengineered from scratch? Zhang Shuang, founder of Sailing Medical, admitted that he was deeply torn at the time but ultimately made the resolute decision to restart R&D. “Unlike some other projects, there is no room for misdiagnosis in coagulation testing. For instance, failure to diagnose disseminated intravascular coagulation (DIC) during surgery can be life-threatening. Testing quality hinges on the manufacturer’s capability and sense of responsibility. Despite having invested substantial resources in the early stages and receiving interest from multiple investors and potential partners in our first-generation device, we still chose to start over from the beginning.”

At 2 a.m., Zhang Shuang sent four Chinese characters to his partner: “人命关天” (a matter of life and death). The partner replied instantly: “Start over.” After several years of research and development, Sailing Medical successively developed its second- and third-generation devices. The third-generation device has now received regulatory approval.

Automation is only meaningful if it does not compromise accuracy, and accuracy has always been the bottleneck for integrated automated thromboelastography analyzers. To address this bottleneck, some researchers have attempted to resolve the issue through software modifications or by altering the “hanging wire.” Zhang Shuang believes that “the problem of random vibration in system modules cannot be solved by software modifications,”Hanging wire, sample transfer, and liquid aspiration are the keys to developing high-accuracy, automated thromboelastography.”

First is the hanging filament.Conventional thromboelastography (TEG) testing employs the classic “pin-and-torsion wire” method, which requires a level, vibration-free environment and constant rotational speed to simulate human blood flow conditions. The “pin-and-torsion wire” approach is considered the gold standard for TEG; any modification to this methodology may introduce random errors into test results due to external vibrations during detection. Consequently, further validation is required for both overall system performance and clinical applications.

Next is sampling and pipetting.Thromboelastography systems require customization based on product characteristics. Although the use of steel needles for sample loading offers low costs, the absence of dedicated national and industry standards means that variations in manufacturing processes may lead to experimental errors. Furthermore, factors such as the condition of the upper and lower cups, reagent status, and mixing uniformity all influence the automation process of thromboelastography.

Overall, the threshold for achieving full automation of thromboelastography is extremely high. It is essential to foster a correct understanding among more enterprises and experts regarding the factors influencing the fully automated thromboelastography process, thereby promoting the healthy development of the industry. In this regard, Sailing Medical has taken a leading position.

Based on a profound understanding of the principles underlying thromboelastography (TEG), Jiangsu Sailing Medical Technology Co., Ltd. has developed a fully automated TEG system that comprehensively accounts for various influencing factors, thereby achieving exceptionally high detection accuracy.

Sailing Medical’s fully automated thromboelastography system mitigates risk factors that could compromise accuracy,Do not alter the classic "hanging drop" method, effectively resolving vibration issues within the system;Use disposable TIP headsrather than reusable steel needles for sample addition, ensuring that the coagulation process is not prematurely activated, thereby avoiding sample hemolysis or specimen dilution caused by carryover;Simulates manual mixing, ensure thorough mixing of whole blood specimens and reagent dispensing; adopt an assembly-line approach,Channel-Independent Horizontal Level, ensuring the hanging thread remains stably suspended and does not detach from the cup, thereby guaranteeing that the test results reflect actual measurements without software modification.

Zhang Shuang remarked, “At some Grade A tertiary hospitals, although there are only dozens of thromboelastography tests performed per day, it requires two graduate students to operate the equipment, engaging in repetitive tasks throughout the day, making it a rather frustrating endeavor.” Sailing Medical has adopted a completely new approach,Achieve high-throughput, fully automated specimen reception, processing, testing, and reporting in a streamlined, assembly-line workflow., poised to usher in a new era of automated thromboelastography.

Currently, the third-generation devices from Sailing Medical have been deployed in multiple hospitals and have become the primary instruments for thromboelastography (TEG) testing at these facilities. The clinically validated and widely used activated clotting time reagents and heparinase test reagents have also obtained regulatory approval certificates.

According to calculations by Jiangsu Sailing Medical Technology Co., Ltd., the current market size for thromboelastography (TEG) in China is approximately RMB 1.2 billion, with promising future growth potential. China performs over 50 million surgeries annually, more than 40% of which involve patients with bleeding conditions or risks. For routine perioperative risk prevention before and after surgery, 3–4 TEG tests are typically required. With 56 million surgeries performed in 2021, the potential market size for TEG in the surgical sector is estimated to reach around RMB 9 billion. Furthermore, as a coagulation screening test, the potential market size for TEG in coagulation screening is approximately RMB 40 billion.

“Thromboelastography (TEG) testing is both a general-purpose clinical application and a screening tool. With the automation of TEG, testing costs have further decreased, positioning it to become a routine coagulation analysis test alongside standard coagulation panels. As it moves into centralized laboratory departments, TEG is poised for broad development prospects,” stated Zhang Shuang.

“Fully automated thromboelastography is expected to be rapidly adopted in healthcare institutions within the next 1–2 years.“Amid this wave, Sailing Medical is going all out. The company’s fourth-generation instrument is currently under development and will feature a fully in-house developed and manufactured automated sample loading system and detection unit. Furthermore, the company plans to further reduce the device’s size, lower costs, enhance its aesthetic design, and optimize both hardware and software systems, thereby achieving automation while maintaining highly accurate results.”