Shandong Haidike Medical Products Co., Ltd. Submits IPO Prospectus: China's First Gold Needle Manufacturer with Global Reach in Wound Closure

Driven by the widespread adoption of minimally invasive procedures such as laparoscopy and thoracoscopy, an aging population, rising demands for postoperative recovery and wound healing, along with technological innovations and breakthroughs in materials science, the market size of medical devices for wound closure continues to expand.

According to relevant data from BizWits Consulting, the global market size for wound closure devices reached RMB 86.339 billion in 2023. It is projected that the global market size will grow to RMB 148.802 billion by 2029, with a compound annual growth rate (CAGR) of 9.5% during the forecast period.

Among these, medical suture needles constitute a fundamental and critical segment of the wound closure market. “Medical suture needles may appear to be ordinary metal needles, and many people even believe they are no different from those used for mending clothes, but this is not the case,” explained Cheng Guangqi, Chairman of Shandong Haidike Medical Products Co., Ltd. In reality, these small suture needles and threads embody sophisticated expertise, involving multiple technical barriers. They are subject to stringent requirements in terms of machining precision, sterilization control, and testing validation. As high-end products within the medical device sector, they require Class III medical device registration certification.

For a long time, China’s high-end medical suture needles have been monopolized by foreign giants. The domestic market is dominated by mid- and low-end products, with relatively concentrated competition and serious homogenization. To address this industry pain point, Shandong Haidike Medical Products Co., Ltd. (hereinafter referred to as “RTMED”) has entered the market to alleviate the situation.

RTMED, established in 2012, is a comprehensive medical device enterprise integrating research and development, manufacturing, and sales. Its product portfolio covers the field of surgical wound closure, including sutures, suture needles, staplers, and adhesives, with a commitment to becoming a key driver in the global wound closure industry.

Aerial View of RTMED

Mr. Cheng Guangqi, Chairman of RTMEDSenior Engineer, Shandong Province "Taishan Industry Leading Talent," Council Member of the Shandong Biomedical Engineering Society, Distinguished Industry Mentor at Shandong University, and Pioneer in Returning to Hometown for Entrepreneurship. He has received numerous honors, including the First Prize of the National Commercial Science and Technology Progress Award under the China General Chamber of Commerce Science and Technology Award, the "Golden Bridge Award" from the Shandong Provincial Science and Technology Market, and the Heze Municipal Science and Technology Progress Award.

Mr. Cheng Guangqi’s initial academic qualification was in International Trade. During his engagement in the overseas sales of medical devices, he keenly perceived the significant gap between Chinese surgical sutures and needles and international standards. “At that time, China ranked very low in manufacturing technology within the global surgical suture materials industry.” At that time, the domestic market for surgical sutures and needles was nearly monopolized by foreign giants, with Johnson & Johnson, Medtronic, and B. Braun collectively holding 80%–85% of the market share and achieving virtually 100% market coverage in large Grade IIIA hospitals in first- and second-tier cities. In contrast, domestically produced surgical sutures and needles were only used to a limited extent in small township hospitals and private hospitals, facing the predicament of “surviving in the cracks.”

Mr. Cheng Guangqi stated that during his experience in exporting medical devices, he was often troubled by the inability to respond to customers' demands for product performance updates and optimizations. “When facing customers who trust us, I often found myself at a loss for words.” However, he firmly believes that China’s medical suture market, with its large scale and strong demand, will inevitably give rise to several influential world-class enterprises. Therefore, Mr. Cheng decided to start his own business to accelerate domestic substitution and innovation in the field of medical suture materials in China. Thus, RTMED was established.

RTMED started with medical suture needles, continuously innovating this most fundamental product in the field of surgical suturing,The company has also established a comprehensive presence in the field of wound closure, encompassing suturing, stapling, and adhesive-based techniques.

“RTMED’s growth trajectory can be described as a microcosm of China’s industrial progress. Over the past thirteen years, we have transitioned from imitation to innovation, a transformation closely tied to our team’s dedicated efforts,” stated Cheng Guangqi. The team comprises both seasoned technicians with extensive experience and innovative talents recruited from well-known industry giants. Technical personnel account for more than 12% of the company’s total workforce, covering specialties such as polymer material processing technology, biotechnology, pharmaceutical formulation technology, and mechanical design and manufacturing. All possess substantial R&D experience and strong innovation capabilities.

Meanwhile, RTMED places significant emphasis on collaborative innovation. To ensure the advanced nature and market applicability of its technologies, the company has engaged in diverse forms of industry-academia-research cooperation and joint technical research with prestigious domestic institutions, including the Chinese Academy of Sciences, Qingdao University of Science and Technology, the Institute of New Materials under the Shandong Academy of Sciences, and Jiangnan University. Furthermore, RTMED operates seven provincial- and municipal-level innovation platforms, such as the Provincial Collaborative Innovation Center for Laser Green Intelligent Manufacturing Technology and Equipment, the Provincial Enterprise Technology Center, and the Postdoctoral Innovation Practice Base, providing robust hardware support and technical assurance for its scientific research endeavors.

RTMED Technical Center

In addition, with the support of relevant government departments, RTMED participated in the establishment of the Suture Needle and Thread Consortium and the Innovation and Entrepreneurship Consortium. By working closely with clinicians and pooling multi-party efforts, it has built a unique innovation ecosystem, providing RTMED with distinctive scale and ecological barriers that facilitate technological breakthroughs and sustained growth.

In its deep cultivation of high-end suture needles, RTMED has continuously met market challenges and adapted to market demands, driving constant technological iteration. Initially, RTMED was in a follower position, researching and manufacturing silver needles. Later, in response to market demand, it developed black needles widely used in endoscopic procedures, which reduced glare and brought the company up to world-class standards. However, the company did not stop there; based on thorough market research and insights into clinical needs, it developedThe golden needle not only resolves issues associated with silver needles, such as high reflectivity that may cause visual distraction for physicians and interference with imaging equipment, but also addresses the challenges posed by black needles, including reduced visual contrast upon contact with blood and increased operational risks. Furthermore, it enhances the physician’s procedural experience, achieving a world-leading standard.

According to Mr. Cheng Guangqi,RTMED is the world’s second and China’s first manufacturer of gold needles.The barriers to the development and manufacturing of gold needles are extremely high, with material research and development constituting the primary technical barrier. Currently, many high-end suture products rely on imported steel, making it difficult to avoid issues such as supply chain instability and price fluctuations. To address the bottleneck problem of raw materials, RTMED has partnered with the Chinese Academy of Sciences to conduct R&D and manufacturing of gold needles, starting from the raw materials. Meanwhile,Leveraging its R&D expertise in gold needle raw materials, RTMED has been selected as a finalist for the second batch of the “Open Competition Mechanism” for Innovation Tasks in Biomaterials, launched by China’s Ministry of Industry and Information Technology (MIIT). The company has achieved full independent control over its entire value chain, from upstream raw material development to downstream manufacturing.

RTMED gold needles utilize the advanced principle of interference color formation through oxide film coating. The material ensures high strength while offering excellent biocompatibility, effectively reducing tissue rejection and accelerating wound healing. The precision manufacturing process results in an extremely smooth needle surface, minimizing friction against tissues during suturing and thereby reducing damage to surrounding tissues to the greatest extent—a critical factor for delicate surgical procedures.

Specifically, RTMED gold needles offer the following advantages:

First, it possesses the capability to adapt to the requirements of various types of surgical procedures.In vascular suturing procedures, the sharpness of the needle tip is of paramount importance; in orthopedic suturing procedures, the needle tip requires greater strength and the ability to withstand repeated, forceful punctures. Currently, RTMED leverages 3D modeling and AI technologies for scenario simulation and validation, and has launched a series of gold needles designed to meet the demands of diverse surgical procedures. Featuring a proprietary needle tip geometry, unique coating treatment, and advanced punching technology, RTMED’s gold needles cause less trauma when suturing soft tissues and deliver superior penetration power when suturing hard tissues.

“In fact, every change in product models entails a significant increase in the number of specifications, thereby intensifying the pressures on costs, inventory, and mold development. However, I believe this also constitutes one of our company’s moats,” stated Mr. Cheng Guangqi. He noted that such long-term accumulation of experience and persistent technological breakthroughs make RTMED’s competitive advantages difficult to imitate or replicate in the short term. It is precisely for this reason that the company possesses the ability to “play its cards openly.”

Second, it can flexibly respond to customer needs.According to Mr. Cheng Guangqi, Japanese companies currently engaged in the R&D and production of gold needles can only offer a few different models for consumers to choose from. In contrast, RTMED is able to provide customized services based on consumers’ personalized needs, while also offering certain cost-effectiveness advantages.

Third, extremely low reflectivity and ease of operation.RTMED’s gold needles exhibit an extremely low reflectance rate under the intense direct light of surgical lamps. They do not turn red-black upon contact with blood, ensuring high visibility during procedures in confined spaces and reducing visual fatigue for surgeons. Reportedly, these gold needles demonstrate particular advantages in endoscopic procedures and situations involving significant blood loss.

Fourth, durable and safe.RTMED’s gold needles ensure product durability through a unique coating process. They do not become dull even after multiple sutures, demonstrating superior efficiency and stability in surgical applications. Their excellent handling helps shorten surgical time and reduce surgical risks, providing more reliable assurance for patient prognosis. In addition, the company’s self-developed high-quality medical-grade stainless steel gives the gold needles high bending strength and good flexibility, making them resistant to deformation and highly safe, while ensuring stability and uniformity of quality.

From a manufacturing perspective, the production of high-end medical suture needles demands extremely high machining precision, requiring companies to possess advanced processing equipment, precise inspection methods, large-scale production capabilities, and long-term accumulation of process parameters and expertise. Currently, RTMED has established strengths in all these areas.

In terms of production processes, RTMED’s medical suture needles leverage laser micro-nano manufacturing technologies, including laser-based local heat treatment for needle tips and high-quality laser micro-nano machining of micro-holes at the distal ends of suture needles. By developing new material heat treatment processes, RTMED has achieved an upgrade and replacement of traditional manufacturing techniques, enhanced automation and intelligence levels, and attained internationally advanced and domestically leading standards within the industry.

In terms of hardware infrastructure, RTMED has a building area of 32,000 square meters and operates four workshops. It currently maintains four production lines for catgut sutures, absorbable sutures, bulk packaging, and suture needles, with an annual processing capacity of 7.2 million meters of polymer-based synthetic absorbable suture needles and threads. Meanwhile, the company has established a comprehensive quality management system and has obtained certifications for ISO 13485 (Quality Management System), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health and Safety Management System).

Furthermore, RTMED places great emphasis on the development of its R&D infrastructure. It currently operates a laboratory spanning approximately 500 square meters, constructed in strict accordance with national design standards. The facility is equipped with 56 advanced sets of instruments, including needle tube rigidity testers and suture needle toughness testers, which have been introduced or independently developed and manufactured. The laboratory is capable of inspecting, testing, and analyzing various technical process indicators of related products, conducting small- to medium-scale trials for new products, and integrating product testing, quality assurance, and product R&D into a unified system.

Currently,RTMED’s products have obtained four major certifications: China NMPA, U.S. FDA, EU CE, and Brazilian BGMP. The products have been exported to more than 160 countries and regions, covering nearly two-thirds of the global market, with a global marketing network.Regarding the domestic market, Mr. Cheng Guangqi candidly stated that although RTMED has entered the Chinese market for only about a year, its market coverage has accelerated significantly, with its products already in use at over 500 hospitals and purchase orders received from more than 1,000 hospitals.

RTMED Participates in Overseas Exhibitions

Currently, RTMED has established a product portfolio in the fields of wound suturing, anastomosis, and adhesion, including medical suture needles and threads, medical adhesives, disposable laparoscopic trocars, minimally invasive fascia closure devices, sterile surgical zip-type wound closures, and endoscopic linear cutting staplers. In the future, with the further popularization and widespread application of minimally invasive surgery, more innovative wound closure methods will emerge. RTMED will build a more comprehensive product line around the field of wound closure and expand into related products, such as hemostatic materials and wound care materials.

“In the future, I hope RTMED will reshape the landscape of the wound closure field, accelerate the substitution of imported products with domestically produced ones, provide surgeons with more personalized surgical instruments and wound closure options, reduce surgical costs for patients, and become a major player and driver in China’s general surgery market.” This is the expectation Mr. Cheng Guangqi has placed on RTMED. What remarkable story RTMED will write in the global wound closure market remains to be seen.