Heiyan Medical Files IPO Prospectus Following Expansion of Collaborative 3D Printing Centers Across China and New Regulatory Guidelines
On July 4, 2019, the National Medical Products Administration, in conjunction with the National Health Commission, issued the Provisions on the Supervision and Administration of Custom-Made Medical Devices (Trial), which came into effect on January 1, 2020.
The release of these regulations can be seen as a signal that the “spring” of the 3D printing industry has arrived. An industry insider stated that after more than 900 days of waiting—from participating in the first regulatory seminar in 2016 to the eventual promulgation of the current regulations—the measures have finally been implemented. Indeed, while manufacturers of 3D-printed medical devices had previously developed through self-exploration, the introduction of the new regulations has charted a clear path for the practical implementation and commercialization of the 3D printing industry.
After years of dedicated exploration, Heiyan Medical, which focuses on the research and development of 3D printing and digital technology applications in the medical field and secured tens of millions of yuan in Series A financing from Sinopharm Capital in early 2018, has pioneered a unique model combining medicine and engineering by co-establishing 3D printing centers with hospitals. VCBeat (WeChat ID: vcbeat) has learned that “Heiyan Medical” has currently established more than 20 3D printing centers in over 10 cities across China.
Throughout this process, Shanghai Heiyan Medical Science and Technology Co., Ltd. endured significant hardships. However, as anticipated by the company’s senior management, this unique collaboration model aligns closely with the requirements of the newly issued regulations.
Article 8 of the Provisions on the Supervision and Administration of Custom-Made Medical Devices (Trial) states: “Medical device manufacturers and medical institutions shall jointly serve as the filers for custom-made medical devices.” Article 18 further clarifies: “While protecting patient privacy, manufacturers shall extend the design phase of custom-made medical device products to medical institutions.”
Evidently, physicians are no longer mere end-users but can also participate in the design and planning process. In the future, Heiyan Medical, a leading domestic enterprise in 3D printing and digital technologies, will engage in deeper collaborations with more clinical institutions.
Currently, Heiyan Medical leverages its independently developed digital medical design software, equipment, materials, and cloud-based 3D printing service platform to apply 3D printing technology in preoperative planning, intraoperative navigation, postoperative rehabilitation, and personalized customization. The company provides optimal personalized and digital medical solutions, fostering deep integration of 3D printing and digital technologies with clinical medical applications, thereby empowering physicians to drive greater medical innovation.
“Heiyan Medical”’s clinical applications primarily include: independently developed medical 3D design software, 3D-printed personalized custom braces and orthoses, 3D-printed custom surgical planning models and medical teaching aids, 3D-printed custom surgical and radiotherapy guides, 3D-printed custom dental products, and 3D-printed custom implants made from various materials. Its products are widely applicable across various fields of surgical and rehabilitative clinical care, including orthopedics, dentistry, oncology, plastic and reconstructive surgery, oral and maxillofacial surgery, and cardiothoracic medicine and surgery.
In the preoperative phase, taking orthopedics as an example, 3D printing technology can rapidly and accurately construct 1:1 monochrome or color patient-specific models. These models assist surgeons in surgical planning, simulation of complex procedures, pre-contouring of plates and screws, and simulation of the placement of custom surgical guides and implants. This facilitates surgeries with shorter operative times, reduced blood loss, and more precise positioning. Additionally, it enables more convenient and efficient communication between physicians and patients and their families.
During surgery, 3D-printed patient-specific surgical guides assist physicians with precise positioning and navigation, enabling rapid determination of screw insertion location, angle, and depth, thereby facilitating accurate, safe, and efficient procedures.
In the fields of internal medicine and surgical rehabilitation, Heiyan Medical has also established a comprehensive presence. Through professional design approaches such as new material development and topological lightweighting, the company has significantly enhanced the comfort and wearing flexibility of various braces and orthoses. Its patented materials, which allow for repeated low-temperature thermoplastic reshaping, reduce clinical fabrication complexity, are suitable for diverse emergency scenarios, and enable batch printing for inventory stockpiling. Furthermore, its rehabilitation products, when integrated with therapeutic modalities such as neuromuscular electrical stimulation, can improve limb healing rates; synergy with cloud platform technology also enables remote monitoring.
Even higher value is added by 3D-printed patient-specific implants. In this regard, Heiyan Medical has collaborated with multidisciplinary experts in China to successfully perform over 100 surgeries using patient-specific implants made from various materials. Beyond enabling morphological customization, 3D-printed patient-specific implants can mimic the porous three-dimensional structure of trabecular bone, offering advantages in promoting bone ingrowth and optimizing biomechanical design.
Mr. Lu Yidong from Shanghai Heiyan Medical Science and Technology Co., Ltd. stated that the company has conducted various studies in bioprinting. In the near future, there will surely be more breakthroughs in the field of customized bioprinted implants.
In the clinical application of medical devices, safety is a greater concern than innovation. Mr. Lu Yidong pointed out that there are two main risks associated with 3D-printed implants: first, the risks related to implant materials; and second, whether the implants can meet patients’ needs. Heiyan Medical has made substantial efforts in both areas. The selection of materials for each customized implant, preoperative planning for every surgical case, and analysis and simulation in aspects such as biomechanics are all supported by a robust technical team. In terms of quality control, a backup of each prosthesis is produced using the same material on the same machine and retained for archival purposes, thereby establishing a product traceability and verification system to ensure safe and worry-free clinical use.
In other respects, Heiyan Medical is collaborating extensively with numerous research institutions and scholars from university-affiliated hospitals in China to develop more innovative medical products.
To date, more than 100 surgeries involving personalized implant designs have been successfully performed, all facilitated by a 3D printing center jointly established with the hospital. Mr. Lu Yidong describes this “collaborative co-building of the printing center” model as “moving the factory into the hospital.” He emphasizes that locating the center within the hospital enables engineers stationed there to respond quickly and efficiently to clinicians’ needs, engage in detailed communication, and leverage technologies such as 3D software and printed surgical models to assist physicians in rapidly refining surgical plans and contingency strategies.
In terms of payment, Hebei Province, Henan Province, Shandong Province, Jiangsu Province, Anhui Province, and Guangzhou City have all incorporated “3D printing medical services” into their fee schedules, while several other provinces and municipalities are currently undergoing application and approval processes.
When discussing the “threshold” of 3D printing regulatory approval, Mr. Lu Yidong mentioned that the company is a standing director member of the China Food and Drug Administration (CFDA)-affiliated Industry Association for 3D-Printed Medical Devices, and participates in the formulation of industry standards for Class III 3D-printed implants. He believes that the review process will become more efficient in the future.
It is evident that, following the implementation of new regulations, precisely meeting the medical needs of clinicians and patients will become the greatest challenge for companies in launching their products. Mr. Lu Yidong stated that over the years, the communication skills developed by Heiyan Medical’s engineering team through interactions with clinicians have become a valuable asset accumulated by the company. Although the products are personalized, the service processes and key milestones involved can be standardized. Meanwhile, the company is also developing semi-automated or intelligent software solutions. In the future, Heiyan Medical will continue to collaborate with clinicians to jointly accelerate the application and promotion of 3D printing and digital technologies in the fields of healthcare and scientific research.