Meditool Files IPO Prospectus Amid Policy Tailwinds in Customized Medical 3D Printing

“Once the ‘Technical Review Guidelines for the Registration of Customized Additively Manufactured Medical Devices’ are officially promulgated, customized medical 3D printing will emerge as an independent niche sector, with its own product registration standards and corresponding registration certificates.” Jin Xin, founder of Medvance, expressed great excitement when discussing the “Technical Review Guidelines for the Registration of Customized Additively Manufactured Medical Devices (Draft for Comments)” recently released by the Center for Medical Device Evaluation of the China Food and Drug Administration (CFDA).

As a provider of comprehensive solutions for Class III 3D-printed implants with full industry chain control—integrating the manufacturing of proprietary, independently intellectual property-owned medical 3D printing equipment, development of medical data processing software, R&D of medical-grade raw materials, and medical engineering technical services—Medvance is committed to becoming a leading enterprise in the field of high-value medical consumables utilizing 3D printing. The release of this draft for comment is undoubtedly the most significant positive development for the entire medical device industry at the start of the year. In light of this, VCBeat has conducted follow-up reporting on Medvance to understand how it has established its capability to provide comprehensive medical 3D printing solutions covering the entire industry chain.

3D printing technology has numerous applications in the healthcare industry, including anatomical models, personalized surgery, orthopedic implants, mass customization, regenerative medicine, and bioprinting. Among these, orthopedic implants represent the most significant application area. Due to advantages such as customizable production and a wide range of material options, the market share of 3D-printed products is expected to continue growing across various sub-sectors.

According to SmarTech, the global 3D printing medical market reached $1.229 billion in 2016 (with the 3D-printed orthopedic implant market at $823 million), and is projected to reach $9.639 billion by 2024 (with the 3D-printed orthopedic implant market at $8.12 billion), representing a compound annual growth rate (CAGR) of approximately 30% over the eight-year period.

Jin Xin, Founder of Medvance, and Jin Qingyu, R&D Director

The company’s primary founders are all clinicians by training, with over a decade of experience working at renowned domestic and international medical device manufacturers. During their careers, they gained exposure to 3D printing technologies and developed a profound appreciation for the significance and impact of 3D technology in the healthcare industry.

The founding team encompasses expertise in R&D and engineering, software and hardware design, clinical applications, regulatory registration, and marketing and sales. Core members possess international backgrounds and extensive industry experience (averaging nearly 20 years), with complementary skill sets. Drawing on years of relevant professional experience, the team deeply understands the significance of customized, personalized implantable medical devices to the industry. This insight led to the establishment of a company dedicated to promoting, popularizing, and advancing the application of medical 3D printing, giving rise to Medvance.

At its inception, Medvance positioned itself as a manufacturing enterprise specializing in high-value medical consumables, with 3D printing as its core technological specialty.To this end, Medvance established departments for production, R&D, regulatory affairs, and medical engineering at the early stage of its founding. Among these, the R&D department is the core of Medvance, focusing on key areas such as software development, hardware R&D, raw material development, and the R&D of Class III implantable medical devices.。

Medvance spent over a year establishing these departments. The heads of these core departments possess extensive experience in the medical and R&D sectors; for instance, the overall head of R&D previously served as the R&D Director for Medtronic’s Greater China region. Most core R&D personnel have prior work experience at companies such as Johnson & Johnson, Medtronic, B. Braun, Marquis, Smith & Nephew, GE, Siemens, Philips, and Huawei.

In addition, given the unique characteristics of the implantable medical device industry, Medvance has established a dedicated Regulatory and Compliance Department, staffed by seasoned regulatory and compliance professionals who oversee the registration of the company’s relevant medical products.

“In short, Medvance’s core asset is our team. Our team’s comprehensive strength stands out in the industry. We have come together with the mission of shouldering the future development of China’s medical device industry,” said Jin Xin, founder of Medvance, proudly during the interview.

In addition to its well-established corporate team, another highlight of Medvance is its comprehensive medical 3D printing solution that covers the entire industry chain.

“The company’s ultimate goal is to manufacture customized Class III implantable medical devices; 3D printing is merely our distinctive manufacturing process and a technical means.“Jin Xin began by clarifying his positioning when introducing Medvance’s comprehensive 3D printing solutions for medicine.”

Medvance’s comprehensive medical 3D printing solutions, which cover the entire industry chain, encompass two dimensions.

The first dimension refers to the manufacturing and processing sector of high-value medical devices, encompassing materials, research and development (R&D), production, registration, clinical application translation, outcome follow-up, and efficacy evaluation.. Medvance is among the first companies in China to hold software product registration certificates, medical device class I registration certificates for medical tools, medical certifications for related raw materials, and filings for related specialized equipment. Medvance told VCBeat that these capabilities are not possessed by traditional medical device manufacturers.

As a global-minded innovator (“In China For Globe”), Medvance participates annually in the industry’s premier international professional exhibitions, such as the annual American Academy of Orthopaedic Surgeons (AAOS) meeting, to stay closely aligned with cutting-edge technologies worldwide.

The second dimension refers to the field of medical 3D service provision, from the perspective of the clinical departments targeted by the services., all of Medvance’s products are medical-grade and classified as medical devices, suitable for use in departments such as orthopedics, neurosurgery, plastic surgery, general surgery, and dentistry. Due to the complexity of medicine, different specialties have varying requirements for 3D technology, with even greater disparities in the standards for implantable medical devices. Furthermore, different printed products demand a high degree of medical specialization in both 3D printing equipment and raw materials.

Therefore, prior to providing implantable products to its customers, Medvance undertook a range of initiatives, including market education, channel development, selection of clinical departments, and the research, development, and manufacturing of implants.

Compared with the few domestic peers, Medvance can achieve fully customized solutions, as its products and technologies across all core segments of the industry chain are independently developed.。

Medvance can design hardware and software solutions tailored to the needs of different clinical departments, producing customized and personalized medical 3D-printed products by integrating hardware, software, materials, and specific requirements. This comprehensive integration and flexible application of technologies across the entire industry chain constitute the technical barrier for the entire medical 3D printing sector.

Liao Guoping from Morning Star Venture Capital also stated that the reason Medvance’s R&D spans the entire industry chain is primarily because customized medical devices, with additive manufacturing as the primary processing method, involve a broad range of aspects. This requires collaboration across multiple fields and disciplines, including software, materials, printing equipment, clinical medicine, and manufacturing processes. It is highly challenging to assemble experienced teams in China. Among medical device manufacturers already listed on the Hong Kong Stock Exchange, AK Medical is a typical traditional medical device manufacturer that has distinguished itself by adopting 3D printing as its core technological specialty.

Therefore, the recent public consultation notice issued by the Center for Medical Device Evaluation of the China Food and Drug Administration (CFDA) on the “Technical Review Guidelines for the Registration of Customized Additively Manufactured Medical Devices (Draft for Comment)” holds significant importance for Medvance and the entire medical 3D printing industry.

Previously, the approval pathway for customized implantable medical device products across the entire industry was akin to participating in “Yi Zhan Dao Di” (a Chinese quiz show), requiring"Forging Ahead Through Exploration: Mastering Both Astronomy and Geography". Once this guideline is officially released, the approval process for Medvance and the entire customized medical 3D printing industry will be akin to taking the National College Entrance Examination: everyone will know which subjects are tested and what question types are included, so they can simply prepare accordingly.

In terms of commercial channel expansion, since Medvance already possesses R&D and manufacturing capabilities across all stages, along with a comprehensive product portfolio, it will persist in providing holistic solutions to medical institutions, thereby truly popularizing the application of 3D printing technology. Currently,Medvance primarily promotes its business by establishing joint laboratories with hospitals.。

During the establishment of medical 3D printing laboratories, clinicians and patients have gradually become familiar with and started using customized medical 3D-printed products, while reimbursement models are being progressively explored. Currently, Medvance has established partnerships with over 150 hospitals, securing a clear leading position in China and effectively achieving the goal of market education. Additionally, Medvance collaborates with hospitals through scientific research partnerships, thereby obtaining government-funded research grants.

Regarding future development, Jin Xin stated that Medvance willThe primary focus will remain on securing regulatory approvals. The issuance of these guidelines provides clear direction for customized medical 3D printing. Medvance will accelerate the registration and approval processes for its orthopedic, neurosurgical, and plastic surgery products to meet market demand.。

In terms of market expansion, in addition to accelerating its domestic layout in China, Medvance has also extended its business to medically advanced countries and regions such as Japan, the United States, and Europe.

According to the VCBeat database, Medvance has completed two rounds of financing. In early 2016, it secured its first round of funding from Puhua Capital, and in November 2016, it raised tens of millions of yuan in Series A funding from Morningside Venture Capital.