Medicore Files IPO Prospectus: Expanding Full-Chain Medical Device Services from a CRO Foundation

In 2016, several like-minded professionals in the healthcare sector decided to leverage their respective strengths and establish a medical device CRO (Contract Research Organization) service provider—Ningbo Maidi Keke Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Maidi Keke” or “Medicore”). By 2019, the company had already assisted over one hundred enterprises in obtaining medical registration certificates, achieving a net profit of nearly RMB 10 million, representing a 200% increase compared to 2017.

It is understood that Maidikeke was founded in 2016. The core team members each have over ten years of industry experience, and the founder has more than 15 years of experience in the sector. Maidikeke currently has subsidiaries in Beijing, Hangzhou, Nanjing, and Shenzhen, with a workforce of over 100 employees. Its business segments cover medical device registration, clinical trial services, product investment promotion, exhibition and conference services, translation of literature and documentation, healthcare industry training, and investment consulting.

In 2016, Maidi Keke was established to provide medical device CRO services (CRO refers to Contract Research Organizations, which are professional institutions that primarily deliver clinical research services for products to companies in the pharmaceutical and medical device sectors through contractual agreements). The decision to enter the medical device CRO sector was driven by Maidi Keke’s recognition of market opportunities in medical device registration.

From the perspective of the development landscape of the medical device industry, China’s domestic sector currently lags behind its international counterparts, with many high-quality foreign products yet to enter the Chinese market. For foreign companies, China represents a highly promising market, characterized by its large population and substantial market capacity.

Although government authorities welcome the entry of imported products into the domestic market, the medical device review and regulatory system is becoming increasingly stringent with regard to compliance in the evaluation process and subsequent post-market surveillance.

For imported products to enter the Chinese market, they must obtain a Medical Device Registration Certificate. This process requires foreign companies to be well-versed in China’s medical device review and approval system; otherwise, it will consume substantial time and capital. Since most foreign companies lack an in-depth understanding of China’s relevant regulations, professional Contract Research Organizations (CROs) are needed to provide them with specialized services.

As for domestic startups, they tend to focus more on R&D or marketing and sales, while being notably weak in areas such as medical device registration. This also creates a need for professional CRO companies to provide specialized services.

Therefore, the Maidikeke team believes that both foreign and domestic enterprises require medical device CRO services, indicating that the medical device CRO sector holds significant promise.

In fact, with the implementation of a series of policies such as the Special Approval Procedure for Innovative Medical Devices and the Priority Approval Procedure for Medical Devices, the medical device industry has positioned itself at a favorable policy-driven juncture. As the business of medical device CROs is heavily dependent on the downstream medical device sector, the rapid growth and robust demand in the medical device industry will present a significant development opportunity for the medical device CRO sector.

It is worth noting that in August 2019, the National Medical Products Administration (NMPA) issued the "Notice on Expanding the Pilot Program of the Medical Device Registrant System." The notice explicitly stated that the pilot program for the medical device registrant system would be expanded to 21 provinces, autonomous regions, and municipalities directly under the Central Government. This represents a significant benefit for medical device CRO+CDMO companies.

Zhang Wenchao, Partner and Head of Operations for East China at Maidi Keke, stated: “For large companies, this allows for better resource allocation in areas such as tax policies and registration filing strategies. For startups, it reduces facility construction costs and accelerates product time-to-market. For foreign enterprises, it facilitates the establishment of R&D centers in China, thereby easing the introduction of their products into the domestic market. In summary, the Medical Device Registrant System has played a significant role in promoting the development of the medical device industry.”

Zhang Wenchao also stated that during the development of the Medical Device Registrant System, some R&D-driven or technology-oriented enterprises have placed greater emphasis on their core patented technologies and expressed concerns about potential patent leakage when selecting CDMO services. Consequently, such companies are highly cautious in choosing CDMOs and tend to opt for CRO services instead.

Maidekeke’s business operations primarily include product registration and clinical trials. According to reports, 50% of Maidekeke’s clients are foreign enterprises, while domestic startups and large companies account for approximately the remaining 50%.

In terms of product registration, Maidikeke provides services such as medical device registration, product testing, and translation of registration dossiers. In the area of clinical trials, it offers services including clinical evaluation of medical devices, design of clinical trial documentation, clinical monitoring, data management, and statistical analysis.

To date, MaiDiKeKe has assisted hundreds of enterprises in obtaining medical device registration certificates, issuing over 150 certificates annually, with more than 80% pertaining to high-risk Class III products. Case examples include injectable hyaluronic acid, surgical robots, orthopedic implants, dental implants, energy-based surgical platform devices, and in vitro diagnostic reagents. Its clientele includes international giants such as Medtronic, Johnson & Johnson, and Allergan.

When evaluating foreign products, VCBeat pays particular attention to those that are scarce in the domestic market or possess significant market potential. For such products, VCBeat leverages its extensive channel network to assist companies with product promotion. This not only facilitates the smooth entry of foreign products into the Chinese market but also addresses sales challenges, thereby enhancing VCBeat’s differentiated competitiveness within the industry. The ability to deliver these services stems from VCBeat’s long-term business relationships with numerous medical device distributors.

Precisely because Maidi Keke has long maintained a focus on overseas projects and products, as well as international scientific advancements and global trends, it is better positioned to provide product consulting services to domestic enterprises. Zhang Wenchao stated, “Our team keeps pace with global trends and possesses a thorough understanding of the future development trajectories of many products. From a professional standpoint, our team can offer valuable guidance to domestic enterprises within our areas of expertise. Furthermore, all members of the Maidi Keke team have extensive experience in the medical device sector and demonstrate strong stability, providing clients with confidence. We hold particular competitive advantages in fields such as medical aesthetics, robotics, energy-based surgical platforms, and orthopedics.”

Medical device CROs can reduce project development costs, increase the success rate of product development, and shorten development timelines for startups. For Maidikeke, this model generates revenue by assisting enterprises in product development and securing medical device registration certificates, while also facilitating connections with distributors. This creates a win-win situation for startups, Maidikeke, and distributors.

Given the specialized nature of clinical trials for medical devices, a CRO company’s prior experience is as critical as its talent pool. A proven track record in handling diverse product types, project teams with operational expertise, and abundant access to clinical experts are all indicators of a CRO firm’s strength.

Maidikeke focuses on the medical device industry. While providing one-stop services to medical device enterprises, it has also conducted in-depth research into products within specialized niche segments. Zhang Wenchao added, “We have devoted significant effort to conducting surveys, research, and summaries in certain areas. The Maidikeke team has carried out very detailed research in the following fields: hard-tissue surgical robots for spine and neurosurgery, soft-tissue laparoscopic surgical robots, AI-powered software that leverages deep learning techniques based on imaging or genomic data to assist in disease diagnosis, and medical aesthetics products such as facial thread lifts and dermal implants including hyaluronic acid and poly-L-lactic acid (PLLA).”

MaDiKeKe’s past performance has already demonstrated strong competitive advantages. What are the company’s plans for the future? Zhang Wenchao stated, “MaDiKeKe is actively expanding into overseas markets, with a particular focus on South Korea, Japan, and Taiwan in East Asia, as well as Europe and North America, to help imported brands establish their presence locally. We are also actively pursuing collaborations with multinational third-party research institutions and certification bodies to assist domestic products in entering international markets.”

“Meanwhile, we are actively establishing third-party testing laboratories, including facilities for electrical safety and animal testing, to break down operational barriers. In terms of long-term strategic development, we aim to form strong alliances with industry partners; if our development philosophies align, we are also open to the involvement of investment institutions.”

In short, Maidike’s growth has been inseparable from the trust of medical device companies, while its future plans reflect a service-oriented commitment to providing even greater support to these enterprises. Perhaps it is precisely this combination of willingness to trust on one side and dedication to service on the other that has created a win-win outcome for both parties.