Links CRO Files IPO Prospectus: A Leading Medical Device-Focused CRO Partnering with Nearly 200 Tier-3 Hospitals in China

Clinical trials and regulatory registration are indispensable pathways for the market launch of pharmaceuticals and medical devices. In particular, clinical trials are extremely capital-intensive, time-consuming, and laborious. As social division of labor becomes increasingly specialized and government policies gradually tighten, a growing number of companies are opting to outsource these processes to professional, efficient, and experienced third-party Contract Research Organizations (CROs) to achieve safer and faster market entry. Currently, the CRO model in China is primarily focused on pharmaceutical research. In recent years, with the continuous expansion of the medical device industry, CROs have begun to extend their services into the medical device sector.

As a rapidly evolving sector, what is the current state of the medical device CRO industry? What market opportunities lie ahead? How will companies strategize to respond? To explore these questions, VCBeat conducted an exclusive interview with a leading medical device CRO firm—Links CRO (Shanghai Lingshi Medical Technology Co., Ltd., hereinafter referred to as “Links CRO”).

Chen Zhenlang, Founder of Links CRO

Currently, the development of the medical device CRO industry is characterized by three key features.

First, the market continues to grow. According to statistical data from the “China Medical Device Industry Market Demand Forecast and Investment Strategic Planning Analysis Report” released by Qianzhan Industry Research Institute, China’s medical device market size was approximately RMB 445 billion in 2017, an increase of RMB 75 billion from RMB 370 billion in 2016, representing a growth rate of about 20.27%. The compound annual growth rate (CAGR) for the next five years (2019–2023) is projected to be approximately 14.41%, with forecasts indicating that China’s medical device market size will exceed RMB 1 trillion by 2023.

Second, government oversight is becoming increasingly stringent. In June 2016, the China Food and Drug Administration (CFDA) implemented the Good Clinical Practice for Medical Devices and conducted a series of more rigorous inspections of clinical trials. Clinical trials for medical devices are now governed by clear regulations, with ever-stricter requirements. For instance, upon completion of a trial, sponsors must consider whether the trial design aligns with the review principles of the Center for Medical Device Evaluation (CMDE), and whether they are confident in passing the CFDA’s inspections for data authenticity and compliance. These are all critical factors that need to be taken into account.

Third, the entry barriers are not particularly high. Although CRO companies provide highly specialized outsourcing services—with core businesses including clinical trial protocol design, clinical monitoring, project management, data management, and statistical analysis, primarily serving pharmaceutical and medical device companies—there are no clear qualification requirements for market entry, resulting in uneven industry standards.

Driven by the rapid expansion of China’s medical device industry, along with favorable factors such as policy support, consumption upgrades, and technological innovation, demand for Contract Research Organizations (CROs) among device manufacturers has shown a trend of rapid growth. In the high-end market, import substitution policies have also, to some extent, stimulated vitality in China’s high-end medical device sector.

What market opportunities are available for entry into the medical device CRO sector? Mr. Chen Zhenlang, Founder of Links CRO, believes they lie primarily in three areas:

First, companies with greater specialization are better positioned to seize opportunities. As policy oversight tightens and market expectations for clinical trial compliance rise, higher levels of expertise are demanded from medical device manufacturers and contract research organizations (CROs).

Second, market potential has been further amplified. Driven by stringent regulatory requirements, established pharmaceutical companies that previously conducted clinical trials and regulatory submissions in-house are now seeking more professional, efficient, and experienced execution partners, such as contract research organizations (CROs).

Third, the industry is currently in a phase of rapid growth, presenting significant opportunities for medical device CRO companies at all stages of development.

In response to the current industry landscape and opportunities, how will CRO companies strategize? Shanghai Lingshi’s approach encompasses four dimensions.

I. More Professional

Links CRO is dedicated to providing high-end clinical trial services for medical devices, facilitating key pre-market access pathways for implantable and interventional devices. It offers domestic and international medical device companies a comprehensive suite of services, including clinical trials, clinical data management, statistical analysis, product registration submissions, type testing, and EU CE certification, thereby delivering one-stop consulting, advisory, and strategic implementation solutions for medical devices.

“LINK originally means ‘to connect,’ signifying Links CRO’s ambition to serve as a multi-dimensional connector among sponsors, research institutions, and drug regulatory authorities, thereby facilitating clinical trials and registration submissions for medical device products,” further elaborated Chen Zhenlang. Moreover, Links CRO is a member of the China Association for Medical Device Industry (CAMDI) and a director unit of its Clinical Trial Branch, and has obtained BSI ISO 13485 certification for its medical device clinical trial and regulatory consulting service system.

II. Greater Efficiency

Links CRO’s pursuit of efficiency is evident in the strategic location of each of its offices. Most regional offices are situated adjacent to subway stations; for instance, the Shanghai headquarters is within a 30-minute commute from major medical centers such as Zhongshan Hospital and Ruijin Hospital, while the Nanjing office is only a 10–15 minute drive from Jiangsu Province Hospital and Gulou Hospital.

Currently, Links CRO personnel are distributed across eight cities with the highest concentration of key medical resources in China: Beijing, Shanghai, Guangzhou, Wuhan, Nanjing, Chengdu, Shenyang, and Zhengzhou. It is expected to expand to more than 10 cities within the next two years.

In terms of organizational mobilization efficiency, Links CRO also responds to client needs at the earliest opportunity. “Even during holidays, our response time to work-related matters does not exceed 12 hours.”

III. More Resources

From device development to commercial launch, in addition to professional expertise, high-quality partners are essential. Currently, Links CRO collaborates with nearly 200 research centers (Grade A tertiary hospitals) and has established strong partnerships with major statistical centers and medical device testing centers.

IV. More Experienced

“Our team has accumulated extensive technical expertise and experience in conducting clinical trials for innovative medical device products,” said Chen Zhenlang. In terms of team composition, Links CRO boasts widely recognized senior consultants and a robust execution team. Its core personnel have many years of experience in clinical registration at major pharmaceutical companies in Europe and the United States, listed medical device companies, and well-known CRO firms both in China and abroad. Currently, all key team members have extensive prior experience working with sponsors, giving them a deep understanding that domestic medical device sponsors not only require rigorous control over the trial process but also place greater emphasis on the delivery of results. “Solving problems and creating value for our clients” has been the company’s mission since the inception of Links CRO.

Leveraging a high-caliber team and extensive project experience, Links CRO’s premier service offerings include:

Taking the “Left Ventricular Reconstruction System (Imported)” project as an example, Links CRO completed the registration testing of the investigational device within 6 months, initiated all study centers within 2 months, and finished enrollment of all subjects within 2 months. Three academicians were highly involved throughout the study, during which live surgical broadcasts were organized and study results were presented at medical conferences.

High-quality service offerings have built a strong brand reputation. Currently, 40% of Links CRO’s business comes from repeat purchases by existing clients, and a significant number of new clients are acquired through referrals from satisfied customers.

Looking ahead, Chen Zhenlang stated that in addition to continuing to deepen its expertise in the traditional field of cardiovascular and cerebrovascular diseases, Links CRO will also continuously explore and make solid progress in emerging areas such as surgical robots and AI, thereby bringing greater possibilities and contributions to the clinical trial and registration outsourcing services for cutting-edge medical devices, including innovative medical devices.