JetMed Clinical Research: Specializing in Medical Device CRO Services to Capture a Share of China's Booming $10B+ Market

China’s medical device industry has entered a “golden age” of rapid development. In 2021, there were 386 financing events in China’s medical device sector, with total financing reaching RMB 48.93 billion. In the innovative medical device segment, domestic companies have begun to exert significant momentum, with multiple domestically pioneered products successively receiving regulatory approval.

As innovative medical device products enter clinical trials and receive successive approvals, a related industry is experiencing rapid growth. Medical device CROs, as outsourced service providers, are closely tied to the development of the medical device industry and are becoming an essential requirement for medical device clinical trials.In 2020, the market size of China’s medical device CRO industry reached RMB 10 billion. As of the end of May 2021, there were more than 200 institutions whose primary business was medical device CRO services.

CRO refers to an academic or commercial third-party organization that, through contractual agreements, provides specialized services to pharmaceutical companies, medical institutions, small and medium-sized enterprises engaged in pharmaceutical and medical device R&D, and even various government-funded entities during the process of basic and clinical medical research and development.

In the 1970s, intense competition in the U.S. pharmaceutical industry spurred the emergence of the clinical CRO sector. China’s CRO industry began more than a decade later and was predominantly concentrated in the field of drug clinical trials. As regulatory oversight and registration requirements for clinical trials of medical devices in China have been progressively strengthened and refined, related device-focused CRO services have developed. Large-scale pharmaceutical CRO companies have gradually expanded into device-related services, while smaller, specialized CRO firms focusing on specific device categories have also emerged.

In 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices, which reformed clinical trial management and accelerated the review and approval process for market authorization. The Opinions promoted the comprehensive implementation of the Marketing Authorization Holder (MAH) system in China. Subsequently, in 2019, the National Medical Products Administration (NMPA) issued the Notice on Expanding the Pilot Program of the Medical Device Registrant System, further expanding the pilot provinces for the medical device registrant system to 21.

The Marketing Authorization Holder (MAH) system encourages non-manufacturing enterprises to outsource preclinical research, clinical trials, manufacturing, distribution and logistics, adverse event monitoring, and pharmacovigilance to other companies and institutions, thereby promoting specialized division of labor and driving the continuous growth of China’s medical device CRO market.

Medical devices encompass a wide variety of categories, with significant differences across various fields. Conducting preclinical research, designing clinical trial protocols, managing the entire clinical trial process, handling data management and statistical analysis, and preparing regulatory submissions all require a multidisciplinary team to ensure high-quality execution. Furthermore, rapid product updates and iterations, coupled with the steep learning curves associated with the clinical use of certain innovative products, contribute to the inherent complexity of their clinical trials.

Moreover, most medical device startups are small in scale and lack dedicated teams for regulatory review consulting and clinical trial execution.The involvement of a professional medical device CRO team in clinical trials and regulatory submissions can accelerate product development and approval, saving medical device companies both financial and time costs. This is particularly critical for innovative devices, where first-mover advantage is paramount.Currently, medical device companies with products involving clinical trials basically all require CRO services.

Since its establishment in 2014, Jano Medical has been committed to building a more professional and dedicated service industry chain for medical devices, and to creating a more trustworthy brand in the medical device CRO industry.

Jano Medical’s core business is primarily focused on the field of cardiovascular medical devices. The company has undertaken clinical trial services for more than 30 innovative cardiovascular medical devices, accounting for over one-fifth of all national innovative cardiovascular medical devices in China., is one of the earliest CROs in China to engage in the field of cardiovascular interventional medical devices.

During its development, the company has continuously expanded its business scope.It has expanded into multiple fields, including the entire cardiovascular circulation sector, intravascular imaging, respiratory intervention, oncology intervention, surgical robotics, electrophysiology, medical aesthetics and wellness, and orthopedics.

The company has implemented a forward-looking personnel strategy, establishing offices in 18 cities across China and deploying on-site staff in four additional cities. This approach optimizes resource utilization and integration, thereby minimizing the impact of external environmental changes on clinical trials, particularly in the context of normalized pandemic conditions.

In response to the increasingly complex and regulated landscape of the medical device industry, Jano Medical has independently developed and iterated a specialized Clinical Trial Management System (CTMS) to manage the entire clinical trial process. This initiative further enhances operational efficiency and project management capabilities, while integrating risk awareness throughout all stages of clinical trials.

The company is equipped with a professional audit team, whose members all have more than five years of industry experience, enabling it to provide high-quality third-party auditing services. As the National Medical Products Administration (NMPA) imposes increasingly stringent requirements on clinical studies of medical devices, medical device companies are placing greater emphasis on quality management in clinical trials and are engaging third parties to conduct independent audits of clinical trial quality.

Meanwhile,Jano Medical established its core laboratory in early 2015, primarily undertaking vascular image analysis.Unlike drug clinical trials, clinical trials for medical devices sometimes require independent imaging assessment. The core laboratory team at Jano Medical has received specialized imaging training at Fuwai Hospital of the Chinese Academy of Medical Sciences, Yale University, and the Cardiovascular Research Foundation (CRF) in the United States, and has completed angiographic image analysis for dozens of clinical trials to date.

Beyond CRO services,Jano Medical established its SMO (Site Management Organization) in early 2014., specializing in clinical trials for medical devices, with core team members possessing many years of industry experience and a relatively stable team structure.

SMOs directly assist in the execution of clinical trials, primarily by dispatching Clinical Research Coordinators (CRCs) to clinical trial sites to perform non-medical, operational tasks under the guidance of the Principal Investigator (PI). Generally, sponsors and CROs outsource clinical research activities to SMOs; however, Jano Medical provides SMO services independently, thereby enhancing the efficiency and quality of clinical trials.

Talent and clinical resources are the core of medical device CROs.

Medical device CRO services are highly talent-dependent, requiring professionals with expertise in medicine, medical device R&D, laws and regulations, and comprehensive management. Although there is a shortage of talent in the medical device sector, demand continues to grow, further exacerbating turnover in the medical device CRO industry and driving up labor costs.

Jano Medical has a stable core team internally.Founders Zhai Qichao, Xu Zhiyuan, and Li Dan have been involved in medical device clinical trials since the early stages of their development in China. The core team members are among the first professionals in China to specialize in medical device clinical trial services, each with over ten years of industry experience.

Currently, the internal team at Jano Medical comprises nearly 200 members, with a well-established talent pipeline. Since its inception, the company has undertaken numerous clinical trial projects for innovative medical devices, boasting extensive project experience, a stable team, and low staff turnover.

Moreover, over the years of development, Jano Medical has collaborated with nearly 400 clinical trial institutions in China, maintaining close partnerships with several authoritative institutions such as Zhongshan Hospital Affiliated to Fudan University, Fuwai Hospital of the Chinese Academy of Medical Sciences, the General Hospital of the Northern Theater Command of the Chinese People's Liberation Army, and Beijing Anzhen Hospital Affiliated to Capital Medical University. Through these collaborations, it has accumulated extensive expert resources in areas including product testing, animal studies, clinical trials, statistics, and regulatory review.

To date,Jano Medical Research has successively served over 70 medical device companies, undertaken clinical trial services for more than 30 innovative cardiovascular medical devices, and cumulatively secured over 20 medical device registration certificates., including several China-first products such as the first domestically produced left atrial appendage occluder, peripheral venous stent, and cardiovascular OCT catheter, as well as products with significant market impact such as drug-coated coronary balloons, aortic valve prostheses, endovascular grafts for abdominal aortic aneurysm, drug-coated peripheral balloons, and intracranial thrombectomy devices.

In addition, it includes domestically pioneered or clinically advanced investigational products such as sirolimus-coated balloons, transcatheter mitral valve replacement/repair, balloon-expandable aortic valves, venous closure adhesives, asthma ablation therapy, CTEPH treatments, surgical robots, aortic arch repair systems, and ultrasonic balloon systems.

A strong reputation has always been the cornerstone and goal of Jano Medical’s development. According to Li Qingsong, head of the company’s Project Department, “Many clients repeatedly purchase our services and even proactively recommend us to other providers.”

Overall, China’s medical device CRO industry is characterized by low concentration, with numerous but small-scale enterprises. Due to the inherently low concentration of China’s medical device sector, order values for device CRO services are relatively small, resulting in modest net profits for CRO firms. Moreover, the barrier to entry in the device CRO industry is low; some market participants may capture market share through price competition, yet they lack adequate capabilities in clinical trial design, end-to-end project management, and risk control.

However, with the gradual development of the domestic medical device industry,The medical device CRO industry is evolving toward specialized talent, standardized practices, and refined operations.。

In the long run, the medical device CRO industry will inevitably undergo consolidation. Companies with large scale and strong comprehensive capabilities will emerge from the fragmented market, leveraging their significant advantages in talent, service scope, and expertise. These leading players may also pursue acquisitions of smaller firms to expand their business. Meanwhile, medical device CRO services will trend toward greater specialization and refinement.

Against this backdrop,Jano Medical Research is committed to building a comprehensive outsourced service industry chain. Beyond clinical trials, it extends downstream into CDMO services and laterally into related businesses such as data management and statistical analysis, thereby efficiently linking the scientific research and industrial sectors.。

Meanwhile, amid intensifying domestic competition and the pressures of centralized procurement, Chinese medical device companies are proactively expanding overseas. Aligning with this industry trend, Jano Medical is also venturing into international markets to assist Chinese enterprises in going global. In the context of globalization, achieving success in both domestic and overseas markets can become a key source of competitive advantage for enterprises.

References:

“How Large Is the Medical Device CRO Market? A Comprehensive Guide” — SIBLUE Devices

"Annual Summary: A Comprehensive Analysis of Financing Activities for Chinese Medical Device Companies in 2021" – China Business Industry Research Institute