CoreMed Celebrates a Decade of Pioneering Support for China's First-in-Class Medical Devices and Expands Global Ambitions

Medical devices represent a fertile ground for innovation. Clinical trials for innovative medical devices are also entirely new endeavors, requiring that trial protocols, reference standards, clinical endpoints, and other parameters be established from scratch. The emergence of third-party CRO services has not only shortened the clinical trial cycle for innovative devices but also enhanced the standardization of these trials, thereby accelerating the regulatory approval process.

Behind the clinical trials of China’s first bioresorbable coronary stent, left atrial appendage occluder, and transcatheter implantable aortic valve, among other innovative products, stands such a CRO company—CoreMed.CoreMed, established in 2013, specializes in clinical research services for medical devices. It provides efficient and professional CRO services to numerous innovative products both domestically and internationally, accumulating extensive experience in randomized, multicenter, large-sample studies ranging from feasibility trials and confirmatory trials to post-marketing clinical trials and investigator-initiated studies.

With the rapid development of the medical device industry and a market size approaching one trillion yuan, demand for medical device CRO services has surged. As the Medical Device Registrant system is fully implemented, Comed also celebrates its 10th anniversary. Brick by brick, Comed has built a benchmark position in the medical device CRO sector over the past decade, serving numerous renowned domestic and international medical device companies while maintaining sustained growth for many years.

Currently, Comed has established branches in multiple cities across China. With a workforce of over 100 employees, all of whom hold GCP certificates issued by the National Medical Products Administration (NMPA), the company possesses extensive expertise in various fields, including clinical research strategy consulting for medical devices, clinical trial implementation, imaging core laboratory analysis, and market access.. Meanwhile, the company’s founding team comprises professional managers with extensive domestic and international industry experience. Its core members possess multidisciplinary backgrounds in medicine, biostatistics, and other fields, along with global work experience. Having collaborated closely for a decade, the team has achieved rapid development while maintaining stability.

Medical device CRO is a specialized niche, with varying demands for clinical research services across different types of medical devices. At its inception, Comed chose to enter the market by focusing on high-difficulty, high-standard cardiovascular medical devices. At that time, the prevalence of cardiovascular diseases in China was continuously rising, and multiple first-in-class products were successively breaking through barriers. Seizing this wave of innovation, Comed pioneered new frontiers in the field of clinical trials.

Comaide has supported multiple Class III implantable first-in-class medical devices, refining its CRO service processes and standards while accumulating extensive experience. Meanwhile, the company continues to seize market demands and expand its business scope. Over the past three years, it has provided clinical research services for active medical devices, drug-device combination products, surgical robots, tumor ablation systems, medical aesthetics equipment, and AI-assisted diagnosis and treatment systems, thereby securing a broader market presence.

Comed provides “4C Services,” namely: “Consultation,” to assist clients in planning clinical trial strategies and pathways; “Clinical Services,” offering CRO services including clinical protocol design and writing, monitoring, CEC and DSMB support, data management and statistical analysis, EDC and randomization or registry system development, medical writing, and third-party audits; “Core-lab,” providing imaging core laboratory services; and “Connection,” facilitating resource matching and international expansion through collaborations with domestic and foreign professional institutions and industry experts to jointly serve clients.

Specifically, Comed leverages multi-party resources to provide “one-stop” CRO services, covering the entire process of medical device clinical trials, efficiently and effectively meeting clients’ comprehensive needs. Among these services, the imaging core laboratory is designed to standardize the analysis of imaging-related outcomes in clinical trials.

Comed Imaging Core Laboratory

In clinical trials of medical devices, imaging analysis is crucial; for instance, in studies of devices related to structural heart disease, medical imaging can be used to assess clinical endpoints. However, during the course of clinical trials, the results of medical imaging analysis may be influenced by various factors, and as the number of individuals involved in the assessment increases, the potential for bias may also increase.

Comed provides professional, objective, and standardized image analysis,The company’s core laboratory utilizes internationally standardized analytical software, with operational procedures aligned with international standards. Comprehensive Standard Operating Procedures (SOPs) have been established, and an imaging management system has been developed to standardize image transmission. Imaging analysis reports are provided by experienced professional analysts and physicians to ensure the authenticity and accuracy of results.

Innovation is in Comed’s DNA. The company has supported the development of multiple first-of-their-kind medical devices in China, including active medical devices and Class III implantable devices.

According to the founding team of Comrade, “The challenges in providing clinical research services for first-of-their-kind medical devices lie in three main areas: first, the lack of reference guidelines during study protocol design; second, the need for stricter process control or the establishment of new processes and standards during clinical trials; and third, the necessity of coordinating with multiple stakeholders, including manufacturers, physicians, hospitals, and relevant administrators.”

Pioneering and innovation test the professionalism, coordination capabilities, and experience of CRO companies. Camide has successfully supported numerous innovative medical devices, attracting a large base of repeat clients, while continuously raising industry standards in the process.

Meanwhile, as the centralized procurement of high-value medical consumables accelerates in China and domestically developed innovative products expand into overseas markets, going global has become an inevitable path for innovative medical device companies. Correspondingly, medical device CROs must also possess the capabilities for international development.

Comed also has an international DNA,Inclusion in the global supplier directory of a Fortune 500 multinational medical device company,Successfully entering the supply chains of multinational corporations demonstrates recognition by both domestic and international clients of the company's service quality.Several research findings involving the company have also been successfully published in top-tier international journals.

Comed has established strategic partnerships with CRO companies in Europe and the United States to facilitate the global expansion of domestically produced innovative medical devices. Leveraging the international background of its core team, Comed has also introduced many international standards to China, such as Clinical Events Committee (CEC) and Data and Safety Monitoring Board (DSMB) processes, thereby promoting the standardization of domestic medical device CRO services.

Among domestic CRO companies, Comed has achieved genuine “going global” and “bringing in.” To date, Comed has served more than 100 enterprises both in China and abroad, the majority of which are innovative medical device projects.

Unlike the pharmaceutical CRO sector, which has spawned several publicly listed companies, the medical device CRO market is relatively niche and fragmented. While there are numerous domestic CRO firms, they are generally small in scale and recently established, with limited service offerings per company. However, with the advancement of innovative medical devices, manufacturers are raising their expectations for the professionalism and comprehensiveness of CRO services.

To better meet the demand for end-to-end services for innovative medical devices and strengthen core competitiveness, some companies have begun expanding upstream and downstream, partnering with testing institutions, animal experimentation centers, and even CDMOs to provide full lifecycle services spanning R&D, testing, and production.

Throughout its development, the Comed team has assisted medical device clients in connecting with upstream and downstream resources; however, the company’s ultimate goal extends beyond merely facilitating resource linkages, aiming toBuild a true "one-stop" translational platform for medical devices, integrating testing, preclinical animal studies, and clinical trial services.

According to the founding team of Comed, “Generally speaking, once clients entrust us with their new medical device products, they need not worry about the subsequent processes, including testing, preclinical animal studies, and human clinical trials. This approach not only reduces communication costs and saves clients time and effort but also further shortens the product approval cycle through standardized end-to-end services, thereby ensuring that clients’ requirements for both timeline and quality are met.”

The Comed team took the lead in strategic positioning,In 2018, it established the first large-animal experimental center in western China, and in 2022, it launched a larger and more comprehensive third-party public service platform in Hangzhou, capable of providing clients with end-to-end services for medical devices.In the field of full-lifecycle services for medical devices, the Comed team has secured a first-mover advantage. As a key component of the “one-stop” device commercialization platform, Comed will continue to deepen its expertise in the CRO sector, establish higher standards for clinical research services, enhance customer satisfaction, and pursue international expansion to help innovative medical devices reach global markets.

“By the next decade, become an internationally renowned provider of full lifecycle services for medical devices.”