Zheke Medical Files Prospectus to Accelerate Commercialization of Innovative Medical Devices Through Comprehensive CRO Services

In the field of medical device CROs, Changzhou Zheke Medical Technology Co., Ltd. and Beijing Zheke Zhongyi Medical Technology Co., Ltd. (collectively referred to as “Zheke Medical”) are continuously expanding their service offerings.

Located in the scenic Changzhou West Taihu Lake Science and Technology Industrial Park, Changzhou Zheke Medical was established in 2018. Since then, it has expanded from Changzhou Zheke Medical to Beijing Zheke Zhongyi Medical, successively establishing branch offices. The company has served nearly 100 clients and completed clinical validations for pioneering projects in China, including the first domestically developed 3D electronic laparoscope, antimicrobial titanium alloy bone pins, and sodium hyaluronate solution. Its project portfolio spans orthopedics, interventional medicine, medical aesthetics, general surgery, ophthalmology, and other fields, with a cumulative total of more than 80 Class II and Class III medical device registration certificates obtained.

Changzhou Zheke Medical

According to Guo Hanqing, founder of Zheke Medical, the company is dedicated to providing medical device clients with one-stop services, including clinical research, clinical trials, clinical audits, clinical market assessments, project evaluations, and personnel staffing.

Medical device CRO services cover a broad spectrum, encompassing the entire product lifecycle from R&D, animal studies, clinical trials/equivalent device clinical evaluation, and regulatory submission to post-market iterative product development. Clinical evaluation is a critical component of the regulatory submission process; it involves the systematic and ongoing analysis and assessment of clinical data using scientifically sound methodologies to confirm the safety, clinical performance, and/or effectiveness of medical devices within their intended scope of use.

Guo Hanqing told VCBeat that Zheke Medical has chosen to focus on clinical trials for innovative medical devices. On one hand, driven by the wave of domestic substitution, China-made innovative medical devices are developing rapidly, with many even reaching international standards. On the other hand, national regulations related to clinical evaluation are continuously being improved and standardized. For instance, the “Technical Guidelines for Clinical Evaluation of Medical Devices” released in 2021 introduced the concept of lifecycle clinical evaluation. The selection of a clinical evaluation pathway is no longer a simple yes-or-no choice as it once was; instead, registration applicants must assess whether their existing clinical data are sufficient to address questions regarding the safety and effectiveness of the product under application, and then determine which methods to use for collecting additional clinical data to fill any gaps.

“Zheke Medical is actively responding to national policies and fully dedicated to supporting the clinical evaluation and regulatory registration of innovative medical devices. We hope to contribute to the translation of technological achievements in high-quality innovative medical devices in China, ensuring that scientific and technological innovations benefit more patients,” said Guo Hanqing.

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

The multidisciplinary, knowledge-intensive, and highly segmented nature of the medical device industry requires CRO firms to employ composite professionals with strong technical backgrounds and extensive experience. This is particularly true for project protocol planning and regulatory policy interpretation related to innovative medical devices, which demand even higher levels of expertise from personnel.

The friction between the shortage of talent in the medical device clinical trial industry and the continuously growing market demand has led to high turnover rates among personnel at device CROs. This turnover significantly impacts the quality of clinical trials, potentially causing delays or even project abandonment.

Zheke Medical boasts an experienced and stable team. Its founder, Guo Hanqing, has over a decade of experience in the clinical trial industry for medical devices and also serves as a visiting professor in the field of clinical evaluation at the China Academy of Emerging Economic and Technological Industries. The core team comprises seasoned orthopedic surgeons from hospitals and university researchers adept at pioneering explorations. With a staff of more than 20, the company may be small in size, but it excels in its extensive industry and project expertise, personnel stability, low turnover, and agile responsiveness.

Given the team’s characteristics, Zheke Medical adopts a flat management structure, fostering a work environment that is free, sincere, and egalitarian. Every employee is encouraged to express their views openly and has the opportunity to take independent responsibility, thereby gaining valuable experience and achieving professional growth.

Furthermore, Guo Hanqing believes that a robust internal system for clinical trial execution standards constitutes the core competitiveness of medical device CRO companies. “Whether it is the National Medical Products Administration (NMPA), the Center for Medical Device Evaluation (CMDE), or various guidelines and industry norms, these entities primarily establish the overall framework and oversee outcomes. However, in practical operations, the key factor ensuring successful clinical results lies in the effective and standardized execution and conduct of trials.” To strengthen the team’s professional capabilities, Zheke Medical has established an internal learning mechanism. In addition to basic onboarding training, the company conducts specialized technical training, project self-inspections, simulation exercises, and invites external experts for training sessions. Meanwhile, the company places significant emphasis on external academic activities, seizing opportunities for exchange and learning with industry experts.

Over the years, Zheke Medicine has established collaborations with more than 100 hospitals, including Peking Union Medical College Hospital, Plastic Surgery Hospital of the Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University Third Hospital, Peking University People’s Hospital, Zhongshan Hospital Affiliated to Dalian University, and Liaoning Provincial People’s Hospital. These partnerships have enabled the accumulation of extensive expert resources, laying a solid foundation for the smooth advancement of clinical trials for its projects.

For several years, Zheke Medical has focused on the field of clinical trials for medical devices, with its advantages mainly reflected in four aspects.

First, provide comprehensive, integrated services.Clinical trials for medical devices and diagnostic reagents (CRO); domestic and international medical device registration; quality assurance (QA) audits for clinical trials; project quality control; new product initiation assessment and market research (consulting); academic support and planning of academic marketing promotion (consulting); drafting technical requirements for medical devices, finite element simulation analysis, registration testing and evaluation, and one-stop solutions. We employ a multi-dimensional, comprehensive approach to resolve the “last mile” challenges in the industrialization of innovative medical devices.

Second, a highly efficient and standardized data-driven management system.To address the time-consuming challenges associated with clinical trial data acquisition and transmission tracking, timely, accurate, and complete data collection, coupled with scientific and rational data management, not only enhances the quality of clinical trials but also shortens the research cycle. The company employs SAS systems, adverse event reporting systems (MedDRA, WHO-ART), Study Manager data management systems, remote data management systems, and EpiDATA data entry systems to ensure that clinical research data is authentic, complete, scientific, and compliant with standards. This standardized data management system enables relevant personnel to access, manage, monitor, and track data at any time, thereby maintaining full visibility over execution progress.

Third, abundant internal and external resources.Zheke Medical’s core team has been deeply engaged in the medical device industry for over a decade, boasting extensive professional networks and diverse information sources. The team is well-versed in the historical project implementation status across various centers and hospitals, and has accumulated substantial resources of clinical experts. In response to the continuously introduced and updated medical device standards both domestically and internationally, particularly within China, the company possesses the capability to rapidly respond, accurately interpret, and effectively apply these standards.

Fourth, the project experience is rich, and the team is stable and solid.Zheke Medical has now undertaken more than 100 clinical trial CRO service projects, including:Active devices,such as ultrasound tumor therapy systems, picosecond laser therapy systems, and irreversible electroporation therapy systems;Interventional, such as thoracic aortic stent grafts, coronary drug-coated balloons, vena cava filters, and CVC catheters;Orthopedics,such as meniscus repair systems, hip prosthesis systems, knee prostheses, interbody fusion cages, and implants;Dressings,such as nano-antibacterial dressings, bio-skin-based antibacterial dressings, and bio-skin-based antibacterial dressings;Medical Aesthetics,such as cross-linked sodium hyaluronate gel for injection, collagen fillers, and aesthetic product injectors. Past clients include Bloomage Biotech, Cofoe Medical, Linhua Medical, Pansheng Medical, Senfeng Medical, and Yeju Medical, covering startups, growth-stage, and mature companies, with extensive project experience. Team members have known each other for many years and maintain a strong, cohesive working relationship.

Meanwhile, Guo Hanqing also shared two tips for selecting a CRO company with entrepreneurs.

First, companies can engage with multiple CROs in the early stages based on their scale and budget. Differences in operational systems among CRO providers directly lead to variations in service fees.

Second, companies can consult industry experts or physicians in the relevant fields. As clinical trials have become increasingly common, many physicians are well acquainted with the work quality of certain CROs and can provide objective and pertinent advice.

Although Zheke Medical has been established for five years, it maintains a low profile, with scant corporate information available online. So, how does Zheke Medical acquire customers?

Guo Hanqing told VCBeat that the company collaborates with provincial administrations and institutions to conduct training sessions, which primarily focus on interpreting relevant industry policies while also promoting the company’s business services. Existing clients are sourced from three main channels: one portion comes from the aforementioned training and promotional events; another is derived from the professional networks cultivated by the core management team over more than a decade; and the remainder consists of continued collaborations with previously served clients.

Looking ahead, Zheke Medical will continue to strengthen its internal capabilities, with a short-term focus on team development and service optimization. In terms of strategic direction, the company will shift its emphasis toward the medical aesthetics sector and provide open consulting services to help enterprises better mitigate risks. Over the long term, while consolidating its strengths in orthopedics, interventional procedures, and general surgery, Zheke Medical will expand into niche segments such as medical aesthetics, dentistry, and peripheral vascular care, thereby facilitating the integration of more innovative medical devices into everyday life.

Changzhou West Taihu Lake Science and Technology Industrial Park has thoroughly implemented the Healthy China Strategy. Leveraging its existing foundational conditions and comparative advantages, the park is vigorously developing the medical health industry, with a focus on advanced medical technologies such as high-end medical devices and cell therapy, as well as premium medical services including rehabilitation and aesthetic medicine. In 2022, the park’s annual output value exceeded RMB 10 billion. It has gathered 300 health manufacturing enterprises, primarily engaged in medical device production, forming three industrial peaks—orthopedic implants, in vitro diagnostic (IVD) reagents, and powered surgical tools—as well as six specialized sub-industry clusters: biomaterials, orthopedic instruments and implants, dentistry, rehabilitation equipment, major surgical instruments, and IVD equipment and consumables. Each of these specialized industries boasts a cohort of key enterprises.