Deneng Medical: Focusing on Innovative Medical Device Clinical Trials to Break Through in the CRO Sector

In the field of medical device CROs, De Neng Medical is continuously expanding its service scope.

From Shenyang and Beijing to Shanghai and Guangzhou, De Neng Medical has successively established branch offices to provide device CRO services. Spanning from north to south, De Neng Medical has served hundreds of clients, managing projects that cover a wide range of products, including passive medical devices, active medical devices, as well as IVD products such as NGS (next-generation sequencing), multiplex quantitative fluorescent PCR, and magnetic particle chemiluminescence immunoassays.

“De Neng Medical is a comprehensive CRO company specializing in clinical trials and registration agency services for medical devices, as well as quality system consulting,” said Liu Xiaowei, CEO of De Neng Medical.

At this stage, De Neng Medical has strategically focused on the regulatory approval of innovative medical devices, undertaking clinical trials for products including an arterial stent positioning system, an endoscopic surgical instrument control system, a microvascular anastomosis device, a fully bioresorbable sinus drug-eluting stent system, a radiofrequency ultrasound surgical system, an AI-powered intelligent disease diagnosis and screening system, an orthopedic surgical navigation and positioning system, and multiplex pathogen nucleic acid detection reagents.

Jiangsu De Neng Medical Technology Co., Ltd. has intensified its efforts in conducting clinical trials for innovative medical devices, having recognized and actively responded to national policy support for such innovations. Liu Xiaowei stated, “Since the implementation of policies such as the ‘Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices’ and the ‘Special Examination and Approval Procedures for Innovative Medical Devices,’ the market launch of highly innovative and technologically advanced medical device products has been accelerated, while also speeding up the pace of domestic substitution for high-end medical devices.”

“On the other hand, while domestic medical device manufacturers in China were once followers of foreign leaders in high-end medical devices or niche segments, they are now capable of independent innovation. Having evolved from imitation and following to autonomous innovation, Chinese enterprises have surpassed their mentors. From a clinical perspective, certain innovative products developed by domestic companies are already far ahead on the international stage.”

Liu Xiaowei stated, “We actively respond to national policies and are fully committed to supporting clinical trials and regulatory submissions for innovative medical devices. We have already undertaken multiple projects involving innovative medical device products. Jiangsu De Neng Medical Technology Co.Ltd aims to contribute to the translation of technological achievements from high-quality innovative medical devices in China, accelerating the market entry of superior products to meet clinical needs.”

De Neng Medical is headquartered in the BioBAY Industrial Park of Suzhou Industrial Park. Since its early development stages, the company has undertaken a substantial number of clinical trials and registration agency services for medical devices through close collaborations with numerous domestic sponsors. After years of accumulation, De Neng Medical has established subsidiaries including Beijing Hui Nengtong, Shanghai Jiaohong Pharmaceutical, Shenyang Weikeda, and Guangzhou De Neng in Beijing, Shanghai, Shenyang, and Guangzhou, respectively. These entities work in coordination to gradually form a nationwide service network.

Liu Xiaowei stated, “Due to factors such as the economy, policies, and the geographic distribution of enterprises, our company is currently focusing its efforts on customers engaged in the research, development, and manufacturing of medical devices in the Yangtze River Delta, the Pearl River Delta, and the Beijing-Tianjin-Hebei region.”

As a seasoned CRO company in the field of clinical trials for medical devices, De Neng Medical specializes in providing comprehensive outsourcing services for the entire clinical trial process. Tailored to diverse client needs, it also offers partial outsourcing solutions, such as clinical monitoring, medical data statistics, and project auditing. Additionally, the company delivers one-stop services covering registration, regulatory consulting, and quality system consulting.

According to Liu Xiaowei, the projects handled by De Neng Medical include passive devices, such as paclitaxel-coated PTCA balloon catheters, knee/hip joint prostheses, and cross-linked sodium hyaluronate for injection; active devices, such as dual-frequency plasma high-frequency surgical systems, breast positron emission tomography (PET) imaging devices, bilevel positive airway pressure (BiPAP) therapy machines, and peritoneal dialysis machines; dressing products, such as gel dressings for wound repair, medical absorbable anti-adhesion membranes, and gynecological gels; consumables, such as medical tissue adhesives, hemostatic materials, and parenteral nutrition infusion bags; and in vitro diagnostic (IVD) products, such as combined detection reagents for gene mutations including EGFR, colorectal cancer test kits, and Alzheimer’s disease detection reagents.

Why Should Medical Device Startups Choose De Neng Medical? Liu Xiaowei stated, “Most individuals or teams skilled in medical device R&D have leveraged the advantages of the Medical Device Registrant System to establish startups. However, with the implementation of the new Good Clinical Practice (GCP) for Medical Devices, clinical trials have become increasingly standardized and stringent. Many peers in startup medical device companies encounter various challenges in interpreting regulations and implementing practices, requiring professional clinical trial CROs to resolve their thorny clinical trial issues.”

“As a vice-chairman unit of the Clinical Trial Branch of the China Association for Medical Devices Industry (CAMDI), and as a standout among hundreds of domestic CRO companies, De Neng Medical has been honored by the Association, which also entrusts us with greater responsibilities. We are committed to serving our clients with an enhanced sense of responsibility. Leveraging our team of seasoned experts, extensive hospital networks, and multi-channel platform resources, De Neng Medical delivers faster and more efficient services to enterprises.”

In short, the CRO services provided by De Neng Medical can help or guide startup teams in addressing clinical trial challenges, thereby reducing costs for startups and accelerating the acquisition of regulatory approval certificates. Leveraging its professional talent pool, De Neng Medical not only supports enterprises but also achieves profitability, creating a win-win situation.

As of now, De Neng Medical has helped hundreds of enterprises obtain Class II and Class III medical device registration certificates.

Clinical trials for medical devices are highly specialized, which has raised the entry barriers for device CROs. The strength of a device CRO company is reflected in aspects such as the professionalism and experience of its personnel, expert resources, and communication channels.

Liu Xiaowei stated, “Specialization is the key to a company’s survival and development. Professional competence is the foundation for maintaining customer relationships; only through professionalism can we earn customers’ trust. Professional competence is also the basis for achieving performance results for both individuals and companies. Only by being professional can individuals and companies achieve long-term development.”

Guided by this philosophy, over 90% of De Neng Medical’s team members hold bachelor’s or master’s degrees in pharmaceutical or medical sciences and have many years of experience in clinical trials for medical devices. The core team members possess more than a decade of continuous experience in GCP-related training and service implementation. In serving our clients, the design of clinical trial protocols for medical devices and the statistical analysis of medical data are handled by professionals within the team who hold Senior Certified Statistical Practitioner qualifications. Additionally, De Neng Medical engages industry experts and clinical directors as external company advisors.

It is worth noting that Liu Xiaowei, CEO of De Neng Medical, serves as the Chairman Expert of the Clinical Trial Branch of the China Association for Medical Devices Industry, Secretary-General of the Animal Experiment Industry-Academia-Research and Biological Evaluation Branch of the China National Health Industry Enterprise Management Association, Executive Director of the Beijing Society for Biomedical Statistics and Data Management, and is a Senior Certified Statistician.

Liu Xiaowei has been engaged in clinical trials for medical devices since 2005, making her one of the earliest practitioners in this field in China. With over a decade of frontline experience in clinical trials, she has served hundreds of international and domestic clients, accumulating extensive expertise and substantial resources.

Among them, De Neng Medical has established long-term collaborations with over one hundred clinical trial institutions at hospitals. Its extensive resources in clinical trial institutions cover regions including North China, East China, South China, Southwest China, and Northwest China. Liu Xiaowei further stated, “De Neng Medical has long been dedicated to clinical trials and has maintained good communication relationships with regulatory review authorities.”

In fact, De Neng Medical’s extensive experience across a wide range of high-volume projects amply demonstrates its core strengths. Looking ahead, the company has already laid out its strategic plans for the future.

Liu Xiaowei stated, “In the future, Jiangsu De Neng Medical Technology Co.Ltd will make steady progress in the field of clinical trial and registration outsourcing services for medical devices, particularly innovative medical devices. We remain focused on providing one-stop, convenient clinical trial and registration services to medical device R&D firms, manufacturers, and registrants across China.”