Recently, the 100% retrievable YonFlow® flow-diverting stent, a nationally recognized innovative medical device independently developed by Nowyon Medical Co., Ltd. (formerly Jiangsu WarmSun Medical Instruments), has officially received approval for market launch from China’s National Medical Products Administration (NMPA). As the first domestically developed device that is fully retrievable after complete deployment from the microcatheter, this innovation provides greater fault tolerance and controlled release during surgery. Physicians can effortlessly retrieve and redeploy the device to ensure optimal positioning and efficacy, significantly enhancing procedural safety and effectiveness. Additionally, it shortens the learning curve for surgeons, facilitating broader adoption of the technique and improving patient access to treatment.
As the clinical research strategic partner for this project, CCRC MedTech leveraged its internationally compliant clinical research system and extensive experience in innovative medical device projects to provide comprehensive, multi-dimensional professional services. The company offered robust technical support for the clinical trial design and execution, contributing to the product’s successful technical evaluation and approval by the NMPA.
Addressing Key Bottlenecks in Clinical Evaluation of Innovative Medical Devices
In the field of innovative medical device development, each “first-of-its-kind” technology brings significant clinical value but also faces more formidable market-entry challenges. First, the lack of reference products makes it difficult to establish a clinical evaluation framework, as regulatory agencies tend to adopt more stringent review standards for “first-in-class” devices. Second, the clinical application of innovative technologies requires the establishment of entirely new operational protocols, where the surgeon’s learning curve directly impacts the quality of clinical trials. Furthermore, breakthrough technologies demand more rigorous evidence-based medical validation, posing higher requirements for clinical trial design. Particularly in high-risk fields such as neurointervention, balancing innovation with patient safety becomes a critical challenge for product approval.
Enabling Full-Cycle Clinical Research Solutions for Innovative Medical Devices
As a leading clinical research partner for medical devices, CCRC MedTech specializes in providing full lifecycle services from early-stage R&D to commercialization for medical device companies. With over a decade of industry expertise, we have built an integrated service system covering clinical trial design, execution management, data analysis, and regulatory submission. We possess unique advantages in high-risk implantable devices, AI medical equipment, and breakthrough therapeutic technologies.
CCRC MedTech boasts a professional team comprising seasoned clinical experts, former regulatory reviewers, and statisticians. With deep insights into the technical features and regulatory requirements of innovative medical devices, we design clinical trial protocols that adhere to scientific standards while highlighting product strengths. Leveraging a robust network of core clinical centers across 30+ cities nationwide, we have established an efficient patient recruitment and management system to ensure rapid enrollment and high-quality trial execution. During project implementation, we employ intelligent clinical trial management systems to enable end-to-end digital monitoring from protocol execution to data collection, significantly improving research efficiency and data reliability.
For globally pioneering technologies lacking comparable reference products, we dynamically adjust trial protocols based on interim results, ensuring scientific rigor while enhancing success rates. Additionally, our stringent quality control system guarantees the authenticity and reliability of research outcomes, providing solid data support for regulatory submissions.
Looking Ahead
CCRC MedTech is committed to becoming the strategic clinical research partner for innovative medical devices worldwide. We will continue investing in service upgrades for cutting-edge fields such as real-world studies and remote intelligent clinical trials, building a more efficient and intelligent clinical research ecosystem. Simultaneously, we will actively advance the globalization of China’s innovative medical devices by developing capabilities for international multicenter clinical studies, helping “Made in China” innovations reach the global stage.
Our vision is to accelerate medical technology innovation through professional services, enabling breakthrough therapies to benefit patients worldwide sooner and collectively advancing the progress of global healthcare.
