On July 25, the inaugural member conference and innovation salon of the Baoshan District Biopharmaceutical Industry Association was successfully held in Shanghai. As a key platform integrating biopharmaceutical resources and fostering industry-academia collaboration in Baoshan District, the event brought together leading biopharmaceutical companies, research institutions, investment firms, and government representatives to discuss “industry innovation breakthroughs and global development.”
At the conference, Julia Yuan, General Manager of CCRC Medtech, was specially invited by the Baoshan District Science and Technology Commission to deliver a keynote speech titled “Empowering Device Innovation for Global Expansion.” Drawing on industry experience and global perspectives, she provided an in-depth analysis of the opportunities and challenges Chinese medical device companies face in international markets, offering forward-thinking and practical insights for global growth.
Three Core Competencies: Pillars of Globalization
Julia Yuan highlighted that while the expanding global medical device market presents significant opportunities for Chinese innovators, challenges such as technical barriers and complex regulatory systems remain. She emphasized that to achieve true globalization, Chinese medical device companies must build three core competencies:
First, technology innovation must focus on clinical needs and breakthroughs in core technologies. Second, compliance capabilities require establishing quality management systems that meet international standards and deeply understanding target market regulations. Third, clinical research demands innovative approaches to enhance the global recognition of clinical evidence. These three dimensions are interdependent and together form the foundation of a company’s global competitiveness.
Enabling Global Innovation and Strengthening Foundations
In the global competition, technological innovation alone is insufficient. Companies must build end-to-end capabilities covering R&D, registration, clinical trials, and commercialization. As a specialized CRO in the medical device sector, CCRC Medtech has become a key enabler in this process through its international team and global resource network.
CCRC Medtech has assembled a professional team of experienced international regulatory experts and clinical operations specialists with extensive cross-cultural project management expertise. This enables the company to navigate differences in regulatory requirements and clinical standards across regions, providing localized registration strategies to mitigate compliance risks. Additionally, CCRC Medtech offers comprehensive support throughout a product’s lifecycle, from early-stage R&D strategy and regulatory pathway planning to clinical trial execution and post-market surveillance, leveraging its network of expert resources.
The company has particularly deep experience in high-risk fields such as cardiovascular and neurointervention, medical aesthetics, surgical robotics, and AI. Through its involvement in multiple innovative medical device special approval projects, CCRC Medtech has developed tailored solutions for high-risk products, covering critical aspects like innovation assessment, clinical protocol design, and risk management, providing robust technical support for the development and commercialization of breakthrough devices.
Julia Yuan’s speech resonated strongly with attendees, with many expressing high regard for CCRC Medtech’s professional services and interest in deeper collaboration in medical device globalization. As a key facilitator in the internationalization of Chinese medical devices, CCRC Medtech will continue to enhance its expertise and expand its global service network, further supporting the overseas expansion of domestic innovations.
Looking ahead, as more Chinese medical device companies succeed globally, the industry will play an increasingly vital role in the worldwide healthcare landscape, contributing significantly to global medical progress.
