Riding the Digital Wave, Collaborating for Global Reach: Empowering Medical Device Companies to Expand Overseas through Digital Intelligence

September 17, 2022, byVCBeat VB100, Purui Chunzheng Medical Technology (Guangzhou) Co., Ltd.Co-hosted by2022 Global Market Access Digital Intelligence Innovation ForumSuccessfully concluded in Beijing. Catalyzed by the COVID-19 pandemic and intensified by centralized volume-based procurement, China’s highly competitive medical device industry has sought new opportunities overseas. However, global expansion has not been smooth sailing. In this new era, going global requires not only innovation but also digital and intelligent leadership. With numerous players vying for success, those who collaborate will go farther. At this forum, industry leaders gathered to share insights on three key themes: “Navigating Hidden Risks, Empowering through Digital Intelligence, and Leading Global Expansion with Smart Strategies.”

Ren Fang: Opportunities and Challenges for the Internationalization of China’s Medical Device Industry Under the New Landscape

(Ren Fang | Director of the Medical Device Department, China Chamber of Commerce for Import and Export of Medicines and Health Products; Secretary-General of the International Cooperation Branch of Medical Devices)

Ren Fang, Director of the Medical Device Department and Secretary-General of the International Cooperation Branch for Medical Devices at the China Chamber of Commerce for Import and Export of Medicines and Health ProductsAs the opening speaker, she shared insights on the opportunities and challenges facing the internationalization of China’s medical device industry under the new circumstances. She noted that in recent years, China’s medical device industry has achieved high-quality development, driven by continuously improving innovation capabilities, supportive scientific regulatory frameworks, inflows of domestic and foreign capital, and deepening industrial internationalization. During the COVID-19 pandemic, Chinese medical device products made significant contributions to global epidemic response efforts. Not only did import and export trade grow rapidly, but the international competitiveness of Chinese products, services, and brands also improved substantially, elevating China’s role in the global healthcare supply chain. She further emphasized that, under the new circumstances, the “Health Silk Road” has opened up new avenues for cooperation within the Belt and Road Initiative, contributing to the improvement of global public health governance, and that China’s medical device industry will play an even greater role in the development of the “Health Silk Road.”

Sun Daguang: Amid the Wave of Global Expansion, How Can Medical Device Companies Cross Regulatory Barriers and Succeed Overseas?

(Sun Daguang | Vice President of PureCert, Global Regulatory Expert for Medical Devices and IVD)

Sun Daguang, Vice President of PureCert and Global Regulatory Affairs Expert for Medical Devices and IVDMr. [Name] noted that to determine the direction, approach, and strategy for the development of the medical device industry, the following dimensions should be considered: first, the national population; second, the age structure of the population. Countries with higher levels of aging tend to have more advanced medical device industries, while higher life expectancy correlates with greater regulatory hurdles for product registration. Finally, per capita GDP and investment in medical devices must also be taken into account.

For medical device companies, ensuring product safety and efficacy while maintaining compliance is essential to enhancing the global reputation of “Made in China” and Chinese medical devices. After obtaining domestic registration certification, securing market access approvals from the United States and the European Union is crucial, as it demonstrates to more countries that the company has been endorsed by the world’s most stringent regulatory authorities. Furthermore, and most critically, companies must be able to issue Certificates of Free Sale (CFS) in these jurisdictions, thereby evidencing comprehensive global regulatory registrations. Under China’s National Medical Products Administration (NMPA) and the EU CE marking framework, manufacturers can apply for a Certificate of Origin or a Free Sale Certificate immediately after successful product registration. In contrast, under U.S. Food and Drug Administration (FDA) regulations, companies are eligible to apply for a Certificate to Foreign Government (CFG) only after achieving substantial exports from the United States, which serves as proof of actual commercialization in the U.S. market. At the event, Mr. Sun Daguang also shared insights on market access regulations in overseas regions, including Southeast Asia, the Asia-Pacific, the Middle East, and Africa.

Meng Zhu: SaaS+Data Digital Empowerment Helps Medical Device Companies Set Sail for Global Markets

(Meng Zhu | CEO of Purui Chunzheng, Recipient of the Dongwu Technology/Gusu Innovation and Entrepreneurship Leading Talent Program)

How to Address the Pain Points and Challenges of Global Expansion?Meng Zhu, CEO of PureDiagnostics and recipient of the Dongwu Technology/Gusu Leading Talent Program for Innovation and EntrepreneurshipThe speaker shared her insights with the audience. First, she emphasized a dual-drive strategy combining R&D and marketing, focusing on innovative product development to meet emerging medical needs and seize first-mover advantages in the global market. Second, she highlighted the importance of embracing digital information technology, as digitalization is leading a new round of changes in the competitive landscape of the industry. Third, she called for optimizing business models and flattening marketing channels.

As an industry-leading global SaaS+Data life sciences service provider, PureCert is dedicated to digitizing the entire process of medical device market expansion worldwide. It offers end-to-end consulting services for global regulatory compliance and market access for medical devices, in vitro diagnostics (IVD), and AI-based medical software products. Its comprehensive service portfolio includes regulatory consulting, local authorized representative services, product certification and registration, overseas clinical trials, technical documentation and quality management system guidance, and product testing. Unlike traditional CROs, PureCert leverages digital-driven solutions to replace manual searches, enabling simultaneous multi-product and multi-country registrations. Furthermore, its data-driven insights feed back into enterprise R&D, providing companies with new directions for product development.

In terms of regulatory compliance, Purui has independently developed a global intelligent regulatory platform that provides translation services for document management, project-specific regulations, regulatory monitoring, and specialized documentation. The platform covers access regulations for over 100 countries, more than 1 million clinical trial records, and over 3 million global medical device registration entries. Regarding clinical trials, Purui currently operates its own clinical bases and laboratories in the United States and Europe. Notably, in response to the recent mpox outbreak, Purui was the first to activate five trial sites in the U.S. and eight in Europe.

“China’s Medical Device Subsector Global Expansion Index” Interpretation

(Meng Zhu and Sun Daguang jointly released the “China Medical Device Subsector Overseas Expansion Index”)

At this forum,Meng Zhu, CEO of PureCertMs.,Sun Daguang, Vice President of PureCureMr. [Name] jointly released the “China Medical Device Subsector Overseas Expansion Index.” Based on the design model and logic of the main index, this subsector-specific overseas expansion index customizes rankings for Chinese medical device companies across various subsectors. It evaluates their registration status in major global target markets, as well as their patent applications and clinical trials, thereby showcasing the strength of Chinese manufacturing.

Zhou Quan: Medical Device Global Expansion: Consensus, Pathways, and Challenges

(Zhou Quan | Managing Director, Legend Capital)

Zhou Quan, Managing Director of Legend CapitalGiven the constraints of China’s healthcare payment landscape, companies that focus solely on the domestic market will face significant survival pressures. Expanding overseas has become a consensus for the future development of medical device enterprises. The core pain points for Chinese medical device companies going global include: lack of forward-looking and systematic planning, low execution efficiency, scarcity of core resources, and high costs and expenses.

Meanwhile, Mr. Zhou also noted that geopolitical risks remain a potential concern. However, the more severe and challenging the external environment becomes, the more enterprises should rise to the occasion, adopting a more open and resolute approach to global expansion. He advised medical device companies pursuing international markets to “avoid putting all their eggs in one basket.” While focusing on the U.S. and EU markets, they should also pay attention to Southeast Asia, the Belt and Road Initiative (BRI) countries, Africa, and Latin America to hedge against geopolitical risks. Accordingly, companies need to develop flexible, region-specific strategies and partner with a reliable CRO (Contract Research Organization).

(From left to right: Meng Zhu | CEO of Purui Chunzheng, recipient of the Dongwu Technology/Gusu Leading Talents in Innovation and Entrepreneurship Program; Yang He | Co-founder and CEO of Weimai Medical; Wu Jie | Co-founder and Deputy General Manager of Weituo Bio; He Ti | Head of Overseas Business Department at Yuewei Genomics;)

During the Expert Roundtable session, panelists shared insights on core challenges in overseas markets, digital and intelligent transformation for enterprises in the process of globalization, product innovation for international expansion, and regulatory compliance. The dynamic exchange of ideas brought new perspectives to industry development.

Meng Zhu, CEO of PureDx and recipient of the Dongwu Technology/Gusu Leading Talents Program for Innovation and EntrepreneurshipMs. [Name], serving as the roundtable moderator, posited that innovation and global expansion are largely contingent upon the inherent strength of a company’s products. Medical device enterprises should embrace digital information technologies, leverage data analytics to drive strategic decision-making, optimize management processes, enhance operational efficiency, and achieve comprehensive global synergies.

Yang He, Co-founder and CEO of Vimai MedicalIn sharing insights, it is noted that for high-end medical equipment, the primary challenge lies in brand trust due to the high cost per unit, followed by the need for remote maintenance or long-term after-sales support. Innovation entails a certain degree of risk and requires continuous communication and iterative development with customers.

He Ti, Head of the Overseas Business Department at Yuewei GenomicsIt is believed that strategic selection is more critical than sheer effort. Enterprises need to formulate comprehensive and precise internal strategies to mitigate risks and reduce costs at the corporate level. Managing overseas operations across finance, shipping, logistics, and administration requires digital and intelligent solutions, as manual efforts alone are insufficient.

Wu Jie, Co-Founder and Deputy General Manager of Weituo BiologyIt was mentioned that Weituo Bio has established corporate accounts on popular overseas self-media platforms to promote its products, brand, and marketing activities while engaging with customers. Additionally, the company has developed a dedicated mobile app that provides customers with 24/7 guidance and tutorials on product usage. The app also features interactive feedback capabilities, enabling the company to promptly obtain information on customer ordering needs, usage inquiries, technical exchange requests, and product quality feedback. This connectivity not only enhances customer stickiness but also significantly reduces the company’s information communication costs.

“Going global” offers a fresh perspective on the development of medical device companies. “The road is long and arduous, yet persistence leads to success; with unwavering commitment, a promising future awaits.” The 2022 China Medical Device Going Global Conference shares this encouragement with all domestic medical device enterprises!