VB-Talk Insights | Pure Global Founder and Chairwoman Meng Zhu Delivers Keynote: AI Empowerment to Propel Chinese Medical Device Companies into Global Markets

On June 30, 2023, at the 2023 China Medical Device Global Expansion Conference held in the Binhai New Area of Tianjin,Meng Zhu, Founder and Chairman of PureCertDelivered a keynote speech titled “AI-Enabled Empowerment: Helping Chinese Medical Device Companies Navigate Global Expansion.”

Meng Zhu highlighted the vast market opportunities for Chinese medical device companies expanding overseas. She introduced how PureReg can support enterprises in their global expansion through its expert teams, registration services, and clinical services. Additionally, she showcased how AI empowers medical device globalization, featuring the industry’s first AI-generated Instructions for Use (IFU.ai) and AI-powered medical translation tool (transla.ai). These digital innovations aim to drive innovation and bolster international expansion. Finally, the “2022 China Medical Device Companies Overseas Expansion Index” was released.

[The following text is compiled from the on-site presentation, with some content omitted]

This chart, prepared by PureCert, illustrates the volume of medical device exports from China, highlighting metrics such as the number of NMPA registrations, overseas clinical trials, and CE certifications across different countries and regions, while also benchmarking these figures against overall customs export data. Several noteworthy insights emerge: Guangdong ranks first among China’s top five exporting provinces, followed by Jiangsu, Zhejiang, Shanghai, and Shandong. These rankings align closely with our overseas regulatory approvals, which serve as the primary threshold for market entry; only with valid registration certificates can substantial export volumes be achieved. The data reveals a significant surge in total export value after July 2020, driven by the global outbreak of the pandemic, which spurred the overseas shipment of substantial domestic supplies. Throughout 2022, export figures continued to rise. A slight dip occurred in the final phase of 2023, attributable to China’s full reopening and the impact of the Spring Festival holiday, which temporarily slowed exports. However, steady growth resumed from April onward.

How should we view overseas expansion? The overseas market is vast; after all, with a population four times that of China, it naturally offers a market size four times larger. How can we effectively capture this overseas market? This is precisely why, when PureCRO returned to China to launch its startup, we aimed to build a digital CRO company, differentiating ourselves from the traditional regulatory and clinical services previously offered by others, particularly in the area of multi-country regulatory submissions.

We are currently committed to becoming a global AI-enabled digital service provider, replacing traditional inquiries with data-driven solutions. By offering end-to-end registration and clinical trial services, we reduce communication and time costs. Furthermore, digital insights will inversely drive corporate R&D; the clinical and research activities of global competitors and industry leaders will determine our own strategic direction.

My years of professional experience have allowed me to truly witness how AI can transform efficiency across an industry. In my view, the medical sector and regulatory science share a common logical framework, and both can certainly be made more efficient through information technology. During the pandemic, all the supplies that my partner and I donated in the United States were sourced from China. This experience led us to recognize and remain optimistic about the global expansion of Chinese medical devices—a trend we believe will occur naturally as the industrial chain continues to upgrade.

We have now established a global team, with many members dedicated to overseas delivery. A European holding company, which is a well-known local institution in Europe, was recently integrated into the PureDiag Group in the first half of this year. Our IVV laboratory, a renowned brand in Sweden, has further strengthened our capabilities in clinical pathways. By presenting the PureDiag team here, we aim to build these data platforms and a global team to effectively address the various challenges enterprises face when expanding overseas.

We now provide support in more than 25 countries, covering approximately 90% of global regulatory frameworks. Beyond Europe and the United States, our presence extends across Asia—including Singapore, Thailand, Malaysia, Northeast Asia, and Japan—as well as South America, where Chinese enterprises are also active. We frequently engage with many countries in this region, such as Brazil, Peru, and Colombia. Notably, Brazil has a limited number of domestic manufacturers, resulting in insufficient local supply of medical devices and heavy reliance on imports. This presents a highly promising market opportunity.

Our core capabilities are concentrated at the regulatory level, encompassing regulatory strategy, market access, post-market surveillance, and multi-country authorized representation. We have currently expanded our operations to 25 countries and regions, securing over 1,000 market access approvals. Among these, more than 300 are registration certificates from markets outside Europe and the United States, including the United Kingdom, Mexico, and Australia.

Our clinical team, Pure Clinical, possesses extensive experience in conducting clinical trials across various therapeutic indications and designing trial protocols. Our team members have received the necessary education in medicine, biomedicine, or pharmaceutical sciences. We have established our own clinical sites with robust medical resources locally in Tennessee. Genetic and pathological validations are conducted at laboratories in Tennessee, which also provide excellent support for the transportation of numerous samples and specimens during clinical trials. In Europe, our primary operations are based in Sweden, where IVV laboratories are distributed across the northern, central, and southern regions, complemented by three biobanking centers. These facilities enable retrospective clinical studies and sample-based clinical research. Additionally, we maintain collaborative partnerships with laboratories in Poland, Switzerland, Germany, Slovakia, and other countries, establishing an extensive network throughout Europe.

Let us focus on the resources of our biobank. As our clinical resources continue to expand, the biobank has become a strategic asset. Currently, it is not open to the public; access for research purposes abroad is extremely limited and highly valuable. PureDiag currently holds two biobanking licenses in the United States. We collect various samples into our biobank, including those from influenza A and B, clinical respiratory cases, infectious blood disorders, hepatitis B, hepatitis C, urine, and tumors. These samples enable retrospective clinical studies across different genotypes and ethnic populations, covering the entire clinical service chain from feasibility analysis to clinical collaboration.

AI empowerment is deeply embedded in the DNA of PureCert. This year, we achieved an industry first by launching the first automated generation system for product instructions for use (IFU). As everyone knows, the IFU is the soul of a product. For some highly complex products, it can take half a month to a month to draft a single IFU during the R&D and regulatory registration phases. Furthermore, to obtain certification for overseas markets, the IFU must be translated into multiple languages. Poorly written instructions that are difficult for physicians to understand can lead to a series of adverse consequences.

However, on our platform, a standardized product manual can be automatically generated with a single click in the time it takes to enjoy a cup of coffee, supporting 25 languages. This product received recognition from Microsoft this year. As manual creation is within our capabilities, translation naturally falls within our scope as well and is conducted alongside our regulatory documentation. Built upon the GPT-4 model, we have developed PureCert Translation, which supports 25 languages and features expert verification, thereby delivering superior translation quality and versions to more outstanding Chinese enterprises.

We have more effective solutions to help streamline the registration certificate process, but global expansion encompasses a broader ecosystem and end-to-end workflow. In many cases, it cannot rely solely on PureReg’s internal capabilities. We are eager to hear your insights on going global, with the ultimate goal of working together to ensure its success.

We released the Q3 2022 Index Rankings, with key evaluation dimensions derived from data in the PureCert database, including overseas registration certificates, patents, clinical trials, and export revenue.

Scan the QR code to view the “2022 China Medical Device Companies’ Overseas Expansion Index Ranking”

From 2015 to 2022, the main export destinations for Chinese medical devices included the United States (shown in blue) and Germany (shown in green), as well as other countries and regions such as Japan, the Netherlands, Australia, South Korea, and Hong Kong, China. Our medical device products have been categorized; in terms of export categories, massage apparatus, prepared reagents, and immune products ranked as the top three. Other categories include color Doppler ultrasound systems, gloves, and face masks.

Significant changes have been observed in export products from 2021 to 2022. In 2020, immunological products dominated exports, including PCR reagents and antigen test kits. However, the momentum for overseas expansion of COVID-19-related IVD products has cooled since 2022. With the pandemic now officially over, pivoting to new product lines requires time, and the entire industry is evolving with the times. We are witnessing a growing trend of digital products going global, particularly those involving clinical trials and patent registrations. Products leveraging AI in emerging fields have also appeared on our radar. In recent years, there has been a marked increase in independently developed products. As the variety of domestically produced alternatives expands, total export value is currently on an upward trajectory.

From the perspectives of multi-country registration, overseas clinical trials, information technology platforms, regulatory science, and medical device registration certificates, PureReg will join hands with leading enterprises to expand into global markets, leveraging digitalization to drive innovation and empower international expansion.