Pure Global: The International Engine of Medical Technology Globalization

Healthcare, Technology Author: Qinqie He Sep 28, 2023 09:30 AM (GMT+8)

As a pioneer in international regulatory management and clinical solutions, Pure Global has evolved into an indispensable partner for medical technology companies. Through its outstanding data technology, seasoned industry expert team, and transnational capabilities, Pure Global empowers its partners to achieve global growth. Presently, Pure Global's services span more than 25 countries and regions, offering tailored solutions for the entire lifecycle of medical devices.


Brand Positioning: A Global AI-Empowered Life Sciences Service Provider

Pure Global's brand identity succinctly embodies its role as a global provider of life sciences services empowered by AI. During the height of the COVID-19 pandemic, Pure Global proactively participated in substantial international donations. This pivotal moment served as a catalyst for the integration of their extensive resources and years of professional expertise, driven by the entrepreneurial vision rooted in the founder's personal journey. Meng Zhu, an alumna of Shanghai Jiao Tong University with specialized expertise in the 8YD coronavirus domain, subsequently spent nearly a decade in the United States, immersing herself in fields such as computer science and natural language processing. Notably, she also made significant contributions to the development of Google's static pressure advertising algorithm.

Meng Zhu mentioned that their donations during the pandemic deepened their awareness of the potential for information technology in the medical field. They chose to delve into the field of regulatory science, starting with regulatory access. Furthermore, during the pandemic as a donating supplier, they personally experienced the vitality of the Chinese market, fostering their confidence in the domestic market. Pure Global identifies itself as a "long China" company, aspiring to enhance regulatory access efficiency through AI technology. Their global overseas resources, multiple subsidiaries, clinical laboratories, and strong expert teams, have erected industry barriers. Beyond technical leadership, their profound understanding of the industry places them at the global forefront of regulatory science.

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Furthermore, Pure Global's AI platform has earned acclaim from leading firms such as Microsoft Marketplace and IP Cosel, solidifying their competitive advantage. This recognition has enabled them to fortify a formidable strategic position. Meng Zhu pointed out that their competitive edge extends beyond national borders and holds a prominent presence on the global stage.

Empowering with AI: Creating Astonishing Cases

Pure Global's business operations are structured around three fundamental sectors. The first sector, global market registration access, revolves around tasks such as technical document drafting, global registration, and third-party certifications. The second sector, international clinical services, caters to clients with comprehensive international clinical support, demanding high levels of operational and informational capabilities. The third sector encompasses the AI platform, offering a wealth of global regulatory data, distributor databases, and registration databases. Meng Zhu emphasized that their mission goes beyond acquiring certificates; they aspire to serve as a global gateway for clients by delivering services such as competitor analyses, overseas market assessments, and various other data-driven solutions.

In operational activities at Pure Global, one outstanding facet is the integration of AI empowerment. Meng Zhu shared an illuminating case study involving a collaboration with BGI Genomics (华大基因). This collaboration presented BGI with a substantial undertaking: the drafting of technical documents for hundreds of products to attain global registration. Traditionally, this process would span several months. However, Pure Global harnessed the power of AI technology to streamline this endeavor, breaking it into manageable batches and completing each within a remarkable two-week timeframe, all while upholding stringent document quality standards. Notably, Pure Global's approach is characterized by the synergy of AI-generated document drafting with meticulous manual review, ensuring precision and compliance.

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Meng Zhu emphasized Pure Global's unwavering belief in the potential for the medical field to achieve transformative breakthroughs through AI. The company's strategic focus lies in the domain of regulatory science, employing advanced technology to catalyze progress within the medical field. She articulated their vision, stating, "We need more patience, more confidence, to combine medicine and AI better. We hope people don't lose confidence due to previous failures. While the market has its ups and downs, we firmly believe that through true technological empowerment, medicine and AI will have a brighter future."

Business Strategy: Focusing on Core Competitiveness

Pure Global adopts a market-oriented pricing strategy, as explained by Meng Zhu. This approach considers various factors, including product category and risk level. Prices for document writing services span a range from CNY 100,000 to 200,000, with higher costs associated with high-risk projects and more competitive rates for low-risk endeavors. Projects involving clinical trials can escalate in cost, potentially reaching the million CNY threshold.

Regarding their marketing strategy, Meng Zhu disclosed that Pure Global's channels are somewhat conventional yet infused with innovation. They leverage their official WeChat account (Chinese: 微信) to disseminate regulatory information, conduct offline lectures, collaborate with local associations, and establish partnerships with research firms and think tanks, thus providing clients with comprehensive global market analysis data. This multifaceted approach positions Pure Global to better assist companies in their pursuit of globalization.

Meng Zhu underscored Pure Global's unwavering commitment to prioritizing core competitiveness as the company's strategic linchpin. She advocates for a pursuit of excellence over a sole focus on profits, emphasizing, "Our goal is how to make our services and technology products better, so they're competitive in the market. If we focus too much on development while neglecting the quality of service and products, we might ultimately fall short."

She outlined Pure Global's strategic blueprint, which involves closely monitoring outstanding Chinese enterprises, intensifying market presence across diverse countries, and utilizing AI products to provide comprehensive support. She highlighted the company's notable success in global medical language translation, emphasizing its pivotal role in its international expansion endeavors.

Challenges and Opportunities: Breaking Hesitation, Leading International Expansion

However, Pure Global's journey has encountered its share of hurdles. Despite the evident trend toward internationalizing medical devices, some companies hesitate due to concerns surrounding certification and regulatory issues. Meng Zhu pointed out that this hesitation is a widespread occurrence. While procurement policies and anti-corruption measures have incentivized many companies to expand globally, the practical challenges of implementation should not be underestimated. Navigating the intricacies of medical device certification, regulations, logistics, and more can be quite complex. Nevertheless, the COVID-19 pandemic has brought certain benefits to select companies by accelerating their internationalization efforts.

To assist companies grappling with hesitancy, Pure Global doesn't just provide local market analysis; they draw upon their extensive experience and exceptional solutions to forge a dependable path to internationalization. Through their diverse range of solutions, companies receive substantial support, expediting the certification process and establishing robust overseas market regulatory systems.

Furthermore, Meng Zhu openly acknowledged that confronting market misunderstandings about the company and seamlessly integrating teams from diverse fields have presented challenges. She believes that the distinctive nature of the medical device industry poses obstacles to inter-industry collaboration, demanding a delicate balance between technological advancement and industry standards—a significant challenge.

In response to this challenge, Pure Global has proactively deepened its industry expertise and perpetually explores enhanced solutions. They actively encourage team members to gain a comprehensive understanding of the industry, engage in extensive experimentation, and effectively convey the advantages of their products and solutions to clients. Through this approach, Pure Global not only elevates its brand image but also plays an active role in shaping its brand during the internationalization process.

Looking Ahead: Market Transformation and Cultivate a Win-Win Ecosystem

When queried about her perspective on the forthcoming changes in the medical device market over the next three to five years, Meng Zhu conveyed an optimistic and pragmatic outlook. She acknowledged the inherent difficulty in predicting future trends and timelines, but in the context of the medical device market's internationalization, she maintained unwavering optimism for the next three years. She underscored that China's burgeoning influence is a driving force behind the industry's ascent. Meng Zhu cited instances of overseas expansion in sectors like textiles and electronics, which underscore a consistent upward trajectory.

Elaborating further, she expounded that the evolution of the medical device market will closely align with China's strengths and global trends. Meng Zhu posited that the market's rapid development is intricately linked to China's overarching capabilities, simultaneously serving as a litmus test for the competitiveness and market positioning of companies. She highlighted the growing trend of international procurement and anti-corruption initiatives as promising indicators for the overseas medical device market. However, she candidly acknowledged that this journey will present diverse challenges, including those pertaining to product competitiveness and market positioning.

Regarding the cultivation of relationships with esteemed clients from both domestic and international institutions and universities, Meng Zhu placed paramount importance on fostering customer loyalty as a pivotal future endeavor for the company. She affirmed Pure Global's vision, which revolves around co-development with clients and shared internationalization goals. Through the delivery of outstanding service, encompassing comprehensive after-sales support and cutting-edge tools, Pure Global has effectively nurtured robust collaborative partnerships with its clients.

As a testament to their commitment, their collaboration with BGI serves as an illustrative case study. This partnership has extended its influence to encompass domestic and international exhibitions, featuring public endorsements from BGI's senior executives for Pure Global. This collaborative synergy not only bolsters Pure Global's impact but also elevates the brand standing for its clients.