In an insightful conversation with TechNews180, Phyllis Meng, CEO of Pure Global, delves into how AI and data analytics are transforming market access and regulatory compliance for MedTech companies seeking global expansion. Meng explains how Pure Global's innovative platform eliminates the need for manual searches by providing seamless access to global registration data and clinical trial information. She also highlights the company's AI-driven translation tool, which ensures high-quality translations and streamlines the regulatory process.
Addressing the challenges of varying regulatory landscapes, Pure Global leverages its extensive expertise and local representatives to guide clients through complex compliance requirements, ensuring successful market entry and ongoing compliance. Meng underscores the importance of AI in enhancing efficiency and accuracy, paving the way for future advancements in the industry.
Gresheen (GG) Libby: Can you describe how Pure Global utilizes AI and data analytics to streamline market access and regulatory compliance for companies seeking global expansion?
Phyllis: With a wide range of self-developed AI & data analytics tools, Pure Global helps MedTech companies maximize market access and ensure regulatory compliance. Without requiring manual searches, our platform offers seamless access to a multitude of resources, such as global registration data for predicate devices and aggregated clinical trial information from various countries. In addition, Pure Global has its own AI-driven translation tool to handle language-related tasks efficiently. By training our AI with our extensive bank of words, we ensure high accuracy rates and quality translations, ultimately streamlining the process.
Gresheen (GG) Libby: What unique challenges do companies face when trying to access new global markets, and how does Pure Global help overcome these challenges?
Phyllis: Companies expanding into new global markets face a multitude of unique challenges, from navigating varying regulatory landscapes to ensuring accurate product classifications. The consequences of misclassification can be significant, leading to delays and regulatory obstacles. Then, the complexity involved in obtaining and organizing all required regulatory documents and conducting the required testing further complicates the process. Moreover, different markets often have distinct regulatory authorities with their own sets of requirements, presenting diverse barriers to entry.
This is why we specialize in addressing these challenges head-on. Leveraging our extensive industry expertise, we guide clients through the process of accurately identifying predicate devices and ensuring proper product classification. Our support extends beyond classification to encompass comprehensive assistance in navigating regulatory requirements and documentation. Whether it entails coordinating necessary tests or identifying complementary markets based on existing registrations, our team is dedicated to simplifying the process and ensuring regulatory compliance. Moreover, with our in-house labs and strategic partnerships, we offer the added advantage of conducting necessary tests efficiently, streamlining the regulatory process further and enhancing our ability to meet our clients' diverse needs.
Gresheen (GG) Libby: Pure Global tracks regulatory trends in over 100 countries. Could you share how this extensive tracking benefits your clients, especially when dealing with complex multi-regional compliance?
Phyllis: By staying aware of regulatory developments across various jurisdictions, we offer comprehensive insights into market dynamics and regulatory landscapes. This proactive approach enables us to provide strategic guidance on emerging opportunities, helping clients identify market trends, assess risks, and make informed decisions about market entry and expansion. Our tracking capabilities also allow us to monitor product popularity, competitor activity, and industry trends, providing valuable intelligence for market positioning and product development strategies. With our in-depth understanding of individual markets and global regulatory trends, we help our clients navigate complex compliance challenges with confidence and efficiency.
Gresheen (GG) Libby: With a team of experts and local representatives across the world, how does Pure Global ensure that its services are both globally informed and locally applicable?
Phyllis: We have established local entities in key markets worldwide. When clients engage with us, they're paired with a dedicated project manager fluent in their native language, facilitating clear communication and understanding throughout the process. These representatives serve as the primary point of contact, ensuring that client needs are effectively communicated and addressed. Meanwhile, our expert local representatives, proficient in the nuances of their respective markets, bridge the gap between clients and government bodies. Being able to speak the local language, they navigate regulatory complexities and advocate for clients' interests, ensuring compliance and facilitating smooth operations in each jurisdiction.
Gresheen (GG) Libby: How does Pure Global’s approach to safeguarding a product's launch and ongoing compliance differ from traditional methods used by other firms in the industry?
Phyllis: Unlike many firms that solely focus on their local markets, we leverage our extensive global network to facilitate access to markets worldwide. Through our comprehensive network, we not only identify potential markets for our clients but also provide local support to navigate regulatory complexities and successfully enter these markets. Additionally, while some companies offering global registration services rely on external partners, we have established our own local entities in key markets. This strategic advantage streamlines the process while also minimizing costs for our clients, as they benefit from direct access to our resources without incurring additional expenses associated with third-party partnerships.
Gresheen (GG) Libby: Looking forward, what emerging trends or technologies do you see as being crucial for the future of market access and regulatory compliance services?
Phyllis: Embracing AI technologies offers unparalleled opportunities to streamline processes, save time, and reduce costs significantly. Beyond expediting research processes, AI can automate tedious tasks, freeing up resources. Additionally, AI-driven analytics helps with decision-making by providing actionable insights from extensive data sets, enhancing efficiency and accuracy in navigating regulatory landscapes. As AI advances, its role in market access and regulatory compliance services will become increasingly indispensable, driving innovation and transforming the way businesses operate in the global regulatory landscape.
