APAC CEO of the Year 2025 | 11 AIS-Feb25016 Born out of the response to an immediate healthcare crisis – COVID-19 – Pure Global quickly recognised that the experience it had garnered sourcing and distributing face masks and medical devices gave it unique insights into the difficulties faced by MedTech companies as they seek the approvals to bring their products to the market. As a result, Pure Global’s mission pivoted, and the company – anchored by CEO Phyllis Meng – is making regulatory compliance more efficient and transparent. We had the pleasure of speaking with Phyllis to learn more. Getting its start during the unprecedented times brought about by the COVID-19 pandemic, Pure Global was created when CEO Phyllis Meng and DJ, her co-founder, were in New York. Witnessing first hand just how urgent the need for medical supplies was, this duo leveraged Phyllis’ background in the medical engineering and computer science spaces to work with government agencies and the community to deliver the necessary equipment and PPE. In the four years since, their focus has been on assisting MedTech companies worldwide. Pure Global has achieved its aim in part thanks to the AIpowered resource centre that it has developed, with this cutting-edge tool collecting and consolidating regulatory data from more than 30 different countries worldwide. More impressively, this data is then made use of to help MedTech companies better understand the compliance hurdles they are facing and to traverse them with ease, ensuring greater swiftness and accuracy. On the back of this, Phyllis herself told us: “A key pillar of our strategy is Global Authorised Representation (AR). We provide local representation and registration services across 30 countries, working through an extensive network of local entities and trusted partners. This allows our clients to meet regulatory requirements without having to establish their own presence in each market.” Beyond this, Pure Global also offers turnkey product registration and post-market compliance solutions, as well as commercial support services. The company chooses to focus on these areas simply because it noticed the market had a clear need for them. Smaller and medium-sized Medtech companies in particular would frequently struggle with managing the developments and shifts in regulation, and they lacked the specialised knowledge or in-house expertise that could see them through. Pure Global strives to bridge this gap. In her role as CEO, Phyllis’ job is to blend strategic leadership with a keen focus on driving Pure Global’s vision. She explained: “My goal is to ensure that global market access is simpler and more efficient, so healthcare innovators can focus on their work.” Due to Phyllis’ aforementioned medical engineering and computer science background, she is the perfect person to lead Pure Global to greatness and see that it achieves its aims. Starting at Shanghai Jiao Tong University, where she developed her skills in biomedical engineering, Phyllis then moved to Carnegie Mellon University in Pittsburgh, USA, focusing on AI and its applications in real-world healthcare environments. Roles followed at Google and Citadel Securities, with these providing Phyliss with the necessary skills and hands-on experience. Her previous jobs also taught Phyllis the importance of developing a collaborative style of leadership, as only through the dual focus of communication and teamwork can the very best solutions be created by a team who are aligned and possess a clear sense of purpose. “What set me on the path to founding Pure Global was recognising how AI and data analytics could break down barriers in medical device compliance and market access. The ability to bridge technology, healthcare, and regulatory challenges has been crucial in shaping Pure Global’s vision.” Working in an industry as diverse as this, every client Pure Global collaborates with has their own set of challenges, and it is for this reason that the company has crafted its ethos around seeing that their unique needs are understood and worked towards. Ensuring transparency and alignment across its entire operation, a further commitment to remaining one step ahead of industry trends and deeply involved in advancements of AI technology compliance sees the team here operate at the forefront of this dynamic space. Having overcome all the challenges the industry has thrown at her over the past few years, it was with great excitement that Phyllis told us of Pure Global’s plans for the rest of 2025, with these revolving around expanding its presence in emerging markets as well as enhancing its AI capabilities further. As for Phyllis herself, this award-winning CEO remains committed to continuing to lead this medical device regulatory consulting firm on the path to success. Contact: Phyllis Meng Web Address: pureglobal.com Clinical Trial Management CEO of the Year 2025
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