Pure Global is revolutionizing the medical device industry by streamlining regulatory processes to bring innovative solutions to market faster.
Could you please tell us about yourself and introduce your startup, Pure Global, to our audience?
I am Phyllis Meng, co-founder and CEO of Pure Global. When the COVID pandemic struck, DJ, the other co-founder, and I were based in New York. We immediately recognized the urgent need for masks and medical devices, so we started collaborating with the government and schools to address the shortage. Through sourcing supplies via donations and locally raised funds, we took proactive steps to address the pressing need. It became evident that most masks were manufactured in China, so navigating the FDA process and CDC testing protocols for the masks was crucial.
Even after the pandemic, our mission remained the same: to efficiently deliver medical devices to save lives. While we initially focused on COVID-related products, our goal has shifted to streamlining the process of bringing medical devices to market. At Pure Global, we aim to provide transparency by sharing global regulatory updates with clients, ensuring that regulatory specialists worldwide receive vetted and accurate information.
What inspired the concept of Pure Global?
The inspiration behind Pure Global stems from two main factors. Firstly, the complex and ever-evolving nature of medical device regulations, marked by frequent updates and emerging requirements, poses significant challenges. Non-compliance risks costly delays, product recalls, and legal consequences. Then, recognizing the substantial hurdles faced by MedTech companies in navigating regulatory affairs due to the specialized knowledge required, we identified a gap, particularly for smaller to mid-size companies lacking in-house expertise and budget for dedicated teams. With the realization that this knowledge gap is magnified in the context of operating across multiple markets, we founded Pure Global to serve as a trusted advisor, providing support for companies seeking expansion opportunities.
What motivated you to launch Pure Global?
The motivation behind launching Pure Global stemmed from several key factors. Firstly, our overarching goal was to support MedTech companies by bringing safe and effective medical devices to the market more efficiently, thereby positively impacting patients’ lives. We recognized that streamlining regulatory processes plays a crucial role in accelerating the development of new, potentially life-changing medical technologies. Additionally, with the medical device industry rapidly expanding due to technological advancements and an aging population, there is a growing demand for regulatory support. By automating regulatory tasks and centralizing information, Pure Global aims to streamline processes and effectively meet the evolving needs of the industry.
Could you share the core vision and mission of Pure Global?
Our mission is simple, we aim to provide next-generation solutions for MedTech companies to expand their global reach, delivering smart and efficient market access solutions powered by transformative data & technology.
Overall, our vision is based on five pillars:
Customer First: We prioritize understanding and exceeding our customers’ true needs, placing them at the heart of our operations.
Integrity: We prioritize honesty and trust, upholding the highest ethical standards to foster transparent and accountable relationships with our customers, employees, and partners.
Excellence: We are dedicated to delivering quality and excellence in all that we do. We maintain unwavering dedication to our craft, continuously seeking innovative approaches to exceed industry standards.
Teamwork: Collaboration is key to our success. We embrace a culture of continuous learning, leveraging each other’s strengths to drive collective growth.
Self-Driven: Empowered by our belief in making a meaningful impact, we approach challenges with determination and resilience, pushing boundaries and pioneering change to achieve remarkable outcomes.
Can you talk about the initial challenges and difficulties you faced while starting up?
When we initially started Pure Global, we encountered several challenges and difficulties inherent to launching a new venture in the MedTech industry. One of the primary hurdles was defining our target market, as different segments within the industry have unique needs and pain points that require careful consideration.
Another challenge we encountered was securing initial customers willing to try our new service and provide valuable feedback. This was particularly challenging because building trust and credibility is crucial in the highly regulated MedTech industry, where companies need to have absolute confidence in our expertise to guide them toward compliance. As a new company with an unproven track record, it took time to establish a client base and demonstrate our ability to navigate complex regulatory processes successfully.
Furthermore, competition from established consultants posed a challenge. The regulatory affairs consulting space already had well-established players, making it challenging to gain initial traction and stand out in a crowded market.
However, we approached these challenges with resilience and determination, leveraging our expertise to overcome obstacles and establish ourselves as trusted advisors in the MedTech industry.
Who do you consider the primary audience for your services?
Our services cater to a diverse range of clients, including startups, global scaleups, and multinational enterprises in the MedTech industry, recognizing their individual needs and goals. For example, we can help startups with agile regulatory guidance and cost-effective solutions tailored to quickly bring their innovations to market. Meanwhile, for global scaleups, we might focus more on partnership development to facilitate expansion into new markets globally. Lastly, for multinational enterprises, the focus would shift to global regulatory strategies and technology integration to navigate regulatory complexities and optimize their portfolio on a global scale.
What sets Pure Global apart from other companies in the same field?
What sets Pure Global apart from other companies in the same field is our comprehensive range of offerings and global reach. Firstly, we provide access to 28 markets worldwide, with established independent companies and partners in the Americas, Europe, Middle East/Africa, and Asia Pacific. This allows us to serve as our clients’ local authorized representative and compliance agent in the medical device market, ensuring seamless market entry and compliance across diverse regions. Additionally, our clinical sites strategically located in the United States, Europe, and Africa enable us to meet our clients’ clinical needs effectively.
Then, through our global database and AI-powered regulatory tool, Pure Global’s Regulatory Intelligence Platform (GRIP), clients can easily access global regulatory news, streamline document searches, compare clinical research data, and navigate databases with unparalleled efficiency and accuracy.
Overall, this combination of global market access, clinical expertise, and advanced regulatory intelligence technology makes Pure Global stand out in the MedTech industry.
Could you describe a typical day at work for you?
A typical day at work begins with scanning global chats, emails, and industry news for insights. After breakfast and sending off the kids to school, the morning is dedicated to meetings with key functional and business unit owners to align on progress and plans. This is followed by a visit from potential investors to pitch the company’s vision and market potential. In the afternoon, one-on-one meetings with team members are held to provide guidance and troubleshoot any challenges. A product team meeting is then held to discuss enhancements based on customer feedback.
The remainder of the afternoon is spent resolving client issues and urgent emails. Later in the day, discussions on client opportunities take place with strategic partners and channels. After dinner, we have a meeting with EU teams to align on key events and action plans. The day wraps up with brainstorming potential strategic partnerships or collaboration opportunities to accelerate the company’s growth.
Where do you envision Pure Global and yourself in the next five years?
Looking ahead five years, the regulatory landscape and global environment are expected to evolve significantly. Despite the dynamic changes, I am confident that Pure Global will expand its footprint globally, and we will also integrate AI more extensively into our existing workflows.
What are three pieces of advice you would offer to aspiring entrepreneurs?
Embrace continuous learning: The world of business (and tech especially) moves fast. Read, attend workshops, and upskill constantly.
Resilience is everything: Expect setbacks, delays, and outright failures. Develop the ability to bounce back, learn from mistakes, and pivot when necessary
Solve real problems: Don’t build solutions in search of problems. Identify true pain points that people or businesses are willing to pay to solve.
And here’s a bonus tip: learn to say no. You’ll have a million opportunities thrown your way. Focus on the things that truly move the needle for your business.
Credit: Phyllis Meng
Thank you Phyllis Meng for the Interview
Statements of the author and the interviewee do not necessarily represent the editors and the publisher opinion again.
