DJ Fang is a technology executive and entrepreneur with over 15 years of experience driving digital transformation and innovation across industries, including finance, energy, and healthcare. He has led initiatives for Fortune 500 companies and government agencies, combining business expertise with technical skills in AI, cybersecurity, and cloud infrastructure.
As a serial entrepreneur, Fang has successfully built and scaled businesses, excelling in product development, market strategy, and operational execution.
Pure Global combines real-world experience, AI, and data to create smart and efficient medical device regulatory consulting solutions for more than 30 markets.
Could you share your journey from working with top consulting firms like Deloitte and PwC to becoming the co-founder of Pure Global? What inspired this transition?
My journey to co-founding Pure Global was shaped by two pivotal moments. First, the COVID-19 pandemic threw the world into chaos, forcing individuals, businesses, and governments to re-evaluate how they operated. As a volunteer helping hospitals and schools source PPE, I gained firsthand insight into the challenges people faced adapting to sudden changes in regulations and market access. That experience really opened my eyes to a critical need.
Second, my entrepreneurial drive came into play. I’ve always been drawn to identifying challenges and creating effective solutions, embracing the process of refining and adapting ideas to address changing needs.
Before Pure Global, I had my own big data and cybersecurity consulting firm, and prior to that, I worked at Big Four firms like Deloitte and PwC. I was constantly pushing the boundaries of technology, creating custom solutions for clients facing unique challenges. It was exciting work, always dynamic and demanding.
At Pure Global, I’m tackling similar challenges but with a healthcare focus. We’re helping MedTech companies bring quality products to market faster and more efficiently. It’s incredibly rewarding to apply my skills and experience to make a real difference in this critical industry.
Pure Global was founded during a critical moment in the pandemic. What were the key challenges and opportunities you identified at that time that led to its creation?
During the pandemic, we began by volunteering to help hospitals and schools source PPE. As we worked with global suppliers, we gained insight into the complexities of international trade and regulations. While assisting manufacturers with changing pandemic rules, we also improved our internal processes for efficiency.
Initially, we only supported a few organizations. However, as requests from manufacturers seeking assistance across various countries grew, we identified a clear need – and a market opportunity – for technology to modernize traditional, often inefficient workflows. We saw an opportunity to make a significant impact by developing solutions to address these challenges
Your Resource Center leverages AI to provide real-time regulatory updates and compliance insights. Can you walk us through how the AI algorithms identify and prioritize regulatory changes across 30+ global markets? What challenges did you face in training these models?
Our Global Markets Resource Center serves as a centralized hub for the latest regulatory updates and insights across all major global medical device markets. We’ve built a robust system to gather regulatory data from diverse sources, such as official agency websites, legal databases, and public announcements. This includes web scraping with intelligent parsing to extract data from unstructured formats like PDFs and HTML, as well as using APIs where available.
When clients register their devices in our Pure Certification module, we leverage AI to suggest the most relevant changes and prioritize them for review. AI text embeddings and similarity calculations rank these updates. For example, if you have a ‘portable dialysis machine’ and three related news articles:
Article #1: New guidelines for the disposal PPEs (cosine similarity to product: 0.2)
Article #2: FDA approves a new portable dialysis machine with improved safety features (cosine similarity: 0.8)
Article #3: Cybersecurity vulnerabilities discovered in connected medical devices (cosine similarity: 0.5)
Text embeddings convert all text into numerical representations in a multi-dimensional vector space. Cosine similarity then calculates the distance between these vectors. The higher the cosine similarity, the greater the relevance of the article to the product.
The Translation Manager uses AI to convert technical documents into over 20 languages. How does the system ensure accuracy and cultural relevance in translations for highly regulated markets, and how does it compare to traditional translation methods in terms of speed and compliance reliability?
AI is truly breaking barriers in this regard. From our internal testing with localized regulatory experts, the accuracy of these AI translations exceeds 80%. Combined with our proprietary MedTech-specific multilingual glossaries, we can push this to over 90%, significantly reducing the time required compared to traditional translation methods.
With AI-driven tools like the Translation Manager and Certification Manager, what kind of feedback have you received from clients about their efficiency gains?
Clients have reported significant efficiency gains through the use of our AI-driven tools. Many have experienced reduced translation costs, particularly for high-volume content, thanks to the automation of previously manual tasks. This has not only cut costs but also accelerated workflows.
Additionally, the consistency and flow of translations have improved. Our multilingual translation terminology management ensures consistent language use across all translated materials, which is critical for maintaining brand identity and clarity in technical documentation. Previously, depending on who performed the translation, the flow could differ slightly. With AI-driven translation, however, the consistency and flow are seamless.
In your opinion, how is big data reshaping the MedTech industry, especially in regulatory compliance and market access?
Some exciting developments in the context of big data are as follows:
- Data-Driven Decision Making (Market Intelligence): Big data tools provide comprehensive analytics, enabling companies to make informed decisions about market opportunities, patient behavior, product development, market access, and commercial success.
- Post-Market Surveillance: Real-world data monitoring can identify safety issues or areas for improvement, leading to faster, more effective post-market surveillance.
- Real-World Evidence (RWE): Analyzing large datasets of real-world data (patient records, clinical trials, device usage) can provide evidence of product safety and effectiveness, supporting regulatory submissions and post-market surveillance. However, much of this information still resides within large hospital systems and research institutions, and accessing it remains a challenge.
- Cybersecurity: With the surge in connected medical devices, wearables, and healthcare IoT devices generating vast amounts of data, the attack surface for cybercriminals continues to expand. Sensitive patient information stored in large datasets becomes a prime target for hackers, potentially leading to data breaches that compromise privacy and safety. Then, many healthcare organizations still rely on outdated systems with insufficient cybersecurity measures, increasing the risk.
How do you envision the intersection of AI, cybersecurity, and MedTech evolving in the future?
There will be more personalized options as AI enables the development of medical devices and treatment plans tailored to individual patient needs. By analyzing patient data, including genomics, lifestyle factors, and medical history, AI can optimize device design and functionality. Additionally, AI can accelerate the design and prototyping of medical devices by generating design options, simulating performance, and optimizing for specific requirements, allowing companies to iterate quickly and bring new products to market faster.
Cybersecurity is becoming increasingly emphasized in the MedTech space. This shift comes as regulators recognize its growing importance and transition from a reactive approach—mainly responding to incidents—to a more proactive approach focused on risk management and prevention. As submission requirements for cybersecurity continue to increase in rigor, companies will need to prioritize cybersecurity throughout the entire product development lifecycle, from design to deployment, to ensure the safety and reliability of their devices.
What do you see as the biggest challenges for medical device manufacturers in the next five years, and how does Pure Global aim to address them?
The biggest challenge is that regulatory agencies worldwide are raising the bar for safety, efficacy, and cybersecurity, making it increasingly difficult to keep up with evolving requirements across multiple markets
How Pure Global can help:
- AI-Powered Regulatory Intelligence: Pure Global’s AI platform monitors regulatory changes across 30+ markets, offering real-time updates and personalized alerts for compliance.
- Streamlined Submission Workflows: AI helps reduce time and costs for regulatory submissions, making the clearance and approval process more efficient.
- Market Intelligence: With a comprehensive database covering regulations, product registrations, and clinical trials across 30+ markets, manufacturers can analyze trends, identify opportunities, and assess competition.
What advice would you give to startups and scaleups in the MedTech space looking to navigate complex regulatory landscapes?
Prioritize Regulatory Strategy Early On:
- Integrate from the start: Incorporate regulatory considerations into your product development from day one, rather than treating them as an afterthought.
- Proactive planning: Establish a clear regulatory strategy early, outlining target markets, device classification, and necessary approvals.
- Expert advice: Consult regulatory experts or experienced consultants to understand the specific requirements for your device and target markets.
Stay Agile and Adaptable:
- Expect changes: Regulatory landscapes are constantly evolving, so be ready to adapt your strategy as needed.
- Flexibility: Keep flexibility in your product development plans to accommodate potential regulatory changes or market requirements.
Thank you for the great interview, readers who wish to learn more should visit Pure Global.
