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 firms 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 greater 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 have really opened my eyes to a critical need.
Second, my entrepreneurial drive got here into play. I’ve at all times been drawn to identifying challenges and creating effective solutions, embracing the means of refining and adapting ideas to handle changing needs.
Before Pure Global, I had my very own big data and cybersecurity consulting firm, and prior to that, I worked at Big 4 firms like Deloitte and PwC. I used to be continually pushing the boundaries of technology, creating custom solutions for clients facing unique challenges. It was exciting work, at all times dynamic and demanding.
At Pure Global, I’m tackling similar challenges but with a healthcare focus. We’re helping MedTech firms bring quality products to market faster and more efficiently. It’s incredibly rewarding to use my skills and experience to make an actual difference on this critical industry.
Pure Global was founded during a critical moment within the pandemic. What were the important thing challenges and opportunities you identified at the moment that led to its creation?
Throughout the pandemic, we began by volunteering to assist 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 number of organizations. Nevertheless, as requests from manufacturers looking for assistance across various countries grew, we identified a transparent need – and a market opportunity – for technology to modernize traditional, often inefficient workflows. We saw a chance to make a major impact by developing solutions to handle these challenges
Your Resource Center leverages AI to offer real-time regulatory updates and compliance insights. Are you able to walk us through how the AI algorithms discover 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 most recent regulatory updates and insights across all major global medical device markets. We’ve built a strong system to collect regulatory data from diverse sources, equivalent to official agency web sites, legal databases, and public announcements. This includes web scraping with intelligent parsing to extract data from unstructured formats like PDFs and HTML, in addition to using APIs where available.
When clients register their devices in our Pure Certification module, we leverage AI to suggest probably the most relevant changes and prioritize them for review. AI text embeddings and similarity calculations rank these updates. For instance, if you will have a ‘portable dialysis machine’ and three related news articles:
Article #1: Latest guidelines for the disposal PPEs (cosine similarity to product: 0.2)
Article #2: FDA approves a brand 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 gap between these vectors. The upper 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 the way does it compare to traditional translation methods when it comes to speed and compliance reliability?
AI is actually breaking barriers on this regard. From our internal testing with localized regulatory experts, the accuracy of those AI translations exceeds 80%. Combined with our proprietary MedTech-specific multilingual glossaries, we are able to push this to over 90%, significantly reducing the time required in comparison with traditional translation methods.
With AI-driven tools just like the Translation Manager and Certification Manager, what sort of feedback have you ever received from clients about their efficiency gains?
Clients have reported significant efficiency gains through the usage of our AI-driven tools. Many have experienced reduced translation costs, particularly for high-volume content, because of the automation of previously manual tasks. This has not only cut costs but additionally accelerated workflows.
Moreover, 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 interpretation, the flow could differ barely. With AI-driven translation, nonetheless, 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 within the context of huge data are as follows:
- Data-Driven Decision Making (Market Intelligence): Big data tools provide comprehensive analytics, enabling firms to make informed decisions about market opportunities, patient behavior, product development, market access, and industrial success.
- Post-Market Surveillance: Real-world data monitoring can discover issues of safety or areas for improvement, resulting in faster, more practical 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. Nevertheless, much of this information still resides inside large hospital systems and research institutions, and accessing it stays a challenge.
- Cybersecurity: With the surge in connected medical devices, wearables, and healthcare IoT devices generating vast amounts of information, the attack surface for cybercriminals continues to expand. Sensitive patient information stored in large datasets becomes a major goal for hackers, potentially resulting in data breaches that compromise privacy and safety. Then, many healthcare organizations still depend on outdated systems with insufficient cybersecurity measures, increasing the chance.
How do you envision the intersection of AI, cybersecurity, and MedTech evolving in the long run?
There shall be more personalized options as AI enables the event of medical devices and treatment plans tailored to individual patient needs. By analyzing patient data, including genomics, lifestyle aspects, and medical history, AI can optimize device design and functionality. Moreover, AI can speed up the design and prototyping of medical devices by generating design options, simulating performance, and optimizing for specific requirements, allowing firms to iterate quickly and produce recent products to market faster.
Cybersecurity is becoming increasingly emphasized within 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 proceed to extend in rigor, firms might want to prioritize cybersecurity throughout your complete product development lifecycle, from design to deployment, to make sure the protection and reliability of their devices.
What do you see as the largest challenges for medical device manufacturers in the following five years, and the way does Pure Global aim to handle them?
The most important challenge is that regulatory agencies worldwide are raising the bar for safety, efficacy, and cybersecurity, making it increasingly difficult to maintain up with evolving requirements across multiple markets
How Pure Global will 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, discover opportunities, and assess competition.
What advice would you give to startups and scaleups within the MedTech space seeking to navigate complex regulatory landscapes?
Prioritize Regulatory Strategy Early On:
- Integrate from the beginning: Incorporate regulatory considerations into your product development from day one, relatively than treating them as an afterthought.
- Proactive planning: Establish a transparent regulatory strategy early, outlining goal markets, device classification, and obligatory approvals.
- Expert advice: Seek the advice of regulatory experts or experienced consultants to grasp the particular requirements to your device and goal markets.
Stay Agile and Adaptable:
- Expect changes: Regulatory landscapes are continually evolving, so be able to adapt your strategy as needed.
- Flexibility: Keep flexibility in your product development plans to accommodate potential regulatory changes or market requirements.
