DJ Fang is a expertise govt and entrepreneur with over 15 years of expertise driving digital transformation and innovation throughout industries, together with finance, power, and healthcare. He has led initiatives for Fortune 500 firms and authorities companies, combining enterprise experience with technical expertise in AI, cybersecurity, and cloud infrastructure.
As a serial entrepreneur, Fang has efficiently constructed and scaled companies, excelling in product improvement, market technique, and operational execution.
Pure International combines real-world expertise, AI, and information to create good and environment friendly medical gadget regulatory consulting options for greater than 30 markets.
Might you share your journey from working with prime consulting corporations like Deloitte and PwC to turning into the co-founder of Pure International? What impressed this transition?
My journey to co-founding Pure International was formed by two pivotal moments. First, the COVID-19 pandemic threw the world into chaos, forcing people, companies, and governments to re-evaluate how they operated. As a volunteer serving to hospitals and colleges supply PPE, I gained firsthand perception into the challenges individuals confronted adapting to sudden adjustments in rules and market entry. That have actually opened my eyes to a important want.
Second, my entrepreneurial drive got here into play. I’ve at all times been drawn to figuring out challenges and creating efficient options, embracing the method of refining and adapting concepts to deal with altering wants.
Earlier than Pure International, I had my very own large information and cybersecurity consulting agency, and previous to that, I labored at Large 4 corporations like Deloitte and PwC. I used to be continuously pushing the boundaries of expertise, creating customized options for shoppers dealing with distinctive challenges. It was thrilling work, at all times dynamic and demanding.
At Pure International, I’m tackling comparable challenges however with a healthcare focus. We’re serving to MedTech firms carry high quality merchandise to market quicker and extra effectively. It is extremely rewarding to use my expertise and expertise to make an actual distinction on this important business.
Pure International was based throughout a important second within the pandemic. What had been the important thing challenges and alternatives you recognized at the moment that led to its creation?
Throughout the pandemic, we started by volunteering to assist hospitals and colleges supply PPE. As we labored with world suppliers, we gained perception into the complexities of worldwide commerce and rules. Whereas helping producers with altering pandemic guidelines, we additionally improved our inside processes for effectivity.
Initially, we solely supported just a few organizations. Nonetheless, as requests from producers searching for help throughout varied nations grew, we recognized a transparent want – and a market alternative – for expertise to modernize conventional, usually inefficient workflows. We noticed a chance to make a major impression by growing options to deal with these challenges
Your Useful resource Middle leverages AI to supply real-time regulatory updates and compliance insights. Are you able to stroll us via how the AI algorithms determine and prioritize regulatory adjustments throughout 30+ world markets? What challenges did you face in coaching these fashions?
Our International Markets Useful resource Middle serves as a centralized hub for the newest regulatory updates and insights throughout all main world medical gadget markets. We’ve constructed a sturdy system to collect regulatory information from various sources, similar to official company web sites, authorized databases, and public bulletins. This consists of internet scraping with clever parsing to extract information from unstructured codecs like PDFs and HTML, in addition to utilizing APIs the place out there.
When shoppers register their gadgets in our Pure Certification module, we leverage AI to counsel probably the most related adjustments and prioritize them for assessment. AI textual content embeddings and similarity calculations rank these updates. For instance, when you’ve got a ‘moveable dialysis machine’ and three associated information articles:
Article #1: New tips for the disposal PPEs (cosine similarity to product: 0.2)
Article #2: FDA approves a brand new moveable dialysis machine with improved security options (cosine similarity: 0.8)
Article #3: Cybersecurity vulnerabilities found in related medical gadgets (cosine similarity: 0.5)
Textual content embeddings convert all textual content into numerical representations in a multi-dimensional vector house. Cosine similarity then calculates the gap between these vectors. The upper the cosine similarity, the higher the relevance of the article to the product.
The Translation Supervisor makes use of AI to transform technical paperwork into over 20 languages. How does the system guarantee accuracy and cultural relevance in translations for extremely regulated markets, and the way does it evaluate to conventional translation strategies by way of velocity and compliance reliability?
AI is actually breaking boundaries on this regard. From our inside testing with localized regulatory consultants, the accuracy of those AI translations exceeds 80%. Mixed with our proprietary MedTech-specific multilingual glossaries, we are able to push this to over 90%, considerably decreasing the time required in comparison with conventional translation strategies.
With AI-driven instruments just like the Translation Supervisor and Certification Supervisor, what sort of suggestions have you ever obtained from shoppers about their effectivity beneficial properties?
Purchasers have reported vital effectivity beneficial properties via the usage of our AI-driven instruments. Many have skilled lowered translation prices, significantly for high-volume content material, due to the automation of beforehand handbook duties. This has not solely minimize prices but in addition accelerated workflows.
Moreover, the consistency and circulate of translations have improved. Our multilingual translation terminology administration ensures constant language use throughout all translated supplies, which is important for sustaining model id and readability in technical documentation. Beforehand, relying on who carried out the interpretation, the circulate might differ barely. With AI-driven translation, nonetheless, the consistency and circulate are seamless.
In your opinion, how is large information reshaping the MedTech business, particularly in regulatory compliance and market entry?
Some thrilling developments within the context of massive information are as follows:
- Knowledge-Pushed Resolution Making (Market Intelligence): Large information instruments present complete analytics, enabling firms to make knowledgeable choices about market alternatives, affected person conduct, product improvement, market entry, and business success.
- Submit-Market Surveillance: Actual-world information monitoring can determine issues of safety or areas for enchancment, resulting in quicker, simpler post-market surveillance.
- Actual-World Proof (RWE): Analyzing massive datasets of real-world information (affected person data, medical trials, gadget utilization) can present proof of product security and effectiveness, supporting regulatory submissions and post-market surveillance. Nonetheless, a lot of this info nonetheless resides inside massive hospital techniques and analysis establishments, and accessing it stays a problem.
- Cybersecurity: With the surge in related medical gadgets, wearables, and healthcare IoT gadgets producing huge quantities of knowledge, the assault floor for cybercriminals continues to increase. Delicate affected person info saved in massive datasets turns into a main goal for hackers, probably resulting in information breaches that compromise privateness and security. Then, many healthcare organizations nonetheless depend on outdated techniques with inadequate cybersecurity measures, growing the danger.
How do you envision the intersection of AI, cybersecurity, and MedTech evolving sooner or later?
There will probably be extra customized choices as AI permits the event of medical gadgets and therapy plans tailor-made to particular person affected person wants. By analyzing affected person information, together with genomics, life-style components, and medical historical past, AI can optimize gadget design and performance. Moreover, AI can speed up the design and prototyping of medical gadgets by producing design choices, simulating efficiency, and optimizing for particular necessities, permitting firms to iterate rapidly and produce new merchandise to market quicker.
Cybersecurity is turning into more and more emphasised within the MedTech house. This shift comes as regulators acknowledge its rising significance and transition from a reactive method—primarily responding to incidents—to a extra proactive method targeted on threat administration and prevention. As submission necessities for cybersecurity proceed to extend in rigor, firms might want to prioritize cybersecurity all through the whole product improvement lifecycle, from design to deployment, to make sure the protection and reliability of their gadgets.
What do you see as the largest challenges for medical gadget producers within the subsequent 5 years, and the way does Pure International purpose to deal with them?
The most important problem is that regulatory companies worldwide are elevating the bar for security, efficacy, and cybersecurity, making it more and more tough to maintain up with evolving necessities throughout a number of markets
How Pure International can assist:
- AI-Powered Regulatory Intelligence: Pure International’s AI platform screens regulatory adjustments throughout 30+ markets, providing real-time updates and customized alerts for compliance.
- Streamlined Submission Workflows: AI helps cut back time and prices for regulatory submissions, making the clearance and approval course of extra environment friendly.
- Market Intelligence: With a complete database protecting rules, product registrations, and medical trials throughout 30+ markets, producers can analyze developments, determine alternatives, and assess competitors.
What recommendation would you give to startups and scaleups within the MedTech house trying to navigate advanced regulatory landscapes?
Prioritize Regulatory Technique Early On:
- Combine from the beginning: Incorporate regulatory issues into your product improvement from day one, quite than treating them as an afterthought.
- Proactive planning: Set up a transparent regulatory technique early, outlining goal markets, gadget classification, and essential approvals.
- Professional recommendation: Seek the advice of regulatory consultants or skilled consultants to know the precise necessities to your gadget and goal markets.
Keep Agile and Adaptable:
- Anticipate adjustments: Regulatory landscapes are continuously evolving, so be able to adapt your technique as wanted.
- Flexibility: Maintain flexibility in your product improvement plans to accommodate potential regulatory adjustments or market necessities.
Thanks for the nice interview, readers who want to study extra ought to go to Pure International.