DJ Fang is a know-how government 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 corporations and authorities companies, combining enterprise experience with technical abilities 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 knowledge to create sensible 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 folks confronted adapting to sudden adjustments in laws 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 huge knowledge and cybersecurity consulting agency, and previous to that, I labored at Huge 4 corporations like Deloitte and PwC. I used to be continually pushing the boundaries of know-how, creating customized options for purchasers going through 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 corporations deliver high quality merchandise to market sooner and extra effectively. It is extremely rewarding to use my abilities 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?
Through the pandemic, we started by volunteering to assist hospitals and colleges supply PPE. As we labored with international suppliers, we gained perception into the complexities of worldwide commerce and laws. Whereas aiding producers with altering pandemic guidelines, we additionally improved our inner processes for effectivity.
Initially, we solely supported just a few organizations. Nonetheless, as requests from producers looking for help throughout varied nations grew, we recognized a transparent want – and a market alternative – for know-how 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 offer real-time regulatory updates and compliance insights. Are you able to stroll us by way of how the AI algorithms establish and prioritize regulatory adjustments throughout 30+ international markets? What challenges did you face in coaching these fashions?
Our International Markets Useful resource Middle serves as a centralized hub for the most recent regulatory updates and insights throughout all main international medical gadget markets. We’ve constructed a strong system to assemble regulatory knowledge from various sources, similar to official company web sites, authorized databases, and public bulletins. This consists of net scraping with clever parsing to extract knowledge from unstructured codecs like PDFs and HTML, in addition to utilizing APIs the place out there.
When purchasers register their units in our Pure Certification module, we leverage AI to counsel essentially the most related adjustments and prioritize them for overview. AI textual content embeddings and similarity calculations rank these updates. For instance, when you’ve got a ‘transportable dialysis machine’ and three associated information articles:
Article #1: New pointers for the disposal PPEs (cosine similarity to product: 0.2)
Article #2: FDA approves a brand new transportable dialysis machine with improved security options (cosine similarity: 0.8)
Article #3: Cybersecurity vulnerabilities found in linked medical units (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 space between these vectors. The upper the cosine similarity, the larger 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 examine to conventional translation strategies by way of pace and compliance reliability?
AI is really breaking limitations on this regard. From our inner testing with localized regulatory consultants, the accuracy of those AI translations exceeds 80%. Mixed with our proprietary MedTech-specific multilingual glossaries, we will push this to over 90%, considerably lowering 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 purchasers about their effectivity good points?
Purchasers have reported important effectivity good points by way of using our AI-driven instruments. Many have skilled diminished translation prices, notably for high-volume content material, due to the automation of beforehand handbook duties. This has not solely lower prices but additionally 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 identification 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 huge knowledge reshaping the MedTech business, particularly in regulatory compliance and market entry?
Some thrilling developments within the context of huge knowledge are as follows:
- Knowledge-Pushed Choice Making (Market Intelligence): Huge knowledge instruments present complete analytics, enabling corporations to make knowledgeable selections about market alternatives, affected person conduct, product improvement, market entry, and business success.
- Publish-Market Surveillance: Actual-world knowledge monitoring can establish questions of safety or areas for enchancment, resulting in sooner, simpler post-market surveillance.
- Actual-World Proof (RWE): Analyzing massive datasets of real-world knowledge (affected person data, scientific 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 methods and analysis establishments, and accessing it stays a problem.
- Cybersecurity: With the surge in linked medical units, wearables, and healthcare IoT units producing huge quantities of information, the assault floor for cybercriminals continues to develop. Delicate affected person info saved in massive datasets turns into a chief goal for hackers, probably resulting in knowledge breaches that compromise privateness and security. Then, many healthcare organizations nonetheless depend on outdated methods with inadequate cybersecurity measures, rising the chance.
How do you envision the intersection of AI, cybersecurity, and MedTech evolving sooner or later?
There will probably be extra customized choices as AI allows the event of medical units and remedy plans tailor-made to particular person affected person wants. By analyzing affected person knowledge, 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 units by producing design choices, simulating efficiency, and optimizing for particular necessities, permitting corporations to iterate shortly and convey new merchandise to market sooner.
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 centered on danger administration and prevention. As submission necessities for cybersecurity proceed to extend in rigor, corporations might want to prioritize cybersecurity all through the complete product improvement lifecycle, from design to deployment, to make sure the protection and reliability of their units.
What do you see as the most important challenges for medical gadget producers within the subsequent 5 years, and the way does Pure International goal to deal with them?
The largest problem is that regulatory companies worldwide are elevating the bar for security, efficacy, and cybersecurity, making it more and more troublesome to maintain up with evolving necessities throughout a number of markets
How Pure International might help:
- 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 overlaying laws, product registrations, and scientific trials throughout 30+ markets, producers can analyze tendencies, establish 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, moderately than treating them as an afterthought.
- Proactive planning: Set up a transparent regulatory technique early, outlining goal markets, gadget classification, and essential approvals.
- Knowledgeable recommendation: Seek the advice of regulatory consultants or skilled consultants to know the particular necessities to your gadget and goal markets.
Keep Agile and Adaptable:
- Anticipate adjustments: Regulatory landscapes are continually evolving, so be able to adapt your technique as wanted.
- Flexibility: Preserve flexibility in your product improvement plans to accommodate potential regulatory adjustments or market necessities.
Thanks for the good interview, readers who want to be taught extra ought to go to Pure International.