All Posts

The Hidden Cost of Manual Regulatory Research—and the ROI of AI Automation

Manual compliance monitoring is costing more than you think. Missed updates, delayed launches, audit findings, staff burnout—the hidden costs pile up. In this article, we explore how AI-powered regulatory intelligence uncovers risks early, saves millions in lost revenue, and frees regulatory teams to focus on strategy.

Pat Bhatt

Sep 185 min read

Biocompatibility Challenges in New Material Selection for Medical Devices

Choosing the right material for a medical device goes far beyond engineering performance—it determines regulatory risk, time-to-market, and patient safety. From unexpected leachables to shifting FDA expectations, biocompatibility challenges can derail even the most innovative designs. Explore how proactive strategies and expert consulting can turn material selection from a hidden risk into a competitive advantage.

Pat Bhatt

Sep 174 min read

Natural Language Processing to Guide Device Development

Using Natural Language Processing to Map Regulatory Guidance to Device Development

Regulatory guidance is full of answers—if you can find them. See how Natural Language Processing makes it possible to instantly extract, map, and apply FDA and ISO requirements across your product development process. Learn how Lexim transforms static guidance into real-time regulatory intelligence.

Pat Bhatt

Sep 174 min read

AI as a Force Multiplier for Regulatory Consulting Firms

Regulatory consulting is built on relationships, but those relationships are driven by results. As the FDA’s guidance expands and timelines shrink, consulting firms must find new ways to deliver faster, more accurate insights without sacrificing quality. Discover how Lexim AI simplifies regulatory complexity, enabling consultants to work smarter, grow faster, and earn more client trust.

Pat Bhatt

Sep 173 min read

Can AI Predict FDA Feedback Before You Submit?

The regulatory path is full of unknowns—but it doesn’t have to be. Discover how LLMs can help predict FDA feedback before you submit, saving time, cost, and rework. Read how Lexim uses AI to turn regulatory uncertainty into strategic clarity.

Pat Bhatt

Sep 174 min read