MedTech Company

An AI-powered report generation platform was implemented to automate R&D documentation for FDA submissions, accelerating product development and establishing a data foundation

Challenge

• The R&D department needs to generate experimental reports to document their product’s effectiveness and safety, including FDA submissions
• With mass production on the horizon, the company lacked a robust data platform to accelerate development cycles and optimize future factory operations.

Solution

• Our proprietary solution with pre-built use cases was deployed to establish a foundational data platform
• LLM-powered report generator automates content creation by taking a protocol document and observational data as input
• The solution includes an interactive editor, allowing users to refine the generated text and chat with the AI model for precise adjustments, ensuring accuracy and compliance

Business Impact

• Core functionalities like SafeChat and FileChat have seen widespread adoption across the company
• Automation of report generation can speeds up the documentation process, enabling faster product development and submission cycles
• Researchers can now focus more on experimentation and analysis rather than on report writing