Role: Product Designer Team: Product Manager, Principle Backend Engineer Lead, Principal Data Engineer Lead, Data Engineer, Sr. Backend Engineer, Principle Frontend engineer, Data Engineer Company: Element Materials Technology Key Objective: Simplify the medical device regulatory journey by reducing the time for compliance review from 80 hours to 20 hours, using AI-driven insights and a streamlined interface. The Brief Regulatory experts often spend around 80 hours reviewing compliance plans for medical devices—a process that’s both time-consuming and stressful. Our challenge was to create a solution that could cut this time down to just 20 hours through the RegNav app. To do this, we needed to present the necessary standards and requirements in a way that was clear, concise, and actionable. Key Requirements Simplify complex regulatory data. Create an intuitive, user-friendly interface. Incorporate LLM’s to support the data we need to generate for each card. Maintain the accuracy and reliability crucial for medical device compliance, while adhering to regulatory standards. Research and Discovery -Conducted interviews with regulatory experts to understand needs to create ‘Jobs to Be Done’. -Analysed current processes to find inefficiencies. -Reviewed global benchmarks for data cards and tables. -Collaborated with data engineers to leverage AI insights. Design Process -Created wireframes and prototypes to define expert flow to view and ammend standards and requirements. -Debated between table and card views, ultimately choosing card view after benchmarking and user testing with the experts for its clarity and visual appeal. -Integrated and expanded the design system for consistency. -Conducted usability testing, iterating on designs based on feedback. -Collaborated with engineering to align design with backend/frontend architecture. -Developed a clean, professional UI with clear typography, color coding, and icons and built the entire card functionality (pictured below).