Orthogonal LLC

Executive Summary

Orthogonal LLC is a specialized medical device software development company that combines Agile methodologies with rigorous regulatory compliance to build, evolve, and scale Software as a Medical Device (SaMD) and connected device systems. Founded in 2018 and based in Cambridge, MA, the company focuses on creating digital health solutions that integrate seamlessly into patients' daily lives, leveraging mobile apps, Bluetooth, machine learning, and cloud integration. Its expertise spans the full development lifecycle, from initial design to post-market cybersecurity, serving clients ranging from startups to large pharmaceutical companies. Orthogonal's approach enables faster time-to-market for clients while maintaining compliance with FDA and other regulatory standards. As a private company with no disclosed funding, Orthogonal operates with a lean model, relying on service revenue and project-based engagements. The growing demand for SaMD and connected health devices positions Orthogonal well for steady growth, though its lack of publicly available financials or product portfolio limits visibility into its market traction.

Upcoming Catalysts (preview)

• Q3 2026Major Pharmaceutical Partnership Announcement70% success
• Q2 2026FDA Clearance for Client's SaMD Product Built by Orthogonal50% success
• TBDSeries A Funding or Strategic Investment30% success