Orthogonal

Orthogonal is a specialized software development firm focused exclusively on Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device systems. Operating from Chicago with a distributed team across the United States, the company has served the healthcare industry for nearly 15 years, working with clients ranging from venture-backed startups to pharmaceutical giants like Roche, Eli Lilly, and Novo Nordisk.

The company operates under an ISO 13485:2016 certified Quality Management System and develops medical device software aligned with IEC 62304, FDA QSR, EU MDR, GDPR, and HIPAA requirements. Orthogonal has adapted Agile development methodologies to work within medical device design controls, allowing for rapid development while maintaining regulatory compliance. Recent projects include building a cloud-native AI-ECG integration platform for HeartSciences in seven months.

Orthogonal positions itself as a partner for companies navigating the intersection of modern software engineering and medical device regulatory requirements. The firm has contributed to industry standards and published thought leadership on topics including Agile development in regulated environments, Bluetooth for medical devices, and AI in medical device systems.

Organizations should consider Orthogonal when developing software that will be regulated as a medical device or when building connected device ecosystems that must comply with FDA, EU MDR, or other regulatory frameworks. The company's ISO 13485 certification and experience with major pharmaceutical and device companies indicates capability to handle complex compliance requirements.

Expect a partner familiar with medical device design controls who can apply modern development practices within regulatory constraints. The company's work with both established healthcare enterprises and venture-backed startups suggests flexibility in adapting to different organizational structures and timelines.

Orthogonal operates exclusively in healthcare with approximately 15 years dedicated to medical device software development. The company specializes in Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device systems across multiple therapeutic areas, with visible work in diabetes care, cardiovascular monitoring, and patient engagement platforms.

Their healthcare focus extends to pharmaceutical companies developing digital therapeutics and consumer health companies entering the regulated MedTech space. All development occurs under medical device design controls with alignment to IEC 62304, FDA QSR, EU MDR, GDPR, and HIPAA requirements.

Medical device manufacturers, pharmaceutical companies, and digital health ventures developing Software as a Medical Device, Digital Therapeutics, or connected device platforms that require FDA, EU MDR, or ISO 13485 compliance. Organizations that need to balance rapid development cycles with rigorous regulatory requirements and design controls.