Software as a Medical Device (SaMD) Case Studies and Best Practices

Orthogonal applies Agile methods aligned with FDA Pre-cert program in order to achieve quality and optimize patient engagement and outcomes.



PhysIQ: Ambulatory Patient Monitoring

Continuous Vital Signs Telemetry and Analytics using Wearable Sensors

Diabetes Management System

Bluetooth-Connected Glucometer and Mobile Medical Apps

Population Health Analytics Engine

Scaling Complex Predictive Analytics to Over 40 Million Covered Lives

Tablet Based Health Counseling App for Substance Abuse

PathWell, a tablet-based, touch screen enabled application, enables Health Educators to gather data and provide enhanced feedback during the…

Early Detection of Clinical Deterioration

Orthogonal worked with our client to develop an interactive application to test for cognitive impairment due to stroke or heart failure. The…

Software as a Medical Device (SaMD): What It Is & Why It Matters

The World Health Organization (WHO) reports that there are around 1.5 million medical devices globally, across more than 10,000 types. They …


From Inception to Launch

We begin every medical software development project with an intense period of data collection and formative assessments called an Inception.

The Inception is a collaborative in-person workshop designed to explore and capture the system’s functionality and intended users. Our subject matter experts in human factors engineering, Agile development and Quality Systems collaborate with project stakeholders to identify and define work flows, user types, functionality, risks and everything else necessary to facilitate the start of a successful and detailed design, development and FDA submission effort.

At Orthogonal, every project begins with an Inception. Contact us to learn more or to schedule an Inception for your Software as a Medical Device (SaMD) project.