Our journey began over a decade ago, when we got a glimpse of the future of digital healthcare. We saw how combining cloud, IoT and smartphones with modern software development methods could revolutionize the design, creation and rapid enhancement of medical devices. We took our many years of experience developing great software products in a range of industries – including financial services, education and research – and applied it to the development of SaMD, DTx and connected medical devices. We’ve never looked back.
For over 10 years, we’ve helped a wide variety of firms – from start-up device manufacturers to pharmaceutical giants – build, evolve and scale regulated, software-enabled medical devices. Our team gets up every day excited to help move the needle on healthcare outcomes, and we’re even more excited to see what we’ll accomplish in the next 10 years during this great acceleration of digital health.
If you speak to any of the members of our leadership team, you’ll be struck by their passion for building high-performance teams, developing great software and improving health outcomes. That’s because at Orthogonal, our passions drive our work.
Our leadership team’s deep educational, professional and personal backgrounds fuel a creative environment that constantly pushes us to improve how we work and what we produce. While we take tremendous pride in our work, we believe that the learning process is never done, and we continue to iterate and innovate as we meet the challenges of developing SaMD and connected medical device systems to drive health outcomes at scale.
Chicago is Orthogonal’s home, a city of thinkers, workers and doers with thousands of companies engaged in all aspects of healthcare and life sciences. Our headquarters is in the historic Merchandise Mart, a building at the heart of Chicago’s downtown that was once known for interior design innovation and is now a thriving hub for MedTech and other tech companies. You’ll find us hard at work (and enjoying our work) at MATTER, Chicago’s healthcare and life sciences innovation hub, working hard on technologies, software and solutions that matter.
Though we love the Windy City, it may be more accurate to describe us as a distributed company that meets face-to-face every opportunity we can. As our growing team continues to add dots for talented employees across the map, you’ll find many of our staff working remotely from Seattle to San Diego to South Florida, in meetings at client sites, and constantly connecting with industry leaders and pioneers at numerous conferences around the globe.
Orthogonal develops connected care systems under design controls, either in our own ISO 13485:2016 certified Quality Management System or under our client’s Quality Management Systems. Our processes are aligned with IEC 62304, AAMI TIR:45, and ISO 14971, as well as FDA QSR, EU MDR, GDPR and HIPAA. We have adapted Agile processes within design controls, have written extensively on the subject, and have participated in industry standards and guidance documents.