About Us

Software Is in Our DNA

Unlike other companies in our field, which have added “software” to their repertoires over time, software has always been at Orthogonal’s core – and our track record of work and thought leadership is a testament to that.

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Our History

At the Forefront of the Industry
For Over 10 Years

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.

Our Leadership Team

Enabling, Accelerating
And Supporting Success

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.

Our Locations

Sweet Home Chicago –
And Anywhere Else We Roam

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 from home, at client sites, meeting with industry leaders or working out of offices in the Bay Area and the Southeast US.

Our Certifications

ISO 13485:2016 Certified

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.

Insights

Talk

Regulation of SaMD in the U.S.: Webinar

Talk

Community Roundtable: SaMD, The Cloud & TINY GVS

Article

Climbing the Mountain of Regulatory Documentation for SaMD

Talk

Blending Agile Practices With Industry Regulations: Webinar