Insights

Orthogonals' experts share whitepapers, articles and presentations from the forefront of research in connected medical devices and companion software.  

40 Years of Milestones in Medical Device Software – A History

From Software in a Medical Device (SiMD) to Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD) Published on Jul…

eBook: Agile in an FDA Regulated Environment

How do you get the benefits of agile while maintaining quality and regulatory compliance?

Two Techniques to Amp Up Your Frequent Release Cycles for Med Devices

Published on July 2, 2020 Bob Moll, Principal UX Architect, Orthogonal Beth Lester, UX Researcher, Bold Insight In last week’s blog, we lo…

White Paper: Smartphone Market Analysis for SaMD, connected devices

Published on July 1, 2020 with data updated through Q1 of 2020 The move towards a highly interconnected, IoT-driven healthcare industry has …

Five Tools to Implement Frequent Releases for SaMD, connected devices

Published on June 25, 2020 Bob Moll, Principal UX Architect, Orthogonal Beth Lester, UX Researcher, Bold Insight In our last blog, we laid o…

White Paper: COVID-19 and The Great Acceleration of Digital Health

Published on June 23, 2020 The tragedy of COVID-19 has opened up a rare window of opportunity for innovators and leaders to have a considera…

Reduce Surprises During FDA-Required HF Validation Tests

The ultimate value of connected medical devices is determined by user engagement. In our experience, ensuring you’ve built something that …

Four Success Factors for Accelerating Digital Health Solutions

Executive Summary This is the fourth and final blog in our late spring/early summer series titled “Sinking, Swimming, or Surfing: COVI…

Digital Health’s Acceleration After COVID-19

After This Pandemic, What’s in Store for MedTech, Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD)? This ar…

COVID-19 and “The Great Acceleration of Digital Health”

What This Pandemic Has Changed for MedTech, Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD) “Yet even as t…

Dear MedTech: We expect you to thrive. Cordially, your shareholders

Executive Summary The people who manage trillions of dollars in stock and bonds are already telling their portfolio companies in every secto…

When Should Your Connected Medical Device Support Bluetooth 5.0?

Bluetooth 5.0 introduces a number of upgrades in speed, security and range to previous versions of Bluetooth. Yet many consumers still don&#…

FDA Software Precertification: A Working Guide for Medical Device Comp…

Published on July 22, 2019 The Food & Drug Administration’s Software Precertification Program represents a fundamental paradigm shift …

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 …

The FDA Gets Serious about Digital Health

And that's a good thing.