Insights

Article

Five Tools to Implement Frequent Releases for SaMD, Connected Devices

Human Factors & UX, SaMD

Bob Moll, Principal UX Architect, Orthogonal Beth Lester, UX Researcher, Bold Insight In our last blog, we laid out ways in which frequent medical device product releases benefit user experiences, thereby benefiting organizations overall. However, making the transition to frequent product releases can seem daunting. Over the course of the next two blogs, we’ll outline […]

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Article

Four Success Factors for Accelerating Digital Health Solutions

digital health, FDA, SaMD

Executive Summary This is the fourth and final blog in our late spring/early summer series titled “Sinking, Swimming, or Surfing: COVID-19 and The Great Acceleration of Digital Health.” In this article, we discuss four critical success factors for digital health solutions. Success Factor #1—Don’t get stuck in Flatland: Think in terms of “And,” not “Or.” […]

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Article

White Paper: Smartphone Market Analysis for Software as a Medical Device

bluetooth, FDA, SaMD

The move towards a highly interconnected, IoT-driven healthcare industry has made the development of mobile health applications, connected medical devices, and software as a medical device (SaMD) essential for companies looking to stay ahead of the curve. Smartphone applications, in particular, are at the forefront of the shift in how care is being delivered. With […]

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Article

SaMD: Software as a Medical Device

SaMD

The U.S. Food and Drug Administration has issued a guidance document entitled "Software as a Medical Device (SaMD): Clinical Evaluation.

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