Articles

Thought Leadership on SaMD, DTx & Connected Device Systems

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Article

The Evolution from Patient to Healthcare Consumer with a Lifestyle

Human Factors & UX, patient engagement, SaMD

This blog is the first in an ongoing series exploring the crucial linkage between successful Software as a Medical Device (SaMD) and patient engagement. The overall theme of this series is that SaMD (and other permutations of connected medical devices) are poised to have a huge impact on the outcomes and ROI that we get […]

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Article

Pharma Experts Weigh in on Challenges to Frequent Releases in Design

cloud, Human Factors & UX

After writing the first three blogs in our series on frequent releases for connected medical devices, we were curious about what our colleagues in the medical device industry had experienced – what difficulties have they encountered when trying to implement a frequent-release cycle? How have they worked to overcome these difficulties? We reached out to […]

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Article

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

Human Factors & UX

Bob Moll, Principal UX Architect, Orthogonal Beth Lester, UX Researcher, Bold Insight In last week’s blog, we looked at implementing frequent releases on an organizational level and touched on a few key approaches we recommend when integrating and introducing frequent releases into your organization’s design and development process for connected mobile medical devices and Software […]

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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

Reduce Surprises During FDA-Required HF Validation Tests

Human Factors & UX

The ultimate value of connected medical devices is determined by user engagement. In our experience, ensuring you’ve built something that meets user expectations is best achieved by implementing an iterative release process, built on feedback over time. The Drawbacks of a Linear Development Process Often organizations invest a large amount of time into a software […]

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Article

Human Factors Engineering & FDA Guidance

FDA, Human Factors & UX

In February 2016, the U.S. Food and Drug Administration (FDA) issued Human Factors Engineering Guidance documents.

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Article

Medical Software Under UX Influenced Development

agile, FDA, Human Factors & UX, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Clayton Miller is a user experience (UX) and visual designer at Orthogonal. His previous agency experience in the visual design world ranges from basic design work to UX design and development. Since joining Orthogonal, Miller […]

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Article

Faster Feedback Through Integrated Cross-Functional Teams

agile, FDA, Human Factors & UX, medical device software development, risk management, verification & validation

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. In FDA regulated software development one of the most important keys to getting the most out of agile methodology is to ensure fast feedback from outside of the development team. One way to do this […]

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