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Orthogonal Congratulates Nanowear on their SimplECG™ FDA Clearance

FDA

Nanowear, a venture-backed nanotechnology startup and Orthogonal client, has successfully developed a remote diagnostic monitoring device embedded in undergarments to monitor cardiac activity.

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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

10 Myths About Agile and the FDA

agile, FDA, medical device software development

Myth: Verification and Validation should only start after all development is complete.  Truth:  In traditional waterfall, verification and validation activities often commence at the tail end of a project, after all, development is complete.  This diverges from the FDA’s recommendations: “The FDA does recommend that software validation and verification activities be conducted throughout the entire […]

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Article

Agile Without Fast Feedback is Not Agile

agile, FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Agile methodology has been adapted to the medical device industry to incorporate risk management, human factors and verification and validation so that it satisfies both the letter and the spirit of the FDA’s Quality System […]

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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 Before Development Starts: Feasibility

agile, FDA, lean startup, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. While change, new discovery and learning are inevitable during any healthcare app product development process, and agile processes reduce the cost and risk of change, there is a significant cost associated with design controls for […]

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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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Article

Getting Your 510K Medical Software Ready

agile, FDA

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Medical devices have become so indispensable to modern healthcare that practically no major diagnosis or treatment can be done without them. According to the WHO, an estimated 1.5 million medical devices are currently available, ranging from […]

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Article

User Experience in an FDA Environment

agile, FDA, Human Factors & UX

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Navigating UX through an FDA Environment Amy Willis brings years of field experience to her current role as Director of User Experience and Visual Design at Orthogonal. As part of her responsibilities in this position, […]

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Article

The Increasing Importance of Software in Medical Devices

agile, FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Medical devices have become such a vital part of modern healthcare that practically no diagnosis or treatment is possible without them. According to the WHO, there are about 1.5 million medical devices available today, ranging […]

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Article

A Fully Functioning Agile Shop in an FDA Environment

agile, FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. As an application and software development project manager at Orthogonal, I’ve been on the front lines of many product development processes, and I’ve witnessed both the successes and obstacles that cross the development path. Working […]

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