Articles

Article

Connected Health Conference for Med Device Companies

agile, digital health, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Mobile apps and connected technologies are changing the way that medical information and services are acquired, processed, conveyed, and implemented. New products, emerging not only from the traditional medical device industry, but from the consumer […]

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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

Why We Need to Bend the Healthcare Cost Curve

Healthcare, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. There’s a lot of discussion about ways to “bend the healthcare cost curve.”  What do people mean by that, and why do we need to bend it? I like to answer that question by showing […]

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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

Catalyze - HIPAA Compliant Cloud Computing for Healthcare

cloud, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. We asked Travis Good, Co-founder at Catalyze to write a guest post with his perspective on the space:  We founded Catalyze a little over a year ago to solve compliance issues arising from healthcare, technology […]

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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

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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Article

Lowering Risk Using Agile and Lean Methodologies

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. We asked Jacque Harper, User Experience Architect of Pathfinder to write a post with his perspective on the space: Several common types of risks in software development can be mitigated by using Agile, Lean and a user-centered […]

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Article

Launching Products Faster with Agile 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. We asked Dan Blake,  Chief Technology Officer of Valence Health and former Senior VP of AirStrip Technologies to write a guest post with his perspective on the space: Experience has shown me the challenges of […]

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