Insights

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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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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Article

4 Keys To Accelerate Development for MedDevice Software

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. I spend a fair amount of time talking to R&D directors and heads of innovation at medical device companies many of whom acknowledge feeling pressure to accelerate their product development efforts.  Many are starting to […]

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Article

A Faster Path to App Development with Orthogonal

agile, digital health, 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 Amanda Plummer, Business Systems Analyst of American Association of Critical Care Nurses (AACN) to write a guest post with her perspective on the space: I’m a business systems analyst with the American Association […]

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Article

In Mobile Medical App Development, MVP is Important

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. Nope, I’m not talking about a Most Valuable Player trophy. The MVP to which I’m referring is minimum viable product, a relatively new concept to product design that’s been gaining worldwide recognition. It’s a way […]

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Article

Selecting Mobile Tech to Achieve Speed to Market

agile, digital health, FDA, mobile medical apps

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. We asked Cameron Brackett, Director of R&D of Honeywell to write a post with his perspective on the space: Process Management and Agile in an FDA Environment to accelerate product timelines. My background is primarily in […]

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