Articles

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 […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More

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, […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More

Article

What is Patient Centered Software Design?

digital health, FDA, Human Factors & UX, medical device software development, patient engagement

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. In today’s fast evolving healthcare landscape, organizations are increasingly adopting patient centered care to remain competitive in the field. One big part of this strategy is to develop software that is designed with the patients […]

Read More
1 … 3 4 5 6
BSI ISO 13485 Logo
Terms of Use | Privacy Policy | Careers
All Rights Reserved © 2025 Orthogonal