Insights

White Paper

Agile in an FDA Regulated Environment

agile, FDA

How do you get the benefits of agile while maintaining quality and regulatory compliance?

Read More

Article

Four Success Factors for Accelerating Digital Health Solutions

digital health, FDA, SaMD

Executive Summary This is the fourth and final blog in our late spring/early summer series titled “Sinking, Swimming, or Surfing: COVID-19 and The Great Acceleration of Digital Health.” In this article, we discuss four critical success factors for digital health solutions. Success Factor #1—Don’t get stuck in Flatland: Think in terms of “And,” not “Or.” […]

Read More

White Paper

White Paper: Smartphone Market Analysis for Software as a Medical Device

bluetooth, FDA, SaMD

The move towards a highly interconnected, IoT-driven healthcare industry has made the development of mobile health applications, connected medical devices, and software as a medical device (SaMD) essential for companies looking to stay ahead of the curve. Smartphone applications, in particular, are at the forefront of the shift in how care is being delivered. With […]

Read More

Article

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.

Read More

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.

Read More

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 […]

Read More

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
1 2 3 … 5
BSI ISO 13485 Logo
Terms of Use | Privacy Policy | Careers
All Rights Reserved © 2022 Orthogonal