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Agile in FDA Regulated Medical Software - Sweat the Details

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. Very few people in the software development community have issues with maintaining good attention to the details. However, I bet those who live in the regulated software community view the “normal” software world as quite […]

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Article

How MIT Media Lab is Transforming Healthcare UX

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. The New Media Medicine group at the MIT Media Lab suggests a key to solving healthcare problems lies in establishing new kinds of collaboration between patients and practitioners. Traditionally, the relationship has been one of […]

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Article

Agile in FDA Regulated Medical Software: Don't Cut Corners

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. I have to thank Tavi Scandiff-Pirvu for coining this expression as it relates to regulated software development. As long as you use industry standard methods, the FDA allows you to determine the rules that you are […]

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Article

Agile in FDA Regulated Medical Software

agile, FDA, medical device software development

Testing is a crucial part of all software development. If you don't believe this you are likely just starting your career or haven't had to support an application in production with users. It becomes

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Article

Agile in FDA Regulated Medical Software - Checklists

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. Let’s be honest: Checklists aren’t the most exciting topic to blog about. However, in the context of regulation, they become interesting. Everybody loves checklists and hates them at the same time. It’s really easy to […]

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Article

Agile in FDA Regulated Medical Software - Have Some Class

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. The FDA states that a medical device is a product that is used for medical purposes in patients, in diagnosis, therapy, or surgery. As opposed to pharmaceuticals, who use the body’s metabolism, medical devices act mechanically […]

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Article

Agile In FDA Regulated Medical Software - It can be done!

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 have all heard that developing software utilizing Agile principles yields high quality, working software in customers’ hands quickly. It is widely believed that utilizing Agile practices leads to better, cheaper software than waterfall methods […]

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Article

Agile for FDA Medical Software Seminar

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 emphasizes minimal documentation, a lot of verbal communication and rapid feedback loops to increase software quality, reduce waste and speed development. FDA regulations run counter to this approach, implying a heavyweight waterfall process with […]

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Article

Starting a Software Product Company? Pitfalls to Avoid

medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Although there are many more pitfalls, I’m only going mention three. Feel free to add your own. The good news is that all of these risks are manageable. Staff User Acceptance Testing Carefully Startups are […]

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Article

TDD Adoption

medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Many developers I talk to say they have tried Test Driven Development (TDD), but it “didn’t work for them”. Why is this so often the case? I believe that the main reasons are 1) it […]

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Article

Requirements Set in Stone and Software Made of Concrete

medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Twas the night before Christmas, and 500 pages of detailed requirements had been produced. No line of code had been written, not even by a mouse. It sounds great in theory: You produce requirements up […]

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Article

You Shall Know Our Velocity!

medical device software development, risk management

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. With apologies to Dave Eggers, this post is not about traveling around the world in a week to give away $32,000, but about measurement and agile development. One objection to agile development we get sometimes […]

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