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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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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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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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Article

Why Traditional “Fixed Bid” Software Projects Usually Fail

medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. By now almost everyone has figured out that traditional fixed bid doesn’t work for software development projects, especially where effective, intuitive user interaction is a significant component of success.  Over time there has been a […]

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Article

10 Keys to Successful Software Development: #8 The Team

medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. According to the latest figures from the Standish Group, only 32% of software development projects are successful. If you follow our list of 10 patterns and avoid the antipatterns, your success rate should be a […]

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Article

Innovation and Treating Developers Like Adults

medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Well-well look. I already told you: I deal with the god damn customers so the engineers don’t have to. I have people skills; I am good at dealing with people. Can’t you understand that? What […]

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Article

Error Messages & Usability

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. I was starting up one of the Adobe apps the other day when this somewhat troublesome message was displayed: Ack! On the one hand, good for them for alerting me that an error had occurred. […]

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