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AAMI’s Groundbreaking Consensus on Cloud Technology in Medical Devices

cloud, medical device software development

Orthogonal is pleased to announce that a groundbreaking and much-needed industry guidance effort that we helped convene has reached the finish line! This is an important milestone in medical device software development and MedTech’s ability to safely and effectively embrace the important innovations of cloud computing, which are being adopted across every industry’s computing usage […]

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A Decade of 'Software Eating the World' of Medical Devices

medical device software development

Ten years ago this month, Marc Andreessen published a now-legendary op-ed in the Wall Street Journal that seemed audacious to some readers and visionary to many others. In that commentary, headlined “Why Software Is Eating The World,” he succinctly forecasts one of the most-consequential changes in recent human history: the transformational integration of software into […]

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Cloud Computing in Medical Devices: Safe, Compliant, Effective. How?

cloud, FDA, medical device software development

The cloud is eating the world, including medical devices. As of early 2020, worldwide cloud infrastructure service revenue was over $96 billion, with the combined market share of the three largest vendors, Amazon, Microsoft, and Google, at approximately 60%.  Cloud revenues of these three vendors have grown by over 50% per year since 2013. Part […]

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Orthogonal™ Announces New Brand and Pivots to IoT Medical Device Software

medical device software development

In light of market changes in health care and the ascension of IoT medical devices, Orthogonal has decided to concentrate its expertise solely in the connected medical device space.

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Article

Connected Health Conference for Med Device Companies

agile, digital health, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Mobile apps and connected technologies are changing the way that medical information and services are acquired, processed, conveyed, and implemented. New products, emerging not only from the traditional medical device industry, but from the consumer […]

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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 […]

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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 […]

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