Insights

Article

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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Talk

AI/ML Regulatory Masterclass from Orthogonal, UCLA Biodesign and HealthXL

AI & machine learning, FDA

Event Description: For over 10 years, Artificial Intelligence (AI) and Machine Learning (ML) have been radically impacting every industry. Yet it still sometimes seems like it should be so difficult to bring AI and ML to market as a component of FDA-regulated medical devices. Given how deep AI has penetrated into many other industries outside […]

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Article

2023 Is the Tipping Point for Bluetooth 5 in Connected Medical Devices

bluetooth, SaMD

ScientiaMobile and Orthogonal Release Data Analysis Showing Bluetooth 5’s Tipping Point Will Come in 2023; Medical Device Manufacturers Need to Act Now to Be Ready Medical device manufacturers will be able to engineer most of their consumer-facing products for the US market to use the Bluetooth 5.x standard by 2023, without having to invest resources […]

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Article

OrthogoPalooza: A Culture of Community and Camaraderie

By Adam Pertman President, Myriad Strategic Partners Every other Friday for the past nine months, Orthogonal employees have gotten together – mostly on Zoom, of course – to engage in a very different kind of team meeting. That is, they don’t just talk shop and report to one another on whatever they’ve been doing since […]

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Article

FDA Software Precertification: A Working Guide for Medical Device Companies 

FDA, SaMD

Recent years, we have seen digital health technologies moving toward rapid adoption in the United States. Yet, Software as a Medical Device (SaMD), mobile medical devices, digital therapeutics (DTx), and Device manufacturers with artificial intelligence (AI) components are often anxious about the lengthy and detailed process of the existing FDA’s premarket review for medical devices. […]

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Article

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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