Articles

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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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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Article

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

bluetooth, SaMD

Introduction Since the introduction of the iPhone in 2007, iOS and Android smartphones have come to define and dominate the U.S. smartphone market, with approximately 81% of American adults owning a smartphone by 2019 and over 99% of those smartphones being either an iOS or Android phone. As the following graph illustrates, since the iPhone […]

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Article

A Conversation with Eric Ries at the Chicago Lean Startup Circle

lean startup

It’s been 10 years since The Lean Startup was published by Eric Ries, an American entrepreneur and creator of the methodology of the same name. The New York Times bestseller has certainly become a core text for many entrepreneurs and is part of standard operating practices for organizations of all types ranging from startups to […]

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Article

Patient Engagement and SaMD - Orthogonal speaks at Med Device Summit

patient engagement, SaMD

On May 25, 2021, Bernhard Kappe and Randy Horton spoke at Celegence’s Medical Device Virtual Summit 2021 on the topic of “Patient Engagement and Software as Medical Device (SaMD):  The Coming of Medical-Grade Lifestyle Devices.” Executive Summary Traditional medical device manufacturers have mastered difficult domains such as distribution, device and integrity, and privacy.  But their […]

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Article

When Should Your Connected Medical Device Support Bluetooth 5.0?

bluetooth, FDA, SaMD

Bluetooth 5.0 introduces a number of upgrades in speed, security and range to previous versions of Bluetooth. Yet many consumers still don’t have Bluetooth 5.0 compatible smartphones.  In this article, we take a closer look at Bluetooth 5.0 support across today’s most popular mobile devices (Apple and Android), and offer those in the medical device […]

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Article

Lifestyle Integration for Medical Devices

digital health, patient engagement

The following is excerpted from a new article we’ve just published at MedTech Intelligence titled Lifestyle Integration for Medical Devices. The article is the second in a series by Randy Horton, Bernhard Kappe, and Adrian Pittman about patient engagement connected medical devices, and the emergence of medical-grade lifestyle devices. The following is an excerpt from […]

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Article

Patient Engagement and Medical-Grade Lifestyle Devices

The following is excerpted from a new article we’ve just published at MedTech Intelligence titled Building the Next Generation of Wearable Devices to Enhance Remote Patient Care. The article is the first in a new series by Bernhard Kappe, Randy Horton, and Adrian Pittman about patient engagement, connected medical devices, and the emergence of medical-grade lifestyle […]

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Article

CEOs and other Digital Health Experts on SaMD in 2020

digital health, SaMD

We didn’t predict it on January 1, 2020, but this has been one heck of a year in healthcare and life sciences, especially in terms of digital health and Software as a Medical Device (SaMD).  We’ve been reaching out to a wide range of industry leaders, thinkers, and pioneers in the spaces of digital health, […]

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