Insights

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& Connected Device Systems

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White Paper

Agile in an FDA Regulated Environment

How do you get the benefits of agile while maintaining quality and regulatory compliance?

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White Paper

AI and the Design of Medical Devices: It’s Getting Better All The Time

Orthogonal was excited that Bernhard Kappe, our CEO and Founder, spoke at Virtual Engineering Week on Friday, December 4th, 2020 on the topic of AI & Machine Learning in Medical Devices: It’s Getting Better All the Time. This talk was hosted by Informa and their Medical Device + Diagnostic Industry (MD+DI) media property. (Shout outs […]

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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

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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White Paper

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

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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