Insights

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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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

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

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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Article

Looking Back at a Pioneer in DTx and SaMD - Propeller Health in 2013

digital health, digital therapeutics, SaMD

In Orthogonal’s digital archives, we recently came across a presentation and extended Q&A session from 2013 at a Chicago Lean Startup Circle event we helped organize.  The event featured David Van Sickle, the co-founder and CEO of Propeller Health.  In a talk titled Propeller Health: Fast Feedback Loops in an FDA Regulated Environment, David discussed […]

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Talk

Operating Medical Devices in Cloud: Experts build consensus on safety

cloud, digital health, SaMD

Orthogonal’s Bernhard Kappe and Randy Horton were thrilled to participate in a webinar on December 16, 2020 place that was hosted by our partners at MedTech Intelligence titled Connected Medical Devices, Software as a Medical Device (SaMD) & the Cloud: Delivering Validated States, Safety & Compliance on Continually-Evolving 3rd Party Platforms This event was a […]

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