Insights

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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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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Article

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

AI & machine learning, digital health, SaMD

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

What Five Digital Health Experts Learned in 2020

digital health, SaMD

We didn’t predict at the beginning of 2020, but this has been one heck of a year in healthcare and life sciences, especially in terms of digital health, connected care, and Software as a Medical Device (SaMD).  We’ve all certainly learned a lot. Curious what others have learned, we’ve been reaching out to a wide […]

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Talk

Medical Devices in Cloud Webinar: Sneak Preview of a New Expert Report

cloud

Orthogonal’s Bernhard Kappe and Randy Horton are looking forward to participating in a webinar taking place this Wednesday (December 16, 2020) from 1-2:30 PM EST that’s hosted by our partners at MedTech Intelligence.  You can register for free here to attend this event: Event Title Connected Medical Devices, Software as a Medical Device (SaMD) & […]

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