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Thought Leadership on SaMD, DTx & Connected Device Systems

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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

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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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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Article

Digital Health in 2020 - Learning from the University of Hard Knocks

digital health

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

Nanowear's New Clinical Trial Fights COVID-19 with Connected Wearables

digital health

The entire Orthogonal team offers a huge congratulations (and thanks!) to Nanowear and its supporters and investors[1] for launching a groundbreaking COVID-19 research project in partnership with two major health systems in the NY Metro region: Maimonides Medical Center in Brooklyn, NY is one of the largest independent academic medical centers in the country, training […]

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Article

Behavioral Health and Digital Therapeutics - Three $10M+ Investments

digital health, SaMD

What we can learn from recent Series A investments of $10M+ in digital health startups One of the most interesting areas for digital therapeutics (DTx) is its application to behavioral health (also referred to as mental health). For several decades, many of the most prominent advances in behavioral health therapeutics were pharmacological—think Prozac and Ritalin.  […]

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Article

40 Years of Milestones in Medical Device Software - A History

digital health, SaMD

From Software in a Medical Device (SiMD) to Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD) By Randy Horton, VP of Solutions and Partnerships, Orthogonal Earlier this week, Orthogonal finished compiling a list of funding announcements from January to March of 2020 for companies building Connected Mobile Medical Devices (CMMD) and […]

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Article

Four Success Factors for Accelerating Digital Health Solutions

digital health, FDA, SaMD

Executive Summary This is the fourth and final blog in our late spring/early summer series titled “Sinking, Swimming, or Surfing: COVID-19 and The Great Acceleration of Digital Health.” In this article, we discuss four critical success factors for digital health solutions. Success Factor #1—Don’t get stuck in Flatland: Think in terms of “And,” not “Or.” […]

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Article

Digital Health's Acceleration After COVID-19

digital health

After This Pandemic, What’s in Store for MedTech, Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD)? This article picks up where we left off with our blog post, What This Pandemic Has Changed for Digital Health, MedTech, Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD). At some […]

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Article

COVID-19 and “The Great Acceleration of Digital Health”

digital health

What This Pandemic Has Changed for MedTech, Connected Mobile Medical Devices (CMMD) and Software as a Medical Device (SaMD) “Yet even as they walk through the valley of the shadow of death, chief executives and corporate strategists are beginning to look to the post-covid world to come. What they think they see, for good or […]

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Article

Dear MedTech: We expect you to thrive. Cordially, your shareholders

digital health

Executive Summary The people who manage trillions of dollars in stock and bonds are already telling their portfolio companies in every sector what they want to see them doing. For these investment managers, it’s not about playing games with financial instruments or raising earnings-per-share in Q2, Q3 or even Q4 of 2020. It’s about thriving […]

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