Articles

Article

Reduce Surprises During FDA-Required HF Validation Tests

Human Factors & UX

The ultimate value of connected medical devices is determined by user engagement. In our experience, ensuring you’ve built something that meets user expectations is best achieved by implementing an iterative release process, built on feedback over time. The Drawbacks of a Linear Development Process Often organizations invest a large amount of time into a software […]

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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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Article

Orthogonal on Artificial Intelligence at MD&M West

AI & machine learning

Orthogonal’s CEO, Bernhard Kappe will be moderating a panel at MD&M West Anaheim on February 13, 2020. The panel titled “Will the Growing AI Application Impact Patient Outcomes through Faster Diagnoses and Precision Treatments?” will cover topics on: Specific AI applications in radiology, surgical robotics, chronic disease, drug discovery, and neurological disorders Challenges AI presents […]

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Article

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

bluetooth, FDA, SaMD

The move towards a highly interconnected, IoT-driven healthcare industry has made the development of mobile health applications, connected medical devices, and software as a medical device (SaMD) essential for companies looking to stay ahead of the curve. Smartphone applications, in particular, are at the forefront of the shift in how care is being delivered. With […]

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Article

Orthogonal Obtains Medical ISO 13485 Certification

agile

Orthogonal, the leader in companion software development for medical devices, today announced it has been successfully certified according to ISO13485:2003, the international standard for medical device quality management systems. The certification bestows official recognition on the company for its agile enabled quality management system governing software product design, development, testing, enhancement and support for medical […]

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Article

Bluetooth and Medical Devices - Part 1: Overview

bluetooth

In the race to create more connected medical devices, many medical manufacturers are opting to leverage Bluetooth technology to connect to devices with WiFi and cellular capabilities and transfer...

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Article

Bluetooth and Medical Devices - Part 2: The Gotchas

bluetooth

Despite the shared name, BLE and Bluetooth Classic are fundamentally different connection protocols. Choosing the wrong one can have disastrous consequences for your connected medical device.

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