Aaron Joseph

Heart rate monitor wearable

Embracing Change: Your Connected Medical Device is Never Finished

1 Comment / Software Development, V2019

The proliferation of software in modern medical devices has enabled innovative new applications and many benefits to patients.  However, it has also created greater challenges for medical device companies: namely, managing greater product complexity and more reliance on third party software components.  For connected devices there are the added challenges of cybersecurity risks, protecting patient […]

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AgileDesignControlWebinar1903

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices

1 Comment / Events, Lean & Agile, News, V2019

This webinar describes a dynamic approach to managing risk analysis and risk controls to keep up with fast moving product development teams.  Learn the nuts and bolts of how to integrate risk management into the overall product development workflow using a requirements management SW tool to create a more flexible and rigorous approach than standalone

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Webinar: Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices

4 Comments / Events, Lean & Agile, News, V2019, Videos

Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices How to examples using Matrix ALM and JIRA Traditional methods for medical device development cannot keep up with the challenges of modern, software-intensive medical devices, which need to be developed iteratively and to be regularly updated after launch.  Software tools for requirements

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Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices

Leave a Comment / Events, Lean & Agile, V2019

How to examples using Matrix ALM and JIRA Traditional methods for medical device development cannot keep up with the challenges of modern, software-intensive medical devices, which need to be developed iteratively and to be regularly updated after launch.  Software tools for requirements management, test management, and defect tracking allow product development teams to make rapid

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Connected Devices Summit

Connected Devices: Cybersecurity & Compliance Summit

1 Comment / Events, Medical Device Development, News, V2018

Is your medical device secure? I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at a conference this week hosted in San Francisco and featuring presentations by cybersecurity experts from the medical device industry, from hospital systems, and from vendors of security tools. Medical device cybersecurity 

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Processes of the IEC 62304 software standard

FDA Software Guidances and the IEC 62304 Software Standard

3 Comments / Lean & Agile, Regulatory Compliance, Software Development, V2018

[updated NOV 2023] “One approach to satisfy two sets of rules” for medical device software As stated in the last blog post, there are two sets of rules for medical device software—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the international IEC 62304 standard, which is easier

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Lean Agile 2 minds for NPD - Slide1

The Two Minds for Successful Product Development

1 Comment / Lean & Agile, Medical Device Development

Aaron Joseph and Roger Tang, PhD, Principal at HR Tang Consulting A successful product development process for innovative products is naturally comprised of two mindsets. Early in the product development process, where the uncertainty is the highest, the team’s focus is on rapid learning to close knowledge gaps. These knowledge gaps are those that are

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