Category Archives: Agile

Agile

Full Cycle Teams in a FDA regulated setting

Posted on January 4, 2021 by Bob

The 200X hot topic was Agile development in a FDA regulated setting. Over a decade later this should (hopefully) be a settled issue. I can’t imagine anyone still doing water-fall these days. The new challenge for medical device companies is … Continue reading →

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Agile Software Development in Regulated Environments

Posted on October 16, 2010 by Bob

As part of a series on High Assurance Agile Development in Regulated Environments is the article Agile Software Development in Regulated Environments Example: Medical Devices. The purpose of this article and future posts is to introduce the FDA regulatory landscape and … Continue reading →

Posted in Agile, FDA, Software Quality | Tagged | 3 Comments

The Software Quality Balancing Act

Posted on May 15, 2010 by Bob

Andrew Dallas’s article Caution: V&V May Be Hazardous to Software Quality touches on a number of good points regarding software quality best practices. Medical device software development V&V (also see here) and the documentation that goes with it have substantial … Continue reading →

Posted in Agile, FDA, Medical Devices, Software Quality | Tagged , | 1 Comment

The Desperate Need for Simplicity

Posted on October 13, 2009 by Bob

Ted Neward’s article “Agile is treating the symptoms, not the disease” touches on several important points about the software industry. Modern software development tools and technologies require a significant learning curve. Development methodologies (like Agile) exist for managing complexity, but … Continue reading →

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Agile Stumbling?

Posted on November 25, 2008 by Bob

James Shore has an interesting post, The Decline and Fall of Agile, that has generated a lot of good discussion over the last couple of weeks. I’ve seen a shift in my business over the last few years. I can’t … Continue reading →

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Software Development: Driven by what?

Posted on February 17, 2008 by Bob

First a definition: driv·en –adjective : having a compulsive or urgent quality : propelled or motivated by something — used in combination <results-driven> Driven software development methodologies abound: Behavior-Driven Development (BDD) Design-Driven Development (D3) Domain-Driven Design (DDD) Feature-Driven Development (FDD) … Continue reading →

Posted in Agile, Programming, Software Quality | 1 Comment

Dilbert on Agile

Posted on November 26, 2007 by Bob

In this mornings paper: 😆

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Understanding Software Defects

Posted on November 25, 2007 by Bob

We tend to focus a lot of attention on tools and methodologies for improving software quality. I thought it would be worth while taking a step back to try to understand what the root causes of software defects are. Fortunately … Continue reading →

Posted in Agile, Software Quality | 1 Comment

Medical Device Software Development – Going Agile

Posted on October 14, 2007 by Bob

I’ve been involved in some informal discussions regarding the use of Agile methodologies for medical device software. The Medical Device and Diagnostic Industry (MD&DI) October 2007 article by Tim Bosch entitled Medical Device Software Development—Going Agile provides a good overview … Continue reading →

Posted in Agile, FDA | 2 Comments

Update: Agile development in a FDA regulated setting

Posted on July 25, 2007 by Bob

I contacted Frank Jacquette regarding my previous port on this subject (Agile development in a FDA regulated setting). His experience using Agile methodologies for pure software medical device projects does not correspond with my conclusion regarding cost effectiveness and regulatory … Continue reading →

Posted in Agile, FDA | 3 Comments