Agile Methods in Medical Device Companies

A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors that the company would now create epic stories and employees would be running very fast around the building (e.g., sprinting).

Spoiler alert: There is no forced exercise, but employees would actually be writing stories and epics.

Conventional waterfall models use versions and products as the development rollercoaster. Someone (hopefully) writes the software requirements, then an exclusive group reviews and approves them. Then came the very difficult task of software design and how it should be documented. And, “what about the architecture – did it ever get copied from the whiteboard into a document?” Next, the software is implemented by “I code – I don’t document” Donnie and when that is almost finished, “do I have to test all that” Connie starts testing the software.
Agile software development models differ such that requirements are written by small group stakeholders, in the form of epics and stories. So how do epics and stories fit into FDA regulations and international standards without duplicating work and thereby negating some of the efficiency of agile?

 

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