Design vs development

After writing about one of my least favourite topics (legal ambiguity), this article is about a more favourable topic: translating regulatory speak for startup people who work on medical apps.

This article is about a very common misunderstanding seemingly obvious terms: design and development. Well, they are obvious for medical app developers as well as for regulatory people. They just understand different things when hearing those terms.

From a medical app perspective, design typically refers to the graphical design of the app. It typically splits into UX and UI. And development means implementation into code. Some companies do strictly the first and then the second. Others have a more integrated approach.

From a regulatory perspective that all means the same. Design, development, and design and development. Design is mostly used by the FDA. Design and development is used by ISO 13485. But still, they mean the same. This also makes sense when looking at medical devices in a bit of a more general sense. Not every medical device has a graphical user interface, e.g. scalpels. Well, guess what, the FDA still refers to design when it comes to the designing and developing it. So you should understand the term design in a more general engineering sense.

One of the next articles will describe how the typical activities fit into the more structured medical device lifecycle process.

Photo by Plush Design Studio on Unsplash