"Hi David - It's true most countries have their own process for registering a medical device for use in their country. Having an FDA or CE Mark approval speeds this process along in many countries. In addition, there are many charities who donate medical equipment abroad as part of phenomenal education & training programs. These charities are often based in U.S. or Europe and want to know they are providing equipment that is at least the same quality as would be used in their home countries. - little do they know that you have to go above and beyond to make this equipment work well in low resource contexts."

"Hi Noodler - You may be right! You are highlighting another aspect of our design: as a non-profit we had a process in which we acknowledged some of the features would be overdesigned (read - extra material, or extra strong) because we didn't want to go through the expensive process of iterating and testing many times. This led to a faster time to market with a robust device, but it could always use some fine tuning."

"Hi Ronny, These are indeed dark times for many of our government agencies, but I would not want to ignore some of the really great things the FDA has enabled for medical device design. To be able to know that a device *will* work well in *some* contexts is a big improvement on where we were before FDA. Many of the documents they have created over the years also support increasing human factors involvement even in the early stages of medical device design to ensure they are designed for the context. "