[bkolko]

When we started, we really didn't have a good estimate of how hacking in the medical space would be different from other kinds of hacking we'd done.

But it's really not that bad once you get the hang of it. If we could say anything to other people considering taking the plunge, it would be to not be afraid of the medical space. Sure, it's a regulated space and some things are more complicated, but the difficult problems are the more interesting ones to solve!

More along those lines: http://www.shiftlabs.com/blog/on-being-a-medical-device-comp...

[jes]

Do you work to comply with IEC 62304?

Do you do FMEAs for risk analysis, or some other technique?

Grateful for any insights you wish to share.

[bkolko]

We do indeed. And we've done FMEA. We're in the midst of FDA clearance, so all the required quality work for product development is totally part of our process.

We're working on the assumption that regulatory processes establish benchmarks for performance, but they don't need to dictate how one makes things -- ie, design considerations can be front and center, not an afterthought.