I'm working on scoping out specific problems facing "software as a medical device" (SaMD) companies. In particular issues around being able to release software at a reasonable cadence. I've been a CTO in this space for a couple of years and I am now consulting with other firms around the intersection of tech and regulatory.
It's a tight-rope walk of ensuring that all testing (software and non-software testing) and evidence is produced correctly and being able to release at a rapid pace to derisk each release. It's not uncommon for software to only be updated yearly, leading to very conservative changes and little iteration. Monthly releases are okay, but still not great.
I want to make it possible to release at least weekly and to do so safely.
If you work in this area, I'd love to chat and hear your experiences (email available via my website in bio).
It's a tight-rope walk of ensuring that all testing (software and non-software testing) and evidence is produced correctly and being able to release at a rapid pace to derisk each release. It's not uncommon for software to only be updated yearly, leading to very conservative changes and little iteration. Monthly releases are okay, but still not great.
I want to make it possible to release at least weekly and to do so safely.
If you work in this area, I'd love to chat and hear your experiences (email available via my website in bio).