disclaimer, I work with a company that builds one of those expensive offerings
I use OrthoRay as a secondary tool — preoperative planning, teaching, research. Clinical reads go through certified PACS, as they should. The app requires explicit consent at launch acknowledging it's not certified for clinical use.
Since you work in this space, I'm curious: is there a realistic FDA/CE pathway for an independent developer, or is certification fundamentally an enterprise-level investment? How do open-source tools like 3D Slicer or OHIF handle this same liability question?
Would appreciate your perspective.
[1] https://opensource.org/license/mit
[2] https://opensource.org/license/bsd-3-clause