Question 1

How much does firmware cost for a Class II medical device?

Accepted Answer

Commonly $75K–$250K from architecture through verification, depending on IEC 62304 software class, connectivity, and V&V depth. Simple accessories or instrument updates can land lower; safety-critical or connected devices trend higher.

Question 2

Why does medical firmware cost more than consumer firmware?

Accepted Answer

The code is often comparable — the evidence is not. Design controls, ISO 14971 risk analysis, traceability, and verification protocols are deliverables in their own right, and they are what the FDA reviews.

Question 3

What is the cheapest way to de-risk the budget?

Accepted Answer

A short fixed-price architecture diagnostic — Kyros runs these at $6K over two weeks. You get a written architecture, risk, and cost plan you keep, whoever you hire for the build.

Question 4

Should medical firmware be fixed price or time-and-materials?

Accepted Answer

Kyros quotes firm-fixed-price tied to milestones for defined scope; T&M is reserved for genuine unknown-unknown R&D phases. Buyers in regulated industries increasingly require fixed-price milestones.