Fixed-Fee vs. T&M Decision Checklist

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

Fixed-Fee vs. Time-and-Materials Decision Guide Aligning your contracting model with FDA submission objectives.

A premarket cybersecurity engagement has a defined deliverable list and a hard regulatory deadline. Most of the cost overruns we see come from contracting models that don't match that shape.

When fixed-fee fits Is the scope tied to a specific FDA submission (510(k), De Novo, PMA)? Are the deliverables enumerable (SPDF, threat model, SBOM, VDS, pen test)? Is there a need for cost predictability for finance or board approval?

Do you want AI-letter responses included without change orders?

When T&M fits

Is the scope research-driven, with no defined submission target?

Are you only purchasing a single, narrow service (e.g. one penetration test)?

Is the engagement explicitly advisory, with no required artifacts?

Red flags either way T&M with no cap and no deliverable list - open-ended billing risk. Fixed-fee that excludes AI-letter response - change-order risk during review. Either model with no named senior practitioner on the engagement.

How to read it. If the engagement is anchored to a submission date and a known set of FDA-expected artifacts, fixed-fee with AI-letter response included is almost always the lower-risk model.

NEXT STEP → Book a 20-minute call to scope the deliverable list and price both models against your submission target. Book your discovery call: go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session

Page 1 · © Blue Goat Cyber · 250+ FDA submissions, zero rejections, since 2014

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