Cost-of-Delay vs. Cost-of-Cyber Checklist

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

Cost-of-Delay vs. Cost-of-Cyber Comparison A frank look at the real ROI of premarket cybersecurity.

Most teams compare the cost of a cybersecurity engagement against their existing budget. The right comparison is against the cost of a Refusal-to-Accept letter, an Additional Information cycle, or a missed launch quarter.

Direct delay costs Have you estimated the revenue impact of a 90-day submission slip? Do you know what an FDA Additional Information request typically adds to the review clock? Have you priced the engineering rework that follows a late-stage threat model? Is the cost of an extended QMS audit cycle accounted for in the model?

Indirect & strategic costs Would a delayed clearance affect an in-flight financing round or strategic milestone? Have you modelled the impact on hospital pilot timelines or partner commitments? Is there a competitor likely to clear ahead of you if your timeline slips a quarter? Have you accounted for postmarket cybersecurity obligations under Section 524B(b)?

How to read it. If most boxes go unchecked, the engagement is being evaluated on cost alone, with no delay model attached. In our experience the cost of a single AI-letter cycle typically exceeds a full premarket cyber engagement.

NEXT STEP → Book a 20-minute readiness call and we will build the side-by-side cost model with your numbers. 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

---

Talk to us

This guide is part of Blue Goat Cyber's MedTech cybersecurity library. To apply it to your device program, book a 30-minute strategy session - no cost, no obligation. Or browse all guides.