Operations & Cost

The Cost of Late Cybersecurity Engagement in MedTech

Quantifying submission delay, deficiency rate, and remediation cost for teams that engage cybersecurity early vs. late.

Forthcoming. This page reflects the methodology and structure of an upcoming report. Numeric findings and charts will be published after the analyst extract and legal review are complete. Press contacts can request early access at press@bluegoatcyber.com.

By Christian Espinosa, MBA

Founder & CEO · Blue Goat Cyber

Published: September 15, 2026

Press kit

Executive summary

Conventional wisdom holds that cybersecurity engagement after design freeze is more expensive. This report attempts to quantify how much more expensive - and how much faster early-engaged teams reach FDA clearance.

Engagements are classified into four timing tiers based on when cybersecurity work was initiated relative to design freeze and submission filing. Outcomes (deficiency rate, time-to-clearance, remediation effort) are compared across tiers.

Pending analyst extract and legal review.

Methodology

Sample: Engagements that reached an FDA outcome between 2022 and 2025.
Time period: January 2022 - December 2025
Inclusion criteria: Engagements where the start date of cybersecurity work and the submission filing date are both recorded.
Engagements with a final FDA outcome by 31 Dec 2025.
Engagements where remediation effort can be estimated from internal time tracking.
Limitations: Cost figures reflect Blue Goat Cyber engagement effort, not the client's total internal cost.
Tier assignment uses a simplified four-bucket model and does not capture all engagement-timing nuances.
Causation cannot be inferred - early engagers may differ from late engagers in unmeasured ways.
Anonymization: All client and product names removed before analysis; records are keyed by an internal study ID.
Device-specific identifiers (510(k) numbers, De Novo numbers, UDIs) stripped from the source dataset.
Findings reported only at aggregate level; minimum cell size of 5 to prevent re-identification.
Free-text deficiency excerpts paraphrased; no verbatim FDA correspondence is reproduced.

Key findings

1. Late-engaged teams receive cybersecurity deficiencies at a higher rate.
internal extract pending
Pending extract.
2. Early-engaged teams clear FDA faster on average.
internal extract pending
Pending extract.
3. Remediation cost grows non-linearly with engagement lateness.
internal extract pending
Pending extract.

Charts

All charts are free to re-use with attribution to Blue Goat Cyber. Each chart has an embed-friendly URL - see the press kit for the iframe snippet.