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.
Published:
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 pendingPending extract.
2. Early-engaged teams clear FDA faster on average.
internal extract pendingPending extract.
3. Remediation cost grows non-linearly with engagement lateness.
internal extract pendingPending 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.
Deficiency rate by engagement-timing tier
internal extract pendingShare of submissions receiving a cybersecurity deficiency, by tier.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: % of submissions
Time to clearance by engagement-timing tier
internal extract pendingMedian days from submission filing to FDA clearance, by tier.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: days (median)
Remediation effort by engagement-timing tier
internal extract pendingMedian engineering hours required to close cybersecurity deficiencies, by tier.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: hours (median)
Deficiency count vs. weeks-before-filing engagement started
internal extract pendingPer-engagement scatter of deficiency count against engagement start time.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: deficiencies
Submission outcome distribution by tier
internal extract pendingShare of submissions clearing on first review, after one round of deficiencies, or later.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: % of submissions
Cite this report
Blue Goat Cyber. (2026). The Cost of Late Cybersecurity Engagement in MedTech. https://bluegoatcyber.com/research/cost-of-late-cybersecurity-engagement-2026
Sources & references
Primary sources cited in this article. Links open in a new tab.