Building Compliance for Federal R&D

A HealthSec Engineering™ Case Study

Client: Anonymous R&D and Federal Commercialization Subsidiary

Challenge

A research and federal commercialization subsidiary was preparing to pursue DoD contract awards requiring CMMC Level 2 certification. Unlike its parent entity, which was already remediating an existing environment, the subsidiary had no federal contracts, no CUI environment, and no SPRS score on file. Leadership needed a clear, costed roadmap to build a compliant environment from the ground up before entering the federal market.

The subsidiary operated adjacent to its parent entity's infrastructure but required its own compliance boundary, documentation, and security architecture. The challenge was designing a secure-by-design federal environment that avoided the technical debt the parent entity was already remediating.

Our Approach

HealthSec Engineering developed a comprehensive CMMC Level 2 readiness roadmap tailored to a clean-sheet build. We analyzed the subsidiary's position relative to the parent entity's remediation effort and designed a phased compliance path that leveraged shared resources without inheriting shared gaps.

Our work included:

• Clean-Sheet vs. Retrofit Analysis: Comparing the subsidiary's build-from-scratch advantage against the parent entity's retrofit costs across network, endpoint, policy, and training domains.

• Infrastructure Requirements Definition: Specifying segmented network architecture, FIPS-validated encryption, MDM enrollment, managed firewall, and VPN requirements for CUI systems.

• Pre-Federal Documentation Planning: Outlining SSP, POA&M, incident response plan, access control policy, CUI handling procedures, and training requirements to be drafted before operations begin.

• Investment and Timeline Development: Delivering a phased timeline (4 phases across 9 months) with a detailed cost estimate for Year 1 infrastructure, tooling, documentation, and C3PAO assessment.

The resulting QMS became the single source of truth for all SaMD quality processes, unifying product design, validation, and postmarket operations across the enterprise.

Results

• Delivered a 4-phase readiness roadmap mapping out infrastructure, documentation, personnel, and C3PAO milestones.

• Defined the Year 1 investment range ($47,000 to $106,000), giving leadership the financial data needed to make a clear go/no-go decision.

• Designed a clean-sheet architecture to achieve a target SPRS score of 88+ at initial filing, bypassing the parent entity's -106 starting point.

• Established a remediation sequence that leverages the parent entity's policy templates, vendor contracts, and validated configurations to reduce costs.