MedCrypt vs Sternum
Both serve the device manufacturer, but they solve different halves of the obligation. MedCrypt is built for the submission: it maps precisely to the enforceable requirements under Section 524B, names its exploitability sources openly, and produces the SBOM, VEX, and VDR reports a reviewer expects, with regulatory literacy as the genuine product. Sternum is built for the field: its patented Embedded Integrity Verification blocks execution flow diversion at runtime, defending the device against unknown exploits even when disconnected, which addresses the postmarket patching problem documentation cannot. Neither leans on machine learning, and this index grades both C on AI centrality and says why rather than inflating it, MedCrypt a rules engine over public feeds, Sternum deterministic by design. If your failure mode is getting through the FDA submission with defensible documentation, start with MedCrypt. If your failure mode is protecting deployed clinical devices you cannot reliably patch, start with Sternum.
- The clearest regulatory literacy in the lane, graded A on FDA status: the product maps directly to the enforceable obligations under Section 524B, from SBOM minimum elements through per vulnerability risk assessments to postmarket monitoring, backed by published analysis of real FDA premarket deficiency patterns.
- Auditable inputs, graded A on model transparency: exploitability is built explicitly on EPSS, CISA KEV, ExploitDB, Metasploit, NVD, and CWE Top 25, named public sources a buyer can evaluate, and it produces FDA ready SBOM, VEX, and VDR reports.
- The submission is the job: Helm manages SBOM generation, validation, and vulnerability tracking across a device portfolio and determines which vulnerabilities are actually relevant to a given device rather than listing every matching CVE.
- Defend the device in the field, regardless of which flaw: patented Embedded Integrity Verification blocks any attempt to divert the execution flow, stopping unknown and zero day exploits without knowing the vulnerability, graded A on autonomy.
- The strongest deployment position in the category, graded A: protection runs inside the firmware and works when the device is disconnected, at a reported 1 to 3 percent overhead, reaching isolated and legacy equipment that documentation tooling never touches.
- A rare commercial signal, graded B on transparency where MedCrypt is C: a genuine free licence covering up to three OpenWrt devices gives engineers a hands on evaluation path without a sales conversation, unique in this category.
Side-by-Side
| Axis | M MedCrypt |
S Sternum |
|---|---|---|
| AI Centrality | ||
| Autonomy and Oversight Model | ||
| Model and Technology Transparency | ||
| Clinical and Operational Evidence | ||
| AI Safety and PHI Stewardship | ||
| HIPAA and BAA Posture | ||
| Security Certifications and Trust Center | ||
| FDA and Regulatory Status | ||
| AI Governance and Bias Disclosure | ||
| EHR and Interoperability Depth | ||
| Deployment Model and Data Residency | ||
| Commercial Transparency | ||
| Setting and Specialty Coverage |
These two sit at opposite ends of the manufacturer obligation: MedCrypt produces the premarket submission documentation, Sternum provides the postmarket runtime defence, and Sternum frames its regulatory value practically, that runtime prevention reduces dependence on field patching, graded B on FDA status against MedCrypt's A statutory specificity. Both grade A on PHI and neither processes patient data. Both grade C on AI centrality, and the reason is the same honest one in each case: MedCrypt's core is a rules engine over public feeds, and Sternum's flagship Embedded Integrity Verification is deterministic rather than model driven, which is precisely what lets Sternum earn A on autonomy since a deterministic check carries no false positive exposure. Both grade C on evidence with no independent benchmark located. Neither publishes a security attestation. MedCrypt publishes no pricing; Sternum publishes a free tier but no premium rate.