Masanari delivers MDS2-grounded risk intelligence, defense-in-depth architecture, and regulatory compliance for Healthcare Delivery Organizations protecting connected medical devices and IoT infrastructure.
Specialized cybersecurity capabilities engineered for the unique threat landscape facing connected medical devices and IoT infrastructure in clinical environments.
Comprehensive inherent risk analysis derived exclusively from Manufacturer Disclosure Statements (MDS2), applying the hermeneutic circle methodology across six weighted security categories.
End-to-end medical device security program development — from device inventory and risk classification to compensating controls implementation and ongoing vulnerability management.
VLAN architecture, NGFW configuration, and Medical Device Isolation Architecture (MDIA) implementation aligned with Medical Device Protection Program and HIC-MaLTS guidance for legacy device network isolation.
HIPAA Security Rule compliance mapping, FDA cybersecurity guidance alignment, MDPP Defense-in-Depth assessment, CISO risk acceptance documentation, and ATO support packages.
Security architecture and policy development for connected IoT ecosystems — infusion pumps, imaging systems, monitors, building automation, and operational technology within HDO environments.
CISO-ready deliverable suites including risk acceptance memos, executive briefings, mitigation roadmaps, and board-level risk dashboards that translate technical findings into leadership decisions.
Our interpretive framework applies Heidegger's hermeneutic circle to medical device security analysis — reading the whole to understand each part, and each part to refine understanding of the whole. Every assessment is self-consistent and reproducible.
We begin with MDS2 Section 2.1 — the device description — to establish whether the device is SaMD or hardware-dependent, how it connects to the network, what ePHI categories it handles, and who hosts it. This context governs every subsequent scoring decision.
Each MDS2 security section is scored in light of the established deployment context. N/A responses are evaluated contextually — hardware N/As carry no penalty, but security-capability N/As require justification against the risk posture.
As scoring progresses, compounding and mitigating relationships between control gaps are identified. A single gap rarely tells the full story — it is the intersection of multiple gaps that creates critical risk clusters demanding immediate remediation.
Deliverables tell a coherent story — from individual MDS2 question responses to holistic risk posture, with every finding cited to a specific Question ID. Reproducible to ±0.2 scoring variance by any qualified reviewer.
We exist at the precise intersection of clinical operations knowledge, regulatory depth, and offensive security methodology — a combination that generalist firms cannot replicate.
Every risk score is derived exclusively from the MDS2 document — no assumptions, no external data. Evidentiary basis is fully auditable and citation-traceable to individual Question IDs.
Our analysts understand the operational constraints of clinical environments. Recommendations never compromise patient care workflows — security and availability are co-designed, not traded off.
Every engagement produces both executive-level briefings for CISO and leadership decision-making and technical artifacts for engineering teams — from risk acceptance memos to NIST control mappings.
Deep familiarity with VA Medical Device Protection Program, Defense-in-Depth architecture, and MDIA isolation requirements. Purpose-built for federal healthcare network environments.
Our flagship offering delivers a complete inherent risk assessment derived exclusively from the manufacturer's MDS2 disclosure. Six weighted security categories produce a reproducible 0–5.0 risk score, with every finding traceable to a specific MDS2 Question ID.
Purpose-built network segmentation and isolation architecture for HDOs — from VLAN design and NGFW policy to full MDIA boundary implementation aligned with Medical Device Protection Program and HSCC HIC-MaLTS guidance.
End-to-end compliance program support from initial gap analysis to ATO documentation packages — covering HIPAA, FDA, NIST, and VA-specific requirements for medical device deployments.
Specialized security programs for connected healthcare IoT ecosystems — from bedside monitors and infusion pumps to HVAC and building automation systems that share the clinical network fabric.
Every engagement begins with a scoping conversation to understand your device portfolio, regulatory environment, and organizational risk appetite. We deliver a tailored proposal within 48 hours.