Security
End-to-End Security for Connected Devices
We design and secure connected medical and consumer devices, from hardware through backend software.
Cross-Stack Security Architecture
Security decisions at one layer ripple across the system. We design security that holds end-to-end.
Usable Security by Design
Security designed around real workflows, strong without friction for patients, clinicians, and end users.
Engineers Who Implement
The engineers who design your security architecture build and harden it.
Regulatory-Ready Cybersecurity
We support the secure framework and submission-ready evidence the FDA requires.
Security in connected systems
A Connected System Has No Single Security Perimeter.
Firmware, wireless protocols, mobile applications, and cloud backends each introduce a distinct attack surface. A decision made in one layer ripples through every other. Security that creates too much friction introduces its own risk: clinicians and end users route around it.
We design security across the full stack, from device hardware to backend systems, so controls hold together end-to-end.
The Result: A connected product where security is coherent across every layer, defensible under regulatory scrutiny, and built to hold up in the field.
Security Problems We Solve
Security Vulnerabilities That Surface Late & Cost More to Fix
Security addressed layer by layer, without a system-level security design, leaves vulnerabilities that surface late and compound across the stack.
System Security Architecture
Component-level security leaves trust boundaries undefined across a connected system.
Common Scenarios:
- Threat modeling absent from early design decisions
- Trust boundaries undefined across firmware, mobile, and cloud
- Security assumptions inconsistent between development teams
- Attack surface growing as system layers integrate
- Security review is happening too late to influence the architecture
Wireless & Protocol Security
Connected devices communicate via protocols with attack surfaces that require purpose-built security.
Common Scenarios:
- BLE pairing models that allow unauthenticated connections
- Control channels without session integrity or replay protection
- Protocol-level vulnerabilities exposing device to man-in-the-middle attacks
- Unencrypted data transmission across wireless links
- Weak authentication between device and mobile application
Device & Firmware Security
Vulnerabilities introduced at the firmware layer are the most difficult to remediate after deployment.
Common Scenarios:
- Firmware running without signature verification or chain of trust
- Cryptographic keys stored in accessible flash memory
- Debug interfaces left exposed in production builds
- No rollback protection on firmware update paths
- Hardware attestation is absent from the device identity model
Compliance-Ready Cybersecurity
Security built without regulatory requirements in mind creates rework when cybersecurity gaps surface late in development.
Common Scenarios:
- Threat model not tied to design history file
- Creating deliverables without a SPDF means FDA rejection
- Security risk management siloed from overall risk management process
- No documented PSIRT or post-market vulnerability response plan
- Security requirements not traced through design and verification
Provisioning & Identity Security
Provisioning flows that are brittle, spoofable, or undocumented create security gaps that scale with every device shipped.
Common Scenarios:
- Device identity not established or verifiable at manufacturing
- First-use pairing flows that can be spoofed or intercepted
- Credential issuance with no rotation or revocation strategy
- Provisioning process that breaks down at production scale
- Decommissioning flows are absent or incomplete
Tell Us About Your Challenge
Cross-Stack Security Capabilities
Purpose-Built Security at Every Layer of a Connected Device
Each layer of a connected device has distinct security constraints, threat surface, and implementation requirements.
System Security Architecture
Security architecture work starts before any implementation decision is made.
We define the threat model, establish security requirements with full traceability, and produce the evidence plan that carries through to regulatory submission.
Key Capabilities:
Security Requirements, Risks & Evidence
- Security risk management integrated with ISO 14971 and IEC 62304 processes
- SPDF-aligned security planning, requirements development, and evidence documentation
- Security requirements traceability
- Security control validation planning aligned to V&V strategy
Security Architecture & Design
- Threat modeling using STRIDE and MITRE frameworks for connected device systems
- Attack surface analysis across the full connected device ecosystem
- Authentication, authorization, and encryption architecture across device, mobile, and cloud
- Key and credential lifecycle design
- Privacy controls and data protection architecture
- Third-party and SOUP security assessment and vulnerability management
V&V & Post-Market Readiness
- Security verification strategy aligned to requirements and DHF
- Penetration test readiness and scope definition
- OTA and patch strategy for deployed devices
- Monitoring and logging architecture for post-market surveillance
- Vulnerability intake, triage, and response planning
Wireless & Protocol Security
Every wireless protocol introduces a distinct attack surface with its own constraints.
We design pairing models, session integrity, and authentication specifically for connected device threat models across BLE, WiFi, and cellular, including multi-radio environments where protocol interactions create additional exposure.
Key Capabilities:
Bluetooth Low Energy Security
- Pairing model selection and authentication design for medical and consumer devices
- Session integrity and replay protection on low-power wireless links
- Encrypted data transmission within BLE timing and throughput constraints
- Advertisement and scanning attack surface hardening
- Man-in-the-middle protection for device-to-mobile communication
Multi-Radio & Protocol Security
- WiFi authentication and certificate management for connected device environments
- Cellular authentication and SIM security considerations
- Coexistence security across multi-radio devices
- Protocol-level attack surface reduction across BLE, WiFi, and cellular
Firmware & Hardware
Security at the hardware layer determines what every layer above it can rely on.
We establish root of trust, harden boot sequences, protect key material, and lock down update paths on resource-constrained devices where standard security assumptions don't apply.
Key Capabilities:
Boot & Firmware Integrity
- Secure boot and chain of trust on resource-constrained microcontrollers
- Anti-rollback version enforcement on firmware update paths
- Signed OTA update paths with staged rollout and rollback protection
- Memory protection and secure enclave configuration
Key Storage & Hardware Security
- Hardware-backed key storage on resource-constrained devices without integrated security processors
- Secure element integration for credential and certificate storage
- Hardware security module integration where device architecture supports it
- Secure manufacturing provisioning at the firmware layer
Hardening & Physical Security
- Debug interface hardening for production and post-market builds
- Tamper detection and physical attack resistance
- Binary protection against reverse engineering and extraction
Mobile Applications
Mobile sits at the intersection of device trust, user identity, and cloud access and carries PHI in regulated environments.
We implement security controls specific to iOS and Android that hold up in clinical and consumer workflows without creating the friction that invites workarounds.
Key Capabilities:
Device & Session Security
- Authenticated device pairing and session management for iOS and Android
- Jailbreak and root detection for regulated application environments
- Biometric authentication integration for device access and clinical workflows
- Binary protection and reverse engineering hardening
Data & Communication Security
- Secure local storage using platform Keychain and Keystore APIs
- Token lifecycle management for device control and cloud access
- Certificate validation and pinning for backend communication
- App transport security configuration
- PHI protection aligned to HIPAA and FDA privacy requirements
- Background data handling and process isolation
Backend Systems
Cloud security for connected devices isn't general infrastructure work. Device identity, credential lifecycle, and post-market vulnerability response require a purpose-built architecture
We design authentication, access control, and monitoring into the backend from the start.
Key Capabilities:
Authentication & Data Protection
- API authentication and authorization for device and user identity
- Identity and access management aligned to clinical roles and workflows
- PHI encryption at rest and in transit across cloud infrastructure
- Access control and audit logging for regulatory traceability
- Secrets management for backend services and integrations
- Anomaly detection and intrusion monitoring for connected device fleets
- Dependency vulnerability scanning and patch management
Provisioning & Identity
- Device identity provisioning and credential issuance at manufacturing
- Credential rotation, revocation, and decommissioning across the device lifecycle
- First-use onboarding flows designed to resist spoofing and interception at scale
System Security Architecture
Security architecture work starts before any implementation decision is made.
We define the threat model, establish security requirements with full traceability, and produce the evidence plan that carries through to regulatory submission.
Key Capabilities:
Security Requirements, Risks & Evidence
- Security risk management integrated with ISO 14971 and IEC 62304 processes
- SPDF-aligned security planning, requirements development, and evidence documentation
- Security requirements traceability
- Security control validation planning aligned to V&V strategy
Security Architecture & Design
- Threat modeling using STRIDE and MITRE frameworks for connected device systems
- Attack surface analysis across the full connected device ecosystem
- Authentication, authorization, and encryption architecture across device, mobile, and cloud
- Key and credential lifecycle design
- Privacy controls and data protection architecture
- Third-party and SOUP security assessment and vulnerability management
V&V & Post-Market Readiness
- Security verification strategy aligned to requirements and DHF
- Penetration test readiness and scope definition
- OTA and patch strategy for deployed devices
- Monitoring and logging architecture for post-market surveillance
- Vulnerability intake, triage, and response planning
Wireless & Protocols Security
Every wireless protocol introduces a distinct attack surface with its own constraints.
We design pairing models, session integrity, and authentication specifically for connected device threat models across BLE, WiFi, and cellular, including multi-radio environments where protocol interactions create additional exposure.
Key Capabilities:
Bluetooth Low Energy Security
- Pairing model selection and authentication design for medical and consumer devices
- Session integrity and replay protection on low-power wireless links
- Encrypted data transmission within BLE timing and throughput constraints
- Advertisement and scanning attack surface hardening
- Man-in-the-middle protection for device-to-mobile communication
Multi-Radio & Protocol Security
- WiFi authentication and certificate management for connected device environments
- Cellular authentication and SIM security considerations
- Coexistence security across multi-radio devices
- Protocol-level attack surface reduction across BLE, WiFi, and cellular
Firmware & Hardware Security
Security at the hardware layer determines what every layer above it can rely on.
We establish root of trust, harden boot sequences, protect key material, and lock down update paths on resource-constrained devices where standard security assumptions don't apply.
Key Capabilities:
Boot & Firmware Integrity
- Secure boot and chain of trust on resource-constrained microcontrollers
- Anti-rollback version enforcement on firmware update paths
- Signed OTA update paths with staged rollout and rollback protection
- Memory protection and secure enclave configuration
Key Storage & Hardware Security
- Hardware-backed key storage on resource-constrained devices without integrated security processors
- Secure element integration for credential and certificate storage
- Hardware security module integration where device architecture supports it
- Secure manufacturing provisioning at the firmware layer
Hardening & Physical Security
- Debug interface hardening for production and post-market builds
- Tamper detection and physical attack resistance
- Binary protection against reverse engineering and extraction
Mobile Application Security
Mobile sits at the intersection of device trust, user identity, and cloud access and carries PHI in regulated environments.
We implement security controls specific to iOS and Android that hold up in clinical and consumer workflows without creating the friction that invites workarounds.
Key Capabilities:
Device & Session Security
- Authenticated device pairing and session management for iOS and Android
- Jailbreak and root detection for regulated application environments
- Biometric authentication integration for device access and clinical workflows
- Binary protection and reverse engineering hardening
Data & Communication Security
- Secure local storage using platform Keychain and Keystore APIs
- Token lifecycle management for device control and cloud access
- Certificate validation and pinning for backend communication
- App transport security configuration
- PHI protection aligned to HIPAA and FDA privacy requirements
- Background data handling and process isolation
Backend System Security
Cloud security for connected devices isn't general infrastructure work. Device identity, credential lifecycle, and post-market vulnerability response require a purpose-built architecture.
We design authentication, access control, and monitoring into the backend from the start.
Key Capabilities:
Authentication & Data Protection
- API authentication and authorization for device and user identity
- Identity and access management aligned to clinical roles and workflows
- PHI encryption at rest and in transit across cloud infrastructure
- Access control and audit logging for regulatory traceability
- Secrets management for backend services and integrations
- Anomaly detection and intrusion monitoring for connected device fleets
- Dependency vulnerability scanning and patch management
Provisioning & Identity
- Device identity provisioning and credential issuance at manufacturing
- Credential rotation, revocation, and decommissioning across the device lifecycle
- First-use onboarding flows designed to resist spoofing and interception at scale
Security Across Disciplines
Security Applied at Every Layer of the Stack
Security isn’t a parallel workstream. It’s embedded in how we architect firmware, design mobile apps, build cloud systems, and design hardware.
Systems Architecture
Threat modeling, trust boundary definition, and attack surface analysis are applied at the system level before any layer begins implementation.
Explore Capabilities
Electronics
Secure element integration, tamper resistance, and manufacturing provisioning designed into hardware architecture before implementation begins.
Explore Capabilities
Embedded Software
Secure boot, key storage, debug interface hardening, and signed update paths built into firmware architecture from project start.
Explore Capabilities
Mobile Apps
Device pairing, session management, PHI protection, and certificate validation designed into iOS and Android application architecture.
Explore Capabilities
Web Apps & Backends
API authentication, device identity, PHI encryption, and access control built into cloud infrastructure before implementation begins.
Explore Capabilities
Our Process
Security Engineered Into Every Phase of Development
Security stays coherent across the stack when each phase builds on the decisions made before it. Here’s how that looks in practice across a full engagement.
1. Discovery & Security Posture Review
We assess existing security posture, identify applicable regulatory requirements, and define the risks that matter before any security decisions are made.
2. Threat Model & Security Requirements
We translate identified risks into documented controls, with traceability from threat to requirement to design decision, that integrate with IEC 62304 processes and the design history file from the start.
3. Architecture & Design
We define trust boundaries, identities, data flows, and key and credential lifecycle across the full connected system. Security architecture decisions are made at the system level before implementation begins.
4. Implementation & Hardening
The engineers who designed the security architecture implement controls across hardware, firmware, mobile, and backend systems. Static analysis, secure coding review, and layer-by-layer hardening are part of implementation and not a separate gate at the end.
5. Verification, Validation & Evidence
We execute security verification, produce traceability matrices and audit evidence, and prepare the documentation package that supports regulatory submission. Findings that surface here loop back into architecture and implementation decisions.
6. Post-Market & Vulnerability Management
We establish monitoring posture, vulnerability triage processes, and coordinated disclosure practices so the device remains defensible after it ships.
What you get
Built to Defend at Every Critical Moment
Security built into the development process puts you in a fundamentally different position at submission, launch, and beyond.
A Defensible Regulatory Submission
We build threat models, security risk management, and SBOM with traceability for a complete Design History File (DHF). Cybersecurity evidence exists when the product is developed, not assembled retroactively.
Security Coherent Across the Full Stack
We define trust boundaries at the architectural level and implement controls at each layer, with verification evidence produced at each phase. Every layer holds up under scrutiny because every layer was designed in the context of the others.
Post-Market Defensibility Built In
We establish SBOM, patch strategy, vulnerability intake, and PSIRT documentation during development. The product remains defensible as threats evolve, dependencies age, and post-market surveillance requirements grow.
Security Carried Through Implementation
The engineers who define the security model implement it across hardware, firmware, mobile, and backend systems. Design intent and execution stay aligned with no translation layer between security architecture and the controls that actually ship.
Security Designed Around Real Workflows
We build authentication flows, pairing models, and access controls around clinical and end-user behavior. Security that creates excessive friction introduces its own risk.
Selected work
Security Architecture Across the Hardest Device Classes
Implantables, clinical platforms, and complex connected systems where the stakes made security non-negotiable.
Inspire Medical
End-to-End Security for an FDA-Approved Class III Implantable Sleep Apnea System
Security design and implementation across multiple generations of the Inspire system, spanning BLE, inductive telemetry, cloud communication, and data at rest. Work included authentication, encryption, keystore management, and OTA firmware update security — delivered across a commercially deployed system supporting patients worldwide.
Implantable Medical Device
Neuromodulation
Sleep Apnea
IEC 62304
FDA Approved
FDA Class III
Connectivity Architecture
Systems Integration
Cybersecurity
BLE
Inductive Telemetry
Synchron
Cybersecurity Architecture for a Brain-Computer Interface Implant System
Custom cybersecurity architecture and implementation for Synchron's BCI, spanning the implant, external devices, and a multi-stakeholder connectivity model serving patients, caregivers, and clinicians. Designed to meet implant constraints — safety, reliability, longevity — on a path toward large-scale studies and commercialization.
Implantable Medical Device
Neuromodulation
Paralysis
BCI
FDA Class III
IEC 62304 Class C
Systems Integration
Connectivity Architecture
BLE
Cybersecurity
ANONYMOUS
Security Architecture for a Large-Scale Connected Building Automation System
Security designed from the ground up for a commercial building automation platform managing tens of thousands of connected devices across complex facilities. Threat modeling, custom authentication and privacy controls, and multi-protocol connectivity architecture spanning BLE and Wi-Fi, which is built to hold in high-density RF environments with offline operation requirements.
Smart Building System
Commercial Facilities
BLE
Wi-Fi
Systems Architecture
Multi-Protocol Connectivity
Cybersecurity
Threat Modeling
Sensydia
Cybersecurity Architecture for a Clinical-Stage Cardiac Performance Platform
Cybersecurity risk reduction across a multi-component cardiac platform ahead of active clinical studies, spanning embedded Linux gateway hardening, BLE communication security, and AWS cloud. Architecture designed to protect PHI and proprietary algorithms while aligning with FDA cybersecurity expectations and supporting a path to commercialization.
Clinicial Measurement Platform
Cardiology
Cardiac Performance Assessment
IEC 62304 Class B
FDA Submission
BLE
AWS
Embedded Linux
FDA Cybersecurity Guidelines
Clinical Stage
Cybersecurity
Security Requirements Aren't Getting Simplier
Let’s talk about where you are and what’s ahead.
1. Quick Discovery Call
Share what you’re building, timelines, and constraints. We’ll confirm fit and the next best step.
2. Team Consultation
We dig deeper into technical challenges, needs, and where we can add the most value.
3. Scope & Kickoff
We align on milestones, documentation, and delivery. Then we get moving and keep you informed.
We reply within 1-2 business days. NDA available.
