Systems
End-to-End System Design For Connected Devices
System requirements, architecture, and risk management across firmware, hardware, mobile, and cloud. Regulatory traceability built in from day one.
Technical decisions validated against real user needs and business outcomes.
Architecture designed from hardware realities outward.
System designers implement their own architecture, ensuring practical decisions.
FDA and compliance requirements embedded in architecture decisions.
Problems We Solve For
System Challenges That Derail Connected Device Programs
We architect connected device systems with cross-stack planning to prevent integration failures, security gaps, and performance issues.
System Integration Failures
When device, mobile, and backend are designed separately, integration problems emerge late.
› Common Scenarios
- ›Device, mobile, and backend teams building against incompatible assumptions
- ›State synchronization breaking across offline/online transitions
- ›Commands not reaching devices reliably
- ›OTA updates that work in testing but fail in production
- ›API versioning conflicts discovered during integration
Security & Compliance Risks
Security designed in isolated layers instead of across the full stack creates vulnerabilities.
› Common Scenarios
- ›Security boundaries that don't align across the stack
- ›Authentication failing between layers
- ›Key management and encryption strategy gaps
- ›Regulatory review finding system-level gaps too late
Performance & Scalability Issues
Isolated technical decisions across components compound into system-wide performance constraints.
› Common Scenarios
- ›Latency budgets that don't add up across device/mobile/cloud
- ›Power and battery constraints compounding across system design
- ›Data flows that bottleneck under real-world conditions
- ›Cloud infrastructure costs scaling beyond projections
Unidentified Technical Assumptions
Without cross-stack visibility, critical technical assumptions go unvalidated until integration.
› Common Scenarios
- ›Critical technical paths unvalidated until integration
- ›Technology selections that don't work together
- ›Requirements conflicts discovered during integration
- ›Regulatory implications of technical decisions surfacing too late
Our Systems Approach
Architecting Device, Mobile, and Cloud as One Integrated System
We produce the traceability matrices, design rationale, and interface specifications that regulators expect, and maintain them as living documentation.
The specialist problem
Most connected device companies split the work across separate teams for hardware, firmware, mobile, and cloud. Coordination meetings are supposed to keep everyone aligned. But when an app decision affects device battery life, or cloud APIs can't support what the device needs, or security gaps fall between teams, the cracks show up fast.
How we design differently
We start by figuring out how devices, mobile, and cloud will work together before anyone writes code. Where does processing happen? How does data move through the system? How do components communicate?
Every technical decision considers the full picture: what the device hardware can handle, how the mobile app needs to perform, what cloud infrastructure can scale to, where security controls need to be, and what documentation will be required for regulatory review.
Regulatory Traceability
Requirements, design decisions, and test evidence are linked from day one — giving you a complete audit trail for IEC 62443, FDA, or CE submissions. Our workflows are built around regulated-industry standards, so compliance is woven into the process rather than retrofitted at the end. Comprehensive design documentation and test reports satisfy auditors and give your internal teams confidence in the delivered system.
The Results
Teams can build simultaneously because they know how their work connects.
Integration issues get caught early when they're easy to fix. When it's time for regulatory submission, the architecture documentation and design rationale are already there. And the system works reliably in real-world conditions because we designed it for actual constraints from the start.
Team Alignment Isn't System Integration
Tell us how your program is structured, and we'll help you find where the gaps are.
Quick Discovery Call
Share what you're building, timelines, and constraints. We'll confirm fit and the next best step.
Team Consultation
We dig deeper into technical challenges, needs, and where we can add the most value.
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.