Systems

End-to-End System Design for Connected Devices

We architect devices, mobile, and cloud as one system for regulated medical devices, digital health, and connected products.

Discuss Your System Design Challenge
A group of medical devices like an implant, mobile phone, and a laptop display patient data while wirelessly signaling each other.
Requirements Drive Integration
Technical decisions validated against real user needs and business outcomes.
Device Constraints Shape the Stack
Architecture designed from hardware realities outward.
Engineers Who Architect
System designers implement their own architecture, ensuring practical decisions.
Regulatory From Day One
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.

Electronics Antenna Design Icon with white background

System Integration Failures

When device, mobile, and backend are designed separately, integration problems emerge late.
  • 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
Embedded Product Security Icon with white background

Security & Compliance Risks

Security designed in isolated layers instead of across the full stack creates vulnerabilities.
  • 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
Embedded Device Functionality Icon with white background

Performance & Scalability Issues

Isolated technical decisions across components compound into system-wide performance constraints.
  • Latency budgets that don’t add up across device/mobile/cloud
  • Power and battery constraints are compounding across system design
  • Data flows that bottleneck under real-world conditions
  • Cloud infrastructure costs are scaling beyond projections
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Unidentified Technical Assumptions

Without cross-stack visibility, critical technical assumptions go unvalidated until integration.
  • Critical technical paths are unvalidated until integration
  • Technology selections that don’t work together
  • Requirements conflicts discovered during integration
  • Regulatory implications of technical decisions surfacing too late
Tell Us About Your Challenge

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.

A diagram of a cloud connected medical system.

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.

What this looks like in practice

When we architect device-to-cloud communication:

  • Updates work in the field without breaking devices already deployed
  • The app handles spotty connectivity and syncs reliably when connection returns
  • Security works as one system, from initial device setup through cloud data storage
  • Performance accounts for Bluetooth timing, cellular realities, and battery constraints
  • Design decisions are documented with the rationale regulators need to see
Vignette of hands on engineering partnership
An illustration of a man looking at his phone with his dog by his side. There is a health impant in his body with wireless signals connecting to the phone while a doctor looks at a dashboard of health metrics.

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.

System Architecture Expertise

From Edge Processing to EHR Integration

Technical evaluators often ask if we’ve solved problems like theirs. Here are system integration patterns we’ve architected across multiple connected device programs.

Icon showing data flow from embedded system to mobile app

Data Acquisition & Edge Processing

Edge architectures for signal integrity, preprocessing, compression, and efficient relay under bandwidth or power constraints.
Icon representing device-to-cloud data pipeline through mobile app.

Store-and-Forward via Mobile/Gateway

PHI-safe buffering with idempotent delivery, replay protection, and offline resilience.
Bidirectional data exchange between device and app.

Provisioning & Device Control

Secure provisioning, authenticated pairing, and configurable calibration and control flows within regulatory bounds.
Device-to-Cloud OTA configuration pipeline

OTA & Configuration Pipeline

Staged, signed updates with rollback and audit support to meet safety and cybersecurity requirements.
Device streaming data through cloud to external system.

EHR/HL7/FHIR Integration

Validated HL7 and FHIR interoperability, including clinical data mapping and secure transport.
Synchronization among multiple connected devices.

Multi-Device Coordination

Coordinated timing across devices with clock sync, jitter management, and tolerance handling.
Discuss Your Architecture Needs

System Integration In Practice

Integrated Systems Across Our Capabilities

Systems thinking isn’t separate from our technical work; it’s embedded in how we deliver capabilities across the stack and cross-cutting concerns.

Our Systems Engineering Process

Requirements, Architecture, and Validation as Connected Disciplines

We produce the traceability matrices, design rationale, and interface specifications that regulators expect, maintained as living documentation.

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Architecting integrated systems requires disciplined requirements management, traceability, and validation planning. Our systems engineering process ensures that technical architecture decisions connect to user needs, that risk controls link to the design rationale, and that validation evidence supports regulatory submissions.
Explore Our Development Methodology

Selected work

Systems We've Architected & Built

Each of these connected systems required formal boundaries, traceability, and integration across devices, apps, and the cloud. Here’s the architecture complexity we’ve solved.

Patient using the Inspire Sleep Apnea Therapy System, with implantable device, handheld remote, and mobile app display for tracking therapy and sleep duration.
Inspire Medical

FDA-Approved Implantable Therapy for Obstructive Sleep Apnea

End-to-end connectivity architecture and security for a Class III implantable system, spanning device, remote, programmer cable, mobile, and cloud. Supported systems engineering and cross-domain integration from system design through FDA submission and global commercial launch.
Implantable Medical Device
Neuromodulation
Sleep Apnea
IEC 62304
FDA Approved
FDA Class III
Connectivity Architecture
Systems Integration
Cybersecurity
BLE
Inductive Telemetry
Illustration of Synchron’s brain-computer interface system, showing a neurotech implant connected from the brain to a chest-worn device, with a zoomed-in view of the brain-embedded stent-electrode array.
Synchron

Implantable Brain-Computer Interface for Patients with Paralysis

Connectivity architecture and security for a Class III implantable brain-computer interface, designed to serve patients, caregivers, and clinicians through a complex multi-stakeholder connected system. Engaged during second-generation device development to define the architecture for larger studies and eventual commercialization.
Implantable Medical Device
Neuromodulation
Paralysis
BCI
FDA Class III
IEC 62304 Class C
Systems Integration
Connectivity Architecture
BLE
Cybersecurity
Osprey Medical’s DyeVert PLUS contrast reduction system, showing the catheter interface and monitor display used to reduce contrast dye exposure during procedures.
Osprey Medical

In-Hospital Contrast Delivery Equipment for Angiography Procedures

System architecture for a next-generation connected cath lab platform, including device and platform selection, MDM integration, and coordination with hospital Operations and IT stakeholders. System-level recommendations drove cost reduction, improved reliability, and enabled remote device management through 510(k) clearance and market launch.
Connected Clinical Device
Contrast Management
Cath Lab
FDA Class II
510(k) Cleared
IEC 62304
Systems Integration
MDM
Connectivity Architecture
Wi-Fi
BLE
Case Study Hero Flowiq
Flow IQ

Spectroscopy-Based Personal Urinalysis Device

System requirements governance bridging client product vision and R&D partner technical specifications for a novel spectroscopic urinalysis prototype. Delivered an extensible serial firmware interface and Interface Control Document supporting future development, alongside a functional proof of concept with protected IP at the pre-seed stage.
Connected Clinical Device
Urology
Spectroscopic
Systems Architecture
Prototype Development
Sensor Integration
Case Study Hero Conduit
ANONYMOUS

Connected Automation System for High-Density Commercial Buildings

Full system architecture for a multi-protocol connected building automation platform, from needs discovery and real-world concept validation through full development. Custom wireless testing tools validated performance in high-density RF environments before committing to development. Security architecture included threat modeling and custom controls for a system managing large numbers of connected devices across complex facilities.
Smart Building System
Commercial Facilities
BLE
Wi-Fi
Systems Architecture
Multi-Protocol Connectivity
Cybersecurity

Let's Discuss Your System Architecture Needs

Whether you’re simply exploring system architecture options or ready to engage on a project, here’s how we start the conversation.

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1. Quick Discovery Call

Share what you’re building, timelines, and constraints. We’ll confirm fit and the next best step.

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2. Team Consultation

We dig deeper into technical challenges, needs, and where we can add the most value.

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3. Scope & Kickoff

We align on milestones, documentation, and delivery. Then we get moving and keep you informed.

Start a Conversation
We reply within 1-2 business days. NDA available.

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How can we help?

Share a few details about your project or challenge. We’ll confirm fit and the next best step within a couple of business days. NDA available.

Person fotoJason SheardTina Hanley
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