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CONNECTED DEVICES · DEVICE-TO-CLOUD · NEX PLATFORM



Connected Device Platforms — End-to-End Engineering for Hardware-Plus-Software Medical Products

A connected medical device platform is the full system: sensor, firmware, mobile app, cloud, clinician dashboard, engineered to work as a unified product, not as four separate ones bolted together.
Sequenex partners with hardware companies and digital health teams to deliver the platform end-to-end, with the NEX Platform accelerating the regulatory groundwork that would otherwise take six to nine months to build from scratch.
Talk to a Platform SpecialistSee the NEX Platform
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End-to-End Engineering for Connected Medical Device Platforms

A connected medical device platform isn't a single product; it's a system. Sensors connect to firmware. Firmware streams data to mobile applications. Mobile applications synchronize with cloud infrastructure. Cloud services power data dashboards, administrative portals, analytics, and integrations. Sequenex builds every layer, including the integration points where most connected device programs struggle.

  • 01

    Firmware & Connectivity

    Custom firmware for biosensors, wearables, and connected medical devices, with BLE, NFC, WiFi, and cellular connectivity built for real-world reliability, not lab conditions.
    • Embedded C/C++ firmware on medical-grade microcontrollers, optimized for the power budget your device actually has
    • BLE pairing that holds across the connectivity scenarios real patients encounter, not just the ones QA can reproduce
    • Cellular fallback for environments where WiFi isn’t reliable — implementations that have shipped in commercial products
    • Secure boot, signed firmware updates, and OTA delivery engineered for production deployment, not just dev devices 
    • Multi-protocol logic so connectivity degrades gracefully instead of failing catastrophically

  • 02

    Mobile & Companion Apps

    Native iOS and Android applications that integrate with connected devices, transmit clinical data, and present it to patients and clinicians, built to your wireframes, brand, and HF/UE design.
    • Native iOS in Swift, native Android in Kotlin, where the platform differences matter
    • Cross-platform via Flutter or React Native, where the engineering tradeoff favors shared code
    • Bluetooth integration tested across the real device matrix that patients actually use
    • Patient-facing UX designed for engagement and validated against the FDA HF/UE methodology, as the FDA expects
    • Clinician-facing views built to your workflow requirements, with the API foundations in place for the integrations and features you need

  • 03

    Cloud Infrastructure & Integration

    HIPAA-ready cloud infrastructure for connected medical device data, built on a foundation that supports clinical-grade scale, audit logging, and the API surface for EHR integration when your project needs it.
    • Backend data architecture designed for medtech, deployed to your AWS environment under your operational control
    • architected to support HIPAA and GDPR compliance requirements
    • Real-time ingestion architected to scale with your device population as it grows
    • RBAC and audit logging architected for the regulatory questions you’ll get asked, not the ones you hope to avoid

  • 04

    Platform Acceleration with NEX

    The NEX Platform delivers prebuilt iOS and Android apps, patient and clinician dashboards, an admin portal, and secure cloud, all engineered under IEC 62304 within an ISO 13485-certified QMS.
    • iOS and Android companion apps ready to brand and customize
    • Patient and clinician dashboards built on a foundation ready to extend with the workflow features your project requires
    • Administrator portal for system management, user provisioning, and audit access
    • Cloud infrastructure pre-engineered for HIPAA and ready to deploy in your AWS or Azure environment
    • Six to nine months of engineering scaffolding inherited, not rebuilt
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WHY SEQUENEX



How Sequenex Connected Device Platforms Reach Market Sooner

Hardware teams build great hardware. Software teams build great software. The integration between them is where months get lost, pairing reliability, data sync, error recovery, OTA updates, version compatibility. That integration is what Sequenex actually specializes in. It’s the work that happens between the disciplines, and it’s where most connected device programs get stuck.

Building the iOS app, Android app, cloud, patient and clinician dashboards, and admin portal from scratch, under IEC 62304, inside an ISO 13485 QMS, takes six to nine months before clinical features even start. NEX delivers all of that prebuilt. Your team inherits the regulatory scaffolding instead of recreating it.

Connected platforms in diabetes care, biosensors, CGM, and connected drug delivery aren’t theoretical for us. Our team has deep subject matter expertise in these product categories, across BLE pairing reliability, calibration drift handling, and the integration patterns that determine whether a connected device makes it through clinical adoption. Every new program benefits from a team that already knows where the sharp edges are.

Most connected device programs stall in the same place: the software is ready, the hardware isn’t. Through deviceless development and device simulators, Sequenex builds, tests, and documents the software before the device is finished. Your validation evidence and documentation move forward now, not after the hardware ships.

Talk to a Platform Specialist
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Built for Scale, Designed for Compliance

Every connected platform we build is engineered under the rigor of our ISO 13485-certified QMS, with cybersecurity artifacts, V&V evidence, and engineering documentation produced as the engineering work happens — a process we call continuous delivery / continuous compliance, applied across firmware, mobile, cloud, and integration layers.

Sequenex develops software, documentation, verification evidence, cybersecurity artifacts, and engineering deliverables that support the manufacturer's regulatory strategy and submission activities.

Platform Architecture

Connected Device → Mobile Apps → Secure Cloud → Dashboards → APIs & Integrations
Advanced analytics
ConnectivityBLE, NFC, WiFi, Cellular (4G/5G)
Custom branding
Cloud & IntegrationHIPAA-ready cloud, GDPR-aligned architecture, REST APIs, and integration-ready design for customer and third-party systems
Storage integrations
AI assistant
Automated reports
Platform FoundationPrebuilt mobile apps, cloud services, Admin Portal, dashboards, device & user management, notifications, and data visualization

Ready to Build a Connected Medical Device Platform?

Whether you're a hardware company adding software for the first time, or a software team integrating regulated connected hardware, the conversation worth having is what your stack actually needs. Let's have it.
SaMD and Connected Devices Software Experts
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