Tepia builds medical device companion apps for iOS and Android that pair with connected devices over Bluetooth Low Energy, show readings patients can act on, and sync data to a HIPAA aware cloud backend. The Bluetooth layer is written natively in Swift and Kotlin, and requirements, risks and tests stay traceable for your regulatory team.
A companion app earns trust when every reading arrives once, in order, with the right units and time, and the patient knows what to do next.
Tepia writes the Bluetooth layer in Swift and Kotlin so pairing, reconnection and background sync hold up across iPhone and Android models.
Read: IoT and Connected Device App Development
Over the air updates include battery checks, resumable transfers and version gates that keep the app and device firmware compatible.
Read: Remote Patient Monitoring App Development
Requirements, risks, test plans and results stay linked, so your quality team can move them into a design history file without rework.
Read: Bluetooth and BLE App Development
Tepia sends readings to clinician dashboards, Apple HealthKit, Health Connect or an EHR as FHIR Observations when your program needs it.
Figures Tepia keeps in mind when scoping a connected medical device app.
The CDC reports about 6 in 10 US adults live with at least one chronic disease, the group most home devices serve.
ONC reports 57 percent of people who accessed online medical records in 2024 used an app, up from 38 percent in 2020.
Tepia clients report apps averaging 4.5 stars on the App Store and Google Play, where device apps live or die by reviews.
A companion app sits between a physical device and the person relying on it. A glucose meter, a connected inhaler, a blood pressure cuff, a wearable ECG patch or a home infusion pump each speaks its own Bluetooth protocol, and the app has to pair once, reconnect quietly, and never drop or duplicate a reading. When a patient opens the app at 2 a.m. because a number looks wrong, the screen has to show the correct value, the correct time and a clear next step. Tepia treats that moment as the core requirement, not an edge case.
Data integrity is where most device apps fail quietly. Devices buffer readings while out of range, so the app must backfill them in order, keep the device timestamp alongside the phone timestamp, and cope with a device clock that drifted after a battery change. Units matter too: a value stored in mmol/L and displayed as mg/dL without conversion is a safety problem, not a cosmetic bug. Tepia writes these rules as user stories with acceptance criteria during Discovery so they get tested rather than assumed.
The app also serves more than one audience. Patients want a simple trend and reminders, caregivers may want shared access, clinicians want a dashboard that flags out of range values, and your support team needs device diagnostics such as battery level, firmware version and last sync time when a customer calls.
Whether your app is part of a regulated medical device depends on what it does, not on what you call it. FDA guidance on device software functions separates software that simply displays or stores data from software that analyzes it to drive treatment decisions. Your regulatory consultant makes that call, and Tepia builds the plan around their answer, because it changes documentation, testing depth and release cadence.
| App function | Typical regulatory posture | What it changes in the build |
|---|---|---|
| General wellness tracking, such as steps or sleep | Usually outside device rules | Standard release process and app store review |
| Displaying and storing readings from a cleared device | Often low risk, confirm with your regulatory lead | Traceable requirements and verified data transfer tests |
| Measurement or medication reminders | Usually low risk | Local notifications that survive phone restarts and time zone changes |
| Calculating a dose or flagging a condition | Likely device software, may need FDA clearance | Formal risk analysis, design controls and locked releases |
| Changing device settings or firmware | Part of the device itself | Validated update flows, rollback and version gating |
| Sending readings to a clinician dashboard | Depends on the alerts and analysis performed | HIPAA aware backend, audit logs and a BAA with the cloud host |
If the app falls under design controls, standards such as IEC 62304 for the software life cycle and ISO 14971 for risk management will shape how your team documents the work. Tepia keeps requirements, risks, test plans and results linked so your quality team can bring them into the design history file without reconstructing them later.
Bluetooth Low Energy behaves differently on every phone. iOS limits what an app can do in the background, Android manufacturers tune power management aggressively, and older Android versions handle bonding in ways that confuse users. Tepia usually builds the BLE layer natively in Swift and Kotlin, even when the rest of the interface is React Native or Flutter, because connection reliability is the feature patients notice first.
Hardware and firmware teams usually move on a different schedule from app teams. Tepia agrees a GATT specification and a shared test fixture early, so app development is not blocked waiting for production hardware.
Most companion apps feed something bigger. Tepia connects readings to the places patients and care teams already look:
Tepia has built hardware connected products before. The Maximum Controls apps for iOS and Android, with an admin portal, operate gates and IoT access devices in the field. The domain differs, but the lessons about pairing, offline behavior and firmware versions carry over. See our work and our IoT and connected device app page.
Every engagement follows Tepia’s six phases, with a US based project manager accountable from the first call.
Typically Discovery runs 1 to 3 months, development and QA 2 to 6 months, and launch about a month; apps under design controls sit at the longer end because of documentation. Read about our process or contact Tepia with your device specification.
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