FOCUSHEART – TWO-LEAD ECG MONITOR
Wearable Chest Device to monitor cardiac health in real time
CATEGORY
- Wearable
- Health Tech
- IoT
Raj S.
QSystems AI
SERVICES
- Feasibility & Product Design
- Full-Cycle Product Design
- Hardware & PCB Design
- Mechanical Design
- Firmware Development
- EVT, DVT, PVT
PROJECT TIMELINE
THE CHALLENGE
Digital creatives often work long hours under stress, yet they lack a comfortable, unobtrusive way to monitor cardiac health in real time. FocusHeart had to deliver: Two-Lead ECG Recording with clinic-grade accuracy, yet zero chest-strap discomfort. Continuous 100-Hour Monitoring without electrode degradation or skin irritation. Reusable Electrodes that maintain low impedance over dozens of uses. Placement Guidance via bio-impedance measurement to confirm proper chest contact. Seamless Connectivity over BLE to a companion mobile app. One-Tap Pairing with NFC, no manual setup.
- ECG Recording: Two-lead, clinic-grade accuracy, no chest-strap discomfort.
- Monitoring Duration: Continuous 100-hour monitoring, no skin irritation.
- Electrodes: Reusable, low impedance, 50+ uses.
- Placement Guidance: Bio-impedance measurement for proper contact.
- Connectivity: BLE to mobile app, NFC one-tap pairing.
KEY HURDLES
- •Preventing motion artifacts during typing or on the move.
- •Balancing high-sample-rate ECG acquisition with battery longevity.
- •Ensuring electrode adhesion and signal quality over multi-day wear.
- •Delivering an intuitive mobile UX that non-clinicians can trust.
THE OPPORTUNITY
Monitoring heart dynamics—heart-rate variability and arrhythmia patterns—helps creatives manage stress and optimize productivity. FocusHeart transforms the chest into a 'focus sensor,' empowering users to:
- Detect early signs of fatigue or stress.
- Receive guided breath-and-posture exercises when irregularities appear.
- Archive personal ECG trends alongside writing or design sessions.
FEATURE SETS
- •Two-Lead ECG Front-End – AD8232 AFE with FDA-certified B-Secure algorithm
- •100-Hour Runtime – 1,000 mAh rechargeable cell with intelligent power management
- •Reusable Silicone Electrodes – Washable pads rated for 50+ sessions
- •Bio-Impedance Placement Check – Confirms electrode contact before each session
- •BLE 5.0 Wireless – Streaming ECG data to iOS/Android app
- •NFC Tap-to-Pair – One-touch device registration
- •Compact Form Factor – 60 × 40 × 10 mm, 30 g total weight
- •AES-128 Encryption – Secure storage & transmission of ECG traces
- •IP54-Rated – Sweat- and splash-resistant
GALLERY
THE SOLUTION
Axio Electronics delivered a wearable ECG monitor with clinic-grade accuracy, all-day comfort, and seamless mobile integration.
Two-Lead AFE + B-Secure
AD8232 AFE with real-time FDA-certified algorithm
100-Hour Battery
Power-save MCU modes and smart sampling
Reusable Electrodes
Medical-grade silicone pads, 50+ reuse cycles
BLE 5.0 Connectivity
250 Hz streaming ECG to mobile app
Bio-Impedance Check
Confirms proper skin contact before recording
NFC One-Tap Pairing
Instant link to user's app profile
AES-128 Encryption
Secure at-rest and in-transit ECG data
IP54 Protection
Sweat and light splashes won't interrupt monitoring
OUR APPROACH
Mechanical Engineering Strategy
Slim, Breathable Housing in matte ABS for comfort beneath clothing.
Low-Profile Electrode Mounts to minimize movement during typing or walking.
Vent Channels to prevent heat buildup on the chest.
Mechanical Engineering Process
CAD modeling to refine grip and button ergonomics
SLA prototypes for fit and electrode alignment
Wear trials to validate breathability and adhesion
Final tooling for injection molding and overmold sections
PCB & Hardware Design
Nordic nRF52810 BLE SoC for low-power wireless
SSD1306-compatible OLED driver IC
Custom haptic motor driver with 1 Vpp control
Micro-USB charging port with Li-Po protection
200 mAh coin-cell-style Li-Po battery and fuel gauge
NXP NTAG for NFC functionality
Firmware Design
Real-Time DSP: B-Secure algorithm computes HR, HRV, arrhythmia flags
Artifact Rejection: Adaptive filter rejects motion noise
Session Management: Auto-start when bio-impedance is acceptable
Data Sync: Background upload of buffered ECG when in range
User Alerts: Haptic pulses for out-of-range events
OTA Updates: Secure firmware upgrades via the mobile app
In-House Prototyping & Validation
Fit & Form: Prototypes tested by 12 writers during 8-hour sessions
Bench Testing: ECG accuracy vs. clinical simulator, artifact stress tests
EVT: Verified IEC 60601-2-47 ECG performance, IP54 sealing
DVT: Two-week home trials with 20 digital nomads—refined button timing and UI text
PVT: 200-unit pilot run; automated test jig for display, haptic response, BLE connectivity
CHALLENGES
- Motion Artifacts— Introduced capacitive shielding and dynamic filter thresholds
- Electrode Delamination— Switched to fluorosilicone adhesive backing
- Battery Drain Spikes— Optimized BLE duty cycle and deep-sleep transitions
- User Misplacement— Enhanced impedance-map wizard with color cues
PILOT & PRODUCTION
PILOT & PRODUCTION
Beta Program: 50 creatives in three markets, 98% compliance, zero adverse skin reactions. BOM Optimization: 12% cost reduction via local electrode supplier. Regulatory: CE-marked under MDD; FDA 510(k) clearance anticipated Q4 2025. Manufacturing Test Jig: Automated gain, offset, impedance check, and BLE range.
Beta Program: 50 creatives, 98% compliance, zero adverse skin reactions
BOM Optimization: 12% cost reduction via local electrode supplier
Regulatory: CE-marked under MDD; FDA 510(k) clearance anticipated Q4 2025
Manufacturing Test Jig: Automated gain, offset, impedance check, and BLE range
How It Works
Attach FocusHeart above the sternum and strap around torso
NFC-Tap to pair instantly with mobile app
Begin Session—auto-start when impedance is in range
Monitor in App—live ECG waveform, HR/HRV stats, stress alerts
Sync Session automatically with your mobile app
WHAT CAN
WE CREATE
TOGETHER
DOWNLOAD THE FOCUSHEART CASE STUDY (PDF)
Client Testimonial
Raj S.
QSyastem AI
FocusHeart blends clinic-grade ECG accuracy with true all-day comfort. It's changed how I manage stress during long writing sessions.
Axio Electronics