Wearable Electrocardiogram (ECG) Monitor

Four generations. Fourteen years. FDA-approved cardiac monitors now used by patients at the Mayo Clinic. What began as a hardware engagement became one of Device Solutions' longest and most technically demanding client relationships, spanning antenna design, firmware, wireless architecture, wireless charging, and full regulatory certification across every product generation.

For cardiac patients recovering from surgery or undergoing diagnostic evaluation, continuous heart rhythm monitoring is not optional. It is the clinical standard that catches dangerous arrhythmias before they become emergencies. In 2009, that monitoring happened in hospitals. The client set out to change that: an ambulatory ECG that could continuously record and relay a patient's heart rhythms from home, giving physicians real-time data and alert capability without requiring hospitalization.

The technical challenges were significant and compounding. Power budgets were tight, since a wearable cardiac device must run continuously without burdening the patient. Wireless performance in home environments is unpredictable. Cellular standards were evolving, requiring the hardware architecture to adapt across generations. And every generation had to clear FDA, FCC, and carrier certification before it could reach a single patient.

The client had a capable internal development team. What they needed was an engineering partner who could own the hardest technical problems across every product cycle, not as a contractor filling gaps, but as a firm with enough depth to carry the work from concept through certification.

The Solution

Device Solutions took ownership of the most technically demanding elements of the product across all four generations, working alongside the client's internal team and expanding scope with each product cycle as the technical complexity grew.

The work covered the full embedded and wireless stack:

1.) Custom Antenna Design Engineered on-body antennas meeting FCC requirements within the constraints of curved enclosures and tight mechanical housing, across each generation of the device.

2.) Wireless Architecture Designed and evolved the full wireless architecture across four generations, transitioning connectivity from 2G through 3G to 4G LTE while maintaining power efficiency and data reliability. Device Solutions worked directly with chip vendors including Nordic, STMicroelectronics, and Telit to resolve throughput challenges at each transition.

3.) Wireless Charging Integration Designed the dockable gateway system in the latest generation, enabling wireless charging of the detachable ECG sensor without interrupting monitoring.

4.) Hardware and Firmware Owned hardware design and development across all generations. Took full firmware ownership on multiple product iterations, with scope defined by program needs rather than client gaps.

5.) Regulatory Certification Led every generation through a full certification stack: FDA, FCC, EN60601, PTCRB, and T-Mobile carrier approval. Pre-testing and validation preparation handled by Device Solutions to minimize submission delays.

The Results

Four generations of FDA-approved ambulatory ECG monitors are in active clinical use, including at the Mayo Clinic. Each generation has extended the capability of the last: from basic cellular transmission to real-time alerts, Bluetooth-based wearable sensors, wireless charging, and full regulatory approval across U.S. and European markets. Thousands of patients are monitored continuously on devices that Device Solutions helped design, certify, and bring to market.

Our 14-year relationship is active. New concepts are already in early development.

The Summary

Technologies & Services

• Hardware Design & Prototyping

• Embedded Firmware Development

• Custom Antenna Design

• Wireless Architecture: BLE, 2G / 3G / 4G Cellular

• Low-Power Design & Battery Optimization

• Wireless Charging Integration

• Certification Support: FDA, FCC, EN60601, PTCRB, T-Mobile

• Production Testing & Launch Support

Recognition & Outcomes

• Four generations of FDA-approved ambulatory ECG monitors delivered

• Devices in active clinical use at the Mayo Clinic

• Full regulatory certification achieved across U.S. and European markets

• 14-year client relationship active with next-generation development underway