SmartMedics - A reinvented 12-lead ECG system

Concept design

We worked with the customer to prioritize product requirements. We did this by weighing the design implications versus the business value. For example features like continuously informing the user through LED’s about the device status have an impact on battery consumption, requiring a larger battery.

The main use case asks for the device to be as small and light as possible which requires a small battery. We scoped the device to an MVP and a final product, this allowed us to deliver the product much faster and meet the business requirements of the customer.

System design

After clarifying and removing ambiguity from the requirements we selected a HW platform to support the requirements and created a system architecture. One of the challenges was to be able to support the high data rate to transport and process all the sensor data while using a low power wireless connection.

We chose Bluetooth Low Energy for transmitting the data as it enabled us to maximize the data throughput while being power efficient. We leveraged the power optimized features of the BLE component and applied it to function as the main controller of the device. The design had to be made really power efficient to support a run time of at least 24 hours, allowing a full day recording and processing of ECG data.

Implementation

We faced the challenge of designing a compact device capable of withstanding high-energy defibrillation surges, which typically require large components and significant PCB space. By selecting the right components and optimizing PCB technology, we achieved a streamlined design. Close collaboration between hardware and mechanical designers was essential to create an easy-to-use attachment and detachment mechanism with minimal patient force, using a specialized locking system with pogo pins.

Certification played a crucial role, influencing our software development strategy. With CE and medical certifications already scheduled, we prioritized hardware certification, initially developing minimal software for testing and later creating a mobile app that utilized this certified software.

The design features Nordic nRF52 series microcontrollers with BLE for data transmission and an ST microcontroller for processing ECG data. Onboard FLASH memory supports local data storage, and the design includes power management options to optimize battery use and size.

12-lead ECG Patch & ECG Pebble Recorder

The Patch includes 10 prepositioned printed electrodes (12-lead). No medical knowledge is required for proper application. Flexible and medical compliant materials do not restrict moves and a gentle adhesive keeps the Patch stick to the body.

Compact wireless wearable pebble that connects to the 12-lead ECG Patch and records a hospital-grade ECG signal. Up to 24 hrs of recording and full defibrillation-proof. Recorded data is transmitted to the SmartMedicsECG App via Bluetooth.

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At any time. Anywhere. By anyone.

SmartMedicsECG is designed to be fully self-applied and wireless. Patients do not need to visit medical facilities for the ECG examination. It spares time and decreases a risk of falling ill with an infectious disease (e.g. Covid-19). SmartMedicsECG is dedicated specially for patients with arrhythmia, ischemia, with high risk PCI and post-procedure.

Discover our medical certified electronic projects

The development of electronic products has transformed the medical sector, advancing from basic instruments to devices that enhance patient diagnosis, treatment, and monitoring. The integration of IoT is now pivotal in reshaping healthcare. Faced with challenges like aging populations and rising healthcare costs. Connected medical devices and Medical IoT holds great promise in decentralizing and optimizing healthcare delivery.

We are specialized in medical device development, from idea to mass manufacturing. We are dedicated to help and guide you on the exciting journey of developing electronic products, accompanying you every step of the way. We use a standardized development process for medical device development. This process and our Quality Management System are certified according to ISO standard 13485:2016.

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Smartmedics - Wireless 12-lead electrocardiograph handheld -