US based healthcare company providing innovative solutions, medical devices and superior support to help healthcare professionals and providers with ensured safety, enhanced patient care, and improved total cost of care.
With evolving technology in the healthcare domain, the client wanted to develop a micro infusion pump with automated operations for dosage filling, monitoring, injection, etc. with wireless BLE connectivity to mobile application. For the same, client was looking for an embedded firmware development partner with expertise in healthcare domain and in-depth knowledge of all the medical standards and safety measures to be complied for healthcare device development along with appropriate testing support.
VOLANSYS helped the client to design and develop firmware of the pump built on ARM® Cortex® – M4 based microcontroller. The controller enabled User Interface, motor functioning and BLE 5.0 connectivity to mobile application.
- Developed embedded firmware based on Micrium RTOS – III complying to IEC 62304 firmware life cycle and ISO14971 risk management processes
- Integrated Micrium GUI stack for User Interface development
- Developed hardware abstraction layer to separate the business logic for modularity
- Developed drivers for GPIO, ADC, Audio, Button, External Flash, External RAM, RTC, RFID, Watchdog
- Developed drivers for stepper motor and encoder for the therapy delivery, and driver to detect occlusion over pressure error conditions
- Integrated nRF SDK for BLE 5.0 functionality
- Developed custom BLE profiles to send data from device to mobile application
- Secure bootloader implementation in MCU to load the medical application during manufacturing or software upgrades
- Unit testing with VectorCast – embedded firmware testing tool
Micrium RTOS | BLE | UART | RFID | IEC 62304 | ISO 14971 | Driver Development | Watchdog | RAM | Micrium GUI | Embedded Engineering | Unit Testing
Micro Infusion Pump Firmware Architecture
- Delivered IEC 62304 (Medical Regulations) and ISO 14971 compliant solution mitigating regulatory risk associated with medical trials
- Automated medicine injection process, reducing human medication errors during infusion