Developed Micro Infusion Pump Controller Software for a Leading Medical Technology Company in the US
Overview
The client is one of the leading medical technology companies in the US, delivering innovative healthcare solutions with better care at lower costs. They are also pioneers in medical devices and equipment, looking to develop a Micro Infusion pump with automated operations.
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Challenges
Mitigating regulatory risks
Reducing human medication errors
Automating medicine injection process
Solution
As a technology development partner, ACL Digital associated with the client to develop controller software for a micro infusion pump with automated operations for dosage filling, monitoring, and injection with connectivity to a mobile app. The solutions we offered include:
- Embedded firmware based on Micrium RTOS – III complying to IEC 62304 & ISO 14971 risk management processes
- Integrated Micrium GUI stack for user interface development
- Hardware abstraction layer to separate the business logic for modularity
- Drivers for GPIO, ADC, Audio, Button, External Flash, RAM, RTC, RFID, Watchdog
- Drivers for stepper motor & encoder for therapy delivery & to detect occlusion over pressure error conditions
- Integrated nRF SDK for BLE 5.0
- Developed custom BLE profiles to send data from device to mobile application
- Secure bootloader implementation in MCU
- Unit testing with VectorCast tool
Outcomes
- Delivered IEC 62304 (Medical Regulations) and ISO 14971 compliant solutions mitigating regulatory risk associated with medical trials
- Automated medicine injection process, reducing human medication errors during infusion
- Reduced medication administration errors, saved time during micro infusion treatment, and enhanced the quality of the medical care
- Variable pump volumes and infusion rates for an extensive range of clinical applications
- Reliable and accessible administration of medication, together with freedom of movement for patient
