Pump Console for Extracorporeal Circulatory Life Support System for a Healthcare Solution Provider
Overview
The client, a medical device company based in the US, known for delivering state-of-the-art medical solutions, was in search of a technology partner experienced in crafting healthcare solutions to facilitate their entry into the US market. ACL Digital designed an FDA-compliant pump console life support system. This system is dedicated to conducting extracorporeal blood circulation procedures, catering to licensed physicians and specialists.
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Challenges
Unavailability of a standalone pump console system compliant with FDA Class C regulation
Lack of in-house experience in developing regulatory compliant solution
Solution
- Designed pump console for licensed physicians & specialists to perform extracorporeal blood circulation procedures
- Performed on the required process needed for FDA Class C medical device software development
- Developed a pump driver module & control display functionality, complying with IEC 62366 standard
- Integrated STM32 based module with a pump control system to control the pump
- Integrated TI ARM chip to control & monitor the sensor equipped in the system
- Designed a Linux based multi-threaded QT application to display temp., blood pressure, & actual measure blood flow
- Visual and audio alerts when sensor values are beyond the set threshold
Outcomes
- Delivered IEC 62366 and FDA Class C compliant solution enabled the client to penetrate the US market with their standalone pump console solution
