Achieving Commercialization and Compliance Success
Potrero Medical is a predictive health company pioneering the next generation of medical devices with smart sensors and artificial intelligence. The company developed the Accuryn Monitoring System, which enables the remote monitoring of urine output, intra-abdominal pressure, and core body temperature to help guide clinicians in treating critically ill patients. The system’s remote monitoring capabilities are also helping frontline workers combat the spread of COVID-19.
Prior to adopting a cloud-based QMS solution, Potrero’s product and quality information was managed using paper-based processes, where bills of materials (BOMs) were documented on paper and then uploaded to a manufacturing system. Engineering change orders (ECOs) were also reviewed manually with limited supplier communication.
“We didn’t have a system that was robust enough for new product introduction and compliance processes. We had FDA clearance, but our product was not commercialized yet and our current manual processes would not scale or hold up to the scrutiny of audits,” stated Sanjay Banerjee, COO for Potrero Medical.
Since implementing Arena QMS, Potrero has seen significant improvements across product design and quality, including the improvement of product nonconformance by nearly 20% and a decrease in complaint resolution cycle time by 25%.