I was asked to lead a project to build an ECG management system using an international engineering team based in Pune India who had no previous device or ECG experience. Using an open-source ECG viewer, and a 3rd party data translation device, I was able to lead the team to a finished proof-of-concept in five weeks. Upon returning how, I used conventional marketing tools such as voice-of-customer (VOC), to create a Product Requirement and Market Requirement document (PRD and MRD). As it was this company’s first FDA cleared project, it was important to build an utilize a ISO 13485 Quality Management System.
After the POC was developed, additional releases were accomplished using Agile software development practices. I coordinated the clinical testing using cardiologists, hospitals and clinics on the west coast. The product went live at King Fahd Military Medical complex in Saudi Arabia using Philips TC-70 electrocardiographs (after applying for and receiving Saudi FDA (SFDA) clearance as well. The product went into production and feature-wise is competitive with any ECG management system on the market, able to store over twenty different data types with comprehensive HL7 back-end using Mirth.