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Arterial oxygen saturation and heart rate measured by pulse oximetry is widely used to monitor critical care patients. This kind of system is classified as embedded hard real-time system and requires rigorous development methodologies to guarantee the correctness and timeliness of the application. Therefore, the proposed development methodology combines agile principles with organizational patterns and adapts them to build medical devices focusing on the issues related to the system's constraints and safety. Strong unit testing is the foundation of the proposed methodology for ensuring timeliness and correctness. Moreover, platform-based design approach is used to balance costs and time-to-market in view of performance and functionality constraints. We conclude that the proposed methodology reduces significantly the design time and cost as well as leads to better software modularity and safety.