Methods of Assessing Medical Devices

Abstract

While designing and validating any complex system has challenges, the medical domain has specific requirements which must be considered for a system or device to be successful. The environments, communities of use, and interactions are varied, unpredictable, uncontrolled, and ever-changing. Given the environments, communities of use, and interactions involved with medical devices, successful early and late validation of the device must be informed by the context of use itself. Building “frameworks” which represent the context of use for the device can focus validation goals, methods, and criteria and ensure that validation is directed and appropriate. In this paper we present a process and associated methods for defining the frameworks in which medical devices can be successfully assessed. The phases of the process include Phase1: Definition in which a framework of understanding is built which represents the environment of use, community of users, and the interactions between systems and users for the medical device in development. In Phase 2: Validation the framework which defines the environment of use, community of users, and the interactions between systems and users is used to develop a validation approach and criteria. The developing device is then validated against the framework itself.