Risk Management Objectives for Distributed Development of Interoperable Medical Products

Medical devices are increasingly being built using interoperability and platform approaches that enable devices and service components from different manufacturers to be combined flexibly into “systems of systems”, so as to achieve integrated care-giving solutions that aim to exceed the capabilities of standalone devices with reduced likelihood of medical errors. In these situations, the primary medical device domain tasks such as risk management are distributed across the organization boundaries of multiple stakeholders, each of whom contributes components as well as development and assurance artifacts to establish the final system and support system assurance arguments. However, ISO 14971 - the primary medical device risk management standard - focuses on single-manufacturer monolithic device and hence cannot effectively guide distributed risk management activities across stakeholders. In this paper, we provide a set of risk management objectives for distributed development of interoperable medical systems. These objectives can be seen as augmenting the requirements of ISO 14971 to provide additional criteria for achieving safe and secure interoperability via integration of components from multiple vendors. These objectives may also be used as top-level claims in assurance cases for interoperable medical products or form the basis of requirements in emerging standards for safe and secure interoperability.