Challenges and Directions for Lifecycle Processes Supporting Conformity Assessment of Interoperable Medical Products

摘要

Health care delivery is increasingly relying on interoperable components and medical systems built from those components. Existing life-cycle processes found in medical device standards such as IEC 62304 do not adequately address the complexities associated with interoperable medical components and systems. Interoperable medical systems and their associated components may be developed, operated, and maintained by many different organizations. Such systems may be built using platform concepts designed to facilitate reuse of both platform infrastructure and assurance artifacts when the platform is used to build different systems. Life-cycle processes supporting conformity assessment of these products would benefit from explicitly addressing issues such as (a) multi-organization development, risk management, and assurance, (b) life-cycle activities that guide interactions between organizations, (c) product-line development and other notions of explicitly managed reuse, and (d) integration and reuse of components at arbitrary levels of abstraction in the system hierarchy. In this paper, we provide an overview of life-cycle issues for interoperable medical products that are not sufficiently addressed in existing medical device standards. We expose issues that need to be considered in designing life-cycle processes for this space that can guide standards development activities and conformity assessment organizations. To help indicate possible directions, we identify lifecycle concepts from other domains that may adapted for interoperable medical systems.