Implementing Cross-Organizational FDA Medical Device Design Controls Using Blockchain

Manufacturing medical devices is a costly and com-plex operation. The Original Equipment Manufacturer (OEM) must enforce United States Food and Drug Administration (FDA) design control regulations during the entire medical device manufacturing life cycle. To lower the costs, the OEMs often out-sources device manufacturing to a Contract Manufacturer (CM). Usually, the OEMs and CMs use incompatible software tools to manage requirements, design documents, and manufacturing data, leading to information silos that makes business process orchestration, and maintaining traceability across documents mandated by FDA challenging. To our best knowledge, existing commercial software vendors still need to address these issues adequately. This paper presents a blockchain-based framework for implementing FDA design control regulations by achieving cross-organizational reviews, document traceability, and tamper-resistant storage and verification of records while allowing the OEM and CM to continue using incompatible software tools. The framework provides an FDA design control ontology, smart contract data model, architecture and a prototype to validate the framework and its applicability using Hyperledger Fabric. Our experimentation shows the framework achieved it's goals with satisfactory performance.