Digital Design Transfer for Healthcare Software

This white paper outlines the evolving landscape of design transfer for digital health products, particularly focusing on Software as a Medical Device (SaMD). It addresses the challenges organizations face in transitioning from traditional hardware-centric models to software-driven solutions. The document emphasizes the necessity for a continuous, deployment-centric design transfer approach that encompasses software architecture transition, CI/CD release governance, and cybersecurity measures. It details the importance of aligning Quality, IT/DevOps, Security, and Regulatory teams under a unified operating model that adheres to standards such as ISO 13485 and IEC 62304. The paper also discusses various deployment scenarios, including onboarding to existing platforms and greenfield development, highlighting the need for compatibility checks, validation requirements, and stakeholder collaboration. By redefining design transfer processes, organizations can enhance their ability to manage regulated software effectively, ensuring compliance and patient safety in dynamic healthcare environments.