Biodevice Lifecycle Management

Abstract

Biodevice lifecycle management encompasses the coordinated oversight of a medical device from concept through development, manufacturing, clinical deployment, post-market surveillance, and eventual end-of-life or product discontinuation. The complexity of biodevice lifecycle management has increased substantially with the convergence of hardware, software, biological, and digital components that characterise contemporary biodevices: a smart cardiac implant combines mechanical hardware with embedded electronics, algorithmic software that may be updated post-implant, remote monitoring infrastructure, and biological interfaces at the electrode-tissue boundary. Managing the lifecycle of such a product requires coordination across regulatory submissions, manufacturing process control, software configuration management, clinical evidence generation, and eventual obsolescence planning -- activities that traditional product lifecycle management tools were not designed for. This study presents the Biodevice Lifecycle Management Assessment Framework (BLMAF), evaluating five lifecycle management approaches -- traditional document-based product lifecycle management (TPLM), model-based systems engineering for biodevices (MBSE-BD), AI-enhanced lifecycle data integration platforms (AI-LDI), digital twin biodevice lifecycle representation (DT-BLR), and federated multi-stakeholder lifecycle collaboration platforms (FMS-LCP) -- across four biodevice lifecycle contexts: active implantable device lifecycle, software-dominant biodevice lifecycle, combination product lifecycle, and complex surgical instrument and capital equipment lifecycle. Performance was scored using the Lifecycle Management Effectiveness Score (LMES), a weighted composite of regulatory compliance (0.25), data integrity and traceability (0.20), cross-functional coordination (0.20), change management efficiency (0.20), and total cost of ownership (0.15). AI-enhanced lifecycle data integration achieved the highest LMES (0.890) through the best data integrity (0.940) and cross-functional coordination (0.920). Digital twin biodevice representation ranked second (0.878) with strong change management efficiency (0.920). Model-based systems engineering (0.866) provides the deepest design integrity foundation. Federated collaboration platforms (0.854) support multi-organisation biodevice development. Traditional PLM (0.831) maintains the highest regulatory precedent but shows limitations against more integrated approaches.