Lean–Agile Product Development in FDA Relevant and Regulated Medical Device Contexts

PURPOSE: This scoping review examines the implementation of Lean, Agile and hybrid Lean-Agile approaches in contexts relevant to the US Food and Drug Administration (FDA) and regulated medical devices. The review assesses whether these approaches can facilitate faster development while ensuring the integrity of lifecycle evidence, regulatory compliance and safety. The focus is on digital QMS, documentation, validation, design controls, and critical adoption barriers and enablers. METHODS: A PRISMA-ScR aligned scoping review from 2015 to 2025 searched major scientific databases and Google Scholar. Empirical studies reporting Lean, Agile, Lean Six Sigma, or hybrid implementations in FDA-relevant device contexts with key compliance outcomes were screened using predefined eligibility criteria. RESULTS: From 432 records, 13 empirical studies were included. Lean and Lean Six Sigma reduced defects and waste while improving traceability and audit readiness. Agile-inspired and Agile V-model approaches improved responsiveness and coordination when applied to design controls, verification, and risk gates. Digitalized validation and Lean 4.0 used real-time data and automation to match speed with evidence needs. However, adoption was limited by outdated systems, cultural resistance, and coordination gaps. CONCLUSIONS: The evidence suggests that Lean-Agile approaches could facilitate accelerated development when integrated into a mature QMS infrastructure alongside digital traceability, validation-aware planning, regulatory governance and active quality. However, this evidence is still context-dependent, conditional and is limited by the predominance of single-site implementation studies.