Lean-agile Product Management in U.s. Medical Technology Device Innovation: Balancing Speed, Safety, and Regulatory Approvals

Purpose This scoping review examines how Lean, Agile, and hybrid Lean-Agile product management are implemented in U.S. medical technology (MedTech) lifecycles. It explores whether these approaches accelerate development while maintaining safety and regulatory compliance. The review considers how these methods work with FDA design controls and ISO-based quality systems. It also examines their effects on speed, quality, safety, and documentation, as well as which organisational factors help or hinder their adoption. 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, 18 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 However, adoption was limited by outdated systems, cultural resistance, and coordination gaps.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 Compliance-based hybrid Lean and Agile operating models, backed by digital QMS systems and combined quality and regulatory roles, can speed up U.S. MedTech innovation without risking safety or regulatory integrity.