This study explores the strategic application of Lean and Six Sigma methodologies in the maintenance systems of medical imaging equipment manufacturing lines. Given the complexity, precision requirements, and stringent regulatory standards involved in producing devices such as MRI, CT, and ultrasound systems, effective maintenance is vital to ensuring consistent equipment performance, regulatory compliance, and product quality. Despite the proven benefits of Lean and Six Sigma in various industrial and healthcare sectors, their targeted application within the context of imaging equipment maintenance remains underexplored. To address this gap, the study conducted a systematic review of 42 peer-reviewed articles, selected and analyzed using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The findings demonstrate that Lean tools like 5S, Value Stream Mapping, and Total Productive Maintenance (TPM), when combined with Six Sigma techniques such as DMAIC, FMEA, and control charts, significantly enhance equipment uptime, reduce maintenance variability, and improve metrics such as Mean Time Between Failures (MTBF) and Overall Equipment Effectiveness (OEE). Furthermore, the study finds that these methodologies promote better documentation, risk-based maintenance planning, and stronger alignment with regulatory frameworks such as ISO 13485 and FDA 21 CFR Part 820. Enhanced cross-functional collaboration and operator engagement were also identified as key enablers of sustained improvement. However, the review also reveals challenges, including variability in implementation outcomes, a lack of sector-specific LSS models, and insufficient empirical benchmarking. As a result, the study recommends the development of customized Lean Six Sigma frameworks tailored to the specific demands of imaging equipment manufacturing. These frameworks should integrate digital maintenance intelligence, compliance-focused documentation, and cross-functional ownership to achieve long-term reliability and regulatory excellence. This review contributes to a deeper understanding of how Lean and Six Sigma can support high-performance, compliant, and efficient maintenance in medical imaging manufacturing.
Shamim et al. (Fri,) studied this question.