I think we can all agree that the current clinical research enterprise is broken. Processes are filled with duplication, overproduction, excessive motion and at the very end of it all, a dark yawning cavernous void of space and time between the translation of scientific discovery into the practical and widespread use in clinical applications. We all know that an entirely new infrastructure is needed, but the question is how do we get there? The methodologies of Lean and Six Sigma are one tool needed to help revamp the research setting.
Since the late 1980’s, healthcare organizations began looking at process-improvement systems. Today, many are implementing the Lean and Six Sigma philosophies to improve healthcare delivery and patient outcomes. Hospitals big and small are now implementing a culture-change toward this style of management. While Lean and Six Sigma methodologies are applicable in both the basic science and clinical laboratory settings, there are currently more articles detailing the success in clinical laboratory settings. But, it is my belief that this will soon change and basic research laboratories will be swept up into the larger vortex of organizational lean thinking.
Here are just a few Lean resources to get you started into the world of Lean-Research:
- Article, “The Applicability of Lean and Six Sigma Techniques to Clinical and Translational Research” by Sharon A. Schweikhart, Ph.D. and Allard E Dembe, Sc.D. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2835466/pdf/nihms-174869.pdf
- National Institutes of Health (NIH) Re-engineering the Clinical Research Enterprise. NIH Roadmap for Medical Research website. Available at: http://nihroadmap.nih.gov/clinicalresearch/
- Article, “GLP (Good Laboratory Practice) Guidelines in Academic and Clinical Research: Ensuring Protection and Safety” by R. Vijayaraghavan, S. Ashok, Jayanthi Swaminathan, and G. Ramesh Kumar. Available at: http://www.rroij.com/open-access/glp-good-laboratory-practice-guidelines-in-academic-and-clinical-research-ensuring-protection-and-safety.pdf
- Article, “Evaluating Laboratory Performance on Quality Indicators With the Six Sigma Scale” by David Nevalainen, Lucia Berte, Cheryl Kraft, Elizabeth Leigh, Lisa Picaso, and Timothy Morgan. Available at: http://www.archivesofpathology.org/doi/pdf/10.1043/0003-9985%282000%29124%3C0516%3AELPOQI%3E2.0.CO%3B2
- Book, “Advanced Lean in Healthcare” by Craig Albanese, Darin Aaby, and Terry Platchek. Available at: http://www.amazon.com/Advanced-Lean-Healthcare-Craig-Albanese/dp/149614189X