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INTRODUCTION
Various business management strategies have been developed to improve the performance of organizations by improving the processes by which they carry out their work. These strategies, which include Lean and Six Sigma , aim to implement process improvements through a coordinated set of principles and practices that promote greater efficiency and effectiveness, with fewer wasteful practices or errors. Evolving from their original application in manufacturing industries, these process improvement strategies have been extended to other settings including construction, software development, financial services, health care delivery, and laboratory sciences.
The creation of the Clinical and Translational Science Awards (CTSA) initiative as part of the National Institutes of Health (NIH) Roadmap for Medical Research is aimed at creating a clinical and translational research enterprise that assures maximal value is obtained from biomedical research investments. Whereas the definition of clinical and translational research is still being debated, there is broad consensus that formal and sustained processes are needed to improve the timeliness and efficiency of research along the biomedical continuum. Reducing the time between biomedical research discoveries and their adoption into clinical practice requires increased coordination, systematic planning, and new types of connections within biomedical research organizations. This article suggests that better coordination, timeliness, efficiency, and value of clinical and translational research can be achieved by applying the set of principles, practices, and methods represented by Lean and Six Sigma.
WHAT IS LEAN?
Lean (also known as Lean Production, Lean Enterprise, and Lean Thinking) involves a set of principles, practices, and methods for designing, improving, and managing processes. The development of Lean is attributed to Taiichi Ohno's 1 articulation of the Toyota Production System. Ohno aimed to improve efficiency by eliminating particular kinds of waste (called muda , in Japanese), which absorb time and resources but do not add value. Examples include mistakes that need rectification, unneeded process steps, movement of materials or people without a purpose, unnecessary waiting because upstream activity was not delivered on time, and the creation of goods or services that are not really needed by end users. 2
A Lean process reflects the goal of continually reducing waste and improving work flow to efficiently produce a product or service that is perceived to be of high value to those who use it.