Steven Kuehn, Editor-in-Chief, recently published a great overview of the progress the Pharmaceutical Industry has made in the recent years in area of cutting waste and improving operations to be “Lean”: http://www.pharmamanufacturing.com/articles/2013/honing-the-competitive-edge/?start=3
It’s only been within the last 15 years that the Pharmaceutical Companies have begun to take the concepts of Lean and Six Sigma more seriously, mainly due to major cost constraints that were tightening profit margins across the industry. Kuehn writes:
“As mentioned, since approximately 2002 the pharmaceutical industry felt increasingly pressured by a number of new and relatively dramatic external and internal market forces (think patent cliff) and began to face up to its profligate spending sustaining inefficient drug development and manufacturing processes. With the cost of bringing a single blockbuster drug to market reaching some $1.3 billion and, according to Eli Lilly, the success rate of new chemical compounds falling from 12% a decade ago to 8% today, drug manufacturers indeed continue to have a tough fight ahead to remain competitive and sustain commercial success.”
However, despite the industries best efforts to reduce waste and variability, Lean hasn’t quite caught on. There were still many pharmaceutical professionals who believed Lean to be a cost cutting methodology. Nigel Smart, prinipal at Smart Consulting Group and author of “Lean Biomanufacturing” says:
Nigel Smart, principal at Smart Consulting Group and author of the just-released book, Lean Biomanufacturing, says, “For perhaps over a decade now, the pharmaceutical/life sciences industry has been attempting to apply Lean systems to its various process systems. Initially, there were attempts to apply the principles to manufacturing processes in an attempt to mimic the advantages seen in other industrial sectors, such as those in the auto industry. However, if one was to critically prepare a performance scorecard of the implementation of Lean throughout the [Pharma] industry, this analysis would at best give you a normalized score of perhaps 4/10.”
The article is worth reading in full to see who and what others in the Pharma Industry are doing to achieve best-in-class manufacturing operations using Lean Six Sigma methodology.