The Life Sciences Industry which cover pharmaceuticals, biopharmaceuticals, biologics, diagnostics, cell & tissue therapeutics, medical devices and medical device combination products, make the  treatment and use of these techniques & tools more complex than other industry sectors like automotive and microelectronics for example.

Principle among these is the regulatory environment that the industry operates within which is policed by agencies like the FDA, MHRA (in the UK) & EMRA (in the EU).

This plays a significant role in changing how certain elements are used and makes the opportunity for successful implementation more of a challenge.

That said simple techniques such as Process Mapping, Value Stream Mapping & the use of Score Cards are often employed sparingly to the detriment of the operating company. In our experience, simply by initiating the use of these tools and techniques, massive gains can be made in the streamlining of processes which result in huge savings as a result of the removal of waste.

In our experience, we have found that most companies follow a pattern of “Invented Here” philosophy which is a culture that inhibits their ability to break out and be truly innovative. This sadly results in wasteful & inefficient practices which ultimately hurts the company’s productivity and profitability.

However, positive case studies show that once initiated, programs using these simple tools can produce sustainable programs and this is possible through the participation in metrics gathering and publication of the results which identifies the direct contributions being made by the workforce to the success of the company.

Perhaps a key to successful implementation of Lean in the Life Sciences Industry is to fully engage the workforce in order to demystify the purpose.

Something to think about.