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Lean Six Sigma – Is It Right or Wrong for the Life Sciences?

Alexandre Alain
by Alexandre Alain on Wed, Jan 06, 2016

The Potential of Lean Six Sigma Quality Improvement is Well-Documented – But is It the Right Fit for the Life Sciences?


First, a quick history lesson for the uninitiated. Six Sigma was a business management strategy developed by Motorola in the 1980s, designed to improve its manufacturing processes, while the Lean philosophy was born out the waste reduction processes originally deployed at Toyota in the late 1940s. Then, in the early 2000s, Lean Six Sigma brought these two principles together, presenting them as the best possible business management solution for uncovering process waste, increasing organizational capability and stripping out zero-value company activity.

Can Lean Six Sigma Really be a Good Fit for the Life Sciences?

On the face of it, relying on a business system developed to improve the efficiency and productivity of the manufacturing and automotive industries might seem inappropriate for the Life Sciences, which are so complex and nuanced.

The Case for Lean Six Sigma

But advocates of Lean Six Sigma would point out that its basic tenets focus on strong outcomes in efficiencies, customer experience, financial savings and process improvements – without ever compromising on quality. And all of this is of critical importance to today's fast-moving Life Sciences sector. The irrefutable truth is that the quality of the sector's products is directly related to their success – and the two most significant quality-based benefits of a successful Lean Six Sigma strategy are the reduction in consumer risk and the avoidance of errors.

Backing up this persuasive argument are studies that reveal Lean Six Sigma can and does boost efficiency within the Life Sciences sector. For instance, recent research has shown that deploying Lean Six Sigma in health care could cut waiting times in hospital emergency departments, while improving patient flow.

So What’s the Problem?

But Lean and Six Sigma have their detractors, and they are just as vocal as Lean Six Sigma advocates. A key criticism aimed at process-centric Lean Six Sigma quality improvement in particular is that it can act as a drain on employee creativity, stifling the very innovation required to design new products in the first place because of its focus on rigorous processes. One commentator has even compared Six Sigma’s traumatic effect on innovation to the effect an epileptic fit has on the human brain.

It's strong stuff, and the Internet is filled with such polarized views – but the truth actually lies somewhere in between. Could Lean Six Sigma quality improvements have a negative impact on innovation, the very lifeblood of the Life Sciences sector? Yes, if management puts in place such a strict interpretation of the methodology that the human element is trapped inside a straitjacket of rigid processes, severely curtailing creativity in the process.

Towards a More Balanced Approach

But just as ‘blue sky thinking’ is critical to the sector, it is also imperative that, when new product research is complete, there are real-world processes in place that can turn such innovation into an actual working reality – a system that sets real-time quality benchmarks for every phase of product development, bringing order to the often chaotic process of innovation. Without Lean Six Sigma quality improvements, potentially trailblazing products risk failing to reach market altogether or, worse still, result in noncompliance.

Perhaps the real danger Lean Six Sigma poses to any organization happens when the ethos is bought ‘off-the-shelf’, superficially embraced by management and pushed on to employees without proper consultation, consideration or training. This potential risk can be further exacerbated by deploying Lean Six Sigma-focused software solutions that aren’t tailored to meet the life sciences sector's unique needs.

To find the right balance, companies should consider seeking out reputable third-party specialists who are able to create Lean Six Sigma-supporting solutions designed for their sector and offer expert guidance about effective rollout and implementation. This approach will create a Lean Six Sigma platform where innovation and best process practices can exist side by side – in effect, creating the best of both worlds.


  • Deploy Lean Six Sigma processes that will improve efficiency, quality and customer experience, while offering financial savings.
  • Handle Lean Six Sigma implementation and rollout correctly and appropriately to ensure successful integration.
  • Monitor that any Lean Six Sigma solution doesn't become so rigid that it stifles innovation. It should offer a structure in which innovation can be nurtured, not neutered.

Discover How to Identify and Manage Risk Effectively Across Your Life Science Company. Download: "Creating a Risk Management Matrix – A Guide for Your Life Science Business".

Creating a Risk Management Matrix - a Guide for Your Life Sciences Business

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Alexandre Alain
Written by Alexandre Alain
Life Science Product Manager
Written by Author

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