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Lean Six Sigma for Regulated Companies

Create more efficient medical device manufacturing processes and improve product quality with Lean Six Sigma.


Increasing regulatory scrutiny, far-flung supply networks, and global competition are the new normal for medical device manufacturers. At a minimum, your company must produce high-quality devices and comply with tough regulatory requirements. To thrive, your company must continually improve its processes, cut waste, reduce costs, and increase customer satisfaction.

Lean Six Sigma, a proven performance improvement strategy, helps companies meet these challenges. But you may have heard about other regulated companies “Leaning” themselves out of compliance. These companies jeopardized their compliance when they worked with Lean Six Sigma experts who did not understand the Life Sciences regulatory environment.

Oriel STAT A MATRIX’s consultants have expertise in both Life Sciences regulatory compliance and Lean Six Sigma.

Our firm combines two professional practice areas – Life Sciences RA/QA and Performance Excellence – to help our customers implement effective Lean Six Sigma programs that enhance their compliance efforts.

What is Lean Six Sigma?

Lean Six Sigma was developed to improve manufacturing efficiency and quality. Traditional manufacturers were the first to embrace Lean Six Sigma, but now all types of industries use Lean Six Sigma to get measurable improvements.

Lean Six Sigma combines two concepts:

  • Lean – Reduce waste by breaking down processes and segregating waste from value.
  • Six Sigma – Reduce process variation and errors by applying quality and statistical tools.

Together, these two activities help companies achieve faster processes with lower costs and higher quality.

The benefits of Lean Six Sigma for medical device manufacturers include:

  • Identify and resolve systemic problems within your organization and supply chain.
  • Eliminate process redundancies, bottlenecks, and waste.
  • Generate fewer production errors.
  • Optimize supply chain management.
  • Increase customer satisfaction.
  • Reduce costs and improve financial results.

Is your company just starting to think about using Lean Six Sigma? Do you need to re-energize an existing Lean Six Sigma effort? Oriel STAT A MATRIX’s medical device sector experts are ready to help. Find out more about our Lean Six Sigma consulting and training solutions for medical device companies.

Learn more about our Performance Excellence Practice.

Provided below are a variety of practice related white papers, market updates and case studies.

Lean Six Sigma Deployment at Medical Device and Pharmaceutical Company Pays Dividends

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