Application of Design for Six Sigma (DFSS) within the Medical Device Sector

What is Design for Six Sigma (DFSS)

Design for Six Sigma (DFSS) consists of a set of needs-gathering, engineering and statistical methods to be used during product and process development. These methods form part of the Product Realization Process. DFSS ensures the product functions meet the needs of the Customer and that the chosen technology will perform those functions in a robust manner throughout the products life.

Why is Design for Six Sigma (DFSS) required?

The key requirement of any business is to make money and increase shareholder value. In order to achieve this, the requirements of the marketplace need to be achieved and exceeded. Some of the key business challenges of this era are customer satisfaction, customer value, sustainable growth, profit margins and cost efficiencies. DFSS offers a sustainable approach to meet these challenges and offers the Medical Device Sector a development methodology that can be utilised in all facets of the business.

Design for Six Sigma (DFSS) Methodologies

Design for Six Sigma (DFSS) can be accomplished using any one of many methodologies. CDOV is one popular methodology for designing products and services to meet six sigma standards. CDOV is a four-phase process that consists of Concept, Design, Optimize and Verify. These four phases parallel the five phases of the traditional Six Sigma improvement methodology, DMAIC €“ Define, Measure, Analyze, Improve and Control.

Concept Phase (C): The Concept phase utilises inputs from the Voice of the Customer (VOC) to generate the best product concept and product requirements. This phase involves developing a team and team charter, gathering VOC, performing competitive analysis, and developing requirements linked to VOC.

Design Phase (D): This phase identifies key inputs using organizational wisdom, engineering principles and DFSS methods and tools. Functional requirements are identified, alternative concepts evaluated, and capability assessed.

Optimize Phase (O): Optimised nominal and tolerance settings for key input parameters are defined and a performance analysis of functional output requirements performed.

Verify Phase (V): The Verify phase consists of testing and validating the design to ensure it consistently meets customer needs.

Design for Six Sigma (DFSS) Tools

Some of the key DFSS tools utilised within each of the four phases are as follows:
Concept Phase (C):

  • QFD (Quality Function Deployment)
  • Pugh Concept
  • FMEA (Failure Means and Effects Analysis)
  • Engineering analysis & 1st Principles
  • Materials selection software
  • Simulation
  • Measurement System Analysis (MSA)

Design Phase (D):

  • FMEA (Failure Means and Effects Analysis)
  • FTA (Fault Tree Analysis)
  • Pugh Concept
  • SIPOC (Supplier, Input, Product, Output, Customer) Mapping
  • Benchmarking
  • Prototyping
  • Engineering analysis
  • DOE (Design of Experiments)
  • Measurement System Analysis (MSA)

Optimize Phase (O)

  • DOE (Design of Experiments)
  • Robust Design Analysis
  • Measurement System Analysis (MSA)
  • Control Charting
  • Capability Analysis
  • Statistical Tolerancing

Verify Phase (V):

  • Control Charting
  • Capability Analysis
  • Sampling Plans
  • Control Plans
  • Statistical Process Control (SPC)


Benefits of Design for Six Sigma (DFSS)

The successful development and commercialization of new products is critical to the long term viability of any business. A key requirement is to utilise a structured process for new product commercialization. A structured process to allocate resources and monitor progress toward successful commercialization is essential. The DFSS methodology is a powerful combination for companies to utilise in identifying new markets and developing products that serve customers in these markets.

The benefits of DFSS usage and implementation are a product that meets all customer requirements. The DFSS application enables a reduced time-to-market and increased revenue combined with reduced product cost based on an optimized customer design.

DFSS is a logical and sequential approach that provides a roadmap for successful product commercialization. The application of the DFSS process will assist the organization in reducing project execution cycle time and maximizing project resource utilisation.


Copyright © Mike Heavey – Medical Device Solutions