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Medical Device Manufacturer

Objective

This medical device company has a corporate goal to double production capacity by 2020.  The company has requested CAI’s assistance with the development and implementation of a DfR program that can be applied programmatically to the engineering design function as well as influence the procurement and capital project functions of the company.

Process

CAI’s senior asset management consultant assisted the client in developing a DfR program, process and toolkit.  CAI then simultaneously supported applying the DfR process via a proof of concept approach to a major new production line and developed and optimized the remaining aspects of the DfR program based upon the application at each stage gate of the capital project process.

The DfR process blends aspects of statistics, probability and reliability theory, and engineering analysis throughout a product lifecycle to evaluate, predict, and verify the application of robust design. Through application of DfR practices, the demand for highly-reliable systems can be met while insuring that the latest methods for the assessment of robust design and risk-management are properly addressed.

Services

Development of the DfR Program included the following activities and deliverables:

  • Develop and execute a DfR Gap Assessment Tool
  • Provide a written DfR Gap Assessment final report with recommendations
  • Develop a Draft DfR Program, Process and Toolkit to apply to a capital project for proof of concept
  • Develop a DfR Directive as the overarching document to define the DfR Program
  • Develop a DfR Tool and supporting DfR Toolkit Training and User Manual
  • Develop the DfR Site Program SOP aligned with the DfR Directive and Toolkit
  • Develop a DfR Enhanced Engineering Specifications Document / Reference Manual

Project Success

The project successfully establishes DfR as the means to reduce Life Cycle Cost (LCC) by at least 10% in the concept and design phases of capital projects.

Time Frame

4 Months for initial DfR Program development

2 Years for Proof of Concept and DfR Program finalization

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