Medical Device Design for Six Sigma (eBook)

The first comprehensive guide to the integration of Design for
Six Sigma principles in the medical devices development cycle

Medical Device Design for Six Sigma: A Road Map for Safety
and Effectiveness presents the complete body of knowledge for
Design for Six Sigma (DFSS), as outlined by American Society for
Quality, and details how to integrate appropriate design
methodologies up front in the design process. DFSS helps companies
shorten lead times, cut development and manufacturing costs, lower
total life-cycle cost, and improve the quality of the medical
devices. Comprehensive and complete with real-world examples, this
guide:

* Integrates concept and design methods such as Pugh Controlled
Convergence approach, QFD methodology, parameter optimization
techniques like Design of Experiment (DOE), Taguchi Robust Design
method, Failure Mode and Effects Analysis (FMEA), Design for X,
Multi-Level Hierarchical Design methodology, and Response Surface
methodology

* Covers contemporary and emerging design methods, including
Axiomatic Design Principles, Theory of Inventive Problem Solving
(TRIZ), and Tolerance Design

* Provides a detailed, step-by-step implementation process for
each DFSS tool included

* Covers the structural, organizational, and technical deployment
of DFSS within the medical device industry

* Includes a DFSS case study describing the development of a new
device

* Presents a global prospective of medical device regulations

Providing both a road map and a toolbox, this is a hands-on
reference for medical device product development practitioners,
product/service development engineers and architects, DFSS and Six
Sigma trainees and trainers, middle management, engineering team
leaders, quality engineers and quality consultants, and graduate
students in biomedical engineering.