Medical Device Design for Six Sigma: A Roadmap for Safety and Effectiveness

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

Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life–cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real–world examples, thisguide:

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

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

Provides a detailed, step–by–step implementation process foreach DFSS tool included

Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry

Includes a DFSS case study describing the development of a newdevice

Presents a global prospective of medical device regulations

Providing both a road map and a toolbox, this is a hands–onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.