El-Haik / Mekki Medical Device Design for Six Sigma

A Road Map for Safety and Effectiveness
2. Auflage 2011
ISBN: 978-1-118-21041-3
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 560 Seiten, E-Book

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 forDesign 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 optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology
* 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.

Autoren/Hrsg.

El-Haik, Basem

Mekki, Khalid S.

Über Autor(innen)

Basem S. El-Haik, PhD, is the CEO and President of Six SigmaProfessionals, Inc. (www.sixsigmapi.com) in Canton, Michigan, andthe author of many bestselling books on Design for Six Sigma. Dr.El-Haik is well known in the DFSS domain and has been a featuredspeaker at many technical conferences. He has seventeen years ofexperience in contemporary design and quality engineering methodsand has trained, certified, coached, and monitored over 600 belts(Green Belts, Black Belts, and Master Belts) in DFSS and Six Sigmain both tracks: product and service (transactional)[e-mail]
Khalid S. Mekki is a Quality Manager at Baxter HealthcareCorporation, where he has served in various capacities since 2001.He is working toward his PhD in industrial engineering at theUniversity of Illinois at Chicago. Khalid holds a master's degreein mechanical/quality engineering and a bachelor's degree inmechanical engineering. He has led and completed numerous Designfor Six Sigma projects.