Six Sigma for Medical Device Design (Hardcover)

~ Jose Justiniano (Author), Smita Gopalaswamy (Author) "The medical device industry (MDI) has grown tremendously over the past few years..." (more)
Key Phrases: Six Sigma, United States, Design of Experiments (more...)

Editorial Reviews

Product Description

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field.

Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical device field. Authored by experienced professionals, it provides a how-to guide to implementing such a program while dispelling commonly held myths regarding deployment and adoption. This volume also links the philosophy with the FDA's Design Control regulation, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control.

For management wishing to launch innovative medical devices as quickly as possible, this text establishes a way to align all levels of the organization to produce a high level of development that is both timely and compliant. It is also an excellent tool for technical and scientific personnel to understand the realities of business and markets and to optimize the product realization process.

Product Details

• Hardcover: 152 pages
• Publisher: CRC; 1 edition (November 15, 2004)
• Language: English
• ISBN-10: 0849321050
• ISBN-13: 978-0849321054
• Product Dimensions: 9.3 x 6.3 x 0.3 inches
• Shipping Weight: 12 ounces (View shipping rates and policies)
• Average Customer Review: 3.0 out of 5 stars  See all reviews (2 customer reviews)
• Amazon.com Sales Rank: #1,970,974 in Books (See Bestsellers in Books)

Customer Reviews

Most Helpful Customer Reviews

0 of 1 people found the following review helpful:

1.0 out of 5 stars Small summary text, August 11, 2006

By	DFSS practitioner "Jim" (Boston, MA) - See all my reviews

The text is a reasonable summary of Six Sigma, DFSS and related tools as used in the medical device industry, but it is mostly a summary (only 100 pages). For $200+ I expected a lot more meat.

0 of 2 people found the following review helpful:

5.0 out of 5 stars Specific Medical Device Industry Insights, March 27, 2008

By	Jose M. Justiniano "Medical Device Quality Ex... (Ohio, USA) - See all my reviews (REAL NAME)

This book is not a canned Six Sigma handbook. It brings specific insights to the medical device industry that is mostly unknown to the typical Six Sigma practitioner. The book highlights that the medical device field is an inexact science as opposed to light bulbs and automobiles in which the available technologies and processes are well understood and highly characterized.