Six Sigma for Medical Device Design Review

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(More customer 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.

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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.

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Process Development: Fine Chemicals from Grams to Kilograms (Oxford Chemistry Primers) Review

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(More customer reviews)Process development is generally not taught in schools. However it is the everyday practice of many industrial chemists. The book is really helpful in bridging these two quite different aspects of organic synthesis. It describes the issues, problems, and solutions in scale-up. It also covers environmental and regulatory issues and more importantly, commonly and preferrably used solvents and reagents in large scale operations. Real examples from pharmaceuticals are used to demonstrate all these issues and the way to synthesize fine chemicals in multi-kilogram quantities instead of laboratory milligram scale.
An excellent small book, easy and fun to read. Recommended to both the experienced and beginners.


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Process development bridges the gap between the laboratory synthesis of an organic compound and its industrial manufacture on a large scale. This concise and readable text uses real examples and case histories from ICI/Zeneca Pharmaceuticals to show the problems which may be encountered in scaling up chemical synthesis, and the ways these problems may be overcome. It shows how it is possible to synthesize multi-kilogram quantities of a new organic compound which has been made in the laboratory only in the milligram scale. A wide range of aliphatic, aromatic, and heterocyclic compounds is covered. This book will be invaluable both to the research chemist involved in the development phase of novel compounds, and the advanced undergraduate interested in the fine chemicals industry.

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