There is always a better way

In recent years there has been considerable interest in improving the processes used to make medical devices and other similar materials. New manufacturing systems such as Total Quality, Six Sigma, Lean Thinking and others have been applied with varying degrees of success. This book focuses primarily on applying these approaches and others to improve the processes used to make support materials in medical device and similar industries and provides examples from the author’s experience. Many process improvement books look at major innovations or at improving the overall manufacturing system. Often these approaches cannot be applied easily within the regulated manufacturing environment of medical device and allied industries. There are often opportunities to improve the overall production process by focusing primarily on the processes used to produce support materials. These materials are raw material parts used in the device and fixtures used in the manufacturing process. They are made by a variety of manufacturing techniques depending on the nature of the part and its function. This book is an introductory text which describes manufacturing processes used to make support materials. It also introduces many of the framework techniques used for process improvements with chapters on Lean Six Sigma, Brainstorming Techniques, and the Regulatory and Quality Issues that must be complied with for any improvement in regulated industries. TRIZ is introduced. TRIZ, usually known in English as the Theory of Inventive Problem Solving, is a systematic method for finding novel solutions that was developed by Genrich Altshuler in the Soviet Union. Materials developed by Oxford Creativity are a great support for this technique. A new management structure for producing support materials is proposed. The manufacturing processes for making support materials are usually quite different in structure from the main manufacturing operation. It often makes sense to set up a separate department for their manufacture. The final three chapters are studies from my own experience. The first describes improving a chemical mixing process and associated raw material purifications. The second describes improvements made to a solvent extraction process to remove impurities from a medical device. The third describes the invention and development of an injection molded device for the purification of water. The principles applied in these cases can be applied to similar processes to produce support materials in many medical device and other manufacturers. For reasons of confidentiality and to make it easier to apply the approaches of these cases to a variety of similar products and circumstances, many technical details are omitted. I also include references to texts to provide more detail on the techniques introduced. I welcome any suggestions for improving this book to make it more useful to engineers and others working to improve the processes used to manufacture support materials for medical device and similar industries. The book is available from Amazon Print-on-demand and as a kindle. Click on image below.

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