Showing posts with label biotechnology. Show all posts
Showing posts with label biotechnology. Show all posts

8/14/2012

Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices Review

Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices
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I am using this text in a commercializing biomaterials course and highly recommend it to graduate students and post-docs who want to enter the world of start-up biotechnology. I think it would also be very helpful to junior faculty who are thinking about commercializing their research. It is brilliantly constructed to walk you through the basics of taking your research from the bench to bedside and the challenges you are going to face along the way. I also found the author's use of vignettes and specific examples very helpful to illustrate complex points. This book won't write your business plan for you but should help you do your market analysis and give you the questions to ask when you initiate disclosures to your university's Technology Transfer office. Highly recommended.

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Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This 2008 book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.

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6/14/2012

Biosignal and Medical Image Processing (Signal Processing and Communications) Review

Biosignal and Medical Image Processing (Signal Processing and Communications)
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This book assumes that you have both a prior knowledge of Matlab and of signal processing concepts. It spends the first three chapters going over measurement and transducer systems, basic signals and systems, and classical methods of spectral analysis. Even though these chapters are meant to be a quick review, there are some Matlab implementations of basic algorithms in each chapter. Chapter four introduces digital filters and shows Matlab implementations of both IIR and FIR filters. A special treat of chapter four is that some time is spent introducing the reader to the Matab signal processing toolkit. Now that the basics of digital filtering have been introduced, more advanced signal processing techniques are tackled. These include modern methods of spectral analysis and also time-frequency analysis using such methods as the Wigner-Ville distribution. Again, in all cases, the equations are concise, the prose is very accessible, and all concepts are demonstrated using Matlab programs. There is a separate chapter devoted to the wavelet transform and to its use in filter banks, denoising, and feature detection. Quite frankly, I found this chapter far more accessible than entire books that have been devoted to the subject, especially if you are interested in getting to the heart of the matter and using wavelets to perform a task. Two more chapters round out the section of the book on general signal processing techniques- one is about adaptive filters and another on principal component analysis. The final four chapters of the book concern themselves with image processing and Matlab, and the Matlab image processing toolkit in particular. You should already be familiar with the basic concepts behind image processing, and as with the signal processing portion of this book, the point is to have a single text with all of the relevant signal processing techniques briefly described along with Matlab code for the purpose of biosignal processing. However, even if you are not a biomedical engineer, and I am not, you should find this book helpful in the general sense of producing implementations of signal processing concepts. This book would also be helpful for biometric professionals since it goes into great detail on how to turn biological features into measurements that can be processed and compared.

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4/17/2012

Biomedical Informatics: Computer Applications in Health Care and Biomedicine (Health Informatics) Review

Biomedical Informatics: Computer Applications in Health Care and Biomedicine (Health Informatics)
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This second edition of Shortliffe's textbook is an excellent overview of the field. Although I used it as a course text, it is extremely readable. The chapters are not overly technical, as befits an introductory text, but by no means is this a "Dummmies" book either.
There are now a variety of introductory/overview books on medical informatics. However, of the ones I've read (including van Bemmel's Handbook of Medical Informatics and Coiera's Guide to Medical Informatics), this book is by far the best.

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2/21/2012

Peptide Nucleic Acids, Morpholinos and Related Antisense Biomolecules (Medical Intelligence Unit) Review

Peptide Nucleic Acids, Morpholinos and Related Antisense Biomolecules (Medical Intelligence Unit)
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This is the standard book in this field of research. A compilation of what is known about these synthetic nucleic acid analogues that no researcher in the field should be without.

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This volume is unique to the existing literature in the Peptide Nucleic Acid field, in that it focuses on comparing and contrasting PNA with other available oligonucleotide homologues and considers areas in which these biomolecules could be profitably applied to clinical and diagnostic applications. Part I of the book addresses comparative strengths and weaknesses of various nucleoside homologues. Part II of the book addresses specific translational or clinical applications for PNA and related antisense biomolecules. The editors have succeeded in presenting a balanced yet broad view of the methods available for gene targeting and modification.

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1/29/2012

Design, Execution, and Management of Medical Device Clinical Trials Review

Design, Execution, and Management of Medical Device Clinical Trials
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In Latinamerica it is important increasing our knowlege in Medical Devices. This book is an excelent oportunity to improve the methodology of clinical trials with this kind of products.

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11/30/2011

Reliable Design of Medical Devices, Second Edition Review

Reliable Design of Medical Devices, Second Edition
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This book provides a solid reference for the Systems Engineer who is working on a medical device, including for IVD devices. The book is specifically structured to cover the design process and important documentation requirements in order to meet FDA 510(k) submissions. It also introduces the more typical reliability design process approach used in other industries such as telecommunications, to the design of medical devices.
The chapters of the book develop many areas of the engineering design process specific to biotechnology. The book covers the important area of 14971 Risk Assessment requirements and how this standard impacts the engineering design process. The book provides good ideas for incorporating 14971 into the standard engineering design process.
The book is useful for both medical devices (60601 requirements) as well as providing guidance for IVD devices. It lists many references for the medical systems engineer. I highly recommend it as a reference book.

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As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy.The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design.Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

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