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MEDICAL INSTRUMENT

DESIGN AND DEVELOPMENT 

Claudio  Becchetti, Alessandro Neri,

John Wiley & Sons, 590 pages, 250 figures, 145 tables

Why should you select this textbook? To the best of our knowledge this is the first textbook that:1)  explains how a medical device is developed in all the stages from the concept to the certification and 2)  for each stage, contains the theory of the relevant University coursesand the implementation section showing how theory is applied in the industrial context and3)  discloses all the structure of a medical instrument (a commercial ECG under open license) that shows how theory and industrial implementation know-how is applied. 
A University perspective: why selecting this textbook “This book fills a gap in the technical literature, because it approaches, as a whole, the design and implementation process necessary to build and to put on the market a piece of medical instrumentation. Even if many good books deal with the design of biomedical equipment, and others discuss the signal processing that is implied or the problems related to certification, no one links all these steps together in the ingenious way that the authors have devised here. The book presents an integrated view of the whole process involved from the first phases of the conception, through the design, realization and signal processing and on to the hardware realization and certification. This approach is made possible by means of a unique feature of the book: a manufacturer has revealed their know-how and the structure of a commercially available instrument (the Gamma Cardio CG from Gamma Cardio Soft, which complies with the ECG technical standard ANSI AAMI EC 11). Therefore, the integrated view that this book provides is done with reference to the technical details of the design of a marketed instrument; here, concepts and tools find their practical application. This hands-on approach is extremely useful, in that the electrocardiograph is a product that is both sufficiently easy to deal with for a prospective biomedical engineer, butencompasses all the main areas involved, thus helping in understanding medical instrumentation design. In this way, not only will the readers be familiar with the basic concepts, principles and analytical tools needed to design a medical instrument but they will also have the clear idea of how all these concepts and tools are translated into practice. … ”
Tommaso D’Alessio
Professor of Biomedical EngineeringUniversity Roma TRE