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Home			“True progress is that which places technology in everyone’s hands”
· Contents  2 · Approach   2 · Target 2 Readers · Pedagogy  3 · Organization   3 · Goal 3 · Reviews · Disclosed Ecg · Open Ecg Sources	Official Book Website Medical Instrument Design and Development From Requirements to Market Placements Claudio  Becchetti, Alessandro Neri, John Wiley & Sons, 590 pages			Link on Line
	Contents This book explains all of the stages involved in developing medical devices; from concept to medical approval-certification. These topics are introduced according to the following chapter organization:  system engineering (Ch.1), bioinstrumentation requirements (Ch.2) and design (Ch.3), signal processing (Ch. 4), electronics, software (Ch. 6), medical informatics and e-Health (Ch. 7), medical certification/approval (Ch. 8 ). Book structure (Chapter numbers are circled) Approach The book explains how the theory is translated into industrial medical products. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product using a market-sold Electrocardiograph (ECG or EKG) disclosed in its design by the Gamma Cardio Soft manufacturer. The ECG is used as an example as it is a suitable device to explore and to fully understand medical instrumentation. It is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment.  Target Readers · Students of Biomedical engineering courses (upper-level undergraduate and graduate) Practitioners interested in medical device design Pedagogy Through this book, we emphasize the system-wide technical design approach that encompasses the basic theory, the associated implementation techniques – disclosed for a market product – and the application of regulations and standards. A good background in mathematics and electronics is helpful for using this book, but undergraduates will be helped by the various checklists, recap tables and notes that summarize the main technical background. The book has 250 figures and 145 tables; most of them offering a schematic representation of the main concepts. Text in bold is used to communicate concepts in speed reading. Figures have been designed with different graphic aspects to help readers’ memorization. The implementation part is organized to offer a didactic perspective, starting from a general medical device and arriving at the ECG details. Organization Chapters are self-contained, addressing the relevant biomedical engineering courses. At the same time, chapters are logically linked as they describe the design process from conception to certification (from Chapter 1 to Chapter 8) with increased technical details. The sections of each chapter are introduced following the sequential and logical process of the design. For example, in the electronics chapter, the paragraphs are organized according to the flow of the input signal. Each chapter begins with a conceptual map showing the relations among the sections and the associated topics. Regulations, standards and technologies are critical elements of product design. We have addressed the main concepts and principles of these topics avoiding specific regulations, standard versions or technological implementations as possible. Regarding references, we have preferred a selected list of public domain material and tutorials that are helpful to further investigations. Goal · “True progress is that which places technology in everyone’s hands” · Through the disclosure of a marketed product, authors aim to diffuse the medical device and the ECG-related design know-how. · For the ECG, please refer also to the Open Ecg Resources Web Page that contains ECg resources under open licence ( Creative Common, GPL, … ) Reviews · "The book tackles a very interesting topic, namely "how medical devices and instruments are designed from the conception to the market placement". Its utility and educational potential is high because it shows how the principles of design and the methodological steps for final product implementation are applied in a specific case, an electrocardiograph (ECG) device. "  - From a reviewer of the editorial review process. · "..., the electronic details of a market-sold ECG device are fully presented. The choice for such a device as a case study is fortunate since it is a device that "is sufficiently simple to be addressed in a book at University level, but it is also adequate to show the main components required for any complex medical device design". "- From a reviewer of the editorial review process. · "The succession of chapters in the book is sound, leading, step-by-step, from general principles to the final development stages. The division of each chapter into a theoretical and an implementation part is appropriate and helps greatly in connecting each step in the design and development phases from both the theoretical principles and the actual case study perspective. This is crucial, since the material existing in the book is inevitably overwhelming. The reader is also helped by the preface of each chapter ("Chapter Organization"). " The content is very relevant. ...  The use of this text would be beneficial in a 3-4 credit hour educational course, especially at the graduate level and as a reference in professional/company engineering situations. I will use this text for Masters course at my University." - From a reviewer of the editorial review process. · " the book seems well suited for biomedical engineering courses and is also of interest to design engineers. Its publication will be an interesting and rather innovative contribution, especially due to its "all-inclusive" scope in the presentation of design and implementation of medical devices, in conjunction with the specific details given for the commercial ECG device that constitutes the case study of the book." -  From a reviewer of the editorial review process.
	Gamma Cardio CG, the Open Ecg disclosed in the book: · A commercial Ecg connected to the PC, sold in the European market, with performance compliant with Ansi Aami EC 11 standard · The hardware is fully licensed under Creative Common Attribution Non Commercial Alike 3.0 Unported · This product has been certified under the European Medical Device Directive (93/42/EEC, 2007/47) in class IIb, electrical isolation class II CF (double insulation, applied parts suitable for direct cardiac application) (standards EN 60601-1, EN 60601-2-25, EN 60601-1-2). · All the hardware circuits and PCB are disclosed. Software for PC and firmware of the hardware board will follow. · Electrical circuit schematics · Block diagram · All the schematics are contained in the book: "Medical Instrument Design and Development", Becchetti, Neri, Wiley. · Bill of Material · PCB There is a bug on PCB (Printed Circuit Board). Special mention on this site for who discovers the bug first
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