Medical Instrument Design and Development: From Requirements to Market Placements

This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. 

Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer.

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.  The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. 

Key Features:

• Introduces a system-level approach to product design
• Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification
• Explains how to use theory to implement a market product (using ECG as an example)
• Examines the design and applications of main medical instruments
• Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc.
• Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book)
• Discloses the details of a marketed ECG Product (from Gamma Cardio Soft)  compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common)

This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.

Dr. Claudio Becchetti, RadioLabs, Italy
Claudio Becchetti graduated with honors in Electronic Engineering in 1994 at the University of Rome, where he achieved the Ph.D. in Telecommunications in 1999. From 2002 to 2009, he was adjoint professor at the University "La Sapienza", faculty of Telecommunication Engineering where he held first a course on Industrial design and then a course on Signal Theory.  Claudio has 7 years teaching experience working with students studying ECG. This device is well suited as a practical example for signal theory, digital signal processing, electronics and software engineering.

Professor Alessandro Neri, University of Roma TRE, Italy
Alessandro Neri he received the Doctoral Degree cum laude in Electronic Engineering from the University of Rome "La Sapienza" in 1977. Since 1992 he is responsible for coordination and management of research and teaching activities in the Telecommunication fields at the University of Roma TRE, currently leading the Digital Signal Processing, Multimedia & Optical Communications at the Applied Electronics Department. His research activity has mainly been focused on information theory, signal theory, and signal and image processing and their applications to both telecommunications systems and remote sensing.