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
designCovers topics such as bioinstrumentation, signal processing,
information theory, electronics, software, firmware, telemedicine,
e-Health and medical device certificationExplains how to use theory
to implement a market product (using ECG as an example)Examines the
design and applications of main medical instrumentsDetails 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.
General
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