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Medical Instrument Design and Development From Requirements To Market Placements Claudio Becchetti
Medical Instrument Design and Development From Requirements To Market Placements Claudio Becchetti
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MEDICAL INSTRUMENT
DESIGN AND
DEVELOPMENT
MEDICAL INSTRUMENT
DESIGN AND
DEVELOPMENT
FROM REQUIREMENTS TO
MARKET PLACEMENTS
Claudio Becchetti
Alessandro Neri
This edition first published 2013
# 2013 JohnWiley & Sons Ltd.
Registered office
John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, United Kingdom
For details of our global editorial offices, for customer services and for information about how to apply for permission to
reuse the copyright material in this book please see our website at www.wiley.com.
The right of the author to be identified as the author of this work has been asserted in accordance with the Copyright,
Designs and Patents Act 1988.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright,
Designs and Patents Act 1988, without the prior permission of the publisher.
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names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The
publisher is not associated with any product or vendor mentioned in this book.
Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this
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shall be liable for damages arising herefrom. If professional advice or other expert assistance is required, the services of a
competent professional should be sought
Becchetti, Claudio.
Medical instrument design and development : from requirements to market placements / Claudio Becchetti,
Alessandro Neri.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-1-119-95240-4 (cloth)
I. Neri, A. (Alessandro) II. Title.
[DNLM: 1. Electrocardiography–instrumentation. 2. Equipment Design–methods. 3. Electrical
Equipment and Supplies. 4. Equipment Safety. 5. Software. WG 140]
R856.A1
610.28–dc23
2013002809
A catalogue record for this book is available from the British Library.
ISBN: 9781119952404
in memory of
My Father and of Italo Corti, MD, Cardiologist
Contents
Foreword xv
Preface xvii
Acknowledgment xxi
1 SYSTEM ENGINEERING 1
Chapter Organization 1
Part I: Theory 4
1.1 Introduction 4
1.2 Problem Formulation in Product Design 4
1.3 The Business Context for Design 6
1.4 The Engineering Product Design Process 10
1.5 System-subsystem Decomposition 15
1.6 The Product Development Life Cycle 21
1.7 Project Management in Product Design 24
1.8 Intellectual Property Rights and Reuse 30
Part II: Implementation 32
1.11 The ECG: Introduction 32
1.11.1 The ECG’s diagnostic relevance 32
1.11.2 ECG Types 33
1.12 The ECG Design Problem Formulation 34
1.13 The ECG Business Plan 36
1.13.1 Market Size and Trend 37
1.13.2 Core and Distinctive Features 38
1.14 The ECG Design Process 40
1.14.1 Transverse Activities of the ECG Design Process 43
1.14.2 Core Activities of the ECG Design Process 44
1.15 ECG System–subsystem Decomposition 44
1.15.1 Hardware Platform Decomposition 45
1.15.2 Software Application Decomposition 45
viii Contents
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 its 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 suffi-
ciently easy to deal with for a prospective biomedical engineer, but encompasses 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.
The field of medical instrumentation shares with industrial product implementation the
knowledge of various engineering methodologies and techniques, and these aspects must be
combined with specific requirements, such as the medical device certification, a point that is
crucial in order to put an instrument onto the market. Moreover, the scenario has evolved, in
that an increasing number of medical instruments are being conceived to be closely linked
into a hospital information system and/or to be integrated in a distributed management in the
context of a virtual (distributed) health record. Part of the book is thus devoted to seeing
medical instrumentation in the context of cloud computing, for which the authors introduced
the new term of c-Health, thus also helping in understanding future developments.
The book is self-contained because in every chapter it presents the theoretical concepts, on
signal and information theory, digital signal processing, electronics, software engineering
and digital communications, which remain valid across technological evolutions of medical
instrumentation. Moreover, the book explores the additional know-how required for product
implementation such as the business context, system design, project management, intellec-
tual property rights and the project life cycle.
1.2: Problem Formulation in Product Design 5
Ambiguous
Dilemmas Mess
Solution
Puzzles
Well-
defined
Well-defined Ambiguous
Formulation
In these messy problems, the traditional step-by-step logic useful for solving puzzles may
not be sufficient, but here other techniques such as ‘abstraction’ and ‘divide and conquer’
may help.
In product design, a simplified model of the product is derived through abstraction. From
this first model, other more detailed models are derived, each getting closed to the real
system to be implemented. This technique is exploited also for system-subsystem decompo-
sition (Section 1.5) using the ‘divide and conquer’ technique. In this paradigm, a complex
problem can be faced when it is broken down into smaller solvable components.
A systematic approach to defining a problem helps greatly in solving the problem itself:
‘If I had only one hour to save the world, I would spend fifty-five minutes defining the
problem, and only five minutes finding the solution.’ (Albert Einstein).
In a simplified approach, problem management may be schematized as depicted in
Figure 1.4. A customer assigns to the executors a problem to be solved with a clear goal.
The customer then identifies the output to be delivered when problem is solved.
The customer itself usually defines the input and constraints to be considered. Within
constraints, the customer may include time-scheduling, milestones, budget, resources,
expected quality, expected organizational interfaces and testing procedures and mini-
mum results. The input may include at first level: customer needs, technological environ-
ment and preferred standards. The executor has to provide the output, given the input and
constraints. During the execution of the task, the executor generates the assumptions
required to solve the problem and the possible risks. The problem-solving activity in more
complex cases will be performed through a project using techniques encompassed in the
project management area (Section 1.7).
All the previous elements should be agreed between the customers and the executors before
the project initialization phase so that all the stakeholders are committed to solving the prob-
lem with the same elements. The executor has to define the problem formulation in as much
detail as possible before starting, to avoid misunderstandings during the task execution.
Complex problems usually involve social and psychological issues. The definition may
not be simple and negotiation on the various constraints probably has to take place with all
the stakeholders, who are conditioned by their own background. If problem definition does
not take into account all the stakeholders’ perspectives, people involved in the task may
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