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Reliable Design of Medical Devices [Book Reviews]

Article  in  IEEE Engineering in Medicine and Biology Magazine · April 1999

DOI: 10.1109/MEMB.1999.752995 · Source: IEEE Xplore

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Paul H. King
Vanderbilt University
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 Book Reviews
Reliable Design of Medical Devices
By Richard C. Fries. Marcel Dekker, Inc., 1997 (ISBN
0-8247-9843-0). xix + 703 pages. $215
I teach the course titled “Design of Biomedical Engineering
Devices and Systems,” which is the one-year senior design
course at Vanderbilt University. I have taught the course lecture
portion using a combination of notes from workshops and mis-
cellaneous sources. I have been looking for a single text that can
serve as the mainstay of the lecture portion of this course (-10
weeks) and as a reference source for the subsequent student pro-
ject work (-20 weeks). Having proposed to write my own text,
and having reviewed several other related texts, I was very in-
terested to find the text by Fries, Relicihle Desigii (?f’McdicuI
Deiicrs. this past summer.
According to the preface, this text is aimed at the developer of
medical devices. and it is intended to acquaint these persons with
basic concepts of reliable device design, including current devel-
opment processes and techniques. It is secondarily aimed at pur-
chasers of these technologies, and finally may be used by
nonmedical developers and purchasers, as the techniques are
deemed relevant.
Five chapters comprise the initial section of this text, titled “Re-
liability Basics.” The chapters cover medical device
the concept of failure, reliability assurance, an introduction to de-
vice safety, and an introduction to device economics. Taken as a
separate entity, this section, when expanded upon, forms the ba-
sis for senior-level courses in reliability. Each of the fairly short
chapters here (as well as in the remainder of the text) has a brief
list of references, and n o footnotes appear in thc text.
Section two contains material that should be mandatory in any
medical design text and course, under the title of “Medical De-
vice Regulation and Standards.” Chapters cover the Food and
Drug Administration, Medical Device Directives, I S 0 9000
standards, domestic standards, and international standards. This
section is a reasonably succinct description of standards and the
related alphabet soup of agencies, in a easily readable form.
Section three is titled “Specifying and Designing the Product”
and comprises almost half of the text. Chapters cover device defi-
nition, requirements engineering, risk management, liability, in-
tellectual property, human factors, good laboratory practices,
128 IEEE ENGINEERING IN MEDICINE AND BIOLOGY
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Paul H a King
hardware and software design, and software coding. This is the
section of the text that I consider most generic to the process of
design; the majority of this material should also again be manda-
tory in a design course. Given the relatively recent publication
date, I was surprised to not see mention of languages such as C++
and visual C++, as well as related language extensions. Several
very useful checklists appear in this section.
Section four is titled “Testing and Data Analysis” and covers
the basis for/and types of testing, then hardware and software
verification and data analysis in depth. For the first time, the
reader is given several specific examples of analysis
(Chi-squared tests, Weibull and Pareto charts) that aid in under-
standing the text.
A final section, “The Manufacturing and Maintenance Pro-
cess,” covers GMP (good manufacturing processes), configura-
tion management, and analysis of field data in a very brief
fashion. Appendixes next cover Chi-squared data, regulatory
agency addresses, the IS0 9000 standard, common failure
modes, and a glossary.
I can use this text as a reference, but not as my main text, for the
following reasons:
My course covers systems and processes, and I need coverage of
flowcharting and quality improvement as applied to this area.
I cover forensics and consulting relating to medical device ac-
cidents, and I need examples of errors and costs of errors to
drive home the point of medical device design and misuse er-
rors (see, for example, Geddes’ Medicul Daice Acciclerits, or
one of several web sites).
Our design projects involve current projects, which requires
use of the web as an information source.
Newer safety design tools, such as the software program
“designsafe” have become available.
A newer design tool, TechOptimizer, has come upon the scene.
The landscape for academia is becoming one of immediacy.
This text is a good, generic, discussion of reliable design of
medical devices. As such, I consider it a good reference for man-
ufacturing professionals. With the above additions, it could also
become a good to excellent text for use in biomedical engineer-
ing education.
-Paul H. King
Vanderbilt University
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