P A R T I

MEDICAL DEVICES

A medical device is an apparatus used in the diagnosis, mitigation, ther-

apy, or prevention of disease, which does not attain its primary purpose
through chemical action. In Part I of this textbook, we provide an over-
view of medical devices (Chapter 1), followed by a discussion of 19 types
of medical devices (Chapters 2 20). Because many students have minimal
exposure to medical devices, Chapter 1 provides a framework for subse-
quent discussions. Basic concepts like instruments, stimulators, and sen-
sors are considered.
In an introductory survey course, choosing only 19 types of medical
devices for discussion is difficult. Devices were chosen on the basis of the
following criteria:
1. Exclusion of imaging devices because many good textbooks on medical
imaging exist.
2. Medical devices (except for imaging) that have won a Nobel Prize in
Physiology or Medicine or a Lasker Clinical Medical Research Award,
because these devices have met clinical needs and have saved lives.
3. Medical devices that measure the vital signs, because it is an ABET
requirement that bioengineer graduates have “the ability to make
measurements on and interpret data from living systems.”
4. Medical devices in the four high-growth areas of cardiovascular
devices, neural devices, orthopedics, and combination products, in
order to provide student training for the medical device industry.
With these criteria in mind, we describe the following technologies:
electrocardiographs; pacemakers; external defibrillators; implantable cardi-
overter defibrillators; heart valves; blood pressure monitors; catheters,
bare metal stents, and vascular grafts; hemodialysis delivery systems;
mechanical ventilators; pulse oximeters; thermometers; electroencephalo-
graphs; neurostimulators; cochlear implants; functional electrical stimula-
tors; intraocular lens implants; total hip prostheses; drug-eluting stents;
and the artificial pancreas.
2 PART I. MEDICAL DEVICES

Each chapter begins with a discussion of relevant physiology and clini-

cal need. Historic devices are included because they provide insight into
the design-improvement process. System description and system diagrams
provide details on technology function and on the administration of diag-
nosis and/or therapy. The systems approach enables students to quickly
identify the relationships between devices. Each chapter concludes with
five key device features, which are requirements in an applicable consen-
sus standard.
In three chapters, case studies of significant Food and Drug
Administration recalls are included. The Bjork Shiley heart valve (Chapter
6), Guidant endovascular graft (Chapter 8), and Guidant implantable car-
dioverter defibrillator (Chapter 5) recalls had significant effects on how
medical devices are designed and monitored after market release. These
case studies provide a glimpse into medical device business practices such
as design control, verification testing, postmarket surveillance (reporting
of adverse events), and sales.
Exercises at the end of each chapter include traditional homework pro-
blems, analysis exercises, and four questions from assigned primary litera-
ture. In many homework problems, the students download physiologic
waveforms and process them using software, such as Matlab. Because this
is a textbook and not a reference book, the students are asked to analyze
differences between various devices and device components after a group
of devices, such as implantable stimulators, is discussed. This is a more
effective teaching strategy than having these issues readily compared in
an existing table.
It is recommended that the primary literature readings in the exercises
be assigned before each chapter is covered. Reading about the first suc-
cessful implementation of a medical device provides context for the topics
covered in the corresponding chapter. This enables the questions to be dis-
cussed at the start of lecture, and facilitates active learning.