Page 24 - Biomedical Engineering and Design Handbook Volume 2, Applications

CHAPTER 1

MEDICAL PRODUCT DESIGN

James P. O’Leary
Tufts University, Medford, Massachusetts

1.1 INTRODUCTION/OVERVIEW 3 1.12 ARCHITECTURE/SYSTEM DESIGN 13
1.2 SCOPE 5 1.13 DETAIL DESIGN 14
1.3 QUALITIES OF SUCCESSFUL 1.14 DESIGN FOR MANUFACTURE 14
PRODUCT DESIGN 5 1.15 ROLLOUT 14
1.4 CONCURRENT ENGINEERING 5 1.16 PROCESS REVIEW 15
1.5 GOALS 6 1.17 PROTOTYPING 15
1.6 TEAM/TALENT 6 1.18 TESTING 16
1.7 PLANNING/RESOURCES 7 1.19 DOCUMENTATION 16
1.8 DEVELOPING USER NEEDS 7 1.20 TOOLS 17
1.9 PRODUCT SPECIFICATIONS 9 1.21 REGULATORY ISSUES 17
1.10 CONCEPT DEVELOPMENT 10 1.22 CLOSURE 18
1.11 CONCEPT EVALUATION 11 REFERENCES 18

1.1 INTRODUCTION/OVERVIEW

The design of a medical product is a complex task. All design activities involve the resolution of
conflicts and compromise among the desired features, but in medical products the conflicts tend to
be more intense, the stakes are often higher, and the background information is often more uncertain.
This section describes a process that has been found to be useful in bringing successful products
to market. It is based on an approach to design that has recently been described as concurrent
engineering.
This section opens with some groundwork on getting a program started, follows that with a
somewhat specific set of steps to be carried out as the design is developed (Fig. 1.1), and then
examines some issues that pervade the entire process, reviewing how these concerns might affect a
design and in particular the design of a medical device. Figure 1.1 shows the steps in the process to
be described.
In order to be more specific about some of the details, an example is sometimes necessary. In this
section that product is an improved system of exterior fixation of long bone fractures. In exterior
fixation, pins of some type are attached through the skin to the bones above and below the fracture
and these pins are in turn attached to an external structure that maintains the position of the bone
segments during healing. This is a problem that is easy to picture and understand, which makes it a
good example for this document. It is a difficult area in which to make progress, however, and none
will be made here. It will only serve as an illustration.
Everything has to start somewhere, and a medical product may emanate from a variety of origi-
nating events, but at some point a decision is made to pursue a certain need, question, request, or

3