Page 27 - Biomedical Engineering and Design Handbook Volume 2, Applications

6 MEDICAL DEVICE DESIGN

is capable of respecting all aspects of the problems faced. This has been contrasted with the style of
design organization sometimes described as the waterfall scheme, where a group does part of the
design task and then passes their results on to another group, which makes its contribution and in turn
passes the result on again. The most popular image of this is someone throwing a document package
“over a wall” to the next phase. Concurrent engineering is based on assembling a complete design
team at the time the project is begun, and having it work as a unit throughout the design cycle. A
great deal of the success of this technique depends on the composition of the team.

1.5 GOALS

The preliminary efforts should have defined a goal. In the corporate world, this must usually be well
defined in order to be approved, but it’s a good idea to step back at the beginning and be sure that
the goal is clearly defined and agreed on by all parties. There are times when the goal of the project
starts out as an assignment or charge from a higher point in the organization or it might originate
within the group. Regardless of origin, it’s a good idea to critique it, edit it, and turn it into a single
sentence, often with a few important adjectives. When sufficiently polished, it should be displayed
in some way that assists the team in remaining focused.
In the case of the external fixation system, the goal might be: Develop an external fixation system,
that can be quickly installed at all of the common long bone fracture sites, using as few as possible
distinct elements.

1.6 TEAM/TALENT

There are two important aspects to building or recruiting a product design team: covering all of the
specialties required to accomplish the task, and assembling a group of individuals who can work
together effectively and efficiently. It is much easier to discuss the first of these. Although every
function within a corporation will have some impact on how successful the effort is, the product
design team is usually built around a core of people representing marketing, engineering, and
production. In the case of a medical device, an additional specialty in regulatory affairs is important.
The size of this group, the core team, will depend on the nature of the project and could be from four
people, each at one-quarter time, to several dozen full-time key people.
The team will have a working relationship with one or more clinicians who are expected to be
heavy users of the product. Very often this will be an individual who suggested the product oppor-
tunity. This person can be categorized as an expert user, but plays a different role than the users that
the team will deal with later. In almost every case, this is a small part of this person’s professional
activity. He or she has an active practice and is involved here for reasons of intellectual pride or
curiosity. The help of these individuals is vital in formulating the problem and sometimes in main-
taining a correct focus. Finding high-caliber practitioners who are effective in this role can be very
difficult. Many find the give and take of the product design and evolution process frustrating, or do
not find the design team environment very comfortable. Recruiting a knowledgeable clinician who
is helpful in this regard should be an early priority.
The team leader, who might carry the title product manager or some variation of that, may come
from any of the four specialties mentioned earlier, but must be capable of providing insight in each
of them and leadership to the entire team. If possible, the leader should have some control over the
membership of the core team. The effectiveness of communication among the core team will have
much to do with the success of the program, so the leader must feel that the team will be candid, both
with the leader and with each other as problems and challenges arise.
Another position often mentioned in the product design literature is the “champion.” This is an
individual who is high enough in the organization to influence the spending of resources at the level
required and who is personally committed to the project. In some cases the champion may be the