Page 28 - Biomedical Engineering and Design Handbook Volume 2, Applications

MEDICAL PRODUCT DESIGN 7

team leader, but more often is the person the leader reports to. Regardless of the titles and terminology,
the champion is a vital part of the team. If this person doesn’t exist, the project will not weather the
first storm.
The team leader will carry the primary project management responsibilities. This includes drafting
the original plan, defining schedule and resource requirements, assessing the various risks that things
will not proceed as planned, and watching the progress of the plan in all of its details. Much has been
written about the role of the leader, and most professionals with some experience recognize the
importance of the leadership, management, and technical skills required for a successful program.
If there are team members new to the medical device field, they should bear in mind that many
of the rules of thumb that are useful in managing a product design effort need to be recalibrated in
this sector. Things take longer, cost more, and are more difficult to pin down. The same items are
important but the parameters are often different.

1.7 PLANNING/RESOURCES

Before the project gets underway, a fairly detailed plan must be put into place. A good plan is the
best possible start for the project. The team leader along with the core team should compile a
document that spells out the schedule, the people and other assets required to accomplish the various
tasks.
The plan should identify gating events. These are the points in the project where an evaluation of
progress and potential outcomes is made. The plan is held to, changed, or abandoned on the basis of
the gating events. These points should be well defined at the planning stage. The level of formality
at the gate points depends on the nature of the product and the corporate culture. The need for meeting
regulatory requirements will guide the choice of some of these gates, but other issues will also play
a role. The points where the rate of spending increases or when other commitments must be made
are good choices.
The planning process also involves the setting of targets. If the five measures of success men-
tioned earlier are considered, there is at least one target imbedded in each of them. First there is a
product of high quality, with quality measured in market acceptance, performance, and perhaps other
attributes. Target values should be spelled out and serve as a focus throughout the project. Likewise
there are manufacturing cost, development cost, and development time targets that should be delin-
eated. These should be aggressive without being absurd. In the current business environment, there
is little room for any but the best of products. To be successful, the product must have a strong
advantage over its competition. It will have to offer something unattainable elsewhere. A strong
focus on the advantage to be attained is very important. If the thing is worth doing, it is worth doing
well.
It is difficult to set measures for the enhancement of capabilities that is the final measure of
success. One set of objectives could be the establishment and documentation of procedures if the
group is doing things in a really new way. A second approach is to challenge the time and cost
schedules. In a larger, more mature organization, a formal benchmarking process can be used to
measure the strength and effectiveness of the development team. See Ref. 2 for an overview of this
approach.

1.8 DEVELOPING USER NEEDS

Before proceeding to design a product, it is extremely important to establish clearly what it is that
the product will do. It is important that this sequence be understood and respected. First the function
required of the device will be defined, and only then are the means to accomplish the function
sought. Many design efforts have resulted in failure because the object was defined first and the
major effort was aimed at proving the device was needed, trying to make the market fit the design.