Page 38 - Biomedical Engineering and Design Handbook Volume 2, Applications

MEDICAL PRODUCT DESIGN 17

be in one place! It is the collection of all the material just mentioned and it could be in several states,
or even on several continents. The need to provide all of this documentation and to have it accessible
requires that the project have someone in the role of librarian. If the project gets too far along and
too much material is generated before a document control system is in place, it may be a situation
from which there is no recovery. Document control should be part of the initial project planning. If
the organization has experience in device development, it probably has already established formats
and templates to handle the materials and data, and a new master file can probably be built around
existing standards. If the current project is a first, an experienced person will be needed to take
charge of these matters and will need to have the power to demand that procedures are followed.

1.20 TOOLS

There are a number of software products and related items that can be very useful in various aspects
of product development. These include computer-aided design (CAD), computer-assisted manufac-
turing (CAM), various engineering analysis tools for things like finite-element stress analysis or
circuit analysis, planning tools, scheduling products, systems that generate rapid prototypes, and a
vast number of other things that have the potential to save effort, and more important, time. Most if
not all of these tools have associated with them a learning process that requires time and effort. It is
wise to develop at the outset of the project a clear picture of what tools of this kind will be needed
and to be sure that the team includes members who have experience in their use.
As alluded to above, the choice to make use of a particular tool is an investment decision, and
should be dealt with in that way. Software and hardware will have to be acquired, and individuals
may require training in their use. The selection of these tools from the outset allows training to be
done early when it will have the longest-term benefit. (It also requires the expenditure of the corre-
sponding funds at a time that the project may appear to be overspending!) In most categories, there
are competing products from which to choose. Once the requirements are met, the most desirable
characteristic is familiarity. If the people on the team have used it (that might include venders and
others you need to exchange information with), you are well ahead selecting that product. The pur-
chase price can’t be disregarded, but the cost in time spent learning to use a computer tool is usually
higher than its price.
With most tools and particularly with CAD and similar products, there is a more or less contin-
uous version upgrade problem. If at all possible, this is to be avoided. If you select a product that
fills your needs at the outset, you should be able to get along without the three new “hotkeys” and the
six new plotter interfaces that have been added to version 37.3. Installing a new release will cost time
that you do not have, increase the likelihood of losing data, and will not pay off in a productivity
increase that is noticeable.
The previous paragraphs presume an intense design effort on a single product. If a group is spread
out continuously over a large number of projects, upgrades are a fact of life. One can, and many do,
skip some of them. With some products, installing every third or fourth version will keep the group’s
tools sufficiently up-to-date.

1.21 REGULATORY ISSUES

Manufacturing and marketing a medical product in the United States must be done under the regu-
lations of the Food and Drug Administration (FDA). Medical devices are handled by the agency’s
Center for Devices and Radiological Health (CDRH). Complying with these requirements constitutes
one of the major resource requirements in the development process. As with so many other topics in
this section, the extent of effort will vary greatly, depending on the nature of the product, the potential
of it causing harm, and the history of similar products and devices in similar areas. Having available
a person knowledgeable about the agency’s dealings with similar products is a must.