Page 39 - Biomedical Engineering and Design Handbook Volume 2, Applications

18 MEDICAL DEVICE DESIGN

Under the law granting the FDA jurisdiction over devices, products already on the market were
permitted to continue. Products “equivalent to” products on the market require only a formal notifi-
cation of the intent to market, but the agency is the arbiter of what is “equivalent.” (Note also that
the required notification documents can constitute a large package!) Devices without a predicate
product are held to much more stringent controls, usually requiring a series of clinical trials, showing
statistically that the device is safe and effective.
The agency has a responsibility to monitor organizations producing and distributing devices, to
see that they do business in ways that do not endanger the public. This includes assuring that quality
is adequately monitored, that complaints about device performance are promptly investigated, that
steps are taken to correct any potential problems, etc.
The FDA has a very large and difficult responsibility and, given the resources it has to work with,
carries it very well. Those who carefully design products so that they are safe and effective tend to
resent having to explain the way they have gone about it, as they view the effort as unproductive.
Nonetheless, this will continue to be a problem and the team must prepare for it and accept the
burden.
In keeping with its responsibility, the FDA publishes documents that can be very helpful to those
developing products. Most of the useful documents are in the category of “guidance.” Available on
many topics, including specific categories of products, these publications aim to assist people to
understand what the agency expects. It is important to understand that these documents do not carry
the force of law as do the regulations, but they are much more readable and can be very helpful.
A suggested example is the Design Control Guidance for Medical Device Manufacturers. 11 These
documents are indexed on the Web site www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/
topicindex/topindx.cfm.

1.22 CLOSURE

This is clearly a very short introduction to the topic of medical device design. It has been only
recently that design process activities have been written on extensively, and with a few exceptions
where the process is easily codified, most of what has been written is very general. All of the books
in the references address the broader questions, but they provide strategy and advice that is useful to
the medical product designer. All can be read with great benefit. In addition to those cited previously,
attention can be paid to Cooper 12 on planning, to Leonard and Swap 13 for concept generation and
16
teamwork. The remaining three: Otto and Wood, 14 Patterson, 15 and Wheelwright and Clark ; all
provide deep insight into the product design world.

REFERENCES

1. Ulrich, Karl T., and Eppinger, Steven D., Product Design and Development, 2d ed., Irwin/McGraw-Hill,
2000.
2. Tucker, Frances G., Zivan, Seymour M., and Camp, Robert C., “How to Measure Yourself Against the Best,”
Harvard Business Review, January–February 1987, p. 8.
3. Von Hipple, Eric, The Sources of Innovation, Oxford University Press, 1988.
4. Rutter, Bryce G., and Donelson, Tammy H., “Measuring the Impact of Cultural Variances on Product
Design,” Medical Device and Diagnostic Industry, October 2000.
5. Hauser, John, and Clausing, Don, “The House of Quality,” Harvard Business Review, vol. 66, no. 3,
May–June 1988, pp. 63–73.
6. Osborn, Alex F., Applied Imagination, 3d ed., Scribners, 1963.
7. Pugh, Stuart, Total Design, Addison Wesley, 1991.
8. Meyer, Mark H., and Lehnerd, Alvin P., The Power of Product Platforms, The Free Press, 1997.