Page 500 - Biomedical Engineering and Design Handbook Volume 2, Applications

478 REHABILITATION ENGINEERING AND PROSTHETICS DESIGN

As an alternative to shipping completed products to underdeveloped regions, can the device be
designed for construction and repair with local resources? Can it be designed with yesterday’s tech-
nology to reduce the cost and then ship the parts for local assembly? For example, if a system can
use computer hardware 2- to 4-years old, there may be sources willing to donate their older systems.
Whatever the design, let us not forget those in poorer nations.

16.5 WHAT’S NEXT?

Toward the final stages of the embodiment design phase, there are often two or three “most promising”
designs that the team may still be considering. There are still many factors to consider. These include
technical feasibility, safety, cost, and many manufacturing issues. Is the device at risk for failure due
to fatigue or corrosion? Are all applicable codes and standards satisfied? Must the product be registered
with the Food and Drug Administration (FDA) or other regulatory agency? Will it require clinical
trials? Once the final design is selected, it is time for the detail design phase.
The detail design phase will include the preparation of detail drawings and product specifications.
A bill of materials must be prepared along with a detailed cost estimate. A final design review is con-
ducted before releasing all drawings to be manufactured.

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