Biomedical Engineering Reference
In-Depth Information
on need, without regard to commercialization (see
Chapter 5.3).
benefits from the prolonging of a skilled surgeon's
longevity.
Prototyping designs to fill specific
and specialized needs
Documenting
After producing mechanical drawings with CAD, the
next step is to render the design into a working prototype.
Many times, theory does not readily match reality.
Engineers should be prepared to encounter the familiar
Murphy's Law
: Anything that can go wrong will go wrong.
However, with a bit of persistence, a final design is ren-
dered, and the finished product is executed in collabo-
ration with the machine shop or instrumentation shop.
After the device is deployed, care must be taken to
monitor closely the product's safety and effectiveness.
Close consulting with the clients greatly helps to perfect
the finished product.
Typically, the cost of such device-design activity is
built into the general operating fund for the hospital.
Where the project involves a research or an activity with
funding other than by the hospital, the CE department
bills the grant or source of funding through the client
department. This funding mechanism will differ among
institutions.
Should a device design progress to the stage of
patenting, the department could realize some financial
advantage by selling the rights to manufacture the
product. The transition from device design, to patent, to
manufacturing, to marketing and sales is long and costly,
requiring substantial financial resources and device
development infrastructure. Nevertheless, patenting can
be an effective way to preserve the rights of the inventor
to some remuneration from the invention.
Awell-written report can be effective in impressing upon
the hospital and clients the CE's thoroughness, knowl-
edge of the subject, and grasp of the issues involved.
Writing reports helps the CE to understand more thor-
oughly what was accomplished in the evaluation, clinical
trial, or device design. Putting thoughts into words forces
one to consolidate thoughts and to communicate in a log-
ical, understandable fashion for the target audience. On
occasion, in the process of writing, various issues, options,
and alternate solutions emerge that were not considered
during the progress of the work. The CE should never
underestimate the power of the written word. A CE's
responsibility in this endeavor is to be careful and de-
liberate in arriving at conclusions and recommendations
and to be astute enough to modify them as new in-
formation becomes available. Preparing a well-written
report can induce a customer-satisfaction response that
exceeds financial reward. A satisfied customer will regard
the engineer highly and will seek help in the future. Fur-
thermore, the customer is likely to recommend the en-
gineer to colleagues.
A CE's good work is only helpful when it is com-
municated properly to the correct audience, who can act
on the findings and recommendations. Good commu-
nication skills require that the author know the intended
audience and phrase words accordingly. In the hospital,
the CE's reports are usually directed to the adminis-
trators, managers, the nursing staff, and the medical
staff. These different audiences require slightly different
approaches that match their expectations, training, ed-
ucation, and experience. A layperson's approach works
well with nonmedical persons. The scientific approach
appeals to the clinical professional. The nursing staff
seems to respond well to reports that address protocol
or standard procedures for its areas of responsibilities.
Doctors, by virtue of their extensive scientific education
and training, respond well to a reporting style used in
medical textbooks and journals. With a mixed audience,
if recommendations particularly affect one group, the
reporting style should be slanted in that direction. An-
other option is simply to write two or three different
reports to send to the different groups.
Design/ergonomics
Increased attention is being paid to ergonomics and
human factors in medical device design. Increased effi-
ciency and reduction in human error are achievable using
an ergonomic approach in equipment design. For exam-
ple, minimally invasive surgical procedures made possible
by ergonomically designed endoscopic instrumentation
has reduced (or, in many cases, eliminated) the need for
an open incision, thus reducing surgical time and expense
and improving patient outcome (e.g., less anesthesia and
reduced chance of infection). Robotic arms now extend
the surgeon's precision beyond unaided physical capa-
bilities. Lengthy surgeries lead to physicians' tired mus-
cles, but when translating motions into action, robot
helpers can eliminate the tremors of a tired surgeon's
hands. Years can be added to a surgeon's career by en-
hancing his senses. The patient population ultimately
Product improvements
CEs are uniquely positioned and qualified to recommend
to manufacturers device modifications that help to
