Biomedical Engineering Reference
In-Depth Information
5.3
Chapter 5.3
Medical device research
and design
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Engineers who are active in the health care sector have
great opportunities to contribute to long-term quality
development by developing new techniques or improving
existing ones. By working daily with commercially avail-
able medical devices and observing ways in which prod-
ucts are used in practice, the clinical engineer (CE) gains
valuable knowledge that, when coupled with keen insight
and creativity, can lead to ways to improve existing tech-
niques or to solve long-standing problems. The CE has
a perspective on developmental requirements, which is an
extremely valuable attribute in order to function as an
innovator. Furthermore, the CE's proximity to the point
of health care delivery provides ample opportunities for
the testing and trial of new products in the end-user
environment. In the pursuit of improvements in health
care, many with expertise in the medical sciences (e.g.,
doctors, nurses, and therapists) collaborate well with
engineers, for they understand the engineer's gifted ability
to analyze problems and synthesize solutions. The bene-
ficial result of such analysis and synthesis, the warp and
weft of the engineer's mantel, is invention, the creation of
something useful; e.g., an object, a machine, or a tech-
nique, that did not exist before.
Clinical engineering was born from the concept that
engineering attributes (i.e., the analysis and synthesis) are
needed to improve health care (Caceres, 1980). Over the
last two decades, however, the pendulum has swung and
paused over the repair-shop and financial spreadsheets.
Mercifully, it is swinging back to its original position, the
bedside, the point of care delivery, with no small impetus
imparted by recent revelations of inadequacies in the so-
called health care delivery system (Kohn
et al
., 2000).
Regulator demands and financial pressures have absorbed
and redirected time and talent, thus denying clinical en-
gineering departments the resources for time-intensive
product-development activities. Available personnel must
resolve the immediate daily tasks such as keeping the
hallway clear of equipment, fixing broken infusion pumps,
and entering no-problem-found codes in the computer.
Inventions and technical development work fell to the
lowest rung on the departmental priority ladder. Sadly,
hospital administrators underutilized or spurned the tal-
ents of even highly competent, well-educated, and skilled
CEs, often out of ignorance of their enormous potential,
but also in part because of the inability of CEs to articulate
their value and to advocate their profession.
The need for improved or new products for health
care is the major driving force for innovations and
industrial production of medical devices. New medical
products are born in the light of new clinical re-
quirements and new technical possibilities. To be able to
identify the new needs and possibilities requires a high
degree of competence in both the engineering and
medical fields.
Developing new products takes time. A 5-10-year
period from inception to commercialization is not un-
realistic. The interpretation of marketplace trends is im-
portant in successful product development. Two main
questions arise: Where will health care be 10 years from
now, and which new techniques will emerge in the
meantime? The needs that one sees today will not neces-
sarily be the same 10 years from now. To correctly assess
future trends and needs is of the utmost importance in the
development of new, commercially successful products.
The world market for medical and health care products is
worth approximately $150 billion, of which pharmaceu-
ticals represent $100 billion; the remaining $50 billion
represents instrumentation and medical devices (OECD,
1992).
Today health care and the biomedical industry use
highly sophisticated technology in their products. It is
reasonable to assume that technological progress will find
