RESEARCH FORUM--Research and Technology in Prosthetics and Orthotics
Charles H. Pritham, CPO
ABSTRACT
Research is the acquisition of new information by scientific
means. Research and development (R&D) is the exploration of that information to solve a problem, and product
development is the process of making it a practical reality.
These concepts are easily confused, particularly when one's
attention is focused on new devices.
Another element that must be considered is the technology transfer. Very real constraints exist for afield as small as
prosthetics and orthotics that is rapidly adopting exotic new
technology. These constraints involve issues of cost and
information to guide manufacturing and utilization efforts.
The O&P profession must weigh carefully issues involving
the evaluation of new techniques and devices. O&P clinicians will also play an essential role in this area as well as in
research, R&D and product development.
Introduction
Research is a method for investigating the world around
us. The result is often the introduction of a new device or
technique. In the O&P profession, this event is so common
that many consider research to be synonymous with research and development (R&D), which complicates the
debate and leads to confusion about outcomes and expectations. Equally confounding are misconceptions about the
differences between R&D and product development.
This article will attempt to explore some of the differences between these concepts. It will discuss some of the
issues involved in introducing new developments to the
practical world of patient care and the interactions among
the players in the process.
Throughout this article, the reader should remember
that the author is not an expert on this subject nor on the
philosophy of science. Also remember that since this article is based more on the author's opinion and philosophy,
many readers likely will have different opinions about
these issues.
Research
In the strictest sense research is about demonstrating the
relationship between two or more variables (1,2,3). The
expected outcome is knowledge, and it can be said to be
value neutral. No judgment is made about the correctness
of the information in a moral sense, the appropriateness of
acquiring it or its usefulness. Knowledge for its own sake is
the goal, and like many good tools, it is a double-edged
sword. We should not be surprised or angry, therefore,
when the results of scientific inquiry challenge our treasured opinions or fail to support conventional wisdom.
The process also is incremental, with progress often
made through the slow and painful accretion of small bits
of knowledge. Frequently these bits only verify clinical
experience. The danger, then, is for "practical-minded"
people to dismiss the results as wrong or trivial and the
process as irrelevant. However, it is always valuable to
have conventional wisdom confirmed where possible or
refuted when necessary, and the seemingly trivial bit of
knowledge about something that "everybody knows" may
embody the quantification of the phenomenon that makes
some later breakthrough possible.
Research and Development
Research and development is the process of using the results of research to solve a problem (4,5,6). Some call it
development, concept development or a feasibility study.
The information applied may be either the result of the
investigatorial efforts of the researchers themselves or data
culled from the literature. The outcome of this process is
the possibility of solving a practical problem, but it is not
necessarily a practical solution to the problem.
Apart from any new knowledge gained, the results frequently include a working model or prototype that demonstrates the feasibility of using the particular approach to solve the problem. While alluring in its solidity and existence, the working model may be as hard to use or manufacture. In this sense, R&D results are not practical; they are merely the faintest glimmer of light at the end of the tunnel.
Product Development
Product, or full-scale, development is taking this faint
flicker of promise and producing from it a reality that is
affordable, useful and practical (4-6). The discipline involved and the difficulties encountered are as rigorous as
those encountered in research and R&D.
While it may be possible to conduct these last two endeavors in isolation, product development is intimately
involved with the real world and all its contrariness. The
developer must explore the most economical ways and
means of manufacturing the device.
This last point frequently hinges on how many devices
are produced, which in turn hangs upon questions of market acceptance, which is influenced by matters of utility
and value, as perceived by the purchaser. It may not be
possible or desirable to include all the features contemplated in the finished product. It may prove to be economically
impractical, or the features may not be user-friendly. Purchasers may want different features.
The interaction of these factors must be juggled and
rejuggled, and the ultimate product may look quite different from what was originally considered. Pre-production
samples, clinical trials and safety testing may result in extensive design changes (7). At some point, the manufacturer must make a decision to gamble and produce the device,
investing in tooling, training fabricators and enacting quality assurance measures. Packaging must be designed and
procured. Resources must be devoted to such matters as
marketing and advertising as well as product support.
Product development may be confused with technology
since the issues involved include commercial ones as well
as purely technological ones. Researchers often fail to realize the realities of commercial and manufacturing issues,
which can lead them to confuse R&D with product development. Such confusion can lead to wasted time and capital if they decide to enter the commercial domain without
an experienced partner, and frustration and culture clash if
they enter into a collaborative relationship with a manufacturer.
Technology Transfer
Technology transfer involves the spread of technology
from its source to some other setting. Originally the term
applied to the transfer of technology from one country to
another. Of late, the process has come to be seen as also
occurring within a society or country and to proceed from
high-tech to low-tech (the trickle down, spin-off theory
used to justify the arms or space race in terms of better
kitchen appliances). It is, of course, beyond the scope of
this article to debate the wisdom of this approach. It is
more to the point to consider the employment of the fruits
of such efforts in O&P.
We have seen the profession changed by such elements
as advanced composites, new alloys, computers and solid
state electronics. We proudly flaunt this as evidence of our
technical sophistication and conveniently overlook the
protracted and tortuous paths many of these elements took
to reach the field. Carbon fiber composites, for example,
first came to widespread prominence in the late '60s in
advanced government-sponsored aerospace applications.
It was only after they had been employed in such mundane applications as tennis racquets and golf club shafts
that they were commercially introduced to prosthetics and
orthotics. Consumer electronic products rival or even exceed the best of electronically controlled prostheses in
their sophistication, and at prices that render the use of
such consumer appliances commonplace. The point is not
to trivialize the use of technology in O&P but rather to put
it in perspective.
Initially, advanced materials and processes are expensive to use and often difficult to master. Our profession is
too small to command the market share necessary to make
it attractive to those developing such markets or products.
We simply cannot buy enough to make it worth their while
to sell to us at a price we can afford or to encourage them to
develop an emerging new technology solely for our needs.
As manufacturers develop new markets and once-glamorous products become mundane, and as manufacturers develop the experience to make the product both cheaper
and safer to use, it then becomes practical to use the material or technique in O&P devices.
We must always remember that such advances in our
profession come as the result of advances in some other
field; we piggyback on their success. Those that would
strive to introduce radically new and untested technologies
to our field would perhaps do best to remember this and
focus their efforts on more mature technologies, adopting
a more "off-the-shelf approach."
Evaluation
With even the best of motives, it is impossible for developers to be truly objective about a new product or technique,
nor should we expect them to be. Ultimately, the decision
to develop and market a new product is not a rational one.
If it were, new products would not be introduced for there
are always more reasons not to develop something (not
least of which is uncertainty) than there are reasons to do
so. To proceed demands faith and commitment on the
developer's part.
Nor, with as many possibilities as there are to pursue, do
people develop products they do not believe in. The question is not whether some product is worth pursuing, but
rather if the market can be convinced of its merits.
Scientific investigations about the merits of a product or
comparisons between similar products are seen as potential proof of a product's value to be used in the marketing
effort. Unfavorable results are condemned as the product
of a poor study facilitated by the fact that the results of
many studies are inconclusive and, right or wrong, investigation methods can be criticized. This is not to single manufacturers out for criticism.
If anything, clinicians who introduce new techniques to
the field are even more impervious to demands for objectivity. The manufacturer at least must bow to the judgment
of the marketplace whereas the clinician need not. He or
she can always dismiss fellow clinicians who are skeptical
about the merits of a new technique as conservative or
uncaring about the patient's best interests. When it does
not work as well for fellow clinicians (it never does at first),
the practitioner is derided as incompetent. A need exists,
then, for independent appraisal of a product's or technique's merits, which brings us back to the realm of research.
Research can independently investigate the claims of
developers and manufacturers. Organs of the American
Academy of Orthotists and Prosthetists (AAOP), such as
the Societies, can assist these efforts by providing forums
for interested individuals to compare notes and develop
consensus about the use of a device or method and the
issues involved. The results of such deliberations spur researchers and guide their efforts. Their results in turn can
be disseminated to the field through such venues as the
national and regional meetings of AAOP and the American Orthotic and Prosthetic Association (AOPA). Researchers also can publish their results in the Journal of
Prosthetics and Orthotics for posterity. Publishing the results completes the cycle and is an integral element of the
researcher's responsibility.
Managed care and efforts to constrain the rise in healthcare costs are probably going to provide further incentives
for such research. Third-party payers and "gatekeepers"
are going to demand objective evidence to justify the use of
components that are more expensive than traditionally
used alternatives. It seems likely that someday accrediting
agencies, such as the American Board for Certification in
Orthotics and Prosthetics Inc. and the Joint Commission
on Accrediting Healthcare Organizations, are going to
mandate that objective data be used in making clinical
decisions and in quality improvement efforts.
This growing interest in evaluation has led some to advocate that one of the organized entities in the field establish
an evaluation unit, something akin to Underwriters Laboratories or Consumer's Union. While superficially attractive, this concept has its problems and should be considered carefully. In the O&P profession, where the affairs of
manufacturers, clinicians and their professional organizations are so closely intertwined, it would be difficult to
avoid issues of undue interference or self-serving subjectivity. Any such organization would be expensive to run and
slow to yield results. It would seem far more productive to
rely on some version of the present system where independent researchers pursue comparative and descriptive
research.
Clinicians' Role
Clinicians who have a bent for research and a setting conducive to research efforts should conduct studies. Very
real impediments exist to conducting basic research in
O&P, and the most pressing need is in using research
methodology to investigate and document clinical outcomes. This embraces such diverse efforts as confirming or
disproving developers' or manufacturers' claims about a
particular product or technique, better defining the prescription criteria for using such devices or methods, comparatively evaluating similar ones, or simply quantifying
the results of their use (3). These efforts can lead to the
development of protocols, based on clinical experience,
for using a new product or technique.
Clinicians also need to be involved in product development and R&D. Indeed, it is something of a maxim that
the best ideas come from the clinical setting. Many clinicians have been involved with manufacturers in this fashion and are familiar with the rewards and frustrations that
can ensue. Others have independently developed and marketed ideas of their own.
It is safe to say that a conscientious, disciplined clinician
is well positioned to conduct meaningful R&D even if
technological resources are limited. The critical factor is
exposure to real-life clinical problems and the insight that
exposure brings-a resource denied to most manufacturers. If a clinician has developed an idea for a new product,
and if he wishes to pursue the matter with a manufacturer,
he would be well-advised to engage in such R&D, documenting the concept's use and the outcome fully. Such
evidence of practical clinical results is far more persuasive
than a crude one-of-a-kind prototype that has never been
used clinically or a conceptualization on paper, patented or
not.
Obtaining a patent is undoubtedly gratifying, but a nondisclosure agreement is probably of greater practical value
in protecting a clinician's interest when the time arrives to
approach manufacturers about a new concept. By signing
such an agreement, a manufacturer assures the clinician
that he will not disclose facts about the proposed product
to a third party or develop the concept independently after
declining to work with the clinician. The agreement is
usually time-limited and does not bind the manufacturer
from pursuing similar work in which he previously had
been engaged or new concepts similar to the clinician's that
might arise independently. Anyone interested in such an
agreement should consult a lawyer.
No clear answer exists as to whether a clinician should
pursue product development independently. While the rewards are greater, it can be costly and time-consuming to
produce and market a device as well as to divert attention
and resources away from one's practice. Costs of manufacturing, testing and marketing are growing all the time, and
the financial repercussions of product liability are growing
even faster. Assuring the continued growth and survival of
a manufacturing company with a continuing stream of new
products is difficult. Failure to do so represents a failure to
fully exploit the indirect expenses devoted to organizing
and sustaining the company itself and is ultimately a waste
of resources.
Turning a concept over to a manufacturer offers protection
from these factors, but it also entails a loss of control and
diminished returns. The manufacturer may not devote as
many resources to developing and marketing the product as
the developer may wish, may take the project in directions
the developer considers inappropriate, or may indeed stop
work on it altogether. The most common arrangement in
such a situation involves the payment of a royalty to the
developer by the manufacturer. The developer's involvement in the product development process and clinical trials
most often is welcome if not sought after, and the developer
should expect to participate in promotional efforts.
Conclusion
Prosthetics and orthotics has traditionally been an object oriented profession. Progress is seen largely as a matter of
making new devices and materials available for clinical
use. Developers, manufacturers and clinicians share this
point of view. Because of this bias, the respective roles of
research, R&D, and product development are not understood well. Nor have most people seriously thought about
the problems inherent in technology transfer and the practical limits a field as small as O&P faces when dealing with
the various industries that command the expertise in which
practitioners are interested.
The misunderstanding is, of course, mutual for many
who come to O&P from other fields are quick to assume
they understand the field when they find a superficial resemblance to a familiar situation. These factors, among
others, have limited the impact of research in the field and
have influenced profoundly the types of research done.
Many factors are working to shift O&P from its relative
isolation to a point where it looks more and more like other
professions and behaves more and more like other markets. The growing cost of O&P devices and the concern
over the cost of healthcare mean that increasingly the
claims the field makes to justify its fees are being subjected
to serious scrutiny. These factors, among others, are likely
to change the sort of O&P research done.
The field likely will be forced to define for whom various
devices are indicated and the benefits to be achieved; the
decision to use a particular component that costs more
than a comparable one is going to have to be defensible in
terms of the benefits to be expected. Evidence is going to
have to be objective and scientific, not anecdotal subjective appeals to "common sense."
As the costs of introducing new products increase and as
cost constraints limit the returns to be expected, manufacturers may decide to devote fewer resources to R&D and
product development. Considerable stature is attached by
healthcare professions to being research-based. As we
seek legitimacy in the eyes of other professions, we will be
driven to perform meaningful research-research that they
recognize and accept as valid by the same standards to
which they hold themselves.
These factors likely will conspire to shift attention in
O&P away from R&D, product development and the collection of anecdotal evidence to objective, scientifically
conducted research that is evaluative and descriptive in
nature. Information about outcomes will be sought.
The growing push to consumerism also means that information about users' attitudes and expectations will become
more important. Scientific inquiry in the O&P field may
come to include much more qualitative research resembling that practiced in such endeavors as sociology or anthropology rather than the almost total emphasis placed
today on quantitative research, such as that done in engineering or physics (8).
CHARLES H. PRITHAM ,CPO, is coordinator of education & research in the department of prosthetics and Orthotics at Duke University Medical Center in Durham, N.C.
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