Vidic 2:00, R21
ETHICAL CONCERNS REGARDING THE 3-D PRINTING OF LOW-COST
PROSTHETIC LIMBS
Kedar Madi (kvm7@pitt.edu)
INTRODUCTION: ETHICAL CONCERNS
WITH 3-D PRINTING
Remarkable advancements are being made in the field of
neuro-prosthetics, and now prosthetic devices are being made
that nearly replicate, or even surpass, the abilities of their
biological counterparts, even going so far as to be controllable
using the thought processes and neural signals of the user.
However, despite the incredible achievements in the study
and design of these prosthetics—increased joint articulation
and sensory/tactile feedback, to name a few—one hurdle still
remains: cost. As advanced as these prosthetic devices are,
the costs in producing them and implementing them in
patients generate an enormous financial burden for those who
must pay for the procedure and installation of such
prosthetics.
Some devices, although novel in their
functionality, require extensive and often dangerous surgical
operations, and include—but are not limited to—such
procedures as: spinal surgeries (to directly route neural
signals to the prosthetic device), placing electrodes near
motor nerves in the area of the lost limb, placing electrodes
directly within the brain itself (in order to measure neural
signals and brain waves), or “re-routing” nerves to another
part of the body to be sensed by an electrode (in a procedure
known as targeted muscle re-innervation [1]). Moreover, the
increased complexity in these prosthetics, whether from
complex designs or from the cost of the materials themselves,
warrants additional costs for users. After all expenses are
taken into account, the total price tag can be enormous, and
for many in need of prosthetic devices, this proves to be too
great of a cost.
However, for those who struggle with the costs of such
advanced prosthetics, a new and promising solution appears
on the horizon: 3-D printing. With their remarkable
affordability, accessibility, and ease of use, 3-D printers have
become wildly popular, particularly among amateurs and
hobbyists, who use these printers to “print” (or rather, create)
a wide variety of customized plastic pieces, from full 3-D
objects to small replacement parts for various devices. Now,
with the growing success of 3-D printing, the technology has
seen a rapid increase in use in a variety of sectors, from
industrial manufacturing to medical device construction. But
perhaps its most novel application lies in the production of
prosthetic limb replacements.
Due to 3-D printing’s
inexpensive nature, cheap, affordable neuro-prosthetics can
be easily produced, eliminating the high costs of traditional
neuro-prosthetics and allowing even those in developing
countries to be able to afford advanced prosthetic devices that
grant full functionality to the user.
University of Pittsburgh, Swanson School of Engineering
At first, the ability to create affordable prosthetic devices
using 3-D printing may appear to be an infallible solution.
After all, relatively inexpensive technology can be used to
create cheap but effective prosthetics that are affordable even
to amputees of third-world countries (where many lack the
means to access such advanced prosthetic limbs, let alone the
procedures to install them); who can deny the benefit in that?
However, upon closer inspection, the use of 3-D printers to
create prosthetic replacements poses a variety of ethical
concerns, the most notable of which is this: with the advent of
3-D printing, amateur hobbyists can create, modify, and
market plastic prosthetics that, while affordable for many,
bypass critical professional and medical regulations and pose
serious health and safety risks. Thus, an ethical dilemma
arises from the fine balancing act between cost and safety: can
the safety of expensive, yet professionally-produced
prosthetics be traded for the affordability and accessibility of
those produced by amateur hobbyists?
To illustrate the ethical dimensions posed by the 3-D
printing of prosthetic limbs, take the following hypothetical
scenario. Suppose that I, a researcher at a biomedical
engineering firm that specializes in prosthetic device
production, discover that a group of engineers that work at the
firm have developed, as a separate side-project, a cheap
neuro-prosthetic limb made using 3-D printed plastic and
other low-cost materials. As an employee of the firm, am I
ethically obligated to require them to integrate their product
into the firm’s product line, driving up costs through safety
testing and the incorporation of our firm’s advanced
technology (which isn’t absolutely necessary, but ensures
professional quality)? Or should I allow the hobbyist
developers to proceed with their prosthetic device, in order to
make the innovative product available to the masses, rather
than only the financially elite? The following discussion,
then, will not only explore the growing problem of high-cost
prosthetics and the solution offered by 3-D printing, but the
ethical ramifications of each course of action and of 3-D
printing inexpensive prosthetic limbs.
PRICEY PROSTHETICS: AN
IMPRACTICAL SOLUTION
While a vast majority of the population enjoys full use of
all four limbs, there remains a sizeable portion of society that,
for a variety of reasons, is missing one or more limbs.
Whether from war, disease, or accident, such amputees exist,
and are in need of prosthetic replacements for their missing
and/or damaged limbs. While there are a multitude of
solutions in the market, few offer the full functionality, or at
least an approximation of such functionality, of the original
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Kedar Madi
be an enormous financial burden for the child’s parents or
caretakers. This, along with the high cost of one prosthetic
device alone, demonstrates a growing need for a new, lowcost solution to prosthetic limbs.
body part, especially in the low-cost range of prosthetic
devices; cosmetic prostheses are of little use and serve merely
as aesthetic replacements, while devices operated via cables
require both the patient “to wear complex and cumbersome
harnesses”, and exert “vigorous effort…to transmit force to
the prosthesis” [2]. However, new developments in the past
two decades have produced wondrous advancements, and
have culminated in a relatively-new generation of prosthetic
devices that can be controlled with a single thought from the
mind. Such neuro-prosthetics, as they are called, are
becoming more commonplace, and offer their users increased
functionality and control. However, they have become so
advanced to such a degree that the costs in producing them
are staggering, and few are able to bear the full financial
burden of a fully-functioning replacement limb. This is
especially true for amputees living in developing countries,
where a startling amount of the population lives at or below
the level of poverty. A 2013 study to develop a low-cost
neuro-prosthetic hand accurately summarizes this problem for
amputees living in such countries:
3-D PRINTERS: PRINTING THE FUTURE
OF PROSTHESES
Fortunately, for those who cannot afford the high costs of
advanced, finely crafted prosthetic replacements, a new
technology is on the horizon, and promises to change the face
of prosthetic device production. 3-D printing, a relatively
new process in the field of product design, has emerged as a
viable alternative to traditional industrial manufacturing
methods. First developed in 1987, the technology was
initially used for rapid prototyping primarily within design
labs, technology companies, and fabrication labs at research
universities. Recently, though, 3-D printing has increasingly
moved into the commercial manufacturing sector, and its use
in production of everyday objects has become more
mainstream [5]. However, the technology has perhaps seen
its most explosive growth occur among hobbyists and
tinkerers alike, whose unique products and designs created
from 3-D printing technologies have garnered unprecedented
attention on hobbyist websites such as Kickstarter and
Instructables.
…Such hands are not always affordable by
patients living in developing countries. The design
of low-cost prostheses should consider restriction to
basic functions, local availability of components,
robustness and durability, ease of assembly, repair
and maintenance and, of course, limitation of the
total cost. Currently, in developing countries, the
cost of a prosthetic limb still varies between US$125
and US$1,875, an expense that, considering the fact
that the prosthesis must be replaced about every 4
years, can hardly be justified, especially in the case
of children. [3]
The process of creating an object through 3-D printing is
rather simple: Computer-aided design (CAD) software is used
to slice a digital object into extremely thin layers; the “2D
pattern of each layer is then transmitted to the 3-D printer,
which extrudes, sprays, or spreads raw material onto a flat,
horizontal platform; the material is cured, laser-sintered,
fused, or bound by UV light, lasers, or electron beams. The
process repeats until the object is fully formed” [6]. While
the simplicity of the process alone is reason enough for the
increasing popularity of 3-D printing, another factor
contributes to its success among both hobbyists and amateurs:
cost. Whereas 3-D printing was once a technology only used
by professionals and the manufacturing industry, the
incredibly low costs and low learning curve associated with
the process has allowed 3-D printing to skyrocket in
popularity, particularly among amateur hobbyists and
tinkerers. Now, with the widespread availability of low-cost
3-D printers, the technology remains easy to use and easily
accessible, allowing anyone—children, high school students,
and college students alike—to easily design and produce
anything that comes to mind, whether it is a small component
needed for a project or an object needed for everyday use.
In the case of Easton LaChappelle, a seventeen-year-old
finalist in the Colorado Science and Engineering Fair and
creator of an award-winning low-cost prosthetic arm,
inspiration for his remarkable invention came in the form of a
seven-year-old girl. Upon meeting the girl, LaChappelle was
shocked to discover that her prosthetic arm cost $80,000. “I
could see the distress, talking to her parents, because that is a
lot of money. And the thing was that she was seven, so she
would probably need two or three of those [prosthetic arms]
in her lifetime,” [4] he remarks in a recent Tedx talk.
LaChappelle’s experience illuminates a glaring issue with
the outrageous expenses of prosthetic device technology. The
high cost of prosthetic limbs with even the most basic of
functionality presents a challenge not only to the average user,
but to child amputees as well, who must wear multiple
prostheses throughout their lifetime to accommodate their
growing bodies. By the time the child has finished growing,
the total cost of all the prosthetic devices combined proves to
3-D printing, therefore, has enormous potential in not only
the design and production of everyday objects, but of
prosthetic devices as well. It is no wonder, then, that the
technology is already being used for such purposes. Take, for
example, seventeen-year-old Easton LaChappelle, previously
mentioned above for his experience with an $80,000
prosthetic arm at a Colorado Science and Engineering Fair. It
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was through his experience with the 7-year-old user of this
prosthetic arm that LaChappelle set his mind on developing a
low-cost, yet fully functioning alternative to the $80,000
device. Using a variety of 3-D printers located both in his
home and elsewhere, he was able to design and produce a
prosthetic arm that not only offered its user full functionality,
but costs less than $500 to manufacture. In addition, 3-D
printing, LaChappelle says, was “essential not only in
building custom gears and prototypes at comparatively low
cost but also in allowing him to construct a prosthetic arm that
looks relatively organic” [7].
while affordable to the masses, disregards key issues of
concern in the design and production of professional
prostheses, such as ergonomics and comfort (to the wearer).
As such, an affordable device would be produced, but it is one
that may cause great physical pain to the user due to
compromises in ergonomics, safety, etc. that would normally
have been avoided if professional, yet costly, safety testing
had taken place. If this scenario is extended to broader scale,
one could potentially envision a prosthetic “black market” of
sorts, where amateur hobbyists mass-produce cheap neuroprosthetic devices that, while affordable to the masses, bypass
critical professional and medical regulations in order to
remain inexpensive. Furthermore, these hobbyists can not
only create, but modify existing prostheses through the 3-D
printing of custom plastic parts; the ability to do so may cause
more harm than good if standard regulations are ignored.
LaChappelle’s remarkable invention is not the only lowcost prosthetic arm to have entered the market, though. The
“Robohand”, a 3-D-printed plastic limb with clutching,
articulating digits, presents yet another novel solution for
amputees. Invented by South African Richard Van As and
Bellingham, Washington resident Ivan Owen, the prosthesis
“costs only $500 to produce and is assembled by the owner”
[8]. The relatively low cost of the device has allowed the pair
to create roughly 170 custom Robohands for people of all
ages, with plenty more on the way [9].
As such, the above concerns regarding the use of 3-D
printing to produce affordable prostheses create an ethicallycharged situation, in which the merits of expensive, yet
professionally-produced devices are pitted against those of
budget-friendly prosthetics created via 3-D printing. In other
words, is it ethically correct to ensure the safety and comfort
of prosthetic users by restricting device production to only
professional manufacturing methods (i.e. through medical or
commercial research firms in which standard regulations and
practices are in place), reserving their use only for the
financially elite, who are able to afford such devices? Or is it
perhaps ethically correct to bring advanced neuro-prosthetic
technology to the masses, so that all can enjoy full use of all
four limbs, regardless of economic status?
Upon observing these amazing 3-D printed innovations,
one can see the benefits of producing such low-cost devices.
Now, with neuro-prosthetic limbs costing under $1,000,
advanced prosthetic technology can be made available to all,
such that even those in developing countries have access to
fully-functional prosthetic limbs. With this in mind, it can be
difficult to find fault (ethically speaking) with the use of 3-D
printers by hobbyist inventors to create cheap, affordable
prostheses.
The above ethical dilemma brings to light a multitude of
ethical codes of conduct followed by the engineering
community. One code in particular, stipulated by the National
Society of Professional Engineers (NSPE), holds that
“engineers shall hold paramount the safety, health, and
welfare of the public” [10]. With this in mind, one can argue
that all prosthetic devices should be professionally-produced
through traditional commercial and research firms. After all,
the standard practices and regulations in place ensure, through
testing, high-quality materials, etc. that all devices remain
safe, durable, and comfortable for their users, whereas 3-D
printed prosthetics may compromise such features in favor of
affordability.
AMATEUR & AFFORDABLE, OR
PROFESSIONAL & PRICEY? THE ETHICS
BEHIND 3-D PRINTED PROSTHETICS
While 3-D printing may seem to be a fool-proof solution
to the ever-increasing prices of high-tech neuro-prosthetics,
closer inspection reveals multiple ethical issues that present
themselves when cheap, inexpensive production methods are
involved. For instance, 3-D printed prosthetics run the risk of
sporting lower quality materials, since 3-D printers
(intrinsically) produce objects with plastic, rather than the
high-quality materials, such as metal, that professionallymade devices offer. As such, cheaper prosthetics, while
affordable to many, may not be as durable as their more
expensive counterparts.
However, providing affordable healthcare to the masses is
also of ethical importance. As outlined by the Biomedical
Engineering Society (BMES) Code of Ethics in 2004,
engineers should “consider the larger consequences of their
work in regard to cost, availability, and deliverability of
healthcare” [11]. In other words, (biomedical) engineers
should consider the costs in providing their products and
services, and must gauge the extent to which others can afford
what they provide. If an engineer develops a product that only
few (i.e. the financially elite) can afford, how can that be
In addition, the ease of use and relative accessibility of 3D printers allow hobbyists to create custom devices with
highly modular components. However, concerns arise when
one realizes that these hobbyists could make such
customizations and modifications without regard to standard
professional or medical procedures that guarantee safety and
comfort. For example, hobbyist inventors, in their pursuit of
an inexpensive, cheap prosthesis, could develop a device that,
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Kedar Madi
ethically correct? Should not the goal of medicine be to
provide access to proper healthcare for all, regardless of age,
sex, financial status, etc.? How can it be ethical to prevent a
large majority of the population from receiving proper
treatment by barring those who cannot afford such costly
procedures? This same argument can be applied to the field
of prosthetics. Engineers, in their pursuit to develop advanced
neuro-prosthetic devices, should consider the high-costs
associated with producing such advanced devices. Are they
only to be available to the financially elite? If so, would that
not entail a breach in the BMES code of ethics in striving to
make healthcare available to all? 3-D printing, then, offers a
viable solution to this problem, and maintains ethical integrity
in reducing costs to make prosthetic devices widely available.
For example, who can fault Easton LaChappelle for
developing his remarkable and inexpensive neuro-prosthesis
that saved a family thousands of dollars? Although he is only
a teenager and an amateur inventor, should his invention be
discredited merely because his product was not professionally
produced, and made using less-expensive 3-D printing
technology? Should he be forced to have his device undergo
extensive testing and modification for the sake of a
professional branding and ensured safety, even though this
would dramatically increase costs and prevent a large number
of amputees from being able to afford the device? The above
rule in the BMES code of ethics provides a simple answer to
this question: No.
horizon and a new generation of prosthetic limbs made with
inexpensive and durable materials can be available to all, no
matter one’s financial status.
However, ethical concerns arise when one debates the
merits of using such 3-D printing technology. Can amateur
hobbyists be allowed to mass produce highly customizable
and inexpensive products, without engaging in expensive yet
professional testing procedures? Or must they do so and
incorporate costly technology, materials, and safety tests in
order to comply with professional and medical standards?
Arguments exist for the ethicality of each option, and both
arguments present a valid ethical reason for pursuing one
course of action over the other.
So, when faced with the scenario outlined at the beginning
of this discussion—whether or not I am ethically obligated to
require a group of researchers to integrate their 3-D printed
prosthetic device into the firm’s product line, which would
result in a dramatic increase in price due to safety testing and
the incorporation of the firm’s advanced technology—the
answer may not be so simple. While requiring the 3-D printed
device to undergo such a process may ensure professional
uniformity, quality, and top-of-the-line technological
complexity, doing so will inevitably alienate a large majority
of the population who cannot afford such a device, and the
impact on the lives of many amputees will be greatly reduced.
Thus, further debate on the ethics of this case are needed.
Moreover, additional codes of conduct in various
engineering societies elaborate further on the ethical merits of
the 3-D printing of prosthetic limbs. As the American Society
for Engineering Education (ASEE) Code of Ethics states, one
should “encourage students to be aware of the environmental
and social impact of their solutions” [12]. Specifically,
researchers and developers in prosthetic solutions should
consider the social and economic impact their products create.
If they develop an expensive device that many could not
afford, would that not have a negative social impact on such
a population?
CONCLUSION: NO SIDE WINS
With the increasing popularity and versatility of 3-D
printing, the ability to create prosthetic devices under $1,000
or even under $500 is completely possible with today’s
standards.
While more advanced and higher-quality
alternatives exist in the market, their enormous costs prove to
be a barrier preventing much of the population from being
able to enjoy such technology. In particular, those most in
need of prosthetic devices (due to war/violence, accidental
landmine explosions, and unsanitary living conditions) reside
in developing countries, where the means to obtain costly and
advanced prosthetic limb replacements are severely restricted.
As such, a significant portion of society remains unable to
experience full use of all four limbs. With the advent of such
technologies as 3-D printing, a solution does exist on the
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Kedar Madi
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_s1
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Kedar Madi
ACKNOWLEDGEMENTS
I would like to thank the following for their contributions
and support in the writing of this paper: My father, Vijay
Madi, who brought to my attention the high costs of
advanced prosthetic limbs and how many cannot afford such
devices; My family friend, Ashok Sabata, who introduced
me to the low-cost technology that is 3-D printing, while
allowing me to experiment with his company’s 3-D printer;
And the engineers who live on my floor (Sutherland West,
floor 5), who provided helpful feedback and constructive
criticism on the structure and content of my paper.
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