Saturday, April 20, 2024

Enable Community Foundation Response to 3D Printed Prosthetic Concern

Jeff Erenstone

Dear Listserv,

We would like to address the concerns that have been recently posted about
3D printed prosthesis and orthosis. It is our to hope to minimize the fear
that 3D printing will disrupt the care that Orthotists and Prosthetists
provide.

Introductions

I am Jeff Erenstone CPO, the founder of Create Prosthetics and owner of
Mountain Orthotics and Prosthetics. Recently I was nominated to serve as
Chairman of the New Device Board for Enable Community Foundation. Here is
an article about my work with ECF and my recent presentation at the United
Nations
.

Also contributing to this response is Andreas Bastian, a senior research
scientist with the Integrated Additive Manufacturing team at Autodesk
, one of the world’s largest design and 3D
printing software companies. At Autodesk, Andreas researches existing and
novel additive manufacturing technologies and workflows and explores how a
systems approach to additive manufacturing can unlock new capabilities,
such as the dramatic advances in speed and scale in 3D printing made
possible with Project Escher . Additionally,
Andreas is a Director of the Enable Community Foundation
(ECF), a non-profit that seeks
to develop and deploy orthotic and prosthetic devices using 3D printing to
those without viable health care alternatives. Andreas spearheads ECF’s
technology development and design research programs and works closely with
Jeff both domestically and in the field.

On Media Coverage of 3D Printed Devices

It’s important to distinguish the media narratives about this work from the
work itself. There are many different groups working in the space with
varied degrees of coordination, experience, and skill. Most devices
portrayed in these stories are actually of extremely limited functionality
and are not built of materials as robust as traditional prosthetic
construction materials. Though ECF has consistently attempted to
de-escalate the increasingly bold claims of cost and performance, these
more nuanced stories are less exciting and the media tends veer away from
the accurate and toward the sensational. With this in mind, we caution
against forming strong opinions based on these stories instead of first
hand experience. Beyond the media hype, there is real and exciting work in
this space.

3D Printed Devices Thus Far

The amateur construction of 3D printed assistive devices really took off in
2013 with the formation of the e-NABLE Google Plus community, a private
forum for 3D printing enthusiasts and the families of limb differences to
socialize and compare notes and ideas. For the most part, the community
has developed partial hand devices with a focus on congenital limb
differences such as Amniotic Band Syndrome. Over the past year, several
devices have been developed for wrist-disarticulation and transradial.
When individuals request a device from e-NABLE, they are strongly
encouraged to work with an O&P local to them, though it is unclear how many
devices are actually fitted under the supervision of an O&P professional.
Additionally, it is unclear if there are regular follow-ups after the
initial fitting. We suspect that recipients of e-NABLE devices might use
the device for a few days and then gradually abandon it, but again, there
is little rigorous data on the subject.

What we do know about the devices is that they have limited physical
functionality for ADLs, but as body-powered devices, they facilitate muscle
growth (see Dr. Jorge Zuniga’s findings here
)
with daily use. While physical functionality is not comparable to most
conventional upper limb prostheses, most of their utility lies in the
social/emotional impact that the devices have on their wearer. The devices
tend to be brightly colored and superhero themed, which has the result of
calling attention to the limb difference and celebrating it rather than
minimizing the visual impact of the device. Granted, this is a preference
that is largely specific to the North American children who form the
largest use population of these devices, but it is an interesting trend in
what the users of these devices request.

It’s important to note that as a global, decentralized community, each
device and story about a device should be treated individually, and not
necessarily representative of all work in the space. There are a lot of
people who know how to use a 3D printer, but who don’t really know a lot
about the work that CPOs do, but nevertheless think that they can replace
them. Now that ECF has worked with both 3D printing enthusiasts and with
CPOs in e-NABLE, we firmly believe that CPOs will continue to deliver
better patient outcomes and are integral to prosthetic care now and in the
future.

3D Printers Won’t Replace Prosthetists, They Will Augment Them

3D printers are just tools and as such reflect the skills and intent of the
operator. Andreas has worked with e-NABLE for over two and a half years,
and has been conducting research in 3D printing since 2011. The key to
making 3D printers useful is in the design software that creates the
blueprints that the printers turn into real objects.

Jeff and Andreas recently traveled to Haiti as part of a program that ECF
and a partner organization, Enable International Haiti, was running with a
clinic in Port-au-Prince. Jeff performed a field evaluation of a patient,
took a mold of her residual limb (40% transhumeral), and captured a 3D scan
of her residual limb. During his physical examination, he discovered a
very sensitive neuroma at the site of the amputation, which was a result of
the 2010 earthquake. Jeff used this knowledge of the patient’s specific
anatomy in combination with his fluency with 3D scanning and 3D printing
workflows to produce a comfortable and functional device for the patient
(using a conventionally formed polypropylene socket). Without a
prosthetist’s experience and knowledge of human anatomy after traumatic
amputations, an enthusiast with a 3D scanner and 3D printer would not have
been able to produce a successful outcome for this patient.

That being said, there is tremendous potential for 3D printing to be of use
to prosthetists and orthotists. There are many advances in materials
science, software workflows, and machine reliability that are necessary
before the technology can become part of an standard workflows, but these
advances are occurring at an ever-accelerating pace.

ECF’s Position and Role

ECF believes that prosthetists should be an integral part of these early
explorations of 3D printing’s potential role in the O&P field. We are
working closely with prosthetists in the US and abroad to develop workflows
and specific devices that address local patients needs. We see 3D printing
as an opportunity to address more and more specific patient needs that
might not be well-served by components or devices produced by conventional
means.

ECF would like to collaborate more closely with members of the O&P field,
both to learn more about the needs and concerns of care providers and to
educate CPOs about the capabilities and applications of 3D printing
technology. This Fall, Jeff Erenstone, Create Prosthetics staff and ECF
volunteers will be running a 3D printing workshop at the AOPA National
Assembly in Boston. We would like to invite everyone of you to come to
this workshop and learn more about 3D printing/additive manufacturing
technology and to learn how it might be of use in your practice.

Jeff Erenstone CPO
Mountain O and P Services
7 Old Military Road
Lake Placid NY 12946

www.mountainoandp.com

Phone (518) 523-2419
Fax (518) 523-7192

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