4.
5.
6.
Finally, it’s crucial that we realize that every
country is different. The same rules, regulations, and hurdles that we face in one country may be completely different in each new
country we enter. Thoughtful due diligence,
including customer and market research, is
required for us to navigate that process.
After we complete field trials for the latest
version and incorporate the knowledge gained
into the design of the prosthesis, we will begin
centrally manufacturing the ReMotion Knee
and distributing it to clinics globally. We aim
to be on the market by the end of 2014.
As we scale production, we’ll also roll out a
large-scale system of impact data collection
incorporating the lessons we’ve learned from
our field trials. We aim to distill the data to
the key aspects of patients and clinics that
are most critical for increasing adoptability
and improving mobility. We hope this will
instigate a new era of impact assessment
that includes new methods of data collection, analysis, and learning.
Throughout each phase of designing,
delivering, and evaluating the ReMotion
Knee, we have been user-obsessed—every
person that interacts with the product is
critical to remobilizing an amputee. Like links
in a chain, if one link breaks, the entire chain
comes apart, and the product won’t reach
the patients who need it.
This user-obsessed mindset requires us to
clearly identify and understand each critical
aspect to reliably deliver an effective medical
device from importation to impact assessment. Without understanding how the product
will reach customers and how to evaluate its
effectiveness, the best technology alone cannot provide mobility for amputees in need. •
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Armstrong, H. Casanova, H. S. Chhabra, and J. Noon, “Lo wer-limb prostheses and wheelchairs in low-income countries.,” IEEE Engineering in Medicine
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is doing,” World Health, 2011. [Online]. Available: http://www.who.int/
disabilities/technology/activities/en/#. [Accessed: 05-Feb-2011].
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REFERENCES
The process for conducting patient surveys as a part of the ongoing field trials of the v3 ReMotion Knee. The trials are being conducted over six months at four
clinics in Indonesia, India, and Guatemala. The survey is administered at both the initial fitting and follow-up assessment. This process was developed to both
provide strict patient confidentially, in compliance with the Stanford Institutional Review Board, and fit into the existing work flow of our partner clinics.
PATIEN T SURVE Y
The patient survey includes questions pertaining
to: ( 1) Gait, Fit Quality, Level of Mobility, and Device
Functionality, ( 2) History of Devices, Work, and Life
Events, and ( 3) Satisfaction with the ReMotion Knee and
previous devices.
SCREENING CHECKLIST
A screening checklist is used to determine if patient
satisfies all requirements to be included in the study.
GAIT TESTS
A series of gait tests are conducted, including the 10 meter
walk test and the Timed Up And Go test. These tests are
used to quantitatively assess the mobility of each patient,
and are conducted with the ReMotion Knee and the
patient’s previous device.
CONSENT FORM
A consent form is read to the patient. This form explains
the patient’s rights. If the patient agrees to be in the
study, the prosthetists signs as a witness.
ELEC TRONIC SURVE Y RE TURN
Once the survey is completed, an electronic copy of the
forms is uploaded to a secure server shared between the
clinic and D-Rev.
PATIEN T ROS TER
Each patient’s personal information is recorded on a
roster. The patient is then assigned a survey packet, which
has a patient ID number. This step is required to maintain
patient confidentiality.
