FIG 2: Early results of the MiraCradle on newborns’ body temperatures
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For the neonatal cooling material, Pluss’ engineers based the design on average calculations
of how much heat a baby’s body emits, which
is about 10 joules per second. They speculated
that using a material that could absorb that
amount of heat for 72 hours would ensure that
the baby’s temperature would remain constant
and that the cooling pad would not melt.
The Pluss team also created a special
conduction mattress made of a gel-based
material to position between the baby and
the phase-change material. This addition was included because the 29-degree
material becomes “rock solid,” as Jhanwar
explains, so the baby cannot placed directly
on top of it. He adds that the mattress’
other purpose is to speed up the transfer of
heat between the phase-change material
and the baby. “Just using a phase-change
material will not cool a baby. You need
thermal conductivity as well.”
BUT WILL THE Y USE IT?
For such an exact product, Jhanwar
describes the process as “basically a shot
in the dark.” The team was working off of
theoretical calculations when designing the
phase-change material, but the only way
to know for sure whether they had struck
the right formula was to test their device
in hospitals’ neonatal units. As the team
quickly discovered, the process for testing
and approving new medical products in India
is murky and challenging for newcomers to
navigate. Upon reflection, Jhanwar says the
company took a complete leap of faith when
it agreed to take the project forward. They
had not done a market survey and had no
understanding of how clinical trials worked.
Dr. Thomas stepped forward to test the
new iteration of his device at Christian
Medical College. Together, they tested the
cooling bed on 41 babies in the CMC neona-
tal intensive care unit, and discovered that
with a few modifications, the 29-degree
material was successful at bringing a
37-degree newborn’s temperature down
to 33. 5 degrees. Furthermore, it could do
it within 45 minutes, and once there, the
material was able to maintain thermal equi-
librium with the child.
Taking the results as an overwhelming
success, Pluss officially launched the
device under the name “MiraCradle” in
April 2014—just under two years after Dr.
Thomas approached them to commercialize
the idea.
But the team’s initial optimism was short
lived. The hospitals that their sales staff
approached responded with severe skepti-
cism, and one after another turned them
away. Jhanwar now jokes of being kicked
out of about 15 hospitals. “They asked us if
we had done a randomized clinical trial,” he
recalls, but outside of the limited testing at
CMC, there was no formal clinical data for
the MiraCradle.
By August, they had gained no traction
in the market and elected to try a differ-
ent approach. Through Dr. Thomas, they
approached a number of India’s top neona-
tologists and invited them to attend a day-
long medical education workshop on cooling
treatment for birth asphyxia at Christian
Medical College in Vellore. Pluss let Thomas
and his team lead.
“We stayed completely out of it and let the
doctors do the talking. Then, if they wanted
to try the product, we gave it to them free of
charge and asked for feedback,” Jhanwar says.
Fifteen hospitals requested a MiraCradle.
