Nisha's Warm Embrace
Posted by Rajan Patel
About a week ago, everyone suddenly quieted down and listened anxiously as Kamalika, our clinical researcher, took a phone call in the middle of the afternoon. Her voice slowly escalated and filled with excitement during the conversation; by the end she was jumping up and down with joy exclaiming, “We’re on our way now!” like an expectant parent. It was the call we had been waiting for: news that the first eligible low-birth weight (LBW) baby for our clinical trial had just been delivered and was ready to be put into the Embrace Infant Warmer.
We were all elated, considering how hard the team has been working to get to this moment: in addition to getting the product ready, preparing our clinical trial protocol, getting it approved by an ethical review board, and then coordinating the study with the doctors and nurses as the hospital. The clinical trial is comparing the Embrace Infant Warmer’s ability to maintain LBW babies’ temperatures against the current standard of care (including radiant warmers, incubators, and other practices that help babies stay warm).
As soon as she hung up the phone, she, Rahul, and I headed over to the hospital to observe the first baby of the study using our device. While I love the stimulating work atmosphere of Embrace, I was far more excited in this moment than any other. It suddenly struck me that what we’ve been working on for so long for was about to become a reality in use!
Nisha, a 2.3kg, rosy-cheeked baby girl, was placed into the Warmer. Luckily, any tense feelings diffused once she was put into the device. Nisha was initially experiencing cold stress, but was safely brought to normal body temperature after being put into the warmer! Also, our device successfully maintained its temperature of 35°C – 38°C for the full four-hour duration. Nisha had a twin brother who was not low birth weight. Interestingly enough, after she had been placed in the Embrace warmer, we observed that Nisha’s temperature was actually higher than her healthy brother’s. As you can see below, she comfortably slept while in the warmer (I’d be willing to bet it was THE most comfortably she’d ever slept in her life!):
Sleeping cozily in the Embrace warmer
Nisha and her twin brother
She stuck her tongue out in this picture just to be cute :-p
To get to this point, it’s been critical for us to do constant prototyping, testing, feedback, and iteration over the last year. This is even more important and difficult with medical devices such as ours, since the efficacy and safety of the product need to be thoroughly assessed before it can be tested in real use case scenarios. The validity and gratification that came from seeing our product effectively work on Nisha was unparalleled. It has taken a tremendous amount of time and effort from the team, and achieving this huge milestone has made it all worth it. But this is just the start.
As I was sitting in the auto rickshaw leaving the hospital at the end of the day, something suddenly struck me: we are one step closer to getting this product out—in fact, we’re one step away from launching. This early success has been a feeling of relief and fulfillment for us, and has inspired and energized our team to do everything we can to get this product to the millions of babies in need.