About this project
Praise for Neopenda!
Our mission: improve newborn survival and health in the developing world
We are developing cutting edge healthcare technologies for where they’re gravely needed and will have an incredible impact—vulnerable populations in low-resource countries. Annually, over 46 million newborns in developing countries around the world need interventions for complications that happen at or around birth, 600,000 in Uganda alone. Every Neopenda device has the potential to save the life of a newborn for less than $1, once it is produced at scale.
What we’re building
Neopenda is a baby hat with a novel sensor array that measures the four most important vital signs for newborns:
- heart rate
- respiratory rate
- blood oxygen saturation
We’ve melded the ease of wearables like Fitbits with the medical accuracy of finger clip pulse oximeters in the hospital.
It’s small, it’s simple, and most importantly it’s validated—and we’re making it cheap and suited for the tough environment of a hospital in Uganda. Hats on up to 24 babies in a single room will send the vital sign data wirelessly to a tablet running Neopenda's custom software. There, it is displayed for the doctor or nurse, and alerts them when something is wrong with one of the babies.
Why Neopenda is needed
Nearly 3 million babies die every year in their first month of life and 98% of these deaths occur in the developing world. Too many newborns continue to die each year, even when there are interventions available to combat the primary causes.
The problem: hospitals in resource-constrained settings are severely challenged by limited manpower, supplies, and equipment. Newborns are especially vulnerable in their first few days of life, and suffer from the strain on resources. These hospitals lack sufficient resources for the devices seen in American neonatal units, and lack sufficient staff to manually measure newborns’ vital signs at the necessary intervals. Babies in distress often go unnoticed while nurses are occupied elsewhere. Neopenda fills this gap in care by giving a voice to newborns in danger.
After a year of learning about these challenges, speaking with stakeholders, visiting hospitals in Uganda, and lots of prototyping, we are excited to launch our creative solution that is going to revolutionize newborn care in low-resource hospitals.
Where we are today
We are currently rounding the corner on the prototyping stage and are beginning testing and small scale manufacturing.
While we are still iterating (and shrinking) the wearable device design, the software component of the system is fully built out. Our app displays multiple babies’ vital signs, has adjustable alerting thresholds, generates trend plots, exports patient histories, and alerts when vitals are out of range.
Neopenda is not classified as a medical device because it’s not diagnostic, and it does not fall under FDA regulation because the application is outside the United States. That being said, we are performing rigorous evaluation for safety and have to demonstrate it for the regulatory process in Uganda. The device is completely safe for newborns: it uses a Bluetooth Low Energy transmitter that is FCC-approved and complies with all safety recommendations.
How we’re going to bring Neopenda to the world
This Kickstarter will fund the first field deployment of the Neopenda device, but that's only the beginning.
Our vision to success includes demonstrating the feasibility and impact of the technology in Ugandan NICUs, scaling deployment and sales in Uganda, and expanding to comparable regional and global markets over the next 3 years. We are partnered with the Uganda Pediatric Association, who will be instrumental in helping us navigate the process of testing and deploying in Uganda. Ultimately, Neopenda is a social enterprise with a double bottom line approach that focuses on achieving social impact while maintaining financial sustainability.
Why Neopenda needs you
We have a strong team of engineers, healthcare professionals, and experts in global health and entrepreneurship. However, getting a global health startup off the ground and getting our product across the world to where it’s needed takes a lot of time and a bit of money. We want to accelerate the journey and start field deployment of Neopenda this year. Most importantly, we care a whole lot about helping these babies, and we think the Kickstarter community does, too.
Many thanks to g martinez cabrera for making our video, check out his work.
Risks and challenges
The regulatory process in Uganda
A potential delay for the completion of the project is getting our pilot study proposal approved by the relevant authorities in Uganda. The time it takes to get approval is very unpredictable, and could force us to push back the study. However, we are working with our partners and colleagues in Uganda who are familiar with the process. With their guidance and advice, we can avoid the worst hiccups. We also know this will be time consuming, and are already planning to submit our IRB proposal based on the most generous estimates of how long it will take.
Getting our technology proven in time
We need to establish the safety and baseline accuracy of the Neopenda wearable sensor before we go to Uganda for deployment. These steps are in progress: we have partnerships with American hospitals and are currently pursuing IRB approval here. Still, there is always the risk of unanticipated delays that could arise from technology iteration that may impact our timeline.Learn about accountability on Kickstarter
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