Neopenda Vital Signs Monitor for Newborns
Teresa Cauvel and Sona Shah
A sensor integrated into a baby hat that measures newborns’ key vital signs. Continuous monitoring improves speed of care to make sure that the newborns have the best chance of survival. The device is a prototype that is still in early testing stages. Interview with representative
Neopenda, Ugandan Pediatric Association
The reusable devices will be available in customizable package sizes to accommodate the needs of diverse facilities, with a per unit list price of the wearables at $75 USD. Interview with representative
Goal 3: to promote and improve health and well-being.
Critically ill newborns in developing countries.
Nurses working in neonatal intensive care units.
The devices are currently manufactured in-house and with local partners by Neopenda. Interview with representative
Patent pending. Interview with representative
Ultimately the product may be purchased and distributed through wholesale distributors of medical equipment; in Uganda, the primary distributors are National Medical Stores for public hospitals and Joint Medical Store for private hospitals. We are also pursuing implementation with multi-national NGO partners. Interview with representative
Prototype. Not available on the market as yet.
LEDs, audio alarm w/dB level, etc.
temperature, oxygen saturation, HR, etc.
The Neopenda vital signs monitor is a wearable sensor device that attaches to a baby hat or band and uses reflectance pulse oximetry and temperature sensors to continuously measure pulse rate, respiratory rate, blood oxygen saturation, and temperature. The vital signs from multiple newborns wearing the devices are wirelessly transmitted to a single tablet via Bluetooth Low Energy, where attending healthcare personnel can view all the patients’ health status in a centralized interface. The interface generates plots with historical trend data, offers customizable alarm thresholds, and alerts staff of abnormal vital signs with visual and auditory alarms in real time. The devices are rechargeable and run for several days, so that newborns can wear them during their entire stay in the hospital. The design is built for the power, cost, and environmental challenges of low-resource facilities, and can be sanitized with alcohol wipes for reuse. The out-of-the-box system is not reliant on continuous power or wireless connectivity. Interview with representative
The type and frequency of preventative maintenance needed is unknown. Neopenda is working with in-country engineers while refining the prototype to ensure that repairs can be performed on-site. Interview with representative
The anticipated lifetime is 2 years.
The Neopenda vital signs monitor gives voice to newborns in medical distress and enables responsive medical care in low-resource hospitals. The prototype is rapidly being refined and tested. Technical data is anticipated to be available in the coming months.
Neopenda is rolling out a pilot in Kampala, Uganda, in 2017 to assess the accuracy of the technology, and preparing for feasibility studies in up to six other facilities in four countries. Interview with representative
Ugandan Pediatric Association, St. Francis Nsambya
The Neopenda device is enclosed in a case made of FDA compliant medical grade polymer, and uses 100% BPA-free, PCV-free, and phthalate-free materials. It has passed preliminary safety testing for compliance with specified standards of IEC 60601-1 Edition 3.1 (pertaining to medical electrical equipment safety), ISO 80601-2-56 (pertaining to clinical thermometers), and ISO 80601-2-61 (pertaining to pulse oximeter equipment) by a third party in February 2017. Interview with representative
Field studies, study results are expected to be published in the near future. Interview with representative
Neopenda was selected as a finalist for the Vodafone Wireless Innovation Project 2016
Neopenda was selected to participate in the inaugural class of Relevant Health’s health tech startup accelerator program.
Neopenda is currently pursuing opportunities to evaluate the technology with Americares in Liberia and Tanzania.
Neopenda was named a finalist in Fast Company’s World Changing Ideas Awards 2017.
Neopenda is a participant in the 2017 PULSE@MassChallenge digital health lab.
Expert advisors have articulated that it is critical to develop an effective way to train end-users in order to ensure correct usage of the product. While NICU nurses are the target users, the role of mothers and grandmothers that are in NICUs should also be considered. Expert advisors also expressed the need for rigorous validation since the product aims to detect several vital signs. Expert advisors indicated that an additional challenge to consider is how the placement of the product on the baby’s head by end-users impacts accurate vital signs detection.
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