[Warmilu] Kenya Product Launch 20160331
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Presented the Warmilu IncuBlanket and heat technology to a group of Ministry of Health officials, County Health officials, Chief Medical Officers, Chief Nursing Officers, neonatologists, pediatricians, and other key influencers seeking positive impact in maternal and infant health. We discuss the Warmilu technology and challenges in infant warming as well as context for applications. Presented by Grace Hsia, CEO, on 3/31/2016 at the Sarova Panafric Hotel.
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[Warmilu] Kenya Product Launch 20160331
- 1. 1 SPREADING THE WARMTH to SAVE LIVES Kenya Product Launch 31/03/2016 IN PARTNERSHIP WITH: GRACE HSIA, CEO hsgracie@warmilu.com
- 2. 2 Born 4 weeks premature, our CEO spent her first few life-saving weeks in an incubator. Why Warmilu?
- 3. Source: WHO Premature Birth, Fact Sheet N°363, November 2015 http://www.who.int/mediacentre/factsheets/fs363/en/ 3 15 million premature infants are born annually. 1.5 million infants die in resource scarce settings.
- 4. 7/21/2016 4 Of 1.5 million deaths, 75% could be saved with interventions including thermal care, safe oxygen use, and CPAP. And premature birth rates are increasing in almost all countries with reliable data. For 1°C in temperature, there is a 28% in infant mortality.
- 5. 5 WHO 2013: 156,700 – 187,500 premature infants born annually in Kenya.
- 7. 7 4 Patents in US, European Union, Canada, and India PATENTED
- 9. 9 Instant Heat: Usage Flow Chart 1. Ready for Use: Liquid Pack 2. Press Disk Place Pack in Blanket 8 Hours of Heat 3. Boil Solid Pack 30 min 4. Cool to Room Temperature 400x Cycles
- 10. 10 The pack can be recharged through boiling for 30 minutes. (Life cycle 400 boiling cycles.) Video in real time.
- 11. 11 SPREAD THE WARMTH to SAVE LIVES Use Segmentation and Context for IncuBlanket
- 12. 12 • Electricity Scarce • No Incubators
- 13. Source: Florencedzame, https://florencedzame.wordpress.com/2013/06/28/sho rtage-of-incubators-in-public-hospitals-in-kenya/ 13 • Electricity Scarce • Not Enough Incubators
- 14. 14 Intermittent Kangaroo Mother Care (KMC) • No Electricity • No Incubator
- 15. 15 Intermittent Kangaroo Mother Care (KMC) • No Electricity • No Incubator Assist Moms with Intermittent Kangaroo Mother Care (KMC) • Goal = Capacity Building • Have Incubators & Electricity
- 16. 16 IncuBlanket Materials & Technical Specifications • Safe temperature • Breathable to wick away sweat • Phthalate-free, lead-free • All medical grade materials currently used in US baby products8” 16”
- 17. 17 SPREAD THE WARMTH to SAVE LIVES Overview Clinical Trials
- 18. Third party testing & validation by: 7/21/2016 18
- 19. 19 35.5 36 36.5 37 37.5 38 38.5 0 15 30 45 60 90 120 150 180 210 300 Infants'CoreBodyTemperature (°C) Length of Thermoregulation (Minutes) Infant Core Temperatures vs. Time
- 20. 20 Clinical Trials Summary • No reported morbidity except being premature or low birth weight in these infants. • Average weight 1.75 kg • Average gestational age 35.25 weeks • Each infant’s temperature started at 36.5°C-37.5°C. These infants were constantly monitored for their time and temperature profiles. • The infant warming blanket demonstrated the ability to maintain the infant’s body temperature between 36.5°C-37.5°C for 5 or more hours. Thermoregulation Clinical Trials Summary
- 21. 21 SPREAD THE WARMTH to SAVE LIVES Overview Regulatory Pathway
- 22. 22 Certifications SGS Certificate of Conformity Kenya Pre-Export Verification of Conformity (PVoC)
- 24. 24 Logistics, Distribution, Customer Care & Support • Channels to distribute, manage logistics, and collaborate for on-the- ground support throughout Kenya, Rift Valley Areas • Great Lakes Region • Horn of Africa
- 25. 25 Relief for Africa Foundation focuses on aid to the Horn of Africa, including Eritrea, Ethiopia, Somalia and Djibouti. About $1,000,000 of medical supplies totaling more than 50,000 pounds donated to date.
- 26. 26 SPREADING THE WARMTH to SAVE LIVES Q&A Feedback Contributions IN PARTNERSHIP WITH:
Editor's Notes
- First, thank you Relief for Africa Foundation and your team for welcoming me here today. Hello everyone, my name is Grace Hsia and I am the Co-Founder and CEO for Warmilu. Today, I am sharing with you the partnership we have with Relief for Africa Foundation, to be on a mission with the IncuBlanket to nonelectrically spread warmth and reduce premature infant death from hypothermia. My team including Director Musa Kannenje and President Rama Kannenje have had the opportunity to meet and work together over the course of the past year. This presentation presented the Warmilu IncuBlanket and heat technology to a group of Ministry of Health officials, County Health officials, Chief Medical Officers, Chief Nursing Officers, neonatologists, pediatricians, and other key influencers seeking positive impact in maternal and infant health. We discuss the Warmilu technology and challenges in infant warming as well as context for applications. Presented by Grace Hsia, CEO, on 3/31/2016 at the Sarova Panafric Hotel.
- When we met and partnered with the Warmilu team, we found ourselves sharing a common mission to improve infant and maternal health. One of the challenges we focus on is that of premature infant death. Of 15 million low birthweight preterm infants born annually, 1.5 million die in resource scarce settings during the neonatal period. For every 1°C drop in body temperature, there is a 28% in infant mortality.
- Of the 1.5 million deaths, 75% could be saved with basic interventions. We recognize that premature birth rates are continuing to increase in almost all countries with reliable data and that these basic interventions including thermal care, safe oxygen use, and continuous positive airway pressure can make all the difference if they can be accessed by trained personnel. This is known in the scientific literature.
- According to the World Health Organization (2013), 8,000 newborns die daily around the world, and 20 of these deaths occur every day in Kenya (DHIS 2012). In total there are 1.25 million – 1.5 million live births annually in Kenya; of these, one in eight or 156,700 -187,500 are born preterm and low birth weight. Of these preterm infants 14,000 die and the leading cause is hypothermia or pneumonia exacerbated by hypothermia.
- We think, together with your team here in Bungoma, we can help reduce premature infant death by providing access to a non-electric infant warming blanket. Almost 5 years ago now, the Warmilu team began developing their nonelectric warming technology. But what do we mean by nonelectric? I have brought with me the Warmilu nonelectric warming pack [and small demonstration packs]. The pack was designed by materials science engineers at Warmilu to be a thermal battery that you can turn on by pressing this metal disk. You can feel it generating warmth in seconds. This pack heats the blanket to 37.5 degrees Celsius. You can feel the warmth in your hands. This pack may then be slid into the back of the IncuBlanket.
- Here is the phase change again in a Warmilu video. As you can see, the heat is generated by flexing the metal activator disk. The composition controls the pack’s temperature and allows it to generate heat for hours with the addition of a proprietary thermal buffer. The pack has undergone validation in clinical trials with the Kempegowda Institute of Medical Sciences in Bangalore, India and testing with Lawrence Berkeley National Laboratory, Kettering University, and the University of Michigan.
- IncuBlanket Demonstration Now we will show you how to use the IncuBlanket. First, you would lay the infant inside the IncuBlanket. The fold would be lifted and laid over the infant’s core and these wings are wrapped around the infant to make sure the heat is directed and kept close to the infant. The temperature is monitored by ThermoSpot stickers.
- In summary, we are proud to be able to present this infant warming solution to you. To finalize and summarize how to use the Warmilu IncuBlanket, I will present this usage flow cart. First, you generate heat by pressing the disk. Then, you place the pack inside of the IncuBlanket to generate heat. Then, after 8 hours and completion of the heat generation, you boil the solid pack for 30 minutes. Finally, let the liquid pack cool to room temperature. When you are ready to use the pack again, press the disk and place it inside of the infant warming blanket.
- The pack can be recharged through boiling for 30 minutes. (Life cycle 400 boiling cycles.) This video is shown in real time. Once you boil the pack, it resets it into the liquid state which is stable and when you need the heat you may press the disk and generate heat in seconds.
- We have had the opportunity to visit a significant number of hospitals in the course of our work throughout Kenya and throughout the Horn of Africa. During our visits to hospitals, we experienced and learned about several specific use cases.
- The first use case is in settings where electricity is scarce and the hospitals do not possess incubators. They might possess, as shown in this photo, a space heater. These hospitals were also often in need of thermometers. Level 2 Hospitals often experienced electricity scarcity with the power going out anywhere from 2-4 times a week for 30 minutes up to an entire day. In these Level 2 to Level 3 hospitals, they did not have any incubators and did not have backup power generators. There was a need within the hospital to have a source of warmth if the mother was not able to provide kangaroo mother care. In addition, if there was a complication in the birth which may affect the mother or infant’s health, the infants and mother may be transferred to a Level 3 or a Level 4 hospital. When the mothers cannot administer kangaroo mother care during transport, there is a need to supplement kangaroo mother care and provide warmth to the infants during transport. Warmilu Use Case In this scenario, we learned that the Warmilu IncuBlanket could serve as a source of warmth to the infants at the hospital and provide warmth during transport.
- One of the most common challenges we encountered was electricity scarcity and just not having enough incubators. If a hospital had incubators, they might only have 1-2 working incubators and there could be anywhere from 2 to 6 infants laid in an incubator. When the mothers cannot administer kangaroo mother care or the power goes out or there are just too many infants, there is a need to supplement kangaroo mother care and incubators to provide warmth to the infants. This tended to apply to Level 3-Level 4 hospitals. When there is no more space in the incubators or the mothers cannot administer kangaroo mother care during transport or in the hospital, there is a need to supplement kangaroo mother care and provide warmth to the infants being kept for observation in a Level 3 or Level 4 Hospital. Warmilu Use Case In this scenario, we learned that the Warmilu IncuBlanket could serve as a source of warmth to the infants in the case of a power outage at the hospital and provide warmth to a greater number of infants who were being cared for in the hospital. In this case, the Warmilu IncuBlanket could also help expand basic thermal care to other infants and could also be used during transport.
- In infants that are stable enough for kangaroo mother care, more hospitals are beginning to evaluate intermittent kangaroo mother care to help with scaling thermal management. When there is a warming gap when the mothers need to rest or use the restroom or take a shower, they often do not have access to electricity or incubators to provide supplemental warmth. Warmilu Use Case In those instances, there is the high potential to help the mothers and caretakers and relatives when they need to rest by providing an infant warming blanket to help provide supplemental warmth.
- Finally, in Level 5 and Level 6 hospitals, we found that there are often enough incubators and electricity. There are backup generators even if the power goes out. In these hospitals, we find that they are helping educate mothers in proper intermittent kangaroo mother care when the infants are stable. Warmilu Use Case In that scenario, the Warmilu IncuBlanket may be used to assist hospitals with scaling and capacity building and providing supplemental warmth when the mother needs to rest from intermittent kangaroo mother care.
- In addition to a strong technical design and being built with the infant and maternal health in mind and how best to help medical practitioners, the materials were selected to improve the comfort and safety of the infant by being breathable, temperature safe, and wicking away sweat to make sure any moisture is swept away from the infant’s skin. All materials are medical grade and currently used in US baby products. They are all phthalate-free and lead-free and comply to the highest medical grade standards for infant products.
- The IncuBlanket has been validated in Clinical Trials.
- We’ve built and tested our IncuBlankets and heat packs in clinical trials to make sure they are safe and effective with third parties.
- In the clinical trials, there was no reported morbidity except being premature or low birth weight in these infants. The infant warming blanket demonstrated the ability to maintain the infant’s body temperature between 36.5°C-37.5°C for 5 or more hours as indicated by the infants’ body temperatures kept between the green rectangle on this graph showing the infant core temperatures versus time.
- In summary the IncuBlanket was able to administer thermal care safely and effectively in premature and low birth weight infants with average weight 1.75 kg and average gestational age of 35.25 weeks. These infants were constantly monitored for their time and temperature profiles.
- Our next steps include completing our regulatory approval. This is an overview on the regulatory pathway in Kenya.
- We have received the SGS Certificate of Conformity which is a way to verify that each IncuBlanket conforms to the highest quality management, quality control, and quality assurance standards. Each shipment is verified to meet the expectations and quality rigor expected by the Kenya Bureau of Standards.
- In the next 1-2 months we will be receiving our regulatory approval for the IncuBlanket. We are currently in the final process of updating the design following feedback from a meeting with doctors, nurses, County Officials, and Ministry of Health Officials on March 31, 2016. This will help us update and finalize our quality management system documentation and get it ready for submission to the Kenya Pharmacy and Poisons Board.
- Upon receiving Kenya Pharmacy and Poisons Board clearance, we at Relief for Africa Foundation will be the logistics, distribution, customer care, and support partner for Warmilu. We have the channels and team to manage these critical tasks and provide on the ground support and collaboration throughout Kenya and the Rift Valley Areas and beyond including the Great Lakes Region and surrounding Horn of Africa.
- Our organization, the Relief for Africa Foundation, is a nonprofit on a mission to provide aid to the Horn of Africa including Eritrea, Ethiopia, Somalia, and Djibouti. We are able to facilitate these donations through the executive team’s roots here in Nairobi and Western Kenya as well through as our President’s work at the University of Michigan Health System and Huron Valley Ambulance and as an ambassador at World Medical Relief. We are builders of partnerships and relationships that help improve healthcare right here in Kenya. About $1,000,000 of medical supplies totaling more than 50,000 pounds have been donated to date through the efforts of our foundation.
- Thank you for your attention and time! We look forward to welcoming and answering your questions. We also welcome your feedback and contributions. Together, we can spread the warmth to save lives.