1. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Modular Incubation System Delivering infants a better start P: 212.854.6196 F: 212.854.8725 351 Engineering Terrace 1210 Amsterdam Ave New York, NY 10027 IncuVive.weebly.com | Indy Bekerie Annabelle Chu Leeanna Hyacinth Min Ye Shen Kiet Vo BME Senior Design 2011-2012 Preliminary Findings and Business Plan

2. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Executive Summary P: 212.854.6196 F: 212.854.8725 351 Engineering Terrace 1210 Amsterdam Ave New York, NY 10027 Incuvive.weebly.com | Company Overview ―Develop technology to combat infant hypothermia that is viable for low-resource countries ―Advisors are leaders in the field of Biomedical Engineering and renown neonatologists with firsthand experience in the field Market —NGOs, non-profits, and the hospitals of over 100 developing countries Business Model —Capital equipment model Design and Development —Overall Plan —Innovative Designs —Proof of Concept 1.0 Heating sources Temperature sensors IncuVive Financial Projections and Key Performance Indicators

3. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Company Overview Our Technology —Will produce the correct amount of heat, maintain temperature —Can be coupled with a crib and cover —Incorporates accurate temperature sensors —Utilizes an innovative feedback mechanism and alarm system Advantages Over Present Solutions —Feedback Mechanism —Affordable, reliable —Viable for low-resource countries Advantages Over Other Companies —Few other companies targeting developing countries + = An innovative solution to combat infant hypothermia

4. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | The Market ~ 4 million annual infant mortality [3] – 18%-42% caused by hypothermia » 720,000 to 1.68 million of neonate deaths can be prevented annually ~ 144 developing countries [1] In Uganda – 80 per 1,000 live births [5] – 15 to 18 neonates suffering from hypothermia can be saved P: 212.854.6196 F: 212.854.8725 351 Engineering Terrace 1210 Amsterdam Ave New York, NY 10027 Incuvive.weebly.com | Market Strategies Neonates Sub-district hospitals Other rural healthcare facilities National and Regional Hospitals Consumers Customers Ministry of Health NGOsDonors Target UgandaOther developing countries [3] UNICEF. Progress for children: a world fit for children statistical review. New York, NY: United Nations Children`s Fund; 2007 [5] Infant mortality rate, Uganda. Google.com/publicdata

5. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | The Market Our MIS Will Incorporate a reliable feedback mechanism Revive current nonfunctional incubators Convert available cribs to modest incubators Competition Van Hemel Baby Incubator (~ $450) Medicine Mondiale’s Liferaft Incubator (~ $1,500) General Electric (GE) incubators ($15,000-$40,000) Risks and Obstacles Secure funding for production Partnership with the Ministry of Health and the NGO’s Protection of Intellectual Property Larger medical device companies P: 212.854.6196 F: 212.854.8725 351 Engineering Terrace 1210 Amsterdam Ave New York, NY 10027 |

6. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | IncuVive in Uganda We plan to follow a capital equipment model. The National Medical Store will be our main purchaser of our MIS; however, we also plan to sell to NGO and private hospitals. Each unit will be priced at $50 after subsidizations Strategic Partnerships Partnerships with NGOs such as UNICEF, ECHO, and the Gates Foundation will help offset production costs and help sustain a low margin operation. We will utilize partner distribution channels in order to quickly establish operations in new markets.

7. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Expansion and Distribution Our main source of income will come from market expansion. Our device will be assembled locally and transported by a third party. After setting up distribution in Uganda we plan to immediately expand into surrounding countries. www.infoplease.com/atlas/country/uganda.html

8. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | December 2011 Proof of Concept completed Finalize preliminary prototype idea January 2012 Start first prototype Start circuitry and code for feedback system March 2012 Complete construction and testing of first prototype on animals Test durability, power efficiency, feedback/fail-safe mechanism Start second prototype May 2012 Finish second prototype Complete integrated heating unit and feedback mechanism Apply for IRB approval for field testing in Mulago Hospital, Uganda

9. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Heating Mat + PCMFeedback System Monitor and display temperature of either mat or environmental temperature Monitor and display temperature of infant Automatically adjust heat setting to maintain infant’s temperature in the normal range Alarm if abnormal temperature readings (too high or too low) Automatic shut off if temperature is too high to prevent overheating

10. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Feedback System Monitor and display temperature of either mat or environmental temperature Monitor and display temperature of infant Automatically adjust heat setting to maintain infant’s temperature in the normal range Alarm if abnormal temperature readings (too high or too low) Automatic shut off if temperature is too high to prevent overheating Space Heater

11. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Feedback System Monitor and display temperature of either mat or environmental temperature Monitor and display temperature of infant Automatically adjust heat setting to maintain infant’s temperature in the normal range Alarm if abnormal temperature readings (too high or too low) Automatic shut off if temperature is too high to prevent overheating Warm Water Pump

12. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | HeaterHeating PadWarm Water Pump CRITERIAWEIGHTValue Affordable100300340042002 Portable1003003 32002 Durable9027031802 2 Easy to Maintain10030032002 2 Intuitive, Easy to Use702103 31402 Sterilizable, Easy to Clean, Diminishing Contamination 1003003 32002 Low Power (e.g. runs on batteries >= 24 hrs) 70210335052103 Preferably made with materials available in Uganda 20603402603 High Infant Visibility902703 31802 Comfortable802403 3 3 Safe1003003 32002 totals:276033279033201025

13. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | PoC- Saline Bag Control Methods A bag of saline with a thermometer inserted was heated to 37 °C in a water bath. The saline was placed on an inactive mat and allowed to cool down. The temperature of the saline was recorded every minute with a calibrated thermistor inserted into the saline until the temperature dropped to 34 °C Use phase change material (PCM) between the neonate and the heating unit to prevent burns Maintain the baby at a temperature of about 37 °C while heating unit is off

14. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | PoC- Phase Change Material (PCM) Methods The PCM was activated in a microwave, then placed on the inactive mat with thermistors placed at specific locations. Meanwhile a bag of saline was heated to 35 °C in a water bath and placed on the PCM. The experiment was repeated with thermistors. Results

15. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Saline on PCMSaline on PCM with Heating Mat Conclusion The PCM cannot raise the saline’s temperature to 37 °C The PCM can only maintain the saline’s temperature above 35 °C for about one hour with no external heat supply Other insulating materials

16. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Temperature Sensors ModelRange ˚ CAccuracy ˚ CPrice/unit Red spirit 305 mm White, Red spirit filled-20 to 1501.5$5.15 Thermistor (NTC) Negative Temperature Coefficient--- ~$0.25 Integrated Circuit (LM34)LM34CAZ −40˚ to 110˚± 0.25$8.33 Digital2210DR 32.0 to 43.9 ± 0.1 $10.00 Water Bath Temperature Red spiritNTCLM34Digital 21.119.8521.21--- 4240.9542.6343.7 36.837.7937.6538 3435.1834.7834.9 Ambient Temperature Red spiritNTCLM34Digital 20.019.9521.14--- 20.019.6921.03--- 20.019.7621.05--- Left Armpit Measurement Approximating Body Temp. Red spirit NTCLM34Digital Oral Reading w/ Digital 3434.3135.0835.535.9 3434.5135.3135.736 34.234.7735.6435.836.1 34.235.0235.7335.836.2 34.235.1535.963636.2 34.235.1735.983636.2 Most viable for Water: LM34 Skin: Digital* Ambient: NTC Red spirit

17. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Continue development of new products Initiate first assembly station in Uganda Develop extensive rapport with NGOs, WHO, UNICEF Apply for funding and grants and start manufacturing Continue R&D Build final prototype Design and build 1 st and 2 nd prototype Product Selection Proof of Concept testing

18. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com |

19. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com |

20. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Estimated MIS Usage projection based on a conservative 10% outreach to all neonatal deaths from hypothermia. A more in-depth explanation is in DS2: Basic summary of problem. As you can see, the curve is sigmoidal and saturated at roughly 72,000 neonates per year.

21. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Further testing of the ability of the space heater and warm water pump to raise and maintain the temperature of a saline bag. Investigate and compare the functionality of other insulating materials. Begin fabrication of feedback mechanism Explore alarm system Finalize what products we will implement in our Modular Incubation System ⁻Method of Heating ⁻Temperature Sensors ⁻Insulating Material (if necessary)

22. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 www.rightcare.com | Acknowledgments Instructors – Dr. Elizabeth Hillman, Ph.D., Biomedical Engineering Dept., Columbia University – Dr. Aaron Kyle, Ph.D., Biomedical Engineering Dept., Columbia University – Mr. Keith Yeager – Sarah De Leo (TA) Advisers and Consultants – Dr. Lance Kam, Ph.D., Biomedical Engineering Dept., Columbia University – Dr. Margaret Nakakeeto-Kijjambu, MD, Mulago Hospital – Dr. Richard Polin, MD, CUMC Pediatrics – Dr. Rakesh Sahni, MD, CUMC Pediatrics – Dr. Helen Towers, MD, CUMC Pediatrics – Dr. Yvonne Vaucher, MD, UCSD – Dr. David Vallancourt, Ph.D., Electrical Engineering Dept., Columbia University IncuVive.weebly.com