Indy Bekerie Annabelle Chu Leeanna Hyacinth Min Ye Shen Kiet Vo BME Senior Design 2011-2012 Preliminary Findings and Business Plan 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Executive Summary • 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 P: 212.854.6196 F: 212.854.8725 P: 555.123.4568 F: 555.123.4567 351 Engineering Terrace 123 West Main Street, New York, 1210 Amsterdam Ave NY 10001 New York, NY 10027 || www.rightcare.com Incuvive.weebly.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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com The Market Market Strategies • ~ 4 million annual infant mortality [3] Target – 18%-42% caused by hypothermia » 720,000 to 1.68 million of neonate deaths can be • Uganda • Other developing countries prevented annually • ~ 144 developing countries [1] • In Uganda – 80 per 1,000 live births [5] Customers • Ministry of Health • NGOs • Donors – 15 to 18 neonates suffering from hypothermia can be saved Consumers • National • Sub-district • Other rural and hospitals healthcare Regional facilities Hospitals Neonates [3] UNICEF. Progress for children: a world fit for children statistical review. New P:NY: 212.854.6196 F: 212.854.8725 York, United Nations Children`s Fund; 2007 P: 555.123.4568 F: 555.123.4567 351 Engineering Terrace [5] Infant mortality rate, Uganda. Google.com/publicdata www.rightcare.com 123 West Main Street, New York, 1210 Amsterdam Ave NY 10001 New York, NY 10027 || Incuvive.weebly.com The Market 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 Our MIS Will • Incorporate a reliable feedback mechanism • Revive current nonfunctional incubators • Convert available cribs to modest incubators P: 212.854.6196 F: 212.854.8725 P: 555.123.4568 F: 555.123.4567 351 Engineering Terrace 123 West Main Street, New York, 1210 Amsterdam Ave NY 10001 New York, NY 10027 || www.rightcare.com Business Model 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. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Business Model 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Short Term Plan December 2011 • Proof of Concept completed • Finalize preliminary prototype idea January 2012 March 2012 May 2012 • Start first prototype • Start circuitry and code for feedback system • Complete construction and testing of first prototype on animals • Test durability, power efficiency, feedback/fail-safe mechanism • Start second prototype • Finish second prototype • Complete integrated heating unit and feedback mechanism • Apply for IRB approval for field testing in Mulago Hospital, Uganda P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Design Ideas Heating Mat + PCM 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Design Ideas Space Heater 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Design Ideas Warm Water Pump 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Decision Matrix Methods of Heating Heater CRITERIA Affordable Portable Durable Easy to Maintain Intuitive, Easy to Use Sterilizable, Easy to Clean, Diminishing Contamination Low Power (e.g. runs on batteries >= 24 hrs) Preferably made with materials available in Uganda High Infant Visibility Comfortable Safe Heating Pad Value 400 4 300 3 180 2 200 2 210 3 Warm Water Pump Value 200 2 200 2 180 2 200 2 140 2 WEIGHT 100 100 90 100 70 Value 300 300 270 300 210 3 3 3 3 3 100 300 3 300 3 200 2 70 210 3 350 5 210 3 20 60 3 40 2 60 3 90 80 100 totals: 270 240 300 2760 3 3 3 33 270 240 300 2790 3 3 3 33 180 240 200 2010 2 3 2 25 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com • • 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 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com PoC- Phase Change Material (PCM) Results 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. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Saline on PCM with Heating Mat Saline on PCM 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Temperature Sensors Water Bath Temperature Red spirit NTC 21.1 19.85 42 40.95 36.8 37.79 34 35.18 LM34 21.21 42.63 37.65 34.78 Digital --43.7 38 34.9 Left Armpit Measurement Approximating Body Temp. Red spirit Oral Reading NTC LM34 Digital w/ Digital 34 34.31 35.08 35.5 35.9 34 34.51 35.31 35.7 36 34.2 34.77 35.64 35.8 36.1 34.2 35.02 35.73 35.8 36.2 34.2 35.15 35.96 36 36.2 34.2 35.17 35.98 36 36.2 Ambient Temperature Red spirit NTC 20.0 19.95 20.0 19.69 20.0 19.76 LM34 21.14 21.03 21.05 Red spirit Thermistor (NTC) Model Range ˚ C Accuracy ˚ C Price/unit 305 mm White, Red spirit filled -20 to 150 1.5 $5.15 Negative Temperature Coefficient ----~$0.25 Integrated Circuit (LM34) LM34CAZ Digital 2210DR −40˚ to 110˚ 32.0 to 43.9 ± 0.25 ± 0.1 $8.33 $10.00 Most viable for • • • Water: LM34 Skin: Digital* Ambient: NTC Digital ------- Red spirit P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Long Range Plan Design and build 1st and 2nd prototype Product Selection Proof of Concept testing Apply for funding and grants and start manufacturing Continue R&D Build final prototype Develop extensive rapport with NGOs, WHO, UNICEF Initiate first assembly station in Uganda Continue development of new products P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Financial Projections Phase I $ in thousands 2012 # of units ($) 0 Unit Sales ($50/unit) 0 Funds from NGO 500 ($50/unit) and Revenue ($) 500 R&D ($) 0 Internatiional 0 Device Approval ($) Material cost ($) 150 Production Cost ($) 350 Wages ($) 0 Transportaton ($) 0 Total Cost ($) 500 Net Income ($) 0 2013 0 0 Phase II 2014 10 500 2016 300 15000 Phase III / Phase IV 2017 2018 2019 500 1000 1500 25000 50000 75000 2015 150 7500 2020 2000 100000 2021 2500 125000 0 3500 10500 18000 28000 53000 78000 103000 128000 0 1000 4000 700 18000 700 33000 800 53000 900 103000 1000 153000 1100 203000 1350 253000 1500 2000 5000 1000 500 500 500 500 500 500 500 500 0 0 4000 -4000 600 500 1500 100 8400 -4400 300 100 22500 200 24800 -6800 15300 19400 30000 300 66300 -33300 15500 19000 60000 400 96300 -43300 16000 18000 85000 1000 121500 -18500 16500 17000 120000 1000 156100 -3100 17000 16000 145000 1000 180850 22150 17500 15000 160000 1000 195500 57500 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Financial Projections Financial Projection 300000 250000 Dollars 200000 150000 Cost Revenue 100000 50000 0 2011 2012 2013 2014 2015 2016 2017 Year 2018 2019 2020 2021 2022 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Estimated Usage of Our Modular Incubation System 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. 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. P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com Future Plans • 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) 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 P: 555.123.4568 F: 555.123.4567 123 West Main Street, New York, NY 10001 | www.rightcare.com