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Modular Incubation SystemDelivering infants a better start

P: 212.854.6196 F: 212.854.8725351 Engineering Terrace1210 Amsterdam AveNew York, NY 10027

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Indy BekerieAnnabelle Chu

Leeanna HyacinthMin Ye Shen

Kiet Vo

BME Senior Design 2011-2012Preliminary Findings and Business Plan

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Executive Summary

P: 212.854.6196 F: 212.854.8725351 Engineering Terrace1210 Amsterdam AveNew York, NY 10027

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• 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

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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

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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: 212.854.8725351 Engineering Terrace1210 Amsterdam AveNew York, NY 10027

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Market Strategies

Neonates

• Sub-district

hospitals

• Other rural

healthcare

facilities

• National and

Regional Hospitals

Consumers

Customers

• Ministry of Health

• NGOs • Donors

Target

• Uganda

• Other 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

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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: 212.854.8725351 Engineering Terrace1210 Amsterdam AveNew York, NY 10027 |

P: 555.123.4568 F: 555.123.4567123 West Main Street, New York, NY 10001

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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.

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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

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Short Term Plan

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

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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: 555.123.4567123 West Main Street, New York, NY 10001

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Design Ideas

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

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Design Ideas

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

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Decision MatrixMethods of Heating

Heater Heating Pad Warm Water PumpCRITERIA WEIGHT Value Value Value Affordable 100 300 3 400 4 200 2Portable 100 300 3 300 3 200 2Durable 90 270 3 180 2 180 2Easy to Maintain 100 300 3 200 2 200 2Intuitive, Easy to Use 70 210 3 210 3 140 2

Sterilizable, Easy to Clean, Diminishing Contamination

100 300 3 300 3 200 2

Low Power (e.g. runs on batteries >= 24 hrs)

70 210 3 350 5 210 3

Preferably made with materials available in Uganda 20 60 3 40 2 60 3

High Infant Visibility 90 270 3 270 3 180 2Comfortable 80 240 3 240 3 240 3Safe 100 300 3 300 3 200 2 totals: 2760 33 2790 33 2010 25

P: 555.123.4568 F: 555.123.4567123 West Main Street, New York, NY 10001

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PoC- Saline Bag ControlMethods• 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

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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

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Saline on PCM Saline 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

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Temperature Sensors

ModelRange ˚

CAccuracy ˚

C Price/unit

Red spirit

305 mm White, Red spirit filled

-20 to 150 1.5 $5.15

Thermistor (NTC)

Negative Temperature Coefficient --- --- ~$0.25

Integrated Circuit (LM34) LM34CAZ

−40˚ to 110˚ ± 0.25 $8.33

Digital 2210DR32.0 to

43.9± 0.1

$10.00

Water Bath TemperatureRed spirit NTC LM34 Digital

21.1 19.85 21.21 ---42 40.95 42.63 43.7

36.8 37.79 37.65 3834 35.18 34.78 34.9

Ambient TemperatureRed spirit NTC LM34 Digital

20.0 19.95 21.14 ---20.0 19.69 21.03 ---20.0 19.76 21.05 ---

Left Armpit Measurement Approximating Body Temp.Red spirit

NTC LM34 DigitalOral Reading

w/ Digital34 34.31 35.08 35.5 35.934 34.51 35.31 35.7 36

34.2 34.77 35.64 35.8 36.134.2 35.02 35.73 35.8 36.234.2 35.15 35.96 36 36.234.2 35.17 35.98 36 36.2

Most viable for• Water: LM34• Skin: Digital*• Ambient: NTC

Red spirit

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Long Range Plan

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 1st and 2nd prototype

Product SelectionProof of Concept testing

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Financial Projections

Phase I $ in thousands 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021# of units ($) 0 0 10 150 300 500 1000 1500 2000 2500Unit Sales ($50/unit) 0 0 500 7500 15000 25000 50000 75000 100000 125000

Revenue ($) 500 0 4000 18000 33000 53000 103000 153000 203000 253000R&D ($) 0 1000 700 700 800 900 1000 1100 1350 1500

Material cost ($) 150 500 600 300 15300 15500 16000 16500 17000 17500Production Cost ($) 350 500 500 100 19400 19000 18000 17000 16000 15000Wages ($) 0 0 1500 22500 30000 60000 85000 120000 145000 160000Transportaton ($) 0 0 100 200 300 400 1000 1000 1000 1000Total Cost ($) 500 4000 8400 24800 66300 96300 121500 156100 180850 195500Net Income ($) 0 -4000 -4400 -6800 -33300 -43300 -18500 -3100 22150 57500

Phase II Phase III / Phase IV

128000103000780005300028000180001050035000500Funds from NGO ($50/unit) and

500500500500500Internatiional Device Approval ($)

5001000500020000

P: 555.123.4568 F: 555.123.4567123 West Main Street, New York, NY 10001

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Financial Projections

2010 2012 2014 2016 2018 2020 20220

50000

100000

150000

200000

250000

300000

Financial Projection

CostRevenue

Year

Dol

lars

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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: 555.123.4567123 West Main Street, New York, NY 10001

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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)

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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

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