international research: medical devices for limited-resource settings david kelso biomedical...
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International Research:Medical Devices for
Limited-Resource Settings
David KelsoBiomedical Engineering Department
McCormick School of Engineering11 June 2014
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Center for Innovation inGlobal Health Technologies
Industry
Academia
Philanthropy
Key Contributions:• Technology, Manufacturing, Regulatory,
Distribution,Current Partners:
Key Contributions:• Project Coordination, New Technology, Market Research and
Product Development, Field ExperienceCurrent Partners:• McCormick School of Engineering – Center for Innovation in Global
Health Technology (CIGHT)• Kellogg School of Management – Global Health Initiative (GHI)• Feinberg School of Medicine
Key Contributions:• R&D Funding, Mission,
Field ExperiencePartners:
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HIV p24 infant rapid test
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Need for point-of-care early infant HIV diagnostic, EID
4
• 1.4 million infants were born to HIV-positive women in 2007• 390 thousand infants infected• If not diagnosed and started on antiretroviral therapy,
35% of infected infants will die by age 1 year, 52% by age 2
• 2.8 million adjusted life years could be saved annuallyassuming 100% sensitivity and availability of ART
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Plasma without centrifugationby filtration
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Variation of plasma volume
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Disrupt immune complexby heat shock
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Effects of heat shock
• Disrupts antibody-antigen complex• 90-95 °C for 5 min required for high
avidity patients• p24 antigen refolds, epitopes of test
antibodies intact• Gel forms in specimens with high
IgG levels
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By SafeTech capillary By absorbent pad By unit dose dispenser
Transfer liquids without pipets
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Detect p24 antigenby immunochromatographic assay
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Cape Town NHLS Verification
Sensitivity: 93.8 – 100%Specificity: 99.3%
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p24 antigen correlation with viral load• 18 samples tested with viral loads 345 to 2 million• All samples positive except the 3 with the lowest viral loads• Lowest viral load detected was 6,580 copies/ml
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Communicate with central lab
Cellular modem with SIM cardPush buttons to enter P, N, IResults stored in flash memoryPhones lab at pre-scheduled timeTransmits results
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HIV p24 rapid test
Technical Issues• Sensitivity/specificity • Reaction
Temperature/Power consumption
• Communications protocol• Performance for 2 day old
Clinical Issues• Heelsticks• User errors• Daily reporting• Improved outcomes• Cure if detect at birth
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HIV p24 rapid test
Business Issues• Small market• Low margins• Large investment• NGOs finance technical & market
development
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Point of care HIV viral load
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Sample in – Answer Out
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Copyright © 2012 AIDS. Published by Lippincott Williams & Wilkins. 19
Global trends in molecular epidemiology of HIV-1 during 2000–2007 Hemelaar, Joris; Gouws, Eleanor; Ghys, Peter D; Osmanov, Saladin; WHO-UNAIDS Network for HIV Isolation and CharacterisationAIDS. 25(5):679-689, March 13, 2011.doi: 10.1097/QAD.0b013e328342ff93
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Point of care HIV viral load
Technical Issues• Sample volume• Linear range• LoQ• Viral diversity
Clinical Issues• Venipuncture/fingerstick• Adherence counseling• Therapy failure• CD4 testing• Chemistries• Dx decisions• Improved outcomes
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Point of care HIV viral load
Business Issues• No US market• Low margins• Large investment• NGOs finance technical & market
development
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Up Skill Healthcare Workers: IMCI tablet
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IMCI tablet
Technical Issues• User interface• Print out• File sharing• Android/iOS• MDM• Security
Clinical Issues• Faster than paper• Improved Dx• Improved outcomes• Non-professional users
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Neonatal Intensive Care
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0 10 20 30 40 50 60 70
25
30
35
40
45
heat pack water
Time (min)
Tem
p (
C)
Neonatal Intensive Care
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BiliBlanket
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Neonatal Intensive Care
• Know your users and use environment• KMC ward device needs:
Breathing monitor CPAP EEG
• Developing world NICU needs• High-income country needs
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Mike Hoaglin
2006Northwestern University
BS, Biomedical Engineering
http://www.practicefusion.com/http://www.quantifiedcare.com/
2014Practice Fusion
SmartPhone Physical
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Mike HoaglinThe SmartPhone Physical
Blood Pressure
SpO2Eye Exam
ECG
Ultrasound
Visual Acuity
http://www.smartphonephysical.org/