International Research:Medical Devices for

Limited-Resource Settings

David KelsoBiomedical Engineering Department

McCormick School of Engineering11 June 2014

2

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:

HIV p24 infant rapid test

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

Plasma without centrifugationby filtration

Variation of plasma volume

Disrupt immune complexby heat shock

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

By SafeTech capillary By absorbent pad By unit dose dispenser

Transfer liquids without pipets

Detect p24 antigenby immunochromatographic assay

Cape Town NHLS Verification

Sensitivity: 93.8 – 100%Specificity: 99.3%

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

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

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

HIV p24 rapid test

Business Issues• Small market• Low margins• Large investment• NGOs finance technical & market

development

Point of care HIV viral load

Sample in – Answer Out

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

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

Point of care HIV viral load

Business Issues• No US market• Low margins• Large investment• NGOs finance technical & market

development

Up Skill Healthcare Workers: IMCI tablet

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

Neonatal Intensive Care

0 10 20 30 40 50 60 70

25

30

35

40

45

heat pack water

Time (min)

Tem

p (

C)

Neonatal Intensive Care

BiliBlanket

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

Mike Hoaglin

2006Northwestern University

BS, Biomedical Engineering

http://www.practicefusion.com/http://www.quantifiedcare.com/

2014Practice Fusion

SmartPhone Physical

Mike HoaglinThe SmartPhone Physical

Blood Pressure

SpO2Eye Exam

ECG

Ultrasound

Visual Acuity

http://www.smartphonephysical.org/