1. International Research: Medical Devices for Limited-Resource Settings David Kelso Biomedical Engineering Department McCormick School of Engineering 11 June 2014

2. 2 Center for Innovation in Global 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 Experience Current 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 Experience Partners:

3. HIV p24 infant rapid test

4. 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 annually assuming 100% sensitivity and availability of ART

5. Plasma without centrifugation by filtration

6. Variation of plasma volume

7. Disrupt immune complex by heat shock

8. 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

9. By SafeTech capillaryBy absorbent padBy unit dose dispenser Transfer liquids without pipets

10. Detect p24 antigen by immunochromatographic assay

11. Cape Town NHLS Verification Sensitivity: 93.8 – 100% Specificity: 99.3%

12. 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

13. Communicate with central lab Cellular modem with SIM card Push buttons to enter P, N, I Results stored in flash memory Phones lab at pre-scheduled time Transmits results

14. 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

15. HIV p24 rapid test Business Issues Small market Low margins Large investment NGOs finance technical & market development

16. Point of care HIV viral load

18. Sample in – Answer Out

19. Copyright © 2012 AIDS. Published by Lippincott Williams & Wilkins.19 Global trends in molecular epidemiology of HIV-1 during 2000–2007 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 Characterisation AIDS. 25(5):679-689, March 13, 2011. doi: 10.1097/QAD.0b013e328342ff93

20. 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

21. Point of care HIV viral load Business Issues No US market Low margins Large investment NGOs finance technical & market development

22. Up Skill Healthcare Workers: IMCI tablet

28. 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

29. Neonatal Intensive Care

32. BiliBlanket

33. 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

34. Mike Hoaglin 2006 Northwestern University BS, Biomedical Engineering http://www.practicefusion.com/ http://www.quantifiedcare.com/ 2014 Practice Fusion SmartPhone Physical

35. Mike Hoaglin The SmartPhone Physical Blood Pressure SpO2 Eye Exam ECG Ultrasound Visual Acuity http://www.smartphonephysical.org/