International Research:
Medical Devices for
Limited-Resource Settings
David Kelso
Biomedical Engineering Department
McCormick School of Engineering
11 June 2014
Center for Innovation in
Global Health Technologies
Academia
Industry
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
Philanthropy
Key Contributions:
• R&D Funding, Mission,
Field Experience
Partners:
2
HIV p24 infant rapid test
Need for point-of-care
early infant HIV diagnostic, EID
• 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
4
Plasma without centrifugation
by filtration
Variation of plasma volume
Disrupt immune complex
by 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
Transfer liquids without pipets
By SafeTech capillary
By absorbent pad
By unit dose dispenser
Detect p24 antigen
by 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 card
Push buttons to enter P, N, I
Results stored in flash memory
Phones lab at pre-scheduled time
Transmits 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
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
Copyright © 2012 AIDS. Published by Lippincott Williams & Wilkins.
19
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
1 - Start Page
If ‘Ini al Visit’
follow from 4 to 8
and then complete
symptom specific
ques ons.
MAIN FLOW – APPLICATION BACKBONE
8 - Resources
6 - Road to Health
Chart (RTHC)
If no,
proceed
4 - Main
Symptoms
4 A - Cough
Home screen should act more like
a menu, something that pops up or
is present at all mes with the
menu op ons
4 - Main
Symptoms
5 - Danger
Signs
If yes, insert
Warning
Statement
3 - Home
Screen
2 - Pa ent
Informa on
13 –
Follow-Up
Care
The RTHC or Immuniza ons screens can either be accessed before evalua ng
main symptoms, or a er. They can also be accessed without the nurse having
to go through all main symptoms through the ‘Rou ne Check-Up’ mode.
9 - Classifica ons
4BDiarrhoea
7 - Immuniza ons
Resources should be
accessible from every
screen, as well as the home
screen. This is less a part of
the flowchart and more an
addi onal feature to be
incorporated.
4 C - Fever
11 - PRINT
10 - Treatment
4 D – Ear
Problem
4E–
Malnutri on/
Anaemia
4F–
Consider HIV
4G–
Consider TB
4 H – Other
Symptoms
The main symptoms will have a series of ques ons on each screen that pertain to the symptom. The ques ons are organized on the IMCILogic.xls sheet. Not all main symptoms
will require answers to every detailed ques on. Every main symptom will need to prompt the user “Does the child have a ______? (Yes/No)”. If YES, ask more detailed ques ons
about symptom, if NO, proceed with other main symptoms.
12 - Finish &
Save
Flow Break
Down
Coming
Soon!
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
Neonatal Intensive Care
45
Temp (C)
40
35
30
25
0
10
20
30
40
50
Time (min)
heat pack
water
60
70
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
2006
Northwestern University
BS, Biomedical Engineering
2014
Practice Fusion
SmartPhone Physical
http://www.practicefusion.com/
http://www.quantifiedcare.com/
Mike Hoaglin
The SmartPhone Physical
Visual Acuity
Blood Pressure
ECG
Ultrasound
SpO2
http://www.smartphonephysical.org/
Eye Exam