1) The document discusses point-of-care testing (POCT) devices and the market potential for these devices. It covers POCT definitions, advantages and disadvantages, types of tests, and where POCTs are currently used. 2) Clinician surveys found that POCTs are used in hospitals for their ability to provide rapid results and diagnosis. Clinicians see the POCT market continuing to grow due to ease of use and cost-efficiency. 3) The global POCT market is forecasted to reach $8.83 billion by 2012, with the largest segments being blood glucose monitoring and critical care. The market is expected to see growth in home use and developing countries

1. Could POCT’s be a business
opportunity?
Presented by Inma Uzkudun
Madrid, 30th of April 2010

2. INDEX
MONDRAGON Health
Point-of-Care Testing (POCT)
Market of POCT’s
What clinicians think of POCT’s?
Trends & Forecasts
Conclusions

3. MONDRAGON Health
MONDRAGON CORPORATION
New Business Development Centre
MONDRAGON Health

4. MONDRAGON Corporation
MONDRAGON
INDUSTRY AREA
In millions of Euros (2008)
Industrial Automation Division
Finance Area (Caja Laboral Automotive Division
Customers Credits): 13,988 Bodywork and Supplies Division
Components Division
Industry Area: 6,511 Construction Division
FINANCE Vertical Transport Division
Distribution Area: 9,073 AREA
División Equipamiento
Household Division
Engineering & Services Division
Machine Tools Division
Personnel (2008)
Industrial Systems Division
Total Employment: 92,773 Tooling & Systems Division
Employment Abroad: 14,938 New Business Development Centre
Knowledge Area
Rusia
Alemania (3)
U.K.(3) Polonia (7)
Rep. Checa (7)
U.S.A. U.S.A.(1) Francia (5) Eslovaquia (2)
Portugal(2) Rumania (2)
China (9)
Mexico (7) Marruecos(2) Italia China
Turquía
(4)
Mexico (2)
India
India(1)
Tailandia (1) Corporate Delegations (6)
Brasil
Manufacturing Subsidiaries (69)
Brasil (6)
Sudáfrica (1)
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5. MONDRAGON New Business Development Centre
Respond to the challenge of generating employment, preferably of
a co-operative nature, in our community with the need seen to
strengthen, amongst other things, our commitment to development
which necessarily means Innovation and New Business
Development.
“Job creation, preferably of a cooperative nature
Corporate
and in line with the ongoing development of our
Challenge:
community”
Instrument NEW BUSINESS DEVELOPMENT CENTRE
5

6. MONDRAGON New Business Development Centre
New Business
Development
Centre
Mondragon Mondragon
Energy Health
6

7. MONDRAGON Health – Current Projects
Telemedicine
Elderly Care
ICT
Services
Profesional
Multimedia Health
MONDRAGON Training
Health
Automation / Integral
Robotics Solutions
Clinical
Distribution
Diagnosis
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8. Point-of-Care Testing (POCT)
Definition
Main goal
Advantages & Disadvantages
Types of POCT’s
Where can we find POCT’s?

9. Point-of-care testing definition
The College of American Pathologists (CAP) defines point-of-care testing (POCT) as
testing that does not require dedicated, permanent equipment space. That is, tests
are performed with devices brought to the bedside or other patient locations such as the
operating room (OR).
The Clinical Laboratory Improvement Amendment (CLIA) mirrors the CAP definition but
further limits the tests and devices to those where the results are used for clinical
decision-making.
(Dondelinger, R. – 2009)
POCT is also defined as “any test taken by or on behalf of the treating doctor on-
site at the time of consultation, which allows the test result to be used to make
immediate decisions about patient treatment”
(Laurence, C. et al. 2010)
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10. The goal of POCT’s and its main advantages
and disadvantages
Point-of-care testing was developed to generate quicker results. The goal of POCT is
GOAL
to provide the clinician with rapid results, which can improve patient outcomes and
quickly supply therapeutic interventions as compared to those results obtained from
MAIN
the core laboratory.
(Sautter, R and Lipford, E. – 2007)
• Generates quicker results • Quality loss
• There are easy to use devices • Overpriced tests
• Enhance patient-convenience • Non-qualified staff reading the results
• Eliminates specimen transportation • Multiplication of tests in order to avoid
• Contributes to rapid diagnosis possible errors
• Minimally invasive • Not appropriate for all testing
• Record of results
ADVANTAGES DISADVANTAGES
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11. Types of POCT’s
Microbiology
Biochemistry Haematology
Immunology
• Glucose Testing •Infectious Disease • Rapid Coagulation
• Blood Gas and •HIV Marker
Electrolytes •Anthrax • Haemoglobin Testing
• Rapid Cardiac Markers •C.difficile
• Drugs of Abuse •Dengue Fever
• Urine Strips •Malaria
• Pregnancy Test •Influenza
• Fecal Occult Blood •Streptococcus
• Cholesterol •Food Pathogens
• Infant Jaundice
• Rupture of Fetal
Membranes (ROM)
• Typhoid
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12. Where can we find POCT’s?
Home
Primary Care
Hospital
Disaster Areas
Pharmacies (Over the Counter)
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13. Home
Nowadays, the most commonly used are gloucometer and coagulometer
Significant growth is expected in the years coming
It is believe that other POCT devices such us those measuring
cholesterol, creatinine, and urea could be used at home for self-monitoring in chronic
patients
The trend at home would be to joint illness monitorization with analite test making
Attention process tend to simplification
Chronic illness monitorization
Analite in POCTs
diagnosed
 It would be important to be able to send the information read at home to the
electronic medical record of the patient
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14. Primary Care
Resistance to POCT expansion in primary care due to a loss of control feeling in
traditional disciplines
Nowadays, POCTs in primary care are not commonly used except for little use of
coagulometers, glucometers and infectious diseases (streptococcus group A, influenza...)
 The growth model would be general clinical analysis based on POCT devices that are
able to perform, in a simple way, the most basic information for a presumption diagnostic
 In Infectious Pathology specific kits would be developed for different etiologies such as
CMV, mononucleosis, rotavirus...
Future systems in medical management with an stronger weight in self-management
would boost the development POCT devices
It would be advantageous to use POCTs to have immediate access to data through
patient electronic medical records
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15. Hospital
CRITICAL CARE UNITS OPERATING ROOMS
Biochemistry, Haematology and Biochemistry, Haematology and
Infectious Diseases Coagulation
Patient monitoring Monitoring during operation
HOSPITAL’S CENTRAL LAB
Some POCTs would be used at
central labs if there is an small
number of tests to be done and if
they are in validation process
HOSPITALIZATION/SURGERIES
Biochemistry, Haematology and EMERGENCY ROOMS
Infectious Diseases Biochemistry, Haematology and
Analysis usually sent to central Infectious Diseases
laboratories Diagnostic acute illness
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16. Disaster areas
Use of POCT in disaster and emergency situations will efficiently facilitate rapid evidence-
based diagnosis at the site of patient care
POCTs are very easy to use and don’t require a previous installation
They are very easy to maintain
Easy to use devices perfect to be used also by nurses
A variety of tests are currently available for POCT in hospitals, but the spectrum of POC tests
for emergency and disaster care must be broadened
In disaster areas a diagnostic with a minimum of security requires a radiologic test as well as
biochemical and hematologic. POCTs facilitate the last two.
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17. Pharmacies (Over the Counter)
It could be an extension of home usage but more occasional and subject to market
demand
 It allows people to remain anonymous in comparison with other types of assistance
Pharmacies are open 24/7 and are easy to access
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18. Market of POCT’s
POCTs revenues and worldwide distribution
Largest Companies and Segments of POCT
How do we see the market?

19. POCTs revenues and worldwide distribution
GLOBAL POCT REVENUES
(2005-2012)
YEAR REVENUES WORLDWIDE DISTRIBUTION OF POCT
($ BILLIONS)
(2008)
2005 4.96 SALES
SECTOR SHARE (%)
($ MILLIONS)
2006 5.50
Europe 3.254 49
2007 6.20
U.S.A. 2.363 36
2008 6.66
Japan 475 7
2009 7.15 China 194 3
2010 7.66 India 139 2
2011 8.23 ROW 234 3
2012 8.83 TOTAL 6.659 100
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Source: Biotechnology Associates

20. Largest Companies and Segments of POCT
WORLDWIDE POCT DIAGNOSTIC & RAPID
LARGEST POCT
TEST MARKET SEGMENTS (2007)
DIAGNOSTIC COMPANIES
SALES GROWTH PERCENTAGE
WORLDWIDE (2007) SEGMENT
($ MILLIONS) RATE(%) DE POCT (%)
COMPANY MARKET Blood Glucose Monitoring 1.425 4 23
SHARE(%)
Critical Care 929 <5 15
Roche 15 Rapid Cardiac Markers 496 15 8
Diagnostics
Infectious Disease 434 5-7 7
Inverness 8
Fecal Occult Blood 372 <5 6
Siemens 8 Cholesterol 310 >10 5
(Medical Coagulation 372 5-7 6
Solutions)
Urinalysis 248 <5 4
Abbott 6 HIV 186 <5 3
Diagnostics
Pregnancy Test 186 <5 3
Instrumentation 5 HbA1c 186 >10 3
Lab
Haemoglobin 124 5-7 2
Rapid Drugs of Abuse 62 <5 1
Other Miscellaneous Tests 866 >10 14
Source: Biotechnology Associates TOTAL 6.196 7 100
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21. How do we see the market?
The market of POCT devices seems to be very promising
Culturally people pursuit the idea of quickness
Technologically fast-growing market
POCTs are specially relevant within the private sector
One interesting market is going to be developing countries such as China, India or Brasil.
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22. What clinicians think of POCT’s?

23. Questionnaire outcomes I
1.) Do you use POCT devices at your hospital?
- Quickness of results
- Rapid diagnosis YES
- Reliability of results
- Easy to perform tests
2.) Main reasons of usage
- Generates quicker results
- There are easy to use devices
- Enhance patient-convenience
- Eliminates specimen transportation
- Contributes to rapid diagnosis
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24. Questionnaire outcomes II
3.) Where in your hospital do you use POCTs?
- Central Lab
- Operating Rooms
- Emergency Rooms
- Hospitalization
- Other
4.) What would you like to measure with a POCT device?
PCR, Procalcitonin, MRSA, Hemogram
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25. Questionnaire outcomes III
5.) Mark with and X the following POCT manufacturers that you know?
- Roche Diagnostics
- Inverness
- Siemens (Medical Solutions)
- Abbott Diagnostics
- Bayer Healthcare
- Other
6.) Do you think the use of POCTs would keep growing? If so, why?
- Useful to take rapid decisions
- Easy to use
- Cost-efficient devices YES
- Better quality through time
- Convenient
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26. Questionnaire outcomes IV
7.) In your opinion the use of POCT devices clashes with the analysis done in
central laboratories ?
- It complements central laboratories
- The use of central labs is still needed NO
- POCTs are for specific things
- Central Labs perform tests in more depth
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27. Trends & Forecasts

28. POCT’s trends & forecasts
• Increase awareness of personal health could boost over the counter sales
• More tests would be available as portable devices, to facilitate home use
• Loss of market control by central laboratories, mainly due to cost cuts in public sector
• Technical improvements would allow POCT devices to broad menu and process a greater
number of tests
• Greater relevance of nurses which could have an allied in POCT technology
It is believe that by 2012, nearly 50% of all clinical diagnostic testing will be done by
point of care devices.
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29. Conclusions

30. Conclusions
 Optimistic forecast for POCT market
 New technology developments
 Value of immediate results and easy to use devices
 According to professionals POCTs are useful and it would keep growing
 Central Lab doesn’t clash with POCT technology
 Use especially indicated for chronic patient monitoring
 POCTs should be able to communicate with patient’s electronic health records
 Clinicians should collaborate with POCT manufactures in order to request the
required parameters for them
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