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Could POCT’s be a business opportunity?
Presented by Inma Uzkudun
Madrid, 30th of April 2010
0MONDRAGON Health
Point-of-Care Testing (POCT)
Market of POCT’s
What clinicians think of POCT’s?
Trends & Forecasts
Conclusions
INDEX
1MONDRAGON Health
MONDRAGON CORPORATION
New Business Development Centre
MONDRAGON Health
4
MONDRAGON Corporation
In millions of Euros (2008)
Finance Area (Caja Laboral
Customers Credits): 13,988
Industry Area: 6,511
Distribution Area: 9,073
Personnel (2008)
Total Employment: 92,773
Employment Abroad: 14,938
Alemania (3)
Rep. Checa (7)
Tailandia (1)
India
Marruecos(2)
Francia (5)
Brasil (6)
Brasil
Mexico (7)
Mexico
Polonia (7)
China
China (9)
U.S.A.
U.K.(3)
India(1)
Italia(4)
Rumania (2)
Rusia
Turquía(2)
Sudáfrica (1)
Eslovaquia (2)U.S.A.(1)Portugal(2)
FINANCEAREA
INDUSTRY AREA
Industrial Automation Division
Automotive Division
Bodywork and Supplies Division
Components Division
División Equipamiento
Household Division
Engineering & Services Division
MONDRAGON
Tooling & Systems Division
Vertical Transport Division
Machine Tools Division
Industrial Systems Division
Knowledge Area
Construction Division
New Business Development Centre
Manufacturing Subsidiaries (69)
Corporate Delegations (6)
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.
NEW BUSINESS DEVELOPMENT CENTREInstrument
“Job creation, preferably of a cooperative nature and in line with the ongoing development of our community”
Corporate Challenge:
6
MONDRAGON New Business Development Centre
New Business Development
Centre
MondragonEnergy
Mondragon Health
Strategic Areas
7
MONDRAGON Health – Current Projects
MONDRAGON Health
Telemedicine
ICT
Profesional Health Training
Integral Solutions
Clinical DiagnosisDistribution
Automation / Robotics
Multimedia
Elderly Care Services
2Point-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)
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 to provide the clinician with rapid results, which can improve patient outcomes and quickly supply therapeutic interventions as compared to those results obtained from the core laboratory.(Sautter, R and Lipford, E. – 2007)
• Generates quicker results• There are easy to use devices• Enhance patient-convenience • Eliminates specimen transportation• Contributes to rapid diagnosis• Minimally invasive
ADVANTAGES
• Quality loss• Overpriced tests• Non-qualified staff reading the results• Multiplication of tests in order to avoid
possible errors• Not appropriate for all testing • Record of results
DISADVANTAGES
MA
IN
GO
AL
11
Types of POCT’s
Biochemistry
• Glucose Testing• Blood Gas and
Electrolytes • Rapid Cardiac Markers• Drugs of Abuse• Urine Strips• Pregnancy Test• Fecal Occult Blood• Cholesterol• Infant Jaundice• Rupture of Fetal
Membranes (ROM)• Typhoid
MicrobiologyImmunology
•Infectious Disease•HIV•Anthrax•C.difficile•Dengue Fever•Malaria•Influenza•Streptococcus
•Food Pathogens
Haematology
• Rapid Coagulation Marker
• Haemoglobin Testing
12
Where can we find POCT’s?
Home
Primary Care
Hospital
Disaster Areas
Pharmacies (Over the Counter)
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
It would be important to be able to send the information read at home to the electronic medical record of the patient
Chronic illness diagnosed Analite in POCTs
monitorization
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
15
Hospital
CRITICAL CARE UNITSBiochemistry, Haematology and
Infectious DiseasesPatient monitoring
OPERATING ROOMSBiochemistry, Haematology and
Coagulation Monitoring during operation
HOSPITALIZATION/SURGERIESBiochemistry, Haematology and
Infectious DiseasesAnalysis usually sent to central
laboratories
EMERGENCY ROOMSBiochemistry, Haematology and
Infectious DiseasesDiagnostic acute illness
HOSPITAL’S CENTRAL LABSome 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
ICT Integration
ICT Integration
ICT
integration
ICT
integration
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.
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
3Market 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 ($ BILLIONS)
2005 4.96
2006 5.50
2007 6.20
2008 6.66
2009 7.15
2010 7.66
2011 8.23
2012 8.83
WORLDWIDE DISTRIBUTION OF POCT (2008)
SECTOR SALES($ MILLIONS) SHARE (%)
Europe 3.254 49
U.S.A. 2.363 36
Japan 475 7
China 194 3
India 139 2
ROW 234 3
TOTAL 6.659 100
Source: Biotechnology Associates
20
Largest Companies and Segments of POCT
LARGEST POCT DIAGNOSTIC COMPANIES
WORLDWIDE (2007)
COMPANY MARKET SHARE(%)
Roche Diagnostics
15
Inverness 8
Siemens (Medical Solutions)
8
Abbott Diagnostics
6
Instrumentation Lab
5
Source: Biotechnology Associates
WORLDWIDE POCT DIAGNOSTIC & RAPID TEST MARKET SEGMENTS (2007)
SEGMENT SALES($ MILLIONS)
GROWTH RATE(%)
PERCENTAGE DE POCT (%)
Blood Glucose Monitoring 1.425 4 23
Critical Care 929 <5 15
Rapid Cardiac Markers 496 15 8
Infectious Disease 434 5-7 7
Fecal Occult Blood 372 <5 6
Cholesterol 310 >10 5
Coagulation 372 5-7 6
Urinalysis 248 <5 4
HIV 186 <5 3
Pregnancy Test 186 <5 3
HbA1c 186 >10 3
Haemoglobin 124 5-7 2
Rapid Drugs of Abuse 62 <5 1
Other Miscellaneous Tests 866 >10 14
TOTAL 6.196 7 100
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.
4What clinicians think of POCT’s?
23
Questionnaire outcomes I
1.) Do you use POCT devices at your hospital?- Quickness of results - Rapid diagnosis- Reliability of results- Easy to perform tests
YES
2.) Main reasons of usage- Generates quicker results- There are easy to use devices- Enhance patient-convenience - Eliminates specimen transportation- Contributes to rapid diagnosis
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
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- Better quality through time - Convenient
YES
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 - POCTs are for specific things - Central Labs perform tests in more depth
NO
5Trends & 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.
6Conclusions
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
Thank you!