Could POCT's be a Business Opportunity?


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Could POCT's be a Business Opportunity?

  1. 1. Could POCT’s be a businessopportunity?Presented by Inma UzkudunMadrid, 30th of April 2010
  2. 2. INDEXMONDRAGON HealthPoint-of-Care Testing (POCT)Market of POCT’sWhat clinicians think of POCT’s?Trends & ForecastsConclusions
  3. 3. MONDRAGON HealthMONDRAGON CORPORATIONNew Business Development CentreMONDRAGON Health
  4. 4. MONDRAGON Corporation MONDRAGON INDUSTRY AREA In millions of Euros (2008) Industrial Automation DivisionFinance Area (Caja Laboral Automotive DivisionCustomers Credits): 13,988 Bodywork and Supplies Division Components DivisionIndustry Area: 6,511 Construction Division FINANCE Vertical Transport DivisionDistribution 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) 4
  5. 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. 6. MONDRAGON New Business Development Centre New Business Development Centre Mondragon Mondragon Energy Health 6
  7. 7. MONDRAGON Health – Current Projects Telemedicine Elderly Care ICT Services Profesional Multimedia Health MONDRAGON Training Health Automation / Integral Robotics Solutions Clinical Distribution Diagnosis 7
  8. 8. Point-of-Care Testing (POCT)DefinitionMain goalAdvantages & DisadvantagesTypes of POCT’sWhere can we find POCT’s?
  9. 9. Point-of-care testing definitionThe College of American Pathologists (CAP) defines point-of-care testing (POCT) astesting that does not require dedicated, permanent equipment space. That is, testsare performed with devices brought to the bedside or other patient locations such as theoperating room (OR).The Clinical Laboratory Improvement Amendment (CLIA) mirrors the CAP definition butfurther limits the tests and devices to those where the results are used for clinicaldecision-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) 9
  10. 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 resultsADVANTAGES DISADVANTAGES 10
  11. 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 11
  12. 12. Where can we find POCT’s? Home Primary Care Hospital Disaster Areas Pharmacies (Over the Counter) 12
  13. 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 measuringcholesterol, creatinine, and urea could be used at home for self-monitoring in chronicpatients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 theelectronic medical record of the patient 13
  14. 14. Primary CareResistance to POCT expansion in primary care due to a loss of control feeling intraditional disciplinesNowadays, POCTs in primary care are not commonly used except for little use ofcoagulometers, glucometers and infectious diseases (streptococcus group A, influenza...) The growth model would be general clinical analysis based on POCT devices that areable 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 asCMV, mononucleosis, rotavirus...Future systems in medical management with an stronger weight in self-managementwould boost the development POCT devicesIt would be advantageous to use POCTs to have immediate access to data throughpatient electronic medical records 14
  15. 15. Hospital CRITICAL CARE UNITS OPERATING ROOMSBiochemistry, 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 processHOSPITALIZATION/SURGERIESBiochemistry, Haematology and EMERGENCY ROOMS Infectious Diseases Biochemistry, Haematology andAnalysis usually sent to central Infectious Diseases laboratories Diagnostic acute illness 15
  16. 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 testsfor emergency and disaster care must be broadenedIn disaster areas a diagnostic with a minimum of security requires a radiologic test as well asbiochemical and hematologic. POCTs facilitate the last two. 16
  17. 17. Pharmacies (Over the Counter)It could be an extension of home usage but more occasional and subject to marketdemand It allows people to remain anonymous in comparison with other types of assistancePharmacies are open 24/7 and are easy to access 17
  18. 18. Market of POCT’sPOCTs revenues and worldwide distributionLargest Companies and Segments of POCTHow do we see the market?
  19. 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 19Source: Biotechnology Associates
  20. 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 15Roche 15 Rapid Cardiac Markers 496 15 8Diagnostics Infectious Disease 434 5-7 7Inverness 8 Fecal Occult Blood 372 <5 6Siemens 8 Cholesterol 310 >10 5(Medical Coagulation 372 5-7 6Solutions) Urinalysis 248 <5 4Abbott 6 HIV 186 <5 3Diagnostics Pregnancy Test 186 <5 3Instrumentation 5 HbA1c 186 >10 3Lab 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 20
  21. 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. 21
  22. 22. What clinicians think of POCT’s?
  23. 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 23
  24. 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 24
  25. 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 25
  26. 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 26
  27. 27. Trends & Forecasts
  28. 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. 28
  29. 29. Conclusions
  30. 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 therequired parameters for them 30