POCkeT: Reducing Cervical Cancer in Peru through GVC analysis
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This document discusses efforts to reduce cervical cancer in Peru through analyzing the global value chain of a point-of-care colposcope called POCkeT. Field interviews were conducted with public and private sector organizations in Lima, Peru to understand how POCkeT could fit within existing healthcare infrastructure and clinical workflows. The interviews revealed opportunities to leverage telemedicine, train midwives on POCkeT usage, clarify midwife and patient roles, and improve coordination between organizations. Mapping the POCkeT value chain showed its traditional focus on manufacturing and sales. However, the ultimate goal is solving the problem of cervical cancer, requiring a holistic GVC analysis of all actors and factors involved in prevention, screening and treatment.
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POCkeT: Reducing Cervical Cancer in Peru through GVC analysis
- 1. POCkeT: Reducing Cervical Cancer in Peru through GVC analysis March 27, 2017
- 2. Global Mortality Rates of Cervical Cancer 2 1 1GLOBOCAN 2012 (IARC) , Section of Cancer Surveillance; 2WHO. 2013; 3Crow. Nature, 2012; 4Arbyn. Annals of Oncology, 2011 5 del Carmen, Gyn Onc 2015 Age Standardized Mortality Rate per 100,000 1
- 3. 3 Tsu, et al. Bull World Health Organ 2013 Burden is “high, growing and inequitable” • 528,000 new cases reported annually • 266,000 women die annually1 • Disproportionate Burden in Low & Middle-Income Countries (LMIC) (85%)2-4 • LMICS only have 5% of global health resources • Women in developing countries are twice as likely to die form cervical cancer than in the US
- 4. Cervical Cancer Incidence in Developed Countries has fallen dramatically since 1975
- 5. Reduction in Mortality attributed to early Screening and Diagnosis Screening:1,2 Pap Smear & HPV Diagnosis:1,2 Colposcopy & Biopsy Therapy:1,2 LEEP / Cryo-Therapy 50-75% of women in LMIC are lost to follow-up after cervical cancer screening 3,4 A profound need to have “see and treat” paradigm! 1 Saslow, Can Cancer J Clin 2012; 2 Cronje, Int. J of Gyn & Ob 2004 3 Musa, Inf. Agents & Cancer 2016; 4 Ezechi, BMC Health Serv Res 2014.
- 6. See and Treat Paradigm 11 WHO 2013; 12 ASCCP 2012; 13 Sankaranyanan Best Pract. & Res Clin Ob Gyn 2012. 6 Limitations of VIA 13 - Subjective - High False + Rate - Over-treatment
- 7. Visual Inspection Test • Visual inspection with acetic acid (VIA) • Can be done with the naked eye or low magnification • Microscope • Digital camera • Magnifying glass • Vaginal speculum exam where the health care provider applies acetic acid to identity color change on the cervix • To determine whether the test result is positive or negative for possible precancerous lesions or cancer 7
- 8. Leisegang Optik 2 Multiple Mags.: 3.75, 7.5, and 15 X US$ 20,000 and >150 lbs Not Portable, depends on AC source Canon SX50HS Digital Camera Single Mag.: 2.5-2.75 X US$ 500 and ~1.5 lbs External light source, Stand for stability Digital Cervicography Digital Colposcopy Technologies used for VIA
- 9. Majengo primary health center clinic, Moshi, Tanzania The Reality Clinical 66, Kenyatta National Hospital, Nairobi, Kenya Limited access to Referral Centers Health provider Shortage
- 10. POCkeT (Point-Of-Care Tampon) Colposcope 10 C Lam et al., Plos One, 2015
- 11. Medical Device Global Value Chain 1111 Components Manufacturing Plastics Extrusion & Molding Precision Metal Works Electronics/Electric al Components Software Development Weaving/Knittin g Textiles Assembly Packaging Sterilization Assembly Wholesale distributors Individual Patients Doctors & Nurses Hospitals (Public/Private) Cardiovascular Orthopedics Infusion Systems Others Marketing & Sales Resin Metals Chemicals Textiles Input Suppliers Disposables Surgical & Medical instruments Capital Medical Equipment Therapeutic Devices Final Products Distribution Market Segments Post-Sales Services Consulting Maintenance, Repair Training Adopter Research & Product Development Regulatory Approval Process Development Sustaining Engineering Prototype Process Development
- 12. 12 Components Manufacturing Casing Camera and Lighting Electrical Components Software Development Applicator Assembly Packaging Sterilization Assembly Wholesale distributors Doctors & Nurses Hospitals (Public/Private) MOH/Gov Formal Health Providers NGOS Patients/End- Users Marketing & Sales Post-Sales Services Consulting Maintenance, Repair Training Buyers Research & Product Development Regulatory Approval Process Development Sustaining Engineering Prototype Colposcope Value Chain 12 Supporting activities and institutions Infrastructure Monitoring and Performance Metrics Financing International Regulation & PolicyDomestic Regulation & Policy Awareness Procurement Feedback / Design Iteration Quality Control
- 13. POCkeT Team in Lima: GVC Interviews
- 14. Field Interviews PUBLIC SECTOR - La Liga Clinic - Pathfinder - Pontifica Universidad Catolica Peru PRIVATE SECTOR - Roche Pharmaceuticals - Medical Start- Ups GOVERNMENT - Ministry of Health - City of Lima - Public Hospitals
- 15. • Women’s cancer clinic with 26 locations in Lima • 5 mobile vans • Partner clinic running 200 patient clinical trial • Failure of preventative measures being taken (HPV Vaccine) • Dr. Venegas supports training midwives to use POCkeT • Full gold standard care provided alongside POCkeT La Liga Contra el Cancer
- 17. La Liga 17
- 18. 18
- 19. 19
- 20. Solidaridad 20
- 21. Leverage Points 1) Tele-connectivity/ Technology 2) Training on use of POCkeT and how it fits in with other trainings (e.g., if a midwife is already trained on outreach to potential patients). 3) Midwives on better understanding their role 4) Patients on end user issues, barriers and goals 5) Collaboration and coordination between various actors country strategy (e.g., who is and isn’t talking to each other and who needs to be included in the conversation for a national structure) 21
- 22. So what does this mean for our old GVC map?
- 23. 23 Components Manufacturing Casing Camera and Lighting Electrical Components Software Development Applicator Assembly Packaging Sterilization Assembly Wholesale distributors Doctors & Nurses Hospitals (Public/Private) MOH/Gov Formal Health Providers NGOS Patients/End- Users Marketing & Sales Post-Sales Services Consulting Maintenance, Repair Training Buyers Research & Product Development Regulatory Approval Process Development Sustaining Engineering Prototype Colposcope Value Chain 23 Supporting activities and institutions Infrastructure Monitoring and Performance Metrics Financing International Regulation & PolicyDomestic Regulation & Policy Awareness Procurement Feedback / Design Iteration Quality Control
- 24. Are we still focusing on scaling the amount of colposcopes that get sold? Do we still care about who manufactures the device?
- 25. The questions evolves: How are we actually trying to create value?
- 26. 1) We built a GVC to map the product, of the POCkeT colposcope. 2) In reality, we’re doing GVC analysis to solve the problem of cervical cancer.
- 27. Key Takeaways - GVCs are an incredibly flexible tool that can be applied beyond the traditional scope of a physical product or service. - The power of GVCs lies in the holistic approach towards factoring in third party actors (ex: government agencies, technological infrastructure, dynamics between doctors and midwives). - Reflect: Taking GVCs in a business classroom context and applying it to a social context.
Notas del editor
- We will go over the biology of cervical cancer, public health aspects, and the POCkeT Colposcope
- US 13,000 new cases and 7,000 deaths 445,000 new cases and 230,000 deaths 85% Burden is in LMIC Tanzania: (in 2014) 4216 deaths due to cervical cancer annually and 7,304 newly diagnosed (see http://www.hpvcentre.net/statistics/reports/TZA.pdf) Total women at risk population 13.7 million in Tanzania US: (in 2011) 4092 deaths due to cervical cancer annually and 12,109 newly diagnosed (see http://www.cdc.gov/cancer/cervical/statistics/) Total women at risk population 44.2 million in the US. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0020109
- This disproportionate burden is a function primarily of discrepancies in the availability of effective screening and treatment methods. This lack of access to adequate care is well-illustrated when we look at ratios of mortalities to new cases between developed and developing countries. In the US, this ratio is 0.27 while in developing countries it rises to 0.53 and climbs even further to 0.67 in sub-Saharan Africa. Developing an effective treatment method appropriate for resource-limited settings could stem this growing disparity. http://globocan.iarc.fr/old/FactSheets/cancers/cervix-new.asp Tsu, V.D., J. Jeronimo, and B.O. Anderson, Why the time is right to tackle breast and cervical cancer in low-resource settings. Bull World Health Organ, 2013. 91(9): p. 683-90. The GLOBOCAN project, which presents epidemiologic data on all forms of cancer as provided by the International Agency for Research on Cancer in Lyon, France, classifies North America, Europe, Australia/New Zealand and Japan as “more developed” and the rest of the world as “less developed” This is purely due to population changes, assuming no change in per capita rates for specific regions.
- The good news is since that time the incidence of cervical cancer has declined dramatically due to the advent of well established screening and diagnostic programs, particularly in high income countries.
- Loop electrosurgical procedure Also the implementation of cytology in resource poor settings has often been accompanied by low compliance of screening high risk group, use of a too low a threshold for colposcopy, need for repeated visits, and general over treatment of non-malignant disease[14]. The concern with VIA as a primary screening tool is the poor sensitivity and resultant overtreatment of healthy women despite the general recommendation for its implementation in low resource settings [49]. Studies on VIA have indicated very large inter-observer variability that would be indicative of a need for improving training due to the subjective nature of the test[14]. However, there are no mandated standardized teaching or training programs in low-resource settings[50]. For example, an intensive 5 day education program for VIA was implemented on a cohort of healthcare workers from Uganda and El Salvador and pre-test accuracy was 57% and post-training markedly improved to 80% with sustained retention at 6 months post training[51]. Barriers for widespread implementation of VIA include lack of funds for training[49], staff shortages prevent in-service training[49], “brain drain” loss of skilled workers to other countries, leading to a shortage of nearly 1,000,000 skilled health care works in 2006 [52]and in some cases lack of required equipment[52].
- American Society for Colposcopy and Cervical Pathology & World Health Organization, recommend visual inspection with acetic acid followed by cryotherapy if + and eligible (visible lesion / transformation zone). If lesions is too deep then must have LEEP (loop electrosurgical excision procedure). If too late, cancer chemo therapy/ but often in resource settings palliative care only.
- Goal: Our goal is to bring benefits of colposcopy to the point of care VIA no magnification no image capture Leads to poor quality control Requires training VIAM/Colposcopy Costly Not portable Requires extensive training Cervicography External light source required Stabilization is problematic
- Unfortunately, challenges in scaling screening still remain.
- An exploded schematic view of the transvaginal digital colposcope with essential components, (1) linear film polarizer (to get rid of specular reflection), (2) concentric 3W (max electrical power) white 5000Kelvin (color temp) and 3W green LED ring (3) Mount for polarizer and LED (4) the hydrophobic optical window with antireflection coating (prevent fogging and allows more light), (5) linear glass polarizer (for imager/CMOS dectector), (6) color CMOS digital camera, (7) and (8) ABS medical grade shell.