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Robert Malkin, PhD, PE Professor of the Practice, Biomedical Engineering Director, DHT-Lab

Robert Malkin’s Developing World Healthcare Technology Laboratory at Duke. University-Based Design of Developing World Healthcare Technologies: What’s Wrong, What’s Right, What’s Next?. Robert Malkin, PhD, PE Professor of the Practice, Biomedical Engineering Director, DHT-Lab

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Robert Malkin, PhD, PE Professor of the Practice, Biomedical Engineering Director, DHT-Lab

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  1. Robert Malkin’sDeveloping World Healthcare Technology Laboratoryat Duke University-Based Design of Developing World Healthcare Technologies:What’s Wrong, What’s Right, What’s Next? Robert Malkin, PhD, PE Professor of the Practice, Biomedical Engineering Director, DHT-Lab Director, Duke-EWH Summer Institute Director, Global Public Service Academies

  2. Robert Malkin’sDeveloping World Healthcare Technology Laboratoryat Duke • What is Global Health? • Developing World • Medical Equipment Landscape • Why Equipment Doesn’t Work • University-based Design • What’s Right • What’s Wrong • What’s Next

  3. What is Global Health? % Without safe water

  4. What is Global Health? % Stunting

  5. What is Global Health? % HIV Positive

  6. What is Global Health? Life Expectancy

  7. Medium Human Development High Human Development (most, first) What is Global Health? Low Human Development (least, third) UN Human Development Index

  8. Why should you care? Buffet and Gates have put in … • US$60 billion

  9. Why should you care? • GE Knows this too! Reverse Innovation

  10. Medical Equipment LandscapeDeveloping World • Director General of WHO about medical equipment in the developing world*: • “About 70% … does not function” • “only 10% to 30% of donated equipment … ever becomes operational” • Speech at September 9, 2010 Medical Device meeting in Bangkok • Citing among others: • Malkin, RA, Design of health care technologies for the Developing World Ann Rev Biomed Eng, 2007

  11. Medical Equipment LandscapeDeveloping World • 112,000 pieces, 16 developing countries [1] • 38.3% (42,925 pieces) out of service • Range: 1% (Costa Rica) to 47% (Venezuela) • Highest: X-ray (48%) and Sterilizers (43%) • 95.8% imported • Wheelchairs, lighting devices locally produced [1] Perry, L, Malkin, RA, How much equipment is broken?, accepted and in print MBEC

  12. Why Current Equipment Doesn’t Work • Most common hypotheses are: • Capital Cost (one-time cost) • Infrastructure • electricity, water … • Spare Parts (cost and availability) • Too complicated • training • Consumables (recurring cost)

  13. Why It Doesn’t Work • Capital Cost – No evidence [1] • Interviewed 54 hospitals, 16 Countries • Most common complaint: TOO MUCH equipment • Large pieces with govt investment • Significant donation stream [2] • 90% donate expired supplies • 60% admit donating broken equipment • 8% donate through non-BME MSRO [1] Malkin, RA, Design of health care technologies for the Developing World Ann Rev, 2007 [2] CHA Medical Surplus Donation Study, April 2011

  14. Why It Doesn’t Work • Infrastructure – Limited [1] • Electricity limited • Gasses • Not water [1] Malkin, RA, Design of health care technologies for the Developing World Ann Rev, 2007

  15. Why It Doesn’t Work • Spare Parts – Partial Evidence [1], [2] • Retrospective • 2849 Work Tickets [1] • 11 countries, 60 hospitals • 66% without importing spare parts, <$50 • Prospective • 106 work tickets Rwanda [2] • 68.9% without importing spare parts, <$50 • Too complicated – No Evidence [1] • 25% Training, >400 documented • No training failures [1] Malkin, Keane, Evidence-based approach to the maintenance of laboratory and medical equipment in resource-poor settings MBEC, 2010 v48, 721-726 [2] Finley, Malkin, BMET in Rwanda, Internal DHTLab Report, 2011

  16. Why It Doesn’t Work • Consumables- YES – sort of • 42,925 out of services pieces [1] • Top three non-personnel reasons • Consumables, accessories, spare parts • Interview in 54 hospitals in 16 hospitals [2] • 133 interviews (50% MD: rest nurse, staff, BMET) • 0 cited consumables [1] Perry, Malkin, MBEC 2011 [2] Malkin, Annals of BME, 2007

  17. Why Medical Equipment in the Developing World Doesn’t Work • Design Constraints: • Spare Parts – Partial: 30-35% • Too complicated – No evidence • Caveat: Training ~= task shifting • Infrastructure (Electricity, gas …) • Capital Cost – No evidence • Consumables – YES – sort of • Caveat: Iceburg PA MD Nurse CHW

  18. University-Based Design • What’s Right? • What’s Wrong? • What’s Next?

  19. What’s Right? • Students are Getting Involved • Product is Reaching Patients

  20. University-Based BME Trips • UPenn Global Biomedical Service Program • U Penn International Development Summer Institute • Rice Beyond Traditional Borders • Vanderbilt VISAGE • Northwestern Global Engagement Summer Institute • Duke EWH Summer Institute • U Michigan Global Course Connections • U Michigan Global Intercultural Experience for Undergraduates > 100 US students per year traveling to resource poor settings focusing on medical equipment

  21. Engineering World HealthSummer Institute ~50 Participants in 2012 1 Month Training in Costa Rica/Tanzania 1 Month in a poor Hospital Nicaragua, Honduras, Tanzania

  22. Students Making a Difference www.gpsa.us • Health Screening (BP, temperature, weight, etc) • Shadowing physicians • Community Health • Design for the disabled

  23. High School in Nashville Summer Camp in Durham LA Tech Science Club In Memphis High School, Middle School, Clubs, EWH Chapters and individuals purchase parts and build equipment Kits Available www.ewh.org

  24. ESU, ECG, Defib Tester • O2 Tester, ECG pads • >$1 Million (replacement value) Nicaragua El Salvador Sudan Philippines Tanzania

  25. www.photogenesismedical.com ~35,000 children: infant jaundice

  26. Cerviscope www.familyhm.org Cervical Cancer Screening Colposcope 100’s devices in dozens of countries Moving to injection molding in 2012

  27. HIV+ Women who give birth at home • 20-50% have HIV+ children [1] • Majority transmitted during delivery [1] • NVP can prevent transmission • Drug expires quickly once out of the bottle Pratt Pouch [1] WHO (2006) 'Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants in resource-limited settings: towards universal access’ Duke Pouch 12 mos NVP Duke Pouch 12 mos AZT Namibia Tanzania IntraHealth EGPAF 2 mos 0mos

  28. What’s Wrong? • Product Success Rate is Terrible! • But why?

  29. Low Success Rate • Top Neonatal University-based Designs: • Apnea Alert - Northwestern • Photogenesis – Duke (Malkin) • Brilliance - Stanford • InfantAir - Rice University • Prevent Fetal Death: Prevention - Stanford • Neo Nurture - MIT • Embrace - MIT 0 of 7 has an African distributor contract 0 of 7 has reached 1M treated 7 of 7 have won design competitions

  30. Success Rate Comparison • My Industrial Experience • Cordis (now St. Jude Medical) – 2 for 2 • Sarns (now 3M Sarns) – 1 for 1 • EM Microelectronics – 1 for 5 (I quit) • University-based design • US Universities charge $: • some achieve >90% deliver • BME – interviewed some colleagues • Some achieve >30% deliver

  31. But Why?A Few Untested Hypotheses • Rapidly Changing Field • Design Approach Wrong • Consensus • NGO Donation • Low Feature • Manufacturing Missing • Capital/Process • Distributors missing

  32. Rapidly Changing Field • Avg manufacturing cycle is 18 months [1] • Very small manufacturing runs (~1000’s) • Huge innovation volume • FDA approved • 260 medical devices/month (510k, 1/2011) • 72 new drugs/year (2009) • Life Expectancy of Medical Device • 5-8 years in US hospital [2] • Note: much longer in developing world [1] AdvaMed, Raalph Ives, WHO Second Meeting of Technical Advisory Group on Healthcare Technology, Rio de Janeiro, 2009 [2] Veteran’s Administration, Rob Campbell, BME at VAMC Ashville

  33. Design Approach: Consensus • 2003 WHO convenes BP committee • specify NIBP for resource poor settings • 2005 WHO committee releases specifications • 5 manufacturers entered discussions • 3 manufacturers submitted a device • 1 Manufacturer met specs • Omron HEM-SOLAR • only for systolic (not diastolic) • Dec 2010, first published data • Manufacturer will sell at a loss for 25 Euros each But, uniject …

  34. Design Approach: NGO/Donation Donating imported medical equipment • Design to be donated via NGO • Solves a non-problem – capital (buy-in) • Donation moves country backwards • Donate bed nets [1] • Local bed net manufacturer out of business • Donate scales, beds and lighting devices [2] • Top three locally manufactured devices • Large fraction of some donor/university portfolios [1] DambisaMoyo: Dead Aid [2] Perry, Malkin, MBEC 2011

  35. Design Approach: Low Features Lower cost by removing features • Solves a non-problem – capital (buy-in) • Customer Acceptance low • Most trained in US/UK • Double Standard - Rotavirus vaccine [1] • Rotashield and intussusception [1] Bines: 2006 Vaccine, e.g., Weijer, BMJ, 2000

  36. Manufacturing Missing • Survey Data from 8 companies (visited 3) • Cameroon (incubators) • Cameroon (sterile fluids) • Namibia (sterile fluids, distributor) • Nigeria (distributor) • Cote D’Ivoire (beds, exam and OR tables) • Tanzania (wheelchairs) • Tanzania (tables, lamps, wheelchairs) • Tanzania (tables, lamps, wheelchairs) Product line, challenges, processes

  37. Manufacturing Missing • No Capital to Expand Production • NO LACK of entrepreneurship • No African manufacturer reported access • Even to small amounts of capital • Three request for powder coat painting capital • TZ: Jafry, Palray: No stick welding • but >80% of line is welded Opportunity: Design for low production capital

  38. What’s Next?

  39. What’s Next? • Capacity Building • Manufacturing Partnerships El Progresso, Honduras

  40. Training BMET’s: BTA [1] Not BME, BMET, EE etc. For Primary School Graduates: 1) BTA curriculum 2) Business 3) Guild [1] Malkin, Keane, Malkin, Evidence-based approach to the maintenance of laboratory and medical equipment in resource-poor settings MBEC, 2010 v48, 721-726

  41. DHT-Lab BTA Curriculumwww.ewh.org Rwanda Handover 2013 Uganda Starting in 2015? Cambodia Started Honduras Handover 2013 Ghana Started Kenya Starting in 2015? Myanmar ???? Rwanda matched study: 35% reduction in out of service equipment 27% increase in resolved cases

  42. Manufacturing Partnerships • Historical role • University of Michigan/Car • Incremental improvements • STTR/SBIR funding model • Current products redesigned for • Low production capital • Low training • Low consumables • Low infrastructure • Local spare parts • Mirror Manufacturing • Mirror a local med device manufacturer

  43. Personnel at DHT-Lab • 5 full-time staff • Pegeen Ryan Murry, Robert Malkin • Alex Dahinten, Dane Emmerling • >5 part-time staff • Joy, Chelsea, Jessie, Judy • 2 summer faculty (2013) • Alex, Daria and many, many more • DHT-Lab Fellows +: • Caroline, Alexa, Bianca • Fuqua students?

  44. Robert Malkin’sDeveloping World Healthcare Technology Laboratoryat Duke Thank you dhtlab.pratt.duke.edu www.ewh.org www.gpsa.org

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