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

2. What is Global Health? Developing World –Medical Equipment Landscape –Why Equipment Doesnt Work University-based Design –Whats Right –Whats Wrong –Whats Next Robert Malkins Developing World Healthcare Technology Laboratory at Duke

3. % Without safe water What is Global Health?

4. % Stunting

5. What is Global Health? % HIV Positive

6. What is Global Health? Life Expectancy

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

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

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

10. Medical Equipment Landscape Developing 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 Landscape Developing 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 Doesnt 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 Doesnt 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 Doesnt 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 Doesnt 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 Doesnt 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 Doesnt 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 Nurse MD PA CHW

18. University-Based Design Whats Right? Whats Wrong? Whats Next?

19. Whats Right? Students are Getting Involved Product is Reaching Patients

20. University-Based BME Trips UPennGlobal Biomedical Service Program U PennInternational Development Summer Institute RiceBeyond Traditional Borders VanderbiltVISAGE Northwestern Global Engagement Summer Institute Duke EWH Summer Institute U MichiganGlobal Course Connections U MichiganGlobal Intercultural Experience for Undergraduates > 100 US students per year traveling to resource poor settings focusing on medical equipment

21. Engineering World Health Summer 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 Health Screening (BP, temperature, weight, etc) Shadowing physicians Community Health Design for the disabled www.gpsa.us

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

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

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

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

27. Pratt Pouch 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 2 mos 0 mos Duke Pouch 12 mos NVP Duke Pouch 12 mos AZT Namibia Tanzania IntraHealth EGPAF [1] WHO (2006) 'Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants in resource-limited settings: towards universal access

28. Whats 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 (~1000s) 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] Veterans 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] Dambisa Moyo: 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 DIvoire (beds, exam and OR tables) –Tanzania (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. Whats Next?

39. Capacity Building Manufacturing Partnerships El Progresso, Honduras

40. Training BMETs: BTA [1] For Primary School Graduates: 1) BTA curriculum 2) Business 3) Guild Not BME, BMET, EE etc. [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 Curriculum www.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. Thank you dhtlab.pratt.duke.edu www.ewh.org www.gpsa.org Robert Malkins Developing World Healthcare Technology Laboratory at Duke