Dr. Manuel Trajtenberg


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Dr. Manuel Trajtenberg

  1. 1. Innovation in Medical Technologies: challenges and opportunities 06/22/11 Prof. Manuel Trajtenberg Chairman of the Planning and Budgeting Committee, The Israeli Council of Higher Education London, Ontario June 10, 2011
  2. 2. The wide reach of Medical Technologies <ul><li>Medical technology encompasses a wide range of, </li></ul><ul><ul><li>devices, equipment, biochemical agents, interventions, procedures, and organizational forms, </li></ul></ul><ul><ul><li>used to prevent, diagnose, monitor or treat human diseases, </li></ul></ul><ul><ul><li>promote health </li></ul></ul><ul><ul><li>perform medical research </li></ul></ul><ul><li>Examples: </li></ul><ul><ul><li>Procedures : angioplasty, joint replacements </li></ul></ul><ul><ul><li>Drugs : statins, Avastin (breast cancer), NRTI ( Nucleoside Reverse Transcriptase Inhibitors) for AIDS </li></ul></ul><ul><ul><li>Devices : CT scanners, stents, pacemakers </li></ul></ul><ul><ul><li>Support systems : electronic medical records, telemedicine </li></ul></ul><ul><ul><li>Research tools : Automated DNA-sequencing instruments </li></ul></ul>06/22/11
  3. 3. Innovation in medical technology: 1816- 2008 1816 Stethoscope 1942 1 st patient treated with penicillin 1818 successful blood transfusion 1943 1 st electron linear accelerator for radiation therapy 1842 Use anesthesia in surgery 1945 1st hemodialysis machine developed 1852 Hypodermic syringe 1948 Plastic contact lenses developed 1879 Vaccine for cholera 1953 1 st heart/lung bypass machine used in surgery on humans 1895 medical use of x-rays 1955 Ultrasound used on pregnant women, Polio vaccine 1899 First bottle of aspirin sold 1958 1 st cardiac pacemaker implanted 1901 ECG machine 1963 1964 1st oral polio vaccine 1st coronary bypass surgery 1922 Use of insulin for diabetes 1967 1st human to human heart transplant 1924 Vaccine for tetanus 1968 Amniocentecis for DownSyndrome 1928 Discovery of Penicillin 1972 CAT scan for brain invented
  4. 4. Innovation in medical technology: 1816- 2008 1816 Stethoscope 1942 1 st treatment w/ penicillin 1818 successful blood transfusion 1943 Radiation therapy 1842 Use anesthesia in surgery 1945 Hemodialysis machine 1852 Hypodermic syringe 1948 Plastic contact lenses 1879 Vaccine for cholera 1955 Ultrasound in pregnancy 1895 medical use of x-rays 1955 Polio vaccine 1899 First bottle of aspirin sold 1958 Cardiac pacemaker 1901 ECG machine 1963 1964 Oral polio vaccine Coronary bypass surgery 1922 Use of insulin for diabetes 1967 Heart transplant 1924 Vaccine for tetanus 1968 Amniocentesis for DS 1928 Discovery of Penicillin 1972 CAT scanner invented
  5. 5. History of medical technology, continued Selected milestones, 1816- 2008 1973 1975 First whole body CAT scan First PET image recorded 1977, 78 First image of MRI scanner; 1 st IVF “test tube” baby born 1982 First permanent artificial heart implant, 1 st biotechnology drug -Humulin 1985 Implantable cardioverter defibrillator 1987 First laser surgery on human cornea First SSRI, First antiretroviral ARV 1989 First proton-pump inhibitor 1992 Prostate specific antigen test 1995 Lasik eye surgery, 1 st protease inhibitor 2000 First robotic system for general laparoscopic surgery 2003 Drug eluting stent for dogged arteries 2004 64 Slice CT scanner approved 2006 First vaccine against cervical cancer 2008 Commercial hybrid PET/MRI scanner produced
  6. 6. Benefits from Innovation in Med Techs: cancer, coronary disease <ul><ul><li>Cancer: </li></ul></ul><ul><ul><ul><li>1988 – 2000: Life expectancy for cancer patients increased by 4 years . 80% of gains due to improvement in treatment. </li></ul></ul></ul><ul><ul><ul><li>1996-2006: mortality rate declined 13.4% , from 207 to 181 deaths/100,000 </li></ul></ul></ul><ul><ul><ul><li>27% of the decline due to drug innovation , 40% due to (lagged) imaging innovation . </li></ul></ul></ul><ul><ul><li>Coronary disease – 1980 - 2000: </li></ul></ul><ul><ul><ul><li>Mortality rate fell by half : from 543 to 267 deaths/100,000 for men, 263 to 134 deaths/100,000 for women </li></ul></ul></ul><ul><ul><ul><li>47% due to treatments , including use of aspirin, statins, angioplasty/stents, CABG, etc. </li></ul></ul></ul><ul><ul><ul><li>44% due to changes in risk factors , e.g. reductions in cholesterol , smoking, and physical inactivity, partially offset by increases in the BMI and diabetes </li></ul></ul></ul><ul><ul><ul><li>9% unexplained </li></ul></ul></ul>06/22/11
  7. 7. The Great Demographic Transition time Stage 2 Declining death rate but birth rates remain high Stage 3 Declining death and birth rates Stage 4 Low birth and death rates Stage 1 High birth & death rates fluctuating with prosperity Birth rate Death rate Population Population
  8. 8. World population growth through History 06/22/11
  9. 9. Economic growth: a very recent phenomenon 06/22/11 Source: Angus Maddison, The World Economy, a Millenial Perspective, OECD and World Bank shrunk scale 1500 years! World GDP: from year 0 to 2000 WWII The Industrial Revolution The Roman Empire
  10. 10. The golden triangle <ul><li>Economic </li></ul><ul><li>growth </li></ul>Population Growth Innovation in MedTech
  11. 11. Innovation in Med Techs: A changing landscape <ul><li>Major shifts in demand and supply factors affecting innovation in Med Techs, leading to: </li></ul><ul><ul><li>Different type of innovations: </li></ul></ul><ul><ul><ul><li>more price sensitive/cost effective techs </li></ul></ul></ul><ul><ul><ul><li>responsiveness to heterogeneous local needs/markets </li></ul></ul></ul><ul><ul><ul><li>system-wide solutions, not better features </li></ul></ul></ul><ul><ul><li>Changing nature of underlying S&T: </li></ul></ul><ul><ul><ul><li>Convergence of scientific disciplines </li></ul></ul></ul><ul><ul><ul><li>Unleashing the power of ICT (“Moore’s Law”) </li></ul></ul></ul><ul><ul><li>Shifting locus of innovation away from the USA? </li></ul></ul>06/22/11
  12. 12. Innovation in Med Tech: the demand side <ul><li>The demand for innovative Med Techs depends upon: </li></ul><ul><ul><li>The volume of demand for HC, influenced by: </li></ul></ul><ul><ul><ul><li>Income per capita - high demand elasticity </li></ul></ul></ul><ul><ul><ul><li>The HC system – type of providers, reimbursement </li></ul></ul></ul><ul><ul><ul><li>Fiscal policy – government expenditures on HC , deficits </li></ul></ul></ul><ul><ul><ul><li>Demographics – aging, dependency ratio </li></ul></ul></ul><ul><ul><li>The identity of decision makers ( providers, doctors, patients, government agencies) impacts , </li></ul></ul><ul><ul><ul><li>Price sensitivity of demand for new MedTechs </li></ul></ul></ul><ul><ul><ul><li>What kind of innovations are favored – e.g. features versus solutions </li></ul></ul></ul>06/22/11
  13. 13. The demand side – zooming-in (i) <ul><li>Expenditures on HC in the US far outstripped other countries, hence has been main determinant of demand for HC innovation for decades, BUT… </li></ul><ul><ul><li>Not sustainable – fiscal limits (see recent reforms, budget deficits) </li></ul></ul><ul><ul><li>As developing nations catch up and their GDP rises, their demand for Health Care (HC) increases even faster </li></ul></ul><ul><li>Total world demand for HC and hence for Med Tech innovation increasing, </li></ul><ul><li>Shifting center of gravity of demand away from US </li></ul>06/22/11
  14. 14. Expenditures on Health Care as % of GDP 06/22/11 USA
  15. 15. The demand side – zooming-in (ii) <ul><li>Changing nature of demand for Med Tech innovation: emerging economies (China, India, Brazil, etc.) versus the USA-Europe: </li></ul><ul><ul><li>More price sensitivity of decision makers; affordability as key; avoidance of capital intensive Med Techs </li></ul></ul><ul><ul><li>More infectious diseases </li></ul></ul><ul><ul><li>Demographics: lesser prevalence of aging </li></ul></ul><ul><ul><li>Lesser availability of medical infrastructure: emphasis on simplicity of operation , low maintenance </li></ul></ul><ul><ul><li>Case in point: GE in Bangalore, India – mini ultrasound, single-slice CT, etc. </li></ul></ul>06/22/11
  16. 16. Innovation in Med Tech: the supply side <ul><li>The supply of innovative Med Techs depends upon: </li></ul><ul><ul><ul><li>Public and Private Investment in R&D </li></ul></ul></ul><ul><ul><ul><li>Technological and Scientific (S&T) Opportunities </li></ul></ul></ul><ul><ul><ul><li>Availability of S&T human capital </li></ul></ul></ul><ul><ul><ul><ul><li>Quality of Universities, motivation of scientists </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Composition of labor force, immigration policies </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Entrepreneurship </li></ul></ul></ul></ul><ul><ul><ul><li>The regulatory environment </li></ul></ul></ul>06/22/11
  17. 17. the supply side: public investment in R&D <ul><li>Government direct support of basic research: major driving force since WWII (see Vannebar Bush “Science the endless frontier”) </li></ul><ul><li>Fiscal incentives for Med Tech innovation: tax credits for R&D and for adoption of medical techs; R&D grants </li></ul><ul><li>The US has played key role: NIH largest research operation in the world (~ US$30 billion), but </li></ul><ul><ul><li>NIH : funding slowdown? Uncertainty as to changing mix of programs (more translational research?) </li></ul></ul><ul><ul><li>University-based research : affected by aftermath of fiscal crisis (see e.g. UC system) </li></ul></ul><ul><li>Surge in other countries, particularly in China, Singapore; diversified opportunities… </li></ul><ul><li>Role also of philanthropy </li></ul>06/22/11
  18. 18. the supply side: private investment in R&D <ul><li>Depends upon: </li></ul><ul><li>Expected profitability  demand factors: </li></ul><ul><ul><li>Thinner margins, less reliance on features-loading and third party reimbursement </li></ul></ul><ul><ul><li>More price sensitivity </li></ul></ul><ul><ul><li>Fast growing markets in emerging economies, but for cheaper, affordable, simpler techs </li></ul></ul><ul><li>Availability of finance: less appetite for risk (less VC’s), but as new S&T opportunities come of age (e.g. genome, nano), probably eager new wave of finance. </li></ul><ul><li>Regulatory environment : tougher in US (stalemate at FDA), but opportunities elsewhere </li></ul>06/22/11
  19. 19. Expenditures on Medical R&D in the USA <ul><li>Total R&D, 2005: $111 billion </li></ul><ul><ul><li>HC Industry , total: $61 billion – 55% (13.4% of sales) </li></ul></ul><ul><ul><ul><li>Pharmaceutical: $35 billion – 31% </li></ul></ul></ul><ul><ul><ul><li>Biotechnology: $16 billion – 15% </li></ul></ul></ul><ul><ul><ul><li>Medical technology: $10 billion – 9%  </li></ul></ul></ul><ul><ul><li>Government: $40 billion – 36% </li></ul></ul><ul><ul><ul><li>NIH: $29 billion – 26% </li></ul></ul></ul><ul><ul><ul><li>Other fed agencies, state and local gov: $12 billion – 10% </li></ul></ul></ul><ul><ul><li>Other - Universities, research institutes, philanthropic foundations: $10 billion (9%) </li></ul></ul>06/22/11
  20. 20. OECD: Government HC R&D as % of GDP 06/22/11
  21. 21. the supply side - S&T opportunities (i) the old paradigm <ul><li>Medical innovation throughout the 20 th century, main thrust: </li></ul><ul><li>Fighting external disease-causing factors - germs, viruses, exposure. Degree of difficulty/complexity as that of external factor, rather than of human subject (see HIV) </li></ul><ul><li>Regulating bodily chemistry – acidity (ulcers), sugar (diabetes), hormones (thyroid) </li></ul><ul><li>Dealing with “mechanical factors” : clogging, fractures, morphological abnormalities, etc. see great gains in cardiovascular </li></ul><ul><li>Changing behavioral factors – nutrition/diet, exercise, smoking, etc. </li></ul>06/22/11
  22. 22. the supply side - S&T opportunities (i) the old paradigm - continued <ul><li>Tremendous inroads in those dimensions: dealing with external disease-causing factors, bodily chemistry, “mechanical factors,” behavioral factors </li></ul><ul><li>Major leap: dramatic advances since the 1970’s in diagnostic imaging – CT, MRI, ultrasound, PET </li></ul><ul><li>Still long way to go, always relevant (see mutations, SARS, the current “e. coli scare” in Europe, etc.) </li></ul><ul><li>But already picked long-hanging fruit, shifting paradigm, innovation challenges elsewhere </li></ul>06/22/11
  23. 23. the supply side - S&T opportunities (ii) the new challenges <ul><li>Fighting “self-generated” diseases : autoimmune, genetically-related cancers </li></ul><ul><li>Understanding the brain -central nervous system-cognition </li></ul><ul><li>Key features: </li></ul><ul><ul><li>Depend upon huge heterogeneity of human genetic makeup </li></ul></ul><ul><ul><li>Heterogeneity of disease itself – see cancer </li></ul></ul><ul><ul><li>Research and treatment at highly localized, molecular level: require nano dimensions </li></ul></ul>06/22/11
  24. 24. How to meet the new S&T challenges <ul><li>Address genetic and disease heterogeneities head-on </li></ul><ul><li>Widespread adoption and reliance upon Information and Communication Technologies (ICT), for research, treatment and delivery </li></ul><ul><ul><li>in particular universal generation and use of individual patient data, also for research </li></ul></ul><ul><li>Strive for interdisciplinary convergence in medical research and innovation </li></ul>06/22/11
  25. 25. How to meet the new S&T challenges Information and Communications Techs (ICT) <ul><li>ICT predominant “General Purpose Technologies” of our time, yet until recently little use of ICT in Med Tech; glaring disconnect: ICT everywhere but… </li></ul><ul><li>Large scale deployment of ICT in Med Tech - revolutionary potential – unleashing “Moore’s Law”: </li></ul>06/22/11
  26. 26. 06/22/11 “ Moore's law” (named after Intel co-founder Gordon E. Moore): the number of transistors in an integrated circuit doubles every two years. CPU Transistor Counts 1971-2008
  27. 27. How to meet the new S&T challenges Information and Communications Techs (ICT) <ul><li>ICT predominant “General Purpose Technologies” of our time, yet until recently little use of ICT in Med Tech; glaring disconnect: ICT everywhere but… </li></ul><ul><li>Large scale deployment in Med Tech - revolutionary potential – unleashing “Moore’s Law”: </li></ul><ul><ul><li>Computerized (electronic) Medical Records – CMR </li></ul></ul><ul><ul><ul><li>Gains in cost-effectiveness , avoid costly mistakes, enhanced competition because of patient mobility; telemedicine </li></ul></ul></ul><ul><ul><ul><li>Potential impact on med research : mass accumulation of highly detailed longitudinal data on diagnostic-treatments-outcomes of whole populations of patients </li></ul></ul></ul><ul><ul><li>Genomics, proteomics : heavy reliance on ICT and micro-electronics – dramatic advances in sequencing </li></ul></ul><ul><ul><li>Personalized medicine: key role of ICT </li></ul></ul>06/22/11
  28. 28. How to meet the new S&T challenges Nanotechnology <ul><li>Nanotechnology: one of most promising new emerging “General Purpose Technology”. Offers great opportunities to improve materials and devices for medical use, such as: </li></ul><ul><ul><li>Nanocoated Surgical Blades , of extreme sharpness and low friction highly suited to optical- and neurosurgery. </li></ul></ul><ul><ul><li>Catheters for Minimally Invasive Surgery - carbon nanotubes successfully added to catheters increase strength and flexibility </li></ul></ul><ul><ul><li>Optical Nanosurgery: “optical tweezers” and “nanoscissors” can be used at the cellular level for cell manipulation </li></ul></ul><ul><ul><li>Contrast agents incorporating nanoparticles for greatly improved imaging </li></ul></ul><ul><ul><li>Bone replacement materials incorporating nanostructured materials allowing better integration in the body </li></ul></ul><ul><ul><li>Wound dressings incorporating antibacterial nanoparticles </li></ul></ul>06/22/11
  29. 29. How to meet the new S&T challenges Convergence: the emerging paradigm <ul><li>Merger of life, physical and engineering sciences , for medical research and innovation </li></ul><ul><li>Integrate advances in ICT, materials, nanotechnology, optics, quantum physics, computing and simulation, with advances in the life sciences themselves. </li></ul><ul><li>Already happening in bioinformatics, synthetic and systems biology, biomaterials, tissue engineering , etc. </li></ul><ul><li>Examples (from MIT report on convergence): </li></ul><ul><ul><li>Nanotechnology for targeted chemotherapy delivery </li></ul></ul><ul><ul><li>Brain grafts for brain disorders and injury </li></ul></ul><ul><ul><li>Bacterial plasticity for tumor detection and drug delivery </li></ul></ul><ul><li>Convergence also fosters innovation in the contributing technologies themselves. </li></ul>06/22/11
  30. 30. Concluding remarks (1) <ul><li>For the first time in history it is feasible to deliver reasonable HC to most of humanity, but </li></ul><ul><li>Med Tech has to come up with affordable and cost-effective HC solutions </li></ul><ul><li>No altruism : HC for emerging economies opens up huge commercial opportunities; globalization of innovation </li></ul><ul><li>Converging trends of sorts: increased price sensitivity in the US, affordability as key in emerging economies </li></ul><ul><li>More stringent financial and regulatory environment, but great new opportunities : converging S&T in HC research, and deployment of ICT and nanotechnology </li></ul>06/22/11
  31. 31. Concluding remarks (2) <ul><li>The shifting trends open up opportunities for new players outside the US, and for Canada in particular: </li></ul><ul><ul><li>Great human capital, both in science and in medicine </li></ul></ul><ul><ul><li>Higher sensitivity to diversity of needs </li></ul></ul><ul><ul><li>Mindful of HC costs </li></ul></ul><ul><ul><li>Next to the US, yet much more outward oriented </li></ul></ul><ul><ul><li>An incipient entrepreneurial culture </li></ul></ul><ul><ul><li>BUT , </li></ul></ul><ul><ul><li>Heavy handed regulation </li></ul></ul><ul><ul><li>Lack of coherent government policy and support </li></ul></ul><ul><ul><li>Disconnect between industry and providers </li></ul></ul>06/22/11 <ul><li>This conference: </li></ul><ul><ul><li>a significant step in the right direction, </li></ul></ul><ul><ul><li>a strident call for action, </li></ul></ul><ul><ul><li>well done! </li></ul></ul>
  32. 32. <ul><li>Thanks! </li></ul>06/22/11
  33. 33. Innovation in the research landscape: A unique opportunity <ul><li>Novel scientific developments open new opportunities for medical innovation: </li></ul><ul><ul><li>The genomic revolution: </li></ul></ul><ul><ul><ul><li>enables the discovery of the basis for human diseases </li></ul></ul></ul><ul><ul><ul><li>enables individually-tailored “personalized medicine </li></ul></ul></ul><ul><ul><ul><li>enables novel regenerative gene therapy </li></ul></ul></ul><ul><ul><li>The cellular revolution: </li></ul></ul><ul><ul><ul><li>enables cell therapy and regenerative medicine </li></ul></ul></ul><ul><ul><ul><li>revolutionizes transplantation and immunity </li></ul></ul></ul><ul><ul><ul><li>opens new therapy to neurodegeneration </li></ul></ul></ul><ul><ul><li>“ hybrid rigor” of multidisciplinary research </li></ul></ul><ul><ul><ul><li>biology & mathematics – addressing biomedical complexity </li></ul></ul></ul><ul><ul><ul><li>biology & material science – from implants to nano-devices </li></ul></ul></ul><ul><ul><ul><li>bio-chem-phys – search for novel energy sources </li></ul></ul></ul>06/22/11
  34. 34. Impact of science-based “new biomedicine” <ul><li>Drug development </li></ul><ul><ul><li>Better, “individually tailored” drugs </li></ul></ul><ul><ul><li>Cheaper development </li></ul></ul><ul><ul><li>Shorter time to market </li></ul></ul><ul><ul><li>The rise of therapeutic “biologics” </li></ul></ul><ul><li>Novel medical devices </li></ul><ul><ul><li>Implants, orthopedic, cardiac, dental </li></ul></ul><ul><ul><li>Molecular imaging systems </li></ul></ul><ul><ul><li>Drug delivery nano-devices </li></ul></ul><ul><li>Prevention </li></ul><ul><ul><li>Better definition of “high risk” individual </li></ul></ul><ul><ul><li>Better understanding of disease causes </li></ul></ul><ul><ul><li>Research addressing environmental & nutritional factors </li></ul></ul>06/22/11
  35. 35. Obstacles and challenges <ul><li>Drug development: Empty pipelines </li></ul><ul><ul><li>Need to develop “mechanism-based” therapies </li></ul></ul><ul><ul><li>need to developed better tailored drug (not “fit-all” drugs) </li></ul></ul><ul><li>Novel & recurrent diseases </li></ul><ul><ul><li>Diseases of old age (people live longer) </li></ul></ul><ul><ul><li>Emerging drug resistance </li></ul></ul><ul><ul><li>Neglected diseases (small patient population, variants) </li></ul></ul><ul><li>High cost </li></ul><ul><ul><li>Better defined patient population </li></ul></ul><ul><ul><li>Better information about disease mechanism </li></ul></ul>06/22/11