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Washington State BioMed Summit - Steve Halasey InHealth Presentation


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2010 Washington State Biomedical Device Summit featured presenter Steve Halasey, InHealth - Reform and the Future of Medical Technology. June 2010

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Washington State BioMed Summit - Steve Halasey InHealth Presentation

  1. 1. 2010 Washington StateBiomedical Device Summit<br />
  2. 2. InHealth at the <br />2010 Washington State Biomedical Device Summit<br />Reform and the Future <br />of Medical Technology Innovation <br />Bothell, WA<br />17 June 2010<br />
  3. 3. InHealth at the <br />2010 Washington State Biomedical Device Summit<br />Reform and the Future <br />of Medical Technology Innovation<br />Steve Halasey<br />Vice President for Programs<br />Institute for Health Technology Studies <br />
  4. 4. InHealth Snapshot<br />MISSION <br />To fund research, analysis, and dialogue about the social and economic effects of medical technology innovation. <br />CURRENT PRIORITIES<br /><ul><li> To identify the role of medtech innovation in reshaping healthcare delivery.
  5. 5. To analyze the impact of medtech on human capital and productivity.</li></ul>GOVERNANCE <br />Governed by independent board; advised by outside research council; and committed to non-interference, pre-publication, and peer-review inquiry. <br />
  6. 6. InHealth Snapshot<br />ORIGINS <br />InHealth is a 501(c)(3) charitable foundation, created by AdvaMed in 2003 and funded by gifts, primarily from medtech companies. <br />DONORS<br />Major corporate donors include<br />Johnson & Johnson Beckman Coulter Foundation<br />Stryker Corp. KCI Inc. <br />Zimmer Edwards Lifesciences<br />St. Jude Medical Foundation<br />Medtronic Foundation <br />C.R. Bard Foundation <br />BD<br />
  7. 7. Research: $11 Million in Grants<br />Duke University<br />Implantable hips and knees; glaucoma devices<br />Harvard University/Beth Israel<br />“Cooling caps” for premature infants; laser ablation for retinopathy <br />Johns Hopkins University<br />Hearing aids <br />Northwestern University<br />Obstructive sleep apnea/CPAP; chronic wound technologies <br />Stanford University<br />Device development process; CT and MR imaging; Physician’s role in innovation<br />
  8. 8. Research: $11 Million in Grants<br />University of Pennsylvania<br />ICDs; drug-eluting stents; carotid stents<br />University of Houston<br />Genomic tests in personalized medicine <br />Tufts New England Medical Center<br />Diagnostics in preventive medicine <br />Medical College of Georgia<br />Insulin pumps <br />University of Southern California<br />QOL and productivity impacts of diabetes devices <br />
  9. 9. Education: $1 Million+ in Programs<br />Medtech in the New Healthcare Economy: Risk or Reward? <br />2010 Summit featuring Alan Garber and Mark Pauly<br />Evidence and Reform: Health Policy and Challenges of Health Tech Research <br />2009 Summit on using health technology research to guide healthcare policy<br />Evidence of Innovation: Impacts of Tech Assessment and Economic Research<br />Mini-symposium within AdvaMed 2009<br />Device Development Model, 2008–2009 <br /> Anaheim, NY, Minneapolis, Stuttgart, Birmingham, Yokohama , and Galway<br />InHealth Mini-Symposium on CER and Personalized Medicine<br />Mini-symposium within AdvaMed 2008<br />
  10. 10. Education: $1 Million+ in Programs<br />Device and Diagnostic Innovation: Opportunities for Industry and Regulators <br />2008 Conference with FDA CDRH Director Dan Schultz<br />InHealth Mini-Symposium on Device Development Process<br />Mini-symposium within AdvaMed 2007<br />Accelerating Technological Change: Value and Healthcare Reform <br />2007 Symposium with Governor Mitch Daniels and futurist Ray Kurzweil<br />Medical Technology: Breaking Barriers between Bench and Bedside <br />2006 Symposium with Mark McClellan<br />
  11. 11. Research Results to Date <br />16 papers published in leading medical and policy journals:<br /><ul><li>American Heart Journal
  12. 12. Health Affairs
  13. 13. Journal of the American College of Cardiology
  14. 14. Journal of the American Geriatrics Society
  15. 15. Journal of Medical Devices
  16. 16. Pediatrics, and many others </li></ul>A commitment to fund original research:<br /><ul><li>InHealth is now known and respected among scholars throughout the country.
  17. 17. InHealth’s board of directors makes available $1 million per year </li></ul> for research grant awards. <br />
  18. 18. U. S. Healthcare Reform<br />Goals of the Patient Protection and Affordable Care Act (PPACA)<br /><ul><li>Expand healthcare coverage
  19. 19. Subsidized program will add 32 million insured
  20. 20. Reform federal healthcare financing
  21. 21. Program will raise more than $1 trillion and contribute $125 billion to deficit reduction
  22. 22. Device manufacturers will contribute via a 2.3% excise tax, effective 1 January 2013
  23. 23. Improve methods of payment and delivery
  24. 24. Experimentation in search of success
  25. 25. Demand for evidence</li></li></ul><li>U. S. Healthcare Reform<br />PPACA and the Law of Unintended Consequences<br /><ul><li>Medicare independent payment advisory board
  26. 26. Could have profound impact on policies affecting technologies
  27. 27. Intended composition of the board is unclear
  28. 28. An opportunity for device manufacturers to help in shaping the board
  29. 29. Patient-centered outcomes research institute
  30. 30. Comparative effectiveness research
  31. 31. Will it adopt existing CER research priorities of IOM and AHRQ?
  32. 32. An opportunity for device manufacturers to help define research priorities </li></li></ul><li>U. S. Healthcare Reform<br />PPACA and the Law of Unintended Consequences<br /><ul><li>Physician payment sunshine act
  33. 33. Strong benefits for relieving public, legislative, and media scrutiny into company-physician relations
  34. 34. Watch out for locally stringent restrictions on company relations, especially with university researchers
  35. 35. Entrepreneurial efforts involving physicians may become more complex and expensive, with uneven and unpredictable effects on the innovation pipeline</li></li></ul><li>U. S. Healthcare Reform<br />PPACA and the Law of Unintended Consequences<br /><ul><li>Medicare system changes
  36. 36. Hospital value-based purchasing program
  37. 37. Mandatory physician quality reporting incentive system
  38. 38. Hospital acquired conditions
  39. 39. Hospital readmissions reduction program
  40. 40. Episode-of-care bundled delivery pilot program </li></li></ul><li>Reform and Innovation<br />An Evidence-Based Future<br /><ul><li>Functioning of nearly all reform-initiated agencies and programs will rely heavily on data analysis or evidence generated through original scientific research
  41. 41. Medicare independent payment advisory board
  42. 42. Patient-centered outcomes research institute
  43. 43. Physician payment sunshine act
  44. 44. Medicare system changes
  45. 45. Ensuring that future research includes technologies appropriately will be a significant challenge
  46. 46. To make headway commercially, manufacturers should be prepared to conduct or finance rigorous technology-oriented studies</li></li></ul><li>Reform and Innovation<br />Dire Consequences?<br /><ul><li>The emerging reform environment is rife with unpredictability—the worst enemy of investors
  47. 47. Early-stage investment may weaken
  48. 48. Not all sectors will be affected equally
  49. 49. Early-stage companies without a clear path to adoption and payment will have the greatest difficulty
  50. 50. Full engagement in building reform-initiated programs is industry’s best hedge against uncertainty</li></li></ul><li>And One More Thing . . .<br />Regulatory Change Is in the Wind<br /><ul><li>Medical device safety issues have resulted in public, legislative, and media scrutiny over the processes used for premarket review of medical devices
  51. 51. FDA’s premarket notification (510(k)) process has attracted particular attention
  52. 52. CDRH will implement revisions to the process in September 2010
  53. 53. The IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process will issue its report in mid-2011
  54. 54. Regulatory reform is contributing as much as healthcare reform to unpredictability and investor uncertainty
  55. 55. Industry input should be an essential part of future changes to FDA’s regulatory processes</li></li></ul><li>Thanks for Attending<br />For announcements of future InHealth events, <br />visit the InHealth Web site<br />
  56. 56. InHealth Contacts<br /><br />Martyn W. C. Howgill Michael Infurnari<br /> Executive Director Senior Vice President for Operations<br /><br /> Steve Halasey Yolanda V. Gule<br /> Vice President for Programs Administrator<br /><br />
  57. 57. InHealth at the <br />2010 Washington State Biomedical Device Summit<br />Reform and the Future <br />of Medical Technology Innovation <br />Bothell, WA<br />17 June 2010<br />
  58. 58. Hosts<br />
  59. 59. Presenting Sponsors<br />
  60. 60. Supporting Sponsors<br />