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

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

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  • Welcome to our 3rd annual Washington State Biomedical Device SummitSpecial thanks to Dr. Bill Christopher and Cascadia Community College for hosting us at Mobius HallBackground on Biomedical Device Innovation ZoneIn September 2007, Governor Chris Gregoire formally recognized the significance of the medical device manufacturing and ultra sound research activities in the Bothell Technology Corridor by designating the City of Bothell as the Biomedical Device Innovation Zone for Washington State. A partnership was formed to foster programs and promote a center of excellence and innovation for the biomedical device industry.Since its founding we’ve seen: growing recognition of the medtech industry in Washington Bothell is currently home to 5 of the top 10 med tech firms in the state with two more in cities adjacent (by revenues and number of employees) - Increased involvement from industry leadership strong sponsorship from the supporting industries new relationships with brokers and property owners to create opportunities for growing and expanding firms New initiatives: a non-profit board is being established to manage the organization’s activities a partnership has been formed with the UW Center for Commercialization (formerly office of tech transfer) to collaborate and explore the establishment of a MedTech Discovery Center with a medtech incubator as its primary program offering to start. the project has received a $500,000 grant from the state of Washington in support of the project semi-annual C-level roundtable lunches for industry executives to share information and resourcesThe WBBA’s has also founded a new Wings – Washington State Medical Technology Angel Network Lots of activity and an overall strong track record of success
  • Thank collaborating organizations in the Biomedical Device Innovation Zone:City of BothellenterpriseSeattleDepartment of CommerceUniversity of Washington BothellEconomic Development Council of Snohomish County WBBA
  • Presenting SponsorsDLA Piper – John Steel & Stacy TaylorMoss Adams – Dan Fowler & Amy Sutherland
  • Supporting SponsorsAH&T – Mark GanleyCarbon Design Group – Paul Leonard & Craig ChamberlainCascadia Community College – Dr. Bill ChristopherLyChron – Rick MolinaWe Work for Health – Jim Blundell


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