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2010 Washington StateBiomedical Device Summit
InHealth at the  2010 Washington State Biomedical Device Summit Reform and the Future  of Medical Technology Innovation  Bothell, WA 17 June 2010
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
InHealth Snapshot MISSION  To fund research, analysis, and dialogue about the social and economic effects of medical technology innovation.  CURRENT PRIORITIES ,[object Object]
 To analyze the impact of medtech on human capital and productivity.GOVERNANCE   Governed by independent board; advised by outside research council; and committed to non-interference, pre-publication, and peer-review inquiry.
InHealth Snapshot ORIGINS  InHealth is a 501(c)(3) charitable foundation, created by AdvaMed in 2003 and funded by gifts, primarily from medtech companies.  DONORS 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	 BD
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
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
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
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
Research Results to Date  16 papers published in leading medical and policy journals: ,[object Object]
  Health Affairs
  Journal of the American College of Cardiology
  Journal of the American Geriatrics Society
  Journal of Medical Devices
Pediatrics, and many others A commitment to fund original research: ,[object Object]
InHealth’s board of directors makes available $1 million per year      for research grant awards.
U. S. Healthcare Reform Goals of the Patient Protection and Affordable Care Act (PPACA) ,[object Object]
Subsidized program will add 32 million insured
Reform federal healthcare financing
Program will raise more than $1 trillion and contribute $125 billion to deficit reduction
Device manufacturers will contribute via a 2.3% excise tax, effective 1 January 2013
Improve methods of payment and delivery

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Washington State BioMed Summit - Steve Halasey InHealth Presentation

  • 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.
  • 5. To analyze the impact of medtech on human capital and productivity.GOVERNANCE Governed by independent board; advised by outside research council; and committed to non-interference, pre-publication, and peer-review inquiry.
  • 6. InHealth Snapshot ORIGINS InHealth is a 501(c)(3) charitable foundation, created by AdvaMed in 2003 and funded by gifts, primarily from medtech companies. DONORS 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 BD
  • 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.
  • 12. Health Affairs
  • 13. Journal of the American College of Cardiology
  • 14. Journal of the American Geriatrics Society
  • 15. Journal of Medical Devices
  • 16.
  • 17. InHealth’s board of directors makes available $1 million per year for research grant awards.
  • 18.
  • 19. Subsidized program will add 32 million insured
  • 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
  • 25.
  • 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
  • 31. Will it adopt existing CER research priorities of IOM and AHRQ?
  • 32.
  • 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.
  • 37. Mandatory physician quality reporting incentive system
  • 40.
  • 45. Ensuring that future research includes technologies appropriately will be a significant challenge
  • 46.
  • 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.
  • 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.
  • 56. InHealth Contacts www.inhealth.org 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

Editor's Notes

  1. 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
  2. Thank collaborating organizations in the Biomedical Device Innovation Zone:City of BothellenterpriseSeattleDepartment of CommerceUniversity of Washington BothellEconomic Development Council of Snohomish County WBBA
  3. Presenting SponsorsDLA Piper – John Steel & Stacy TaylorMoss Adams – Dan Fowler & Amy Sutherland
  4. Supporting SponsorsAH&T – Mark GanleyCarbon Design Group – Paul Leonard & Craig ChamberlainCascadia Community College – Dr. Bill ChristopherLyChron – Rick MolinaWe Work for Health – Jim Blundell