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  • 1. Operating in the US Market Key Considerations for Device & Diagnostics Companies David Avitabile President JFK Communications, Inc.
  • 2. Good News
    • The growth of Personalized Medicine
      • Total market expected to rise $119-$220 billion in a 16 year span
    • U.S. Medical Device Market is still # 1
      • An estimated $94.9 billion will be made in 2010
      • California being the lead state for medical device manufacturing & development
      • Johnson & Johnson highest earnings overall in 2009, $23.6 billion
    • Medical Device innovation in U.S. accredited for
      • 15% decline in annual mortality
      • 25% decline in disability rates
      • 3.2 year increase in life expectancies
      • 56% decrease of the amount of days spent in hospitals
    Sources : 1. PricewaterhouseCoopers 2009; 2. Marketresearch.com; 3. Advamed.org Testimony on U.S. Medical Technology Industry
  • 3. Personalized Medicine Market Projections Sources : 1. PricewaterhouseCoopers 2009; 2. Pascal Yvon, President BioSciences Expansion, Committee Co-Chair
  • 4. Top U.S. Medical Device Manufacturers Source : Medical Products Outsourcing, Top 10 Medical Device Companies
  • 5. 510 (k) Regulatory Pathway
    • FDA Center for Devices and Radiological Health (CDRH) 510 (k) process: the pathway for approval in the US
    • Recent proposed changes raise concerns from medical device and diagnostics companies
    • If you don’t have an approved product in the US, you don’t have a business in the US
  • 6. Medical Device Innovations Contributions Source : Advamed.org, Testimony on U.S. Medical Technology Industry
    • AdvaMed Tesitmony on U.S. Medical Technology Industry :
    • “ The contribution of the life sciences to our economy goes beyond conventional measures of employment, wages, and exports. By improving the health of the population, progress in the life sciences
    • is an engine driving productivity and labor force participation, both significant contributors to economic growth and GDP. Between
    • 1980 and 2000, medical progress added more than three years to
    • life expectancy. The death rate from heart disease was cut in half; the death rate from stroke was cut by one-third, and the death rate from breast cancer was cut 20%”
  • 7. Bad News
    • FDA 510(k) Process changes may cause issues in:
      • Pre-Approval timelines
      • Costs in conducting clinical trials
      • May cause clinical trials and medical devices to go overseas in order to become more cost-effective
    • New Health Care Reform could prove costly to Industry
      • The 2.3 % tax on medical devices companies
    • U.S. could lose lead position in Medical Device manufacturing
      • Increase tax and regulations could cause companies to prioritize overseas markets over US
    Sources : 1. AdvaMed Press Release- Comments in Response on FDA’s Proposed 510(k) Changes; 2. Medicaldevices.org; 3. Advamed.org, Testimony on U.S. Medical Technology Industry
  • 8. Effects of Proposed 501(k) Changes Source : AdvaMed Press Release- Comments in Response on FDA’s Proposed 510(k) Changes
  • 9. Heath Care Reform Effects
    • Scheduled 2013, 2.3 % tax on medical device companies
    • Totals approximately $20 billion over a 10 year span
      • Lay offs
      • Mid-sized companies could owe more in taxes than their annual profits
      • Closing of mid-sized medical device companies
      • Delay development of new devices
      • Cause significant budget cuts to companies
    Source : Associated Pres , September 2010
  • 10. Pathway for EU Companies Entering the US Market
    • Identify partners with experience supporting US market entry
      • Life sciences private equity/VCs
      • Tax advisors to life science companies
      • Legal counsel
      • Regulatory affairs
      • Marketing & communications
      • National / state Bio associations
      • Life sciences incubators
  • 11. Life Sciences Associations