Trends Impacting the U'S' Medical Device Industry

1
Trends Impacting the U.S. Medical Device Industry

• Steve Ubl
• President and CEO, AdvaMed

October 16, 2008
2
Overview

• Trends Impacting the Industry AdvaMeds
  Response
• Impact of U.S. Elections
• Opportunities for Greater Collaboration

3
Transparency

• Greater Expectations for Transparency
• Interaction with health care professionals
• Procedure and product pricing
• Clinical trial results

4
Transparency

• AdvaMed Response
• Embracing Transparency Key to Reputation
• We support robust code governing ethical
  interactions w/HCPs
• We support appropriate disclosure of trial
  results
• We do not support price disclosure at the product
  level

5
Regulation

• Risk/Benefit Imbalance
• Greater information sharing among regulators
• Increasing pre-market data requirements
• Shifting focus to post-market activities
• Questions about 510(k) process in U.S.
• Effort to repeal federal pre-emption for PMA
  devices
• Effort to recast MDD

6
Regulation

• AdvaMed Response
• Support Refinements Keep Focus on Patient Access
• Work with FDA on import safety, MOAs w/China and
  others
• Promote FDAs science-based regulatory decisions
• Partner closely with FDA on post-market
  refinements
• Educate stakeholders on value of 510(k) process
• Launch public relations and lobbying effort on
  pre-emption
• Partner w/EU trade associations to support
  current MDD framework

7
Quality

• Value-Based Reimbursement Means Providers Have a
  Greater Stake in Performance Outcomes
• Pay-for-reporting becoming pay-for-performance
• Increasing efforts to bundle technology component
  with physician and hospital payments
• Bundling physician and hospital payments together
  for episode of care
• Potential government-funded comparative
  effectiveness entity could lead to value-focused
  insurance programs

8
Quality

• AdvaMed Response
• Get a Seat at the Quality Standard Table Focus
  on Data
• Ensure industry role in setting updating
  quality standards
• Support quality standards led by physicians and
  oppose meat axe cuts
• Ensure bundling efforts recognize technology
• Who gets the hospital/physician bundled payment?

9
Global

• See All of the Above! Shift to Emerging Markets?
• Intra-governmental disconnect between
  establishing life-sciences sectors and public
  policies
• Inconsistent and non-transparent public
  procurements
• HTA too often a one-way street
• Emerging markets look more promising

10
Global

• AdvaMed Response
• Preparing to Pick up the Push, So as to Not Eat
  the Football
• More resources into international
• Need to promote best practices
• HTA, procurement, DRGs
• Back to the basics in terms of clear
• regulatory and reimbursement pathway
• Increasing focus on BRIC countries

11

• Cost Control Both Are Largely in Agreetment
• Prevention
• Quality (especially management of chronic
  disease)
• Comparative effectiveness
• Efficiency
• (HIT, transparency, P4P)
• Cut drug spending
• (re-importation, generics)

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Coverage Obama

• Subsidies to make care affordable for all (and
  mandatory for children)
• Employer mandate to provide or contribute to
  coverage
• Medicare-like public program alternative
• Insurance reform
• Guaranteed issue
• Community rating

13
Coverage McCain

• Eliminate employee tax exclusion
• Refundable tax credits for all 2,500 per
  individuals and 5,000 per family
• Insurance reforms
• Sell across state lines
• Association plans
• Health Savings Accounts

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Other Issues

• Divided Government Yes No
• Preemption Supports Opposes
• Trade Policy trade Trade w/ restrictions
• FDA Continued Hill Oversight Less Hill oversight
• Appointments Pro-industry Consumer/Academic

McCain
Obama
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Opportunities for Collaboration

• Close coordination on MDD recast and other impact
  issues
• Improved coordination among AdvaMed, EUCOMED and
  other Assns. on common agenda in Europe
• Policy development as great a challenge as
  coordination
• Create an effective echo chamber in Asia,
  emerging markets, international organizations

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Trends Impacting the U.S. Medical Device Industry

• Steve Ubl
• President and CEO, AdvaMed

October 16, 2008