Medical Devices

1
Medical Devices IVD Addressing Critical Market
Challenges
Schuyler Ritter SVP, Business Development sky_at_beau
fortadvisors.com Tel [phone]
2
THREE KEY CHALLENGES

• Time to Market Issues
• Preparing for and Dealing with Recalls
• Understanding the political and regulatory
  landscape

3
ISSUE 1 TIME TO MARKET

• Anticipate and plan for the important issues
• What are your real goals?
• Small and fast clinical trial?
• Broad indication?
• Beat the competition to market?

4
Prepare and validate a realistic market
opportunity analysis

• Pfizer spent billions of dollars on Exubera, the
  first inhaled insulin. Touted as a major
  medical breakthrough with a sales forecast
  exceeding 1.5 billion. Approved a year ago
  Exubera generated sales of 4 million last
  quarter.
• Forbes, October 29, 2007 Drug Drought, page
  46

5
PLANNING MUST INCLUDE REGULATORY LEGAL

• Developing a viable regulatory strategy
• Basic regulatory pathway 510(k), PMA, etc.
• FDA input, pre-IDE, 513(g)?
• Clinical Quality requirements of pathway
• Successful negotiating with FDA
• INDIPLON, A SLEEPING PILL, WAS LICENSED (by
  Pfizer) FOR 200 MILLION and was turned down by
  FDA
• Forbes, October 29, 2007 Drug Drought, page 46

6
PLANNING MUST INCLUDE REGULATORY LEGAL
(continued)

• Reimbursement Issues
• Intellectual Property Issues
• Import and Taxation Issues
• FDA User Fees
• Advertising (labeling) Issues
• Supplier Assessment (CMO) Issues
• US Registration

7
MARKETING STRATEGY

• Launch preparation
• Promotion plan
• Straight to doctors, consumer education,
  comparative studies, etc.
• Create a US Sales Force or co-market with a US
  company?
• US Office Presence

8
Production plan vs. demand forecast

• In 2003 Pfizer spent 1.3 billion acquiring
  Esperion Therapeutics, maker of a protein to
  Roto-Rooter clogged arteries, but now cant
  manufacture enough to start a new clinical
  trial.
• Forbes, October 29, 2007 Drug Drought, page 46

9
U.S. DISTRIBUTION REALITIES

• Device/IVD distribution is fragmented and
  somewhat confusing in the U.S.
• Three distributors dominate U.S. drug
  distribution
• Not as clear for medical devices
• Distributors often provide marketing support just
  for blockbuster products
• U.S. marketing partner can assist with both
  marketing and distribution

10
ISSUE 2 - RECALLS

• Recalls are a reality and happen to the best of
  companies
• If not properly addressed they can be a
  distraction or worse
• Examples
• Participant experiences?

11
RECALL PREPARATION

• What is your planned I, II and III recall
  response? check your SOPs
• How have you responded to past recalls?
• FDA response may depend on your response
• Competitive response counteraction
• Anticipate customer response

12
ISSUE 3 POLITICAL REGULATORY

• Politics vs. Human benefit.
• E.g. pandemic vaccines and contraceptives
• Policy vs. Washington Financial reality
• Current under-funding of Medicare/Medicaid
• FDA resources
• 2008 Presidential elections healthcare plans
• Case Studies and open discussions

13
THANK YOU!

• Schuyler Ritter
• Beaufort Advisors LLC
• Senior Vice President, Business Development
• sky_at_beaufortadvisors.com

14
Beaufort Advisors LLC 500 East Main Street Suite
1301 Norfolk, Virginia 23510 (757)
383-6000 www.beaufortadvisors.com