Keynote presentation given at Medtech Innovation Education Series event on February 1, 2012 in Atlanta, Georgia. Event was sponsored by the Global Center for Medical Innovation (GCMI).

1. ©2012 MedCelerate LLC, All Rights Reserved.

2. Clearing Commercialization
Hurdles
February 1, 2012
J. Greg Davis
Founder & CEO, MedCelerate
©2012 MedCelerate LLC, All Rights Reserved.

3. My Device Background
3 ©2012 MedCelerate LLC, All Rights Reserved.

4. Fundamental Questions
Do
We
Have
Compelling
Idea?
Should
We
Is
Our
Device
Seek
US
Safe
in
Approval?
Humans?
What
is
Do
We
Have
Reorder
a
Product?
Rate?
Can
We
Supply
in
Quan>ty?
4 ©2012 MedCelerate LLC, All Rights Reserved.

5. Product Development
Key
Ques>on
Major
Ac>vi>es
Do we have a • Conduct preclinical research
compelling Idea? • Animal studies
• Establish IP
• Develop Business Case
fundamentals
1 2 3 4 5 6
Lessons Learned
 Start virtual, run silent, be capital efficient
 Learn how to iterate and fail quickly
 Study long-term trends in healthcare and impact on your technology
 Identify up front how your product will save health care system money
5 ©2012 MedCelerate LLC, All Rights Reserved.

6. FIM/CE Mark Clinical Study
Key
Ques>on
Major
Ac>vi>es
Is our device • Design freeze
safe in • Design controls, GCP
humans? • Align thought leaders
• Trial design
• Study site management
1 2 3 4 5 6
Lessons Learned
 Lay solid Quality System foundation early
 Know and understand regulatory requirements
 Consider using European CRO with relevant device experience
 Continue staying lean and focused
6 ©2012 MedCelerate LLC, All Rights Reserved.

7. Going to Europe First
- Is “Juice Worth the Squeeze”
Pros:
• More predictable regulatory pathway
• Demonstrate clinical acceptance/commercial viability
• Recognized quality of clinical research
• Valuable product development input
• Transfer learning to US submission/launch
• Early look at market development & learning curve
• Revenue generation

8. Going to Europe First
- Is “Juice Worth the Squeeze”
Cons:
• Deciding which markets to pursue is not obvious
- 27 unique healthcare and reimbursement systems
• Attracting top talent is difficult
- Less entrepreneurial, employment contracts, expensive
• Price sensitive markets
• Product adoption impacted by limited clinical data
• Management of distributors
• Revenues – yes, positive cash flow – doubtful

9. Post-Market Clinical Studies
Key
Ques>on
Major
Ac>vi>es
Do we have a • Study design
product? • Assign PIs
• EC approvals
• Study management
• Publish data
1 2 3 4 5 6
Lessons Learned
 Build clinical experience to gain understanding of product limitations
 Customer usage may lead to another product iteration
 Will inform about market development and physician training requirements
 Despite limitations, clinical data is powerful
9 ©2012 MedCelerate LLC, All Rights Reserved.

10. Supply Chain Scale-Up
Key
Ques>on
Major
Ac>vi>es
Can we supply • Identify CMOs or
in quantity? scale in-house mfg.
• Improve yields
• Additional CE Mark
• Logistical support
1 2 3 4 5 6
Lessons Learned
 Making 50 is not the same as making 500 or 5,000!
 Weigh pros & cons of in-house vs. contract manufacturing
 Consider using EU-based contract manufacturers
 Limit number of partners – must be profitable for them as well
10 ©2012 MedCelerate LLC, All Rights Reserved.

11. OUS Commercialization
Key
Ques>on
Major
Ac>vi>es
What is reorder • Build S&M organization
rate of end • Decide countries/customers
customers? • Approach to customers
• Pricing & promotional
elements
1 2 3 4 5 6
Lessons Learned
 Start with basic question: “What are we trying to achieve?”
 Your exit potential heavily tied to account level product adoption
 Stay focused on limited number of countries/accounts
 Resist temptation to add new markets opportunistically
11 ©2012 MedCelerate LLC, All Rights Reserved.

12. U.S. PMA Approval
Key
Ques>on
Major
Ac>vi>es
Should we • Pre-IDE discussions w/FDA
seek US • Bench & animal data
approval? • Trial design
• CRO partner selection
• Patient recruitment/FU
• PMA module submissions
1 2 3 4 5 6
Lessons Learned
 Expensive, time-consuming, potentially risky
 Enrollment will take longer than you project
 Strategic acquirers happy to stay on sidelines
 Assess investors’ dry powder to reach PMA approval
12 ©2012 MedCelerate LLC, All Rights Reserved.

13. Final Thoughts
• Think about economic impact to HC system day 1
• CE Mark does not mean you have product
• Start with what you are trying to achieve OUS
• Experience in Europe is valuable but expensive
• Selecting right manufacturing partners is key
• Understand sales process before expanding
• Focus on account level adoption
• Have ability to see FDA trial to completion
GOOD
LUCK!
13 ©2012 MedCelerate LLC, All Rights Reserved.

14. ©2012 MedCelerate LLC, All Rights Reserved.