clearing commercialization hurdles, 2.1.12
DESCRIPTION
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).TRANSCRIPT
©2012 MedCelerate LLC, All Rights Reserved.
Clearing Commercialization Hurdles February 1, 2012
J. Greg Davis Founder & CEO, MedCelerate
©2012 MedCelerate LLC, All Rights Reserved.
©2012 MedCelerate LLC, All Rights Reserved.
My Device Background
3
Fundamental Questions
4 ©2012 MedCelerate LLC, All Rights Reserved.
Do We Have Compelling
Idea?
Is Our Device Safe in
Humans?
Do We Have a Product?
Can We Supply in Quan>ty?
What is Reorder Rate?
Should We Seek US Approval?
Product Development
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
Do we have a compelling Idea?
Key Ques>on Major Ac>vi>es
• Conduct preclinical research • Animal studies • Establish IP • Develop Business Case fundamentals
5 ©2012 MedCelerate LLC, All Rights Reserved.
FIM/CE Mark Clinical Study
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
Key Ques>on Major Ac>vi>es
• Design freeze • Design controls, GCP • Align thought leaders • Trial design • Study site management
1 2 3 4 5 6
Is our device safe in humans?
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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
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
Post-Market Clinical Studies
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
Key Ques>on Major Ac>vi>es
• Study design • Assign PIs • EC approvals • Study management • Publish data
1 2 3 4 5 6
Do we have a product?
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Supply Chain Scale-Up
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
Key Ques>on Major Ac>vi>es
• Identify CMOs or scale in-house mfg.
• Improve yields • Additional CE Mark • Logistical support
1 2 3 4 5 6
Can we supply in quantity?
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OUS Commercialization
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
Key Ques>on Major Ac>vi>es
• Build S&M organization • Decide countries/customers • Approach to customers • Pricing & promotional elements
1 2 3 4 5 6
What is reorder rate of end customers?
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U.S. PMA Approval
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
Key Ques>on
1 2 3 4 5 6
Should we seek US approval?
Major Ac>vi>es
• Pre-IDE discussions w/FDA • Bench & animal data • Trial design • CRO partner selection • Patient recruitment/FU • PMA module submissions
©2012 MedCelerate LLC, All Rights Reserved. 12
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
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GOOD LUCK!
©2012 MedCelerate LLC, All Rights Reserved.