how to start a med device startup from your garage
TRANSCRIPT
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How to Start a Med Device Startup From Your Garage
David Y. Kay @DavidYKay
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Garage? In New York?
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Seriously — why do it?
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“I need funding to work on my startup”
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Constraints breed creativity.
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Market Trends
• Big Pharma & Med Device are slashing R&D
• Preferring to acquire small startups
• R&D costs are falling
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The Timeline
1000000
2000000
3000000
4000000
Prototype D.V. FDA Production Profitability
Costs
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How to get there?
• Customer
• Problem
• Solution
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ApproachesTech-first Customer-first
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“You don’t have time to develop the wrong app.”
-Tomer Sharon
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“Would you rather sell your [device] to 100% of the people in a 50,000 person market, or 10% of the people in a 500,000 person market?”
-Rob Walling
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Ideation…
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Inspiration strikes!
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“Keep your personal burn rate low. This alone will give you a lot of opportunities in life.”
-Sam Altman
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"...you must get more enjoyment out of saving your money than you do spending your money.”
-Suze Orman
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YNAB
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Hardware
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Moore’s Law
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Moore’s Law
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Sensors
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Arduino vs Raspberry Pi
vs
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Bluetooth & NFC
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Handheld / Tablet
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Wearables
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Not Just Silicon
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3D Printing
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Hackerspaces
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Contract Manufacturing
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Software
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Open Source
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Microsoft
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Big Data & Machine Learning
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Big Data & Machine Learning
Essentially, it’s all statistics
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Cloud
?
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Cloud
Hardware
DIY Cloud Managed
OS
Application
VM
Hardware
OS
Application
VM
Hardware
OS
Application
VM
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What’s your differentiator?
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Carpenters vs Engineers
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Coder Culture
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Regulatory
• 510K / PMA • HIPAA
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510k
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PMA
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510k
• Predicates
• Pre-submission Meeting
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Predicates
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Study
• Validation
• Animal Trial
• Human Trial
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HIPAA
• Privacy Rule
• Security Rule
• BAAs
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BAAs
Hardware
OS
Application
VM
You’re on your own!
It’s on Amazon.
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Cloud, Revisited
Hardware
DIY Cloud Managed
OS
Application
VM
Hardware
OS
Application
VM
Hardware
OS
Application
VM
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Networking
It’s not what you know…
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Revenue Models
• Reimbursement
• Have a plan BEFORE YOU CLEAR FDA!!!
• Direct-to-consumer
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Reimbursement
• Coding
• CPT (AMA)
• HCPCS (HHS)
• But a code is NOT ENOUGH!
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Direct to Consumer
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The Team
• Cross-functional
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Fundraising• Non-dilutive
• SBIR / STTR
• Dilutive
• Angels
• VCs
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Grants
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SBIR Workshop
• Becky Aistrup - 20 yrs exp w/ SBIR
• Tomorrow @ 8:30AM
• $25
• http://bit.ly/nyc-sbir-2015
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Contests
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Investment
"If you want advice, ask for money.
If you want money, ask for advice."
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Mentorship
• Board of Advisors
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Accelerators
Good idea?
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Intellectual Property
• Tech Transfer
• Lawyers
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Recap
• Find something important to work on
• You can do it on a shoe-string budget
• Focus on your differentiator & forget the rest
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Closing Thoughts
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Axiom Orthopaedics
• No outside funding
• Modular Shoulder Replacement
• Several patents
• Acquired after < 2 years
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SALT
• $10K funding
• Urine test for sodium
• Provisional Patent
• Working Prototype
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Bootstrapper’s Bookshelf