how to start a med device startup from your garage - vancouver edition
TRANSCRIPT
How to Start a Med Device Startup From Your Garage
David Y. Kay @DavidYKay
Garage? In Vancouver?
Seriously — why do it?
“I need funding to work on my startup”
Constraints breed creativity.
=
Market Trends
• Big Pharma & Med Device are slashing R&D
• Preferring to acquire startups
• R&D costs are falling
Axiom Orthopaedics
• No outside funding
• Modular Shoulder Replacement
• Several patents
• Acquired after < 2 years
The Timeline
1000000
2000000
3000000
4000000
Prototype D.V. FDA Production Profitability
Costs
Bootstrappability
1000000
2000000
3000000
4000000
Prototype D.V. FDA Production Profitability
How to get there?
• Customer
• Problem
• Solution
ApproachesTech-first Customer-first
“You don’t have time to build the wrong app.”
-Tomer Sharon
“Would you rather sell your [device] to 100% of the people in a million-dollar market, or 1% of the people in a 100-million-dollar market?”
-Rob Walling
Ideation…
Inspiration strikes!
"...you must get more enjoyment out of saving your money than you do spending your money.”
-Suze Orman
Hardware
State of the Art
“State of the Art”
Moore’s Law
Prototyping Boards
$30$50 $8
Sensors
Handheld / Tablet
Bluetooth & NFC
Wearables
More Than Silicon
3D Printing
3D Scanning
Hackerspaces
Contract Manufacturing
What’s your differentiator?
Software
Open Source
Cloud
?
Hardware
DIY Cloud Managed
OS
Application
VM
Hardware
OS
Application
VM
Hardware
OS
Application
VM
Cloud
Big Data & Machine Learning
Big Data & Machine Learning
Essentially, it’s all statistics
Regulatory
• 510K • PMA • Under-the-radar
VS
510k
PMA
510k
• Design Controls
• Predicates
• Pre-submission Meeting
Predicates
Study
• Validation
• Animal Trial
• Human Trial
Under-the-radar
EEGFitness Nutrition
When should I start thinking about regulatory?
• Design Controls • Class I / II / III • Predicates
From day one.
Revenue Models
• Reimbursement
• Have a plan BEFORE YOU CLEAR FDA!!!
• Direct-to-consumer
Reimbursement
• Coding
• CPT (AMA)
• HCPCS (HHS)
• But a code is NOT ENOUGH!
Direct to Consumer
Direct to Consumer
When should I start thinking about my revenue model?
• Coding • Reimbursement • Direct-to-consumer
From day one.
Networking
It’s not what you know…
Fundraising• Non-dilutive
• Grants
• Dilutive
• Angels
• VCs
Grants - USA
Grants - Canada
Contests
$40,000
Investment
"If you want advice, ask for money.
If you want money, ask for advice."
Patents
• Surgical Technique vs Device
• Trade Secret
• Tech Transfer
• Provisional Patent
Exit Strategy
• 1 bidder = :(
• Board of Advisors
• Have options
Recap
• Find something important to work on
• You can do it on a shoe-string budget
• Focus on your differentiator & forget the rest
Closing Thoughts
SALT
• $10K funding
• Urine test for sodium
• Provisional Patent
• Working Prototype
• Minimal funding
• Smart phone case
• Working Prototype
Anal Fistula Startup
• Bootstrapped
• Completed Prototype
• Pending Animal Trials
Bootstrapper’s Bookshelf
