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![“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](https://image.slidesharecdn.com/howtostartameddevicestartupfromyourgarage-160404182002/75/How-to-Start-a-Med-Device-Startup-From-Your-Garage-Vancouver-Edition-24-2048.jpg)
Uploaded byDavid Kay
How to Start a Med Device Startup From Your Garage - Vancouver Edition
The document outlines steps to start a medical device startup, offering insights into funding, regulatory requirements, and market strategies. It emphasizes the importance of identifying customer needs and differentiators, while suggesting that entrepreneurs can launch successfully from a limited budget. Key considerations include revenue models, networking, and obtaining patents as part of the startup journey.
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How to Start a Med Device Startup From Your Garage - Vancouver Edition
- 1. How to Starta Med Device Startup From Your Garage David Y. Kay @DavidYKay
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- 5. Seriously — whydo it?
- 6. “I need fundingto work on my startup”
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- 15. Market Trends • BigPharma & Med Device are slashing R&D • Preferring to acquire startups • R&D costs are falling
- 18. Axiom Orthopaedics • Nooutside funding • Modular Shoulder Replacement • Several patents • Acquired after < 2 years
- 19. The Timeline 1000000 2000000 3000000 4000000 Prototype D.V.FDA Production Profitability Costs
- 20. Bootstrappability 1000000 2000000 3000000 4000000 Prototype D.V. FDAProduction Profitability
- 21. How to getthere? • Customer • Problem • Solution
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- 23. “You don’t havetime to build the wrong app.” -Tomer Sharon
- 24. “Would you rathersell 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
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- 30. "...you must getmore enjoyment out of saving your money than you do spending your money.” -Suze Orman
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- 33. State of theArt
- 34. “State of theArt”
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- 53. Big Data &Machine Learning
- 54. Big Data &Machine Learning Essentially, it’s all statistics
- 55. Regulatory • 510K • PMA •Under-the-radar
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- 59. 510k • Design Controls •Predicates • Pre-submission Meeting
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- 61. Study • Validation • AnimalTrial • Human Trial
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- 63. When should Istart thinking about regulatory?
- 64. • Design Controls •Class I / II / III • Predicates From day one.
- 65. Revenue Models • Reimbursement •Have a plan BEFORE YOU CLEAR FDA!!! • Direct-to-consumer
- 66. Reimbursement • Coding • CPT(AMA) • HCPCS (HHS) • But a code is NOT ENOUGH!
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- 69. When should Istart thinking about my revenue model?
- 70. • Coding • Reimbursement •Direct-to-consumer From day one.
- 71. Networking It’s not whatyou know…
- 75. Fundraising • Non-dilutive • Grants •Dilutive • Angels • VCs
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- 80. Investment "If you wantadvice, ask for money. If you want money, ask for advice."
- 82. Patents • Surgical Techniquevs Device • Trade Secret • Tech Transfer • Provisional Patent
- 83. Exit Strategy • 1bidder = :( • Board of Advisors • Have options
- 84. Recap • Find somethingimportant to work on • You can do it on a shoe-string budget • Focus on your differentiator & forget the rest
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- 86. SALT • $10K funding •Urine test for sodium • Provisional Patent • Working Prototype
- 87. • Minimal funding •Smart phone case • Working Prototype
- 88. Anal Fistula Startup •Bootstrapped • Completed Prototype • Pending Animal Trials
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- 90. Join my HealthTech Newsletter: bit.ly/dk-newsletter