How to Start a Med Device Startup From Your Garage - Vancouver Edition
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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.
![“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-160404182002/85/How-to-Start-a-Med-Device-Startup-From-Your-Garage-Vancouver-Edition-24-320.jpg)
How to Start a Med Device Startup From Your Garage - Vancouver Edition
- 1. How to Start a Med Device Startup From Your Garage David Y. Kay @DavidYKay
- 5. Seriously — why do it?
- 6. “I need funding to work on my startup”
- 14. =
- 15. Market Trends • Big Pharma & Med Device are slashing R&D • Preferring to acquire startups • R&D costs are falling
- 18. Axiom Orthopaedics • No outside 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. FDA Production Profitability
- 21. How to get there? • Customer • Problem • Solution
- 23. “You don’t have time to build the wrong app.” -Tomer Sharon
- 24. “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
- 25. Ideation…
- 30. "...you must get more enjoyment out of saving your money than you do spending your money.” -Suze Orman
- 32. Hardware
- 33. State of the Art
- 34. “State of the Art”
- 36. Moore’s Law
- 39. Sensors
- 41. Bluetooth & NFC
- 42. Wearables
- 44. 3D Printing
- 45. 3D Scanning
- 46. Hackerspaces
- 49. Software
- 50. Open Source
- 51. Cloud ?
- 53. Big Data & Machine Learning
- 54. Big Data & Machine Learning Essentially, it’s all statistics
- 55. Regulatory • 510K • PMA • Under-the-radar
- 56. VS
- 57. 510k
- 58. PMA
- 59. 510k • Design Controls • Predicates • Pre-submission Meeting
- 60. Predicates
- 61. Study • Validation • Animal Trial • Human Trial
- 63. When should I start 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!
- 69. When should I start thinking about my revenue model?
- 70. • Coding • Reimbursement • Direct-to-consumer From day one.
- 71. Networking It’s not what you know…
- 75. Fundraising • Non-dilutive • Grants • Dilutive • Angels • VCs
- 76. Grants - USA
- 77. Grants - Canada
- 79. Contests $40,000
- 80. Investment "If you want advice, ask for money. If you want money, ask for advice."
- 82. Patents • Surgical Technique vs Device • Trade Secret • Tech Transfer • Provisional Patent
- 83. Exit Strategy • 1 bidder = :( • Board of Advisors • Have options
- 84. Recap • Find something important to work on • You can do it on a shoe-string budget • Focus on your differentiator & forget the rest
- 85. Closing Thoughts
- 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
- 90. Join my Health Tech Newsletter: bit.ly/dk-newsletter