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How to Start a Med Device Startup From Your Garage - Vancouver Edition

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New and improved!

This is a Canada-localized, updated version of my talk on starting a medical device startup with no outside capital.

Given on March 31, 2016 at HxD Vancouver.

Published in: Health & Medicine
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How to Start a Med Device Startup From Your Garage - Vancouver Edition

  1. 1. How to Start a Med Device Startup From Your Garage David Y. Kay @DavidYKay
  2. 2. Garage? In Vancouver?
  3. 3. Seriously — why do it?
  4. 4. “I need funding to work on my startup”
  5. 5. Constraints breed creativity.
  6. 6. =
  7. 7. Market Trends • Big Pharma & Med Device are slashing R&D • Preferring to acquire startups • R&D costs are falling
  8. 8. Axiom Orthopaedics • No outside funding • Modular Shoulder Replacement • Several patents • Acquired after < 2 years
  9. 9. The Timeline 1000000 2000000 3000000 4000000 Prototype D.V. FDA Production Profitability Costs
  10. 10. Bootstrappability 1000000 2000000 3000000 4000000 Prototype D.V. FDA Production Profitability
  11. 11. How to get there? • Customer • Problem • Solution
  12. 12. Approaches Tech-first Customer-first
  13. 13. “You don’t have time to build the wrong app.” -Tomer Sharon
  14. 14. “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
  15. 15. Ideation…
  16. 16. Inspiration strikes!
  17. 17. "...you must get more enjoyment out of saving your money than you do spending your money.” -Suze Orman
  18. 18. Hardware
  19. 19. State of the Art
  20. 20. “State of the Art”
  21. 21. Moore’s Law
  22. 22. Prototyping Boards $30$50 $8
  23. 23. Sensors
  24. 24. Handheld / Tablet
  25. 25. Bluetooth & NFC
  26. 26. Wearables
  27. 27. More Than Silicon
  28. 28. 3D Printing
  29. 29. 3D Scanning
  30. 30. Hackerspaces
  31. 31. Contract Manufacturing
  32. 32. What’s your differentiator?
  33. 33. Software
  34. 34. Open Source
  35. 35. Cloud ?
  36. 36. Hardware DIY Cloud Managed OS Application VM Hardware OS Application VM Hardware OS Application VM Cloud
  37. 37. Big Data & Machine Learning
  38. 38. Big Data & Machine Learning Essentially, it’s all statistics
  39. 39. Regulatory • 510K • PMA • Under-the-radar
  40. 40. VS
  41. 41. 510k
  42. 42. PMA
  43. 43. 510k • Design Controls • Predicates • Pre-submission Meeting
  44. 44. Predicates
  45. 45. Study • Validation • Animal Trial • Human Trial
  46. 46. Under-the-radar EEGFitness Nutrition
  47. 47. When should I start thinking about regulatory?
  48. 48. • Design Controls • Class I / II / III • Predicates From day one.
  49. 49. Revenue Models • Reimbursement • Have a plan BEFORE YOU CLEAR FDA!!! • Direct-to-consumer
  50. 50. Reimbursement • Coding • CPT (AMA) • HCPCS (HHS) • But a code is NOT ENOUGH!
  51. 51. Direct to Consumer
  52. 52. Direct to Consumer
  53. 53. When should I start thinking about my revenue model?
  54. 54. • Coding • Reimbursement • Direct-to-consumer From day one.
  55. 55. Networking It’s not what you know…
  56. 56. Fundraising • Non-dilutive • Grants • Dilutive • Angels • VCs
  57. 57. Grants - USA
  58. 58. Grants - Canada
  59. 59. Contests $40,000
  60. 60. Investment "If you want advice, ask for money. If you want money, ask for advice."
  61. 61. Patents • Surgical Technique vs Device • Trade Secret • Tech Transfer • Provisional Patent
  62. 62. Exit Strategy • 1 bidder = :( • Board of Advisors • Have options
  63. 63. Recap • Find something important to work on • You can do it on a shoe-string budget • Focus on your differentiator & forget the rest
  64. 64. Closing Thoughts
  65. 65. SALT • $10K funding • Urine test for sodium • Provisional Patent • Working Prototype
  66. 66. • Minimal funding • Smart phone case • Working Prototype
  67. 67. Anal Fistula Startup • Bootstrapped • Completed Prototype • Pending Animal Trials
  68. 68. Bootstrapper’s Bookshelf
  69. 69. Join my Health Tech Newsletter: bit.ly/dk-newsletter

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