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.

1. How to Start a
Med Device Startup
From Your Garage
David Y. Kay
@DavidYKay

2. Garage? In Vancouver?

5. Seriously — why do it?

6. “I need funding to work on my startup”

11. Constraints breed creativity.

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

22. Approaches
Tech-first Customer-first

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…

26. Inspiration strikes!

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

38. Prototyping Boards
$30$50 $8

39. Sensors

40. Handheld / Tablet

41. Bluetooth & NFC

42. Wearables

43. More Than Silicon

44. 3D Printing

45. 3D Scanning

46. Hackerspaces

47. Contract Manufacturing

48. What’s your differentiator?

49. Software

50. Open Source

51. Cloud
?

52. Hardware
DIY Cloud Managed
OS
Application
VM
Hardware
OS
Application
VM
Hardware
OS
Application
VM
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

62. Under-the-radar
EEGFitness Nutrition

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!

67. Direct to Consumer

68. Direct to Consumer

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

89. Bootstrapper’s Bookshelf

90. Join my Health Tech Newsletter:
bit.ly/dk-newsletter