In "How to Start a Med Device Startup From Your Garage," David Kay will challenge your assumptions about how a medical technology company is born by taking a deep look at how to build a meaningful med device startup on a shoe-string budget. In this whirlwind tour, he will discuss how to build a capital-efficient medical device startup from the ground up, covering topics including: * Meeting potential co-founders * Making smart technology decisions * Buy vs build? * Avoiding agony and saving tens of thousands of dollars by intelligently navigating the FDA submission process * To patent or not to patent? * Understanding the fundamentals of HIPAA * Rapid prototyping techniques * Tech transfer: friend or foe? * Finding the right business for YOU And, for a brief moment of weakness, we'll touch on raising capital. * * * * * * * * About David Kay David Kay is a on a mission to simplify medical diagnostics by wielding modern technology. He currently leads software development at SALT, a medical device startup focused on bringing hassle-free salt monitoring to patients at home. Happy to have been a Google engineer, and even happier to have rapidly resigned, David feels most alive when pushing his own boundaries and the stakes are high. He was the founding CTO at EnHatch, which provides sales and marketing technology to medical device companies, and the founding CTO of Authy, a security startup which was recently acquired by Twilio. David also deeply enjoys teaching, and has led mobile development workshops at Princeton University and Rutgers University, taught Ruby on Rails at iHub Nairobi, and served as an Android instructor at General Assembly. His technical achievements include: * Winner of the MIT Telehealth grand prize and the Merck Telehealth grand prize at the MIT Hacking Medicine Grand Hack * Winner of "best design/best prototype" at the Yale Patient Experience Hackathon * 3rd place at GHG Patient Outcomes Hackathon * 2x Global finalist at NASA Space Apps Challenge * 2x semi-finalist of StartupBus SxSW * 2nd place at TechCrunch Disrupt San Francisco * 2x featured for "Hack of the Month" at New York Tech Meetup * Led development on several pioneering iPad apps for Otsuka Medical * Led an 7-man team to build an app in only 3 weeks for a debut on Shark Tank * Project lead on the Android app for 1-800-GOT-JUNK's worldwide truck fleet * iPad lead for Deutsche Bank's first mobile app, GlobalPrime Apart from his love for medical technology, David is also an avid inline skater and certified skate instructor. You can find him at: www.davidykay.com * * * * * * * * Talk originally given at Hacking Health New York on May 20, 2015: http://www.meetup.com/Hacking-Health-New-York/events/222184028/

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

3. Garage? In New York?

6. Seriously — why do it?

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

11. Constraints breed creativity.

12. Market Trends
• Big Pharma & Med Device are slashing R&D
• Preferring to acquire small startups
• R&D costs are falling

15. The Timeline
1000000
2000000
3000000
4000000
Prototype D.V. FDA Production Profitability
Costs

16. How to get there?
• Customer
• Problem
• Solution

17. Approaches
Tech-first Customer-first

18. “You don’t have time to
develop the wrong app.”
-Tomer Sharon

19. “Would you rather sell your
[device] to 100% of the people in
a 50,000 person market, or 10%
of the people in a 500,000 person
market?”
-Rob Walling

20. Ideation…

21. Inspiration strikes!

24. “Keep your personal burn rate low. This alone
will give you a lot of opportunities in life.”
-Sam Altman

25. "...you must get more
enjoyment out of saving
your money than you do
spending your money.”
-Suze Orman

27. YNAB

29. Hardware

31. Moore’s Law

32. Moore’s Law

33. Sensors

34. Arduino vs Raspberry Pi
vs

35. Bluetooth & NFC

36. Handheld / Tablet

37. Wearables

38. Not Just Silicon

39. 3D Printing

40. Hackerspaces

41. Contract Manufacturing

42. Software

44. Open Source

45. Microsoft

46. Big Data & Machine
Learning

47. Big Data & Machine
Learning
Essentially, it’s all statistics

48. Cloud
?

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

50. What’s your differentiator?

51. Carpenters vs Engineers

52. Coder Culture

53. Regulatory
• 510K / PMA
• HIPAA

54. 510k

55. PMA

56. 510k
• Predicates
• Pre-submission Meeting

57. Predicates

58. Study
• Validation
• Animal Trial
• Human Trial

59. HIPAA
• Privacy Rule
• Security Rule
• BAAs

60. BAAs
Hardware
OS
Application
VM
You’re on your own!
It’s on Amazon.
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}

61. Cloud, Revisited
Hardware
DIY Cloud Managed
OS
Application
VM
Hardware
OS
Application
VM
Hardware
OS
Application
VM

62. Networking
It’s not what you know…

66. Revenue Models
• Reimbursement
• Have a plan BEFORE YOU CLEAR FDA!!!
• Direct-to-consumer

67. Reimbursement
• Coding
• CPT (AMA)
• HCPCS (HHS)
• But a code is NOT ENOUGH!

68. Direct to Consumer

69. The Team
• Cross-functional

70. Fundraising
• Non-dilutive
• SBIR / STTR
• Dilutive
• Angels
• VCs

71. Grants

72. SBIR Workshop
• Becky Aistrup - 20 yrs exp w/ SBIR
• Tomorrow @ 8:30AM
• $25
• http://bit.ly/nyc-sbir-2015

73. Contests

74. Investment
"If you want advice, ask for money.
If you want money, ask for advice."

75. Mentorship
• Board of Advisors

76. Accelerators
Good idea?

78. Intellectual Property
• Tech Transfer
• Lawyers

79. Recap
• Find something important to work on
• You can do it on a shoe-string budget
• Focus on your differentiator & forget the rest

80. Closing Thoughts

81. Axiom Orthopaedics
• No outside funding
• Modular Shoulder Replacement
• Several patents
• Acquired after < 2 years

82. SALT
• $10K funding
• Urine test for sodium
• Provisional Patent
• Working Prototype

83. Bootstrapper’s Bookshelf

84. Fin
• @DavidYKay
• DavidYKay@gmail.com
• DavidYKay.com