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How to Start a Med Device Startup from your Garage

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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

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Talk originally given at Hacking Health New York on May 20, 2015:

http://www.meetup.com/Hacking-Health-New-York/events/222184028/

Published in: Health & Medicine
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How to Start a Med Device Startup from your Garage

  1. 1. How to Start a Med Device Startup From Your Garage David Y. Kay @DavidYKay
  2. 2. Garage? In New York?
  3. 3. Seriously — why do it?
  4. 4. “I need funding to work on my startup”
  5. 5. Constraints breed creativity.
  6. 6. Market Trends • Big Pharma & Med Device are slashing R&D • Preferring to acquire small startups • R&D costs are falling
  7. 7. The Timeline 1000000 2000000 3000000 4000000 Prototype D.V. FDA Production Profitability Costs
  8. 8. How to get there? • Customer • Problem • Solution
  9. 9. Approaches Tech-first Customer-first
  10. 10. “You don’t have time to develop the wrong app.” -Tomer Sharon
  11. 11. “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
  12. 12. Ideation…
  13. 13. Inspiration strikes!
  14. 14. “Keep your personal burn rate low. This alone will give you a lot of opportunities in life.” -Sam Altman
  15. 15. "...you must get more enjoyment out of saving your money than you do spending your money.” -Suze Orman
  16. 16. YNAB
  17. 17. Hardware
  18. 18. Moore’s Law
  19. 19. Moore’s Law
  20. 20. Sensors
  21. 21. Arduino vs Raspberry Pi vs
  22. 22. Bluetooth & NFC
  23. 23. Handheld / Tablet
  24. 24. Wearables
  25. 25. Not Just Silicon
  26. 26. 3D Printing
  27. 27. Hackerspaces
  28. 28. Contract Manufacturing
  29. 29. Software
  30. 30. Open Source
  31. 31. Microsoft
  32. 32. Big Data & Machine Learning
  33. 33. Big Data & Machine Learning Essentially, it’s all statistics
  34. 34. Cloud ?
  35. 35. Cloud Hardware DIY Cloud Managed OS Application VM Hardware OS Application VM Hardware OS Application VM
  36. 36. What’s your differentiator?
  37. 37. Carpenters vs Engineers
  38. 38. Coder Culture
  39. 39. Regulatory • 510K / PMA • HIPAA
  40. 40. 510k
  41. 41. PMA
  42. 42. 510k • Predicates • Pre-submission Meeting
  43. 43. Predicates
  44. 44. Study • Validation • Animal Trial • Human Trial
  45. 45. HIPAA • Privacy Rule • Security Rule • BAAs
  46. 46. BAAs Hardware OS Application VM You’re on your own! It’s on Amazon. } }
  47. 47. Cloud, Revisited Hardware DIY Cloud Managed OS Application VM Hardware OS Application VM Hardware OS Application VM
  48. 48. Networking It’s not what you know…
  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. The Team • Cross-functional
  53. 53. Fundraising • Non-dilutive • SBIR / STTR • Dilutive • Angels • VCs
  54. 54. Grants
  55. 55. SBIR Workshop • Becky Aistrup - 20 yrs exp w/ SBIR • Tomorrow @ 8:30AM • $25 • http://bit.ly/nyc-sbir-2015
  56. 56. Contests
  57. 57. Investment "If you want advice, ask for money. If you want money, ask for advice."
  58. 58. Mentorship • Board of Advisors
  59. 59. Accelerators Good idea?
  60. 60. Intellectual Property • Tech Transfer • Lawyers
  61. 61. Recap • Find something important to work on • You can do it on a shoe-string budget • Focus on your differentiator & forget the rest
  62. 62. Closing Thoughts
  63. 63. Axiom Orthopaedics • No outside funding • Modular Shoulder Replacement • Several patents • Acquired after < 2 years
  64. 64. SALT • $10K funding • Urine test for sodium • Provisional Patent • Working Prototype
  65. 65. Bootstrapper’s Bookshelf
  66. 66. Fin • @DavidYKay • DavidYKay@gmail.com • DavidYKay.com

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