How to Start a Med Device Startup From Your Garage

David Y. Kay @DavidYKay

Garage? In New York?

Seriously — why do it?

“I need funding to work on my startup”

Constraints breed creativity.

Market Trends

• Big Pharma & Med Device are slashing R&D

• Preferring to acquire small startups

• R&D costs are falling

The Timeline

1000000

2000000

3000000

4000000

Prototype D.V. FDA Production Profitability

Costs

How to get there?

• Customer

• Problem

• Solution

ApproachesTech-first Customer-first

“You don’t have time to develop the wrong app.”

-Tomer Sharon

“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

Ideation…

Inspiration strikes!

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

-Sam Altman

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

-Suze Orman

YNAB

Hardware

Moore’s Law

Moore’s Law

Sensors

Arduino vs Raspberry Pi

vs

Bluetooth & NFC

Handheld / Tablet

Wearables

Not Just Silicon

3D Printing

Hackerspaces

Contract Manufacturing

Software

Open Source

Microsoft

Big Data & Machine Learning

Big Data & Machine Learning

Essentially, it’s all statistics

Cloud

?

Cloud

Hardware

DIY Cloud Managed

OS

Application

VM

Hardware

OS

Application

VM

Hardware

OS

Application

VM

What’s your differentiator?

Carpenters vs Engineers

Coder Culture

Regulatory

• 510K / PMA • HIPAA

510k

PMA

510k

• Predicates

• Pre-submission Meeting

Predicates

Study

• Validation

• Animal Trial

• Human Trial

HIPAA

• Privacy Rule

• Security Rule

• BAAs

BAAs

Hardware

OS

Application

VM

You’re on your own!

It’s on Amazon.

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Cloud, Revisited

Hardware

DIY Cloud Managed

OS

Application

VM

Hardware

OS

Application

VM

Hardware

OS

Application

VM

Networking

It’s not what you know…

Revenue Models

• Reimbursement

• Have a plan BEFORE YOU CLEAR FDA!!!

• Direct-to-consumer

Reimbursement

• Coding

• CPT (AMA)

• HCPCS (HHS)

• But a code is NOT ENOUGH!

Direct to Consumer

The Team

• Cross-functional

Fundraising• Non-dilutive

• SBIR / STTR

• Dilutive

• Angels

• VCs

Grants

SBIR Workshop

• Becky Aistrup - 20 yrs exp w/ SBIR

• Tomorrow @ 8:30AM

• $25

• http://bit.ly/nyc-sbir-2015

Contests

Investment

"If you want advice, ask for money.

If you want money, ask for advice."

Mentorship

• Board of Advisors

Accelerators

Good idea?

Intellectual Property

• Tech Transfer

• Lawyers

Recap

• Find something important to work on

• You can do it on a shoe-string budget

• Focus on your differentiator & forget the rest

Closing Thoughts

Axiom Orthopaedics

• No outside funding

• Modular Shoulder Replacement

• Several patents

• Acquired after < 2 years

SALT

• $10K funding

• Urine test for sodium

• Provisional Patent

• Working Prototype

Bootstrapper’s Bookshelf

Fin

• @DavidYKay

• DavidYKay@gmail.com

• DavidYKay.com