Starting a Fundable Medical Device Company Christopher Porter - - PowerPoint PPT Presentation

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Starting a Fundable Medical Device Company Christopher Porter - - PowerPoint PPT Presentation

Starting a Fundable Medical Device Company Christopher Porter Medical Genesis Christopher Porter, PhD n Chemical Engineer/Material Science n 40 yrs in Medical Industry in Product Development and Management n Serial Entrepreneur/Intrapreneur


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Starting a Fundable Medical Device Company

Christopher Porter Medical Genesis

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Christopher Porter, PhD

n Chemical Engineer/Material Science n 40 yrs in Medical Industry in Product

Development and Management

n Serial Entrepreneur/Intrapreneur

  • 6 Successful Startups
  • 2 Divisions (J & J and Pfizer)
  • Multiple exits through IPOs and Sale of Company

n 30 + Products on Market n 50+ Patents n Early Stage Life Science Company Advice

  • LIFE SCIENCE WASH, COMOTION, WINGS, W-FUND,

LSDF, COULTER

  • Over 100 companies/year
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BACKGROUND

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Medical Product’s Characteristics

n Highly Regulated n High Value/High Margins n Different Types

  • Drugs
  • Biologics
  • Diagnostics
  • Devices

n Third Party Payers n Medical IT has a different model

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STARTING AN ENTERPRISE

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Proxima

  • A catheter system to treat

brain and breast cancer with radiation

  • Sold to Cytec in 2005

EXAMPLE

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TUMOR

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Resected Tumor Cancerous Margins EXTERNAL BEAM RADIATION FROM DIFFERENT DIRECTIONS Damage to Healthy Tissue Missing the Target M

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Balloon with Radioactive Fluid Low Level- Localized and Precise Radiation

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Gliasite Clinical Data

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ADVANTAGES

n Less expensive than fractional

radiation

n Does not need specialized and

expensive equipment

n Faster Treatment Time n Easier on Patients n Less Healthy Tissue Damage n Arguably more effective treatment n Can be adapted to other cancers

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MAMOSITE

Radiation following a lumpectomy for Breast Cancer

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GOING FORWARD

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GENESIS OF A MEDICAL PRODUCT COMPANY

CONCEPT

DEVELOPMENT AND CLINICALS COMMERCIALIZATION

EXIT STRATEGY

IDEA

Feasibility Proof of Concept FDA Approval Sales and Profitability IPO or Sale of Company

VALUE ADDER MILESTONES

COMPELLING UNMET NEED

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FUNDABLE STAGES OF A MEDICAL COMPANY

  • 2. Proof of Concept
  • 4. Commercialization
  • 5. Liquidity (Exit Event)

3.Final Development and Regulatory Approval

  • 1. Fundable Idea (Feasibility)
  • 0. Initial Concept (IDEA)

$ $ $

EARLY STAGES PLANNING

Business Plan

LATER STAGES EXECUTION

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COMMON MISTAKES

n Elegant solutions to non-problems

  • Technology in search of a need of a solution
  • Invented needs
  • Funding the lab instead of advancing the company

n Product, not an company

  • Small market
  • Evolutionary, not Revolutionary
  • Belongs with an Existing Company

n Wasting resources on overly complex products

  • Features that are not important
  • Increases cost, complexity and risk
  • In love with the technology
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COMMON MISTAKES

n Not doing enough upfront homework

  • Not addressing critical items
  • Don’t talk to potential customers
  • Get far down the path before the mistake is

clear

n Non-investable management pitching the

company

  • Better to have no CEO rather the wrong one

n Trying to raise investor money to soon

  • Have not fully addressed critical milestones
  • 10 resurrections to take care of one crucifixion
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FUNDING

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Staged Approach

FEASABILITY OK PROOF OF CONCEPT OK PRODUCT DEVELOPMENT OK IDEA

$ $ $

TIME

$

$

Probability of Success VALUE OF COMPANY

LOW HIGH

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Value Increases Discreetly

TIME COMPANY VALUE

IDEA PROOF OF CONCEPT FDA APPROVAL

SIGNIFICANT SALES, POSITIVE CASH FLOW

$

LIQUIDITY

RISK

VALUE RISK

HIGH LOW Value Added Milestones

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FUND RAISING AND DILUTION

FOUNDERS (Common)

  • 5. PUBLIC OFFERING
  • 4. COMMERCIALIZATION
  • 3. FDA APPROVAL
  • 2. PROOF OF CONCEPT

IDEA, KNOWHOW, IP SWEAT-EQUITY $ $ $ $ PUBLIC FUNDING POINT VALUE RECEIVED STOCK IN COMPANY

  • 1. FEASABILITY

$ INVESTORS (Preferred)

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STAGES OF A COMPANY

IDEA- (DEFINE A NEED AND PRODUCT TO FILL IT) DEMONSTRATE PROOF OF CONCEPT COMPLETE DEVELOPMENT AND OBTAIN REGULATORY APPROVAL COMMERCIALIZATION LIQUIDITY EVENT (IPO OR SELL IT) START 6-18 Mo 0.2-1.0 MM$ 1-3 YR 5-15 MM$ 1-3 YR 10-20 MM$ END 0.3-1.0 MM $ 5-10 MM $ 20-40 MM$ 100-200 MM$ STAGE TIME AND $s RAISED PRE-MONEY VALUE

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Value and Ownership

20 40 60 80 100 120

Start 1st 2nd 3rd Liquidity

Round % or $MM

% Ownership Founders Value Company Value

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Sources of Funding

n NON DILUTIVE

  • Government Grants
  • Foundations
  • Other Grants

n EARLY STAGES (DILUTIVE)

  • Sweat Equity
  • Self, Friends and Family
  • Angels
  • Seed Funds

n LATER STAGES

  • Existing Company (Strategic Investors)
  • Venture Capital

n LIQUIDITY

  • Public (IPO)
  • Sell the company
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Venture and Angel Investors

n Good ones can add a lot of value to the

company

  • Connections and Networking
  • Know How and Advice
  • Credibility
  • Continued source of funding

n Their job is to maximize the return for

themselves or their funds

n Want to structure as strong a company as

possible -- even at the expense of the founders

n Will try and get control of the company

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WHAT INVESTORS ARE LOOKING FOR

n A good Return on Investment

  • Liquidity Event

n Sell the Company or Idea n Public Offering

  • High Returns

n Initial value of the venture n Time it takes to get to liquidity n How much total money will go into it by that time n What will be worth at the liquidity event

n Is this worth it for investor to work on

  • Size of the fund
  • Other Opportunities they have to make an investment
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POTENTIAL DEAL KILLERS

n Bet People as Much as (more than)

Ideas

n Evolutionary vs. Revolutionary n Product vs. a Company n Market Potential Too Low n No or Poor Patent Position n Reimbursement is unlikely (Make it

and they will come fallacy)

n Too high expectation of initial value n Regulatory is too risky n Overly optimistic projections

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What I Have Learned

n Most excited about the things you

know the least about- do your homework

n You don’t know what you don’t

know - find experienced help

n The last person you want to fool

is your self – People fall in love with their own ideas and will not listen

n Invest in only things that create

value

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What I Have Learned

n Don’t be too valuation sensitive

  • 100% of nothing is not as valuable of 25%
  • f something
  • Get good investors

n Always raise money before you need it n Raise enough money-It always takes

longer and cost more than you think

n The largest predictor of success

are your expectations