heal ohio october 2, 2008
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Heal Ohio October 2, 2008. So You Want to Start a Bioscience Company? John F. Lewis Jr. Vice President. An Ohio Thomas Edison Center. Why are we here?. Learn a bit about starting a business Boring Challenge you, do you really want to start a business? Fun - PowerPoint PPT PresentationTRANSCRIPT
Heal OhioOctober 2, 2008
So You Want to Start a Bioscience Company?
John F. Lewis Jr.
Vice PresidentAn Ohio Thomas Edison Center
© 2008 BioOhio
Why are we here?
• Learn a bit about starting a business– Boring
• Challenge you, do you really want to start a business?– Fun
Slides modified from Gary Smith & Bill Timmons
© 2008 BioOhio
Technology Innovation Cycle
ADVANCED RESEARCH(8-15 years)
PRODUCT CYCLE(1-3 years)
BREAKTHROUGH(5-8 years)
v:
Discovery Development Application
t
er
CrossIndustrySources
FederalResearch
CollaborativeResearch
ResearchUniversities
GlobalSourcing
CorporateLabs
InternationalSources
Integration
Sense &Locate
GapAssessment
Assess
ProductPlatform
Produc
CustomDrives
UnmetNeeds
Develop
Product Development Involves the “Application” of Technology
© 2008 BioOhio
Medical DeviceCommercialization Pathway
Concept Development and Initial Research
Company Formation / Project Team
Secure IP Portfolio
Product Engineering and Prototype Development
Pre-Clinical and Clinical Studies
Manufacturing Development/ expansion for clinical trials
Clinical Trials/Outcomes
FDA Approval and Market Launch
Expansion/ Investment in Working Capital
$A
B
© 2008 BioOhio
Typical Product Development Process
Source: PTRM
© 2008 BioOhio
Critical Success Factors
• Differentiated, superior product/technology • Sharp, early product definition • Quality of pre-development activities• Strong market orientation• Reduced cost / drives revenue• Customers willing to pay $• Effective organizational structure• Engaged Partners• Quality of execution
– Technical, Business
© 2008 BioOhio
7
Sources of Capital
• Bootstrapping– Who will benefit from your
success? • FF&F
– Find enthusiastic supporters in your personal network
– Put your own money in (investors want to see this commitment)
• Angels– Looking to make money,
but also hope to get involved and add value
• Grants – Lots of free and cheap
money out there
• Venture / Private Equity– Care about making a return
on investment– Often do not have time or
ambition to get to involved
• SBA / Banks – Always take debt before
equity, but often difficult as they require security (receivables, assets…)
© 2008 BioOhio
Pitching
• 10 slides, 20 minutes, 30 Point font
• Differentiate for different audiences
• Investor
• Sales Prospect
• Partner Prospect
• B to B
• Problem• Solution• Business Model• Your Magic• Mktg/Sales• Competition• Mgmt Team• Financial Projections• Current Status – The
Ask
Bill & John ask, why do you want to start your own business?
• Be your own boss
• Set your own hours
• Achieve fame …
• … and fortune $$$
• Spend more time with family … sailing …skiing …[fill in blank]
The Truth of the Matter
“Be your own boss”
means
Self Discipline!
The Truth of the Matter
You Work
like a …
DOG!
“Set your own hours”
means
The Truth of the Matter
You made the headlines!
Local Businessman Runs Naked Through Streets Shouting, “I Can’t Take
It Any More!” Crowd Panics
“Achieve fame …”
means
The Truth of the Matter
You drive the same car for 10 years
“Achieve fortune $$$”
means
The Truth of the Matter
“Spend more time with the family”
means …
Driving your spouse and kids crazy!
“Do The Common Uncommonly Well”
“Know Your Market Needs”
“Have A Product To Sell”
“Get The Right Technical & Business Partners!”
“Make Sure Your Spouse Is On Board”
© 2008 BioOhio
Great Resources
• Regional ESP’s, Edison Centers, Incubators
• Licensing Executive Society
• AdvaMed – wound care sector
• www.wu2008.com
• www.woundpedia.com
• 58 Ohio sources of healthcare capital– North Coast Angels
– Ohio Technology Angel Fund
• BioOhio – Tony Dennis, John Lewis…
© 2008 BioOhio
BioOhio Strategyindustry growth, resource optimization, community
building
Company & Capital Formation
Company Attraction & Expansion
Association Function
Workforce Development
© 2008 BioOhio
BioOhio Statewide Board• John A Bantle, II, PhD, Vice President - Research, Wright State University• Timothy G. Biro, CEO - MORK Process; Partner, Ohio Innovation Fund & Reservoir Ventures• Rathindra Bose, PhD, Vice President of Research - Ohio University• Mark A. Collar, Chairman - Third Frontier Advisory Board• Mark J. Coticchia, VP Research and Technology Management- Case Western Reserve• Sandra J. Degen, PhD, Vice President for Research- University of Cincinnati• Anthony J. Dennis, PhD, President & CEO- BioOhio• Paul DiCorletto, Chairman - Lerner Research Institute (Cleveland Clinic)• John Fisher, Executive Vice President, Ohio Farm Bureau Federation• Mike Hooven, President & CEO - Enable Medical Technologies• Peter G. Kleinhenz, General Partner- CID Equity Partners• Barbara Kunz, President - Health & Life Science Global Division Battelle• Tom Murphy, Senior Vice President, Boehringer Ingelheim’s Ben Venue• John M. Rice, PhD, Managing Partner - Triathlon Medical Ventures• David R. Scholl, PhD, President & CEO - Diagnostic Hybrids, Inc.• Arnold W. Strauss, MD, Director - Cincinnati Children’s Research Foundation• John Voyze, Senior Vice President, Steris• Caroline Whitacre, PhD, Senior Vice President for Research - The Ohio State University
© 2008 BioOhio
By-The Numbers, then & nowYear 1991 2001 2007/2008
Number of bio entities in Ohio
170 352 1162 (3.3X)
University R&D expenditures
$285 million
$481 million
$1.1 billion (2.3X)
New Company starts ≈12 12 64 (5.3X) 04-07
Private capital raised for new starts
Unknown $14 million $295 million (21X)
$964 million
IPO/Acquisitions
Bioscience Capital sources (in State)
4 8 58 (7.2X)
BioOhio (EBTC) membership
52 86 270 (3.1X)
An Ohio Thomas Edison Center
Be Ambassadors for Ohio….
Let me know how we can help you!
John F. Lewis Jr.Vice President
© 2008 BioOhio
Medical Product Development each step has defined Work Processes
Product Requirements(User Functional, Environmental,Physical, Manufacturing, Safety)
Design ValidationPlan
ProductSpecification
DesignVerification Plan
Product ArchitecturalDesign
(Spec allocation,Theory of operation)
SoftwareRequirementsSpecification
SoftwareVerificat./Validat.
Plan
SoftwareSubsystem(s)
Design
Design Transfer
Software SourceCode
SoftwareVerificat./Validat.
Procedures
DesignVerification
Results
SoftwareVerificat./Validat.
Results
DesignVerificationProcedures
Software Develop Plan(QA, Life Cycle, CodingStds., Tools, Environ.)
Initial HazardAnalysis
(Top Down)
Critical Element Flow Diagram (Complex Products with Software)
HardwareSubsystem(s)
Design(Electr. / Mech.)
DesignValidation
Procedures
DesignValidation Results
Hazard Analysis(Cumulative)
Operator Interface
Detailed DesignHazard
Assessment(Bottom Up)
MasterVerificat./Validat.
Plan
Risk/Safety Verification/ValidationDesign/Development
Product Definition(User Needs, Human Factors)