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Medical Device Commercialization A Case Study Robin Winsor

Cybera - Axia cloud session

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Page 1: Cybera - Axia cloud session

Medical Device CommercializationA Case Study

Robin Winsor

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What does IDC do?

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Competing Technologies circa 2000

Kodak GE / Seimens CaresBuilt SwissRay IDC

Kodak Fuji Agfa

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CMOS

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Market

125k

Cost (US$)

350k DR

CR

FILM

Large hospitals

Small & MediumHospitals

Clinics

45 secs

8.5 mins

8 mins

Foothills+

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Market

125k

Cost (US$)

350k DR

CR

FILM

Large hospitals

Small & MediumHospitals

Clinics

750

10,000

Uncounted

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Market

125k

Cost (US$)

350k DR

CR

FILM

Large hospitals

Small & MediumHospitals

Clinics

750

10,000

Uncounted

IDC : 45secs : <$150kIDC : 45secs : <$150k

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TimeLine

November 8th, 1895

November 8th, 1995

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TimeLine

MutinyClinical TestingRegulatory Approvals

Clinical UseNew Products New Building Rapid Expansion

U.S.”Expert” arrives

N.AmericanSalesU.S.”Expert”

leaves

Downsize Mgmt financing Liquidate assetsLuminary Sites

Scientific Validation $$ Revenues $$

Production Ramp-Up Rapid Revenue Growth International Distribution OEM Partners

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Futures

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Lessons Learned

• Trust

• It has to be earned

• Don’t discount the bizarre

• Beware of new friends in good times

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Lessons Learned

• Contingency Plans

• Save for a rainy day… it rains a lot !

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Lessons Learned

• Build The Right Team For Each Stage

• Scientists NEED marketers and financiers and …

• Management team must complement, not duplicate,

each other

• Finder / Minder / Grinder

• Expect and celebrate change in the lineup

• Do the paperwork

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Lessons Learned

• Build An Active Board

• Think carefully before putting a customer on BoD

• Don’t appoint for appearances sake, make it WORK

• Try for diversity

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Lessons Learned

• Know When To Let Go

• If you can do it all, you’re not doing enough

• “There is no limit to how much a man can

accomplish or how far he can succeed as long as

he doesn't mind who gets the credit”

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Lessons Learned

• Know What You Do

• Core competencies

• Be clear

• Keep checking for drift

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Lessons Learned

• Lawyers Can Be Your Friends

• Don’t cheap out on legal services

• Understand their specialities

• Look for chemistry

• File plenty of patents

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Lessons Learned

• Pay Your Taxes Happily• Cybera

• National Research Council (NRC)

• Industrial Research Assistance Program (IRAP)

• Alberta Heritage Fund for Medical Research / AITF

• Shad Valley

Keep it in Canada

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Lessons Learned

• Culture

• Why do you and your staff work so hard – is it for the

same reasons ?

– Fun

– $$$ / Options

– Vision

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Corporate Vision

To provide the highest quality, most cost-

effective digital radiography (DR) products in the

healthcare market

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Vision

Tuberculosis35% of the world’s population infected

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Lessons Learned

• Believe In Angels

• Douglas Street

• Geoffrey Galley

• …and be sure they believe in you

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Lessons Learned

• Retail Investors

• Most brokers don’t care

• Learn the elevator pitch

• Expect turbulence

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Lessons Learned

• Institutional Investors

• Fund Managers DO care

• Know your numbers

• Expect to be held accountable

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Lessons LearnedAREA

ImageQuality

RadiationDose

Cost

NorthAmerica 1 2 3

Europe 2 1 3

Asia 2 3 1

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Lessons Learned

China is a huge marketChinese prefer ChineseProtect your IP, then go

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What Has Changed

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What Has Changed

• Barriers to entry

– Equipment costs falling

– Information easy to access

– Regulatory is a little easier

– Computing power increased by ~8000 x

– Design, prototype cycle reduced from weeks to days

– Competitors know what you’re doing

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What Hasn’t Changed

• Need for a good team

• Need for financing

• Need for hard work

• Need for speed

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Team Building / Networking Tools

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Collaboration / Information Portals

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Government & NGO Assistance

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TechnicalTechnicalAnalysisAnalysis

TechnicalTechnicalFeasibilityFeasibility

EngineeringEngineeringPrototypePrototype

Pre-Pre-productionproductionPrototypePrototype

ProductionProductionProductionProduction

SupportSupport

MarketMarketNeedsNeeds

AssessmentAssessment

MarketMarketStudyStudy

StrategicStrategicMarket PlanMarket Plan

MarketMarketValidationValidation

Sales &Sales &DistributionDistribution

MarketMarketDiversi-Diversi-ficationfication

VentureVentureAssessmentAssessment

EconomicEconomicFeasibilityFeasibility

StrategicStrategicBusinessBusiness

PlanPlan

FinancingFinancingthe Venturethe Venture& Business& Business

Start-upStart-up

BusinessBusinessGrowthGrowth

BusinessBusinessMaturityMaturity

TechnologyTechnologyDevelopmentDevelopment

MarketMarketDevelopmentDevelopment

BusinessBusinessDevelopmentDevelopment

MatureMatureCompany DevelopmentCompany DevelopmentConceptConcept

Goldsmith Model for Commercialization

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Innovation Resources

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Calgary Technologies TCI Programs

Entrepreneur Coaching Services

Financing Your Vision

EntrepreneurBoot Camps

ProgramFocus

Initial Entrepreneur Consultations – any stage or issue

Comprehensive Overview of financing alternatives

Investor-ready business plan and investor pitch coaching

Market Target

Entrepreneurs with ideas and issues with active businesses

Pre-financed startups with a business plan

Start-ups at or near revenue, seeking angel or VC capital

Format On demand with staff and Entrepreneur-in-Residence - no defined length

1 day seminar delivered by industry experts; offered quarterly

2 day seminars and mock investor panels; offered quarterly

Cost No cost but limited time $ 300 $500

ClientsEngaged

~165 31 40

2002 20021997

Technology Commercialization and Incubation

Updated: Jan, 2010

2009

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Calgary Technologies TCI Programs

Go-To-MarketReadiness

Alberta Deal Generator

Innovate AlbertaVoucher Program

Program Focus

Develop market strategy and launch plans for growth companies

Connect growth companies with angel capital

Advise clients on application, match to service provider and administrate voucher program.

Market Target

Companies seeking assistance to launch new products

Start-ups seeking first round of external capital

Companies from concept to growth stage engaged in commercialization

Format Yearly 6 month workshop

4 forums per year in Calgary and Edmonton

Semi-annual program cycle – project length ~6 months

Cost $1800 $1500 + 2% success fee $1000 - $4000 based on voucher/project complexity

ClientsEngaged

9 25 ($1.4+ M raised) 33 ($650,000 project value)

2007

Updated: Jan, 2010

Technology Commercialization and Incubation

2003 2009

2009

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There is a tide in the affairs of men,Which, taken at the flood, leads on to fortune;Omitted, all the voyage of their lifeIs bound in shallows and in miseries

On such a full sea are we now afloat, And we must take the current when serves, Or lose our ventures.

Julius Caesar. Act IV, Scene 3

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? ? ? Questions ? ? ?