M2D2

Connect the Resources of theUniversity of Massachusetts

to Medical Device firms within Massachusetts26 UMass Lowell and 18 UMass Worcester Faculty

Steering Committee – 24 Investment and Industry Leaders

M2D2Massachusetts Medical Device Development Center

UMass Lowell & Worcester

M2D2Massachusetts Medical Device Development Center

UMass Lowell & Worcester

M2D2M2D2

WorkforceWorkforceTrainingTraining

ProductProductRealizationRealizationProcessProcess

Incubators/Incubators/FacilitiesFacilities

BusinessBusinessRealizationRealizationProcessProcess

Worcester

M2D2 ResourcesM2D2 Resources

• Assistance with:– Defining Market & Business Opportunity– Prototype Development– Clinical Trials Assistance

• Funding• Grant Development, Loans, Investors

• Space• Wet/Dry Labs, Office

• Networks of People & Resources

M2D2

Successful Funding Efforts - NIH SBIR/STTRSuccessful Funding Efforts - NIH SBIR/STTR

$150,000 8 proposals submitted 60% success $2.2MM (ROI > 10 x)A. Develop a “Winning” Proposal / Electronic ApplicationB. “Experts” and Facilities to Insure Success

1. VasoTech Worcester - Lowell, MA $1.2 MillionBiodegradable Polymer Drug Eluting Stent

2. Vista Scientific Lawrence, MA $318,000Nanosphere-Antibiotic Corneal Contact Lens

3. Source Production Andover, MA $500,000Brachytherapy for Lung Cancer

4. Kazak Woburn, MA $100,000Portable Jaws of Life

5. Aragon Lowell, MA $100,000Neuromuscular Biosensor

Fig.2:VasoTech®Metal Stent

Worcester

M2D2

Matching “FastLane” Loan FundMatching “FastLane” Loan Fund$500,000 JAII Project Award up to $150K/company

A. Business Assessment / Medical Assessment (15)B. Prototype / Manufacture / Animal & Clinical Trials / IP / FDA (5)

Worcester

Aura Medsystems Boston, MAPhotochemical Tissue Bonding

Oz Technologies Springfield, MA

User Friendly Pessary

Smart Surfaces Worcester, MAUlcer Prevention Mattress

MedicaMetrix Wayland, MAProstate Measurement

M2D2

Matching “FastLane” Loan FundMatching “FastLane” Loan Fund$500,000 JAII Project Award up to $150K/company

A. Business Assessment / Medical Assessment (15)B. Prototype / Manufacture / Animal & Clinical Trials / IP / FDA (5)

Worcester

Aura Medsystems Lowell, MAPhotochemical Tissue Bonding

Oz Technologies Springfield, MAUser Friendly Pessary

Smart Surfaces Worcester, MAUlcer Prevention Mattress

MedicaMetrix Wayland, MAProstate Measurement

MoMelan Cambridge, MAExpanded Skin Grafting

$2.4M of Federal and private fundingleveraging ~$500K of

M2D2 direct commitments to date

Graduation

M2D2 Has Worked With >100Product Concepts to Date

M2D2 Has Worked With >100Product Concepts to Date

M2D2

In less than 2 years

Lead Sources for M2D2Lead Sources for M2D2

WorcesterM2D2

15/month15/

month

3/month3/month

VCs• Brook Ventures, Ned Williams• Prism Venture, John Brooks• Ironwood Equity, Josh Tolkoff•Others

VCs• Brook Ventures, Ned Williams• Prism Venture, John Brooks• Ironwood Equity, Josh Tolkoff•Others

UMass System•UMass Medical, Sheila Noone, John Sullivan,•OTM, James McNamara•CVIP, Bill Rosenberg,

UMass System•UMass Medical, Sheila Noone, John Sullivan,•OTM, James McNamara•CVIP, Bill Rosenberg,

25/Month

300/Year

25/Month

300/Year

2/month2/month

Other Universities•MTTC/MATTO, Abi Barrow•CIMIT , Janice Crosby•WPI, Grant McGimpsey

Other Universities•MTTC/MATTO, Abi Barrow•CIMIT , Janice Crosby•WPI, Grant McGimpsey

2/month

2/month

Mass Hospitals•Partners (CIMIT), Janice Crosby•Children’s Hospital, Jacqueline Armstrong• Baystate Medical Center , David Glass

Mass Hospitals•Partners (CIMIT), Janice Crosby•Children’s Hospital, Jacqueline Armstrong• Baystate Medical Center , David Glass

3/month3/month

Industry Groups•MassMEDIC, Tom Sommer•IGNITE,• MDG, Marty Sclar• MBI, Kevin O’Sullivan

Industry Groups•MassMEDIC, Tom Sommer•IGNITE,• MDG, Marty Sclar• MBI, Kevin O’Sullivan

WorcesterM2D2

M2D2 Business Assessment

•Phase I - Initial Business Assessment Process•3-6 page summary of Business Opportunity•Initial Review by Management Team, Prioritize•Factor into FastTrack, Inventor-Funding Decs•Integrated into UG/G Coursework

•Phase II - Business Plan Consultation•Longer term engagement with Inventor-Founder•Consult w/Expert Business Faculty & Grads•Assist in Business Plan Development

M2D2 Application ProcessM2D2 Application ProcessManagementTeam Review

•Identify FastLaneCandidates

•Identify STTR/SBIRCandidates•Filter Out

Inappropriate

ManagementTeam Review

•Identify FastLaneCandidates

•Identify STTR/SBIRCandidates•Filter Out

Inappropriate

ApplicationReceived

ApplicationReceived

ManagementTeam ReviewManagementTeam Review

Business Scan(All Apps.)

Business Scan(All Apps.)

Medical Assmt.(If Needed)

Medical Assmt.(If Needed)

SteeringCommittee

Review

•Review Allapproved Apps.•Select FastLane

Apps.

SteeringCommittee

Review

•Review Allapproved Apps.•Select FastLane

Apps.

STTR/SBIR3X YR

STTR/SBIR3X YR

FastLaneContract

Developed

FastLaneContract

Developed

M2D2Process Outcomes

•Inventor raisesmatching funds

•Inventor entersM2D2 Incubator

• Inventor contractsfor Support

M2D2Process Outcomes

•Inventor raisesmatching funds

•Inventor entersM2D2 Incubator

• Inventor contractsfor Support

M2D2Worcester

UMW Medical AssessmentUMW Medical Assessment

Selective inclusion in M2D2 application review:• Does concept require feasibility review from a

medical expert/clinical user?• Does concept require clinical trial to satisfy FDA

requirements or clinical acceptance postmanufacturing?

Lessons Learned:• Link inventor with medical expert early for

consultation and development of realistic clinicalpathway

Worcester

M2D2 Massachusetts Life Sciences Center

M2D2 Medical Experts - UMWM2D2 Medical Experts - UMW

Surgery (Plastics, Wound healing, Urology, Vascular)

Orthopedics Nursing Rehabilitation

Cardiology Neurology Stroke Center Anesthesia

Women’s Health Urogynecology Pediatrics

Clinical Labs Medical Education Simulation Center

Radiology (Interventional, Imaging Center)

Worcester

M2D2 Massachusetts Life Sciences Center

UMMS and UMass MemorialUMMS and UMass Memorial

Access to top-notch Clinical ExpertsLarge patient population pool for clinical

trialsCentralized support at UMMS:Dedicated Office for Clinical Research -

support through life cycle of clinical study(feasibility to close-out)Clinical Pathway and Regulatory guidance

M2D2

M2D2 Prototyping CapabilitiesM2D2 Prototyping Capabilities

• 26 UMass Lowell Faculty Spanning 11 Departments– Biological Sciences– Chemical Engineering– Clinical Lab and Nutritional Services– Electrical and Computer Engineering– Health and Environment– Management– Mechanical Engineering– Physics and Applied Physics– Plastics Engineering– Radiation– Work Environment Health

• UMass Worcester and UMass Memorial Medical Center Physiciansand Researchers to provide rapid design feedback

• Network of Private Sector Design, Fabrication and Testing Firms

M2D2Worcester

WorcesterM2D2

M2D2 Steering CommitteeIndustry Focused & EngagedM2D2 Steering Committee

Industry Focused & Engaged

M2D2 Reaches Beyond Boston/CambridgeM2D2 Reaches Beyond Boston/Cambridge

Steering Committee Companies

M2D2 Companies Past & Current

Prospective M2D2 Companies

WorcesterM2D2

Partnerships withIncubators Statewide

Partnerships withIncubators Statewide

LowellLowell

Springfield

BostonBoston

Fall River

Beverly

WorcesterWorcester

WorcesterM2D2

M2D2 Facilities / IncubatorRegional Innovation Center

$4 Million Capital Commitment

M2D2 Facilities / IncubatorRegional Innovation Center

$4 Million Capital Commitment

•Gov. Deval Patrick and Sen. Steven PanagiotakosHelp Establish Innovation Center at UMass Lowell

WorcesterM2D2

M2D2 Facilities / IncubatorRegional Innovation CenterM2D2 Facilities / IncubatorRegional Innovation Center

1. 333 Aiken St. - Incubator Space with Wet LabsVasoTech and Vista Scientific currentlyAura (Jan 2010)

2. Wannalancit Mill – M2D2 Build Out –15,000 sq ft - UMass Building Authority

3. Emerging Technologies Building – M2D2 Labs