M2D2 Massachusetts Medical Device Development Center UMass Lowell & Worcester Connect the Resources of the University of Massachusetts to Medical Device firms within Massachusetts 26 UMass Lowell and 18 UMass Worcester Faculty Steering Committee – 24 Investment and Industry Leaders Incubators/ Facilities Workforce Training M2D2 Product Realization Process Business Realization Process M2D2 Worcester M2D2 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 Successful Funding Efforts - NIH SBIR/STTR $150,000 A. B. 8 proposals submitted 60% success $2.2MM (ROI > 10 x) Develop a “Winning” Proposal / Electronic Application “Experts” and Facilities to Insure Success 1. VasoTech Worcester - Lowell, MA $1.2 Million Biodegradable Polymer Drug Eluting Stent 2. Vista Scientific $318,000 Lawrence, MA Nanosphere-Antibiotic Corneal Contact Lens 3. Source Production Andover, MA $500,000 Fig. 2: VasoTech® Metal Stent Brachytherapy for Lung Cancer 4. Kazak Woburn, MA $100,000 Lowell, MA $100,000 Portable Jaws of Life 5. Aragon Neuromuscular Biosensor M2D2 Worcester Matching “FastLane” Loan Fund $500,000 JAII Project Award A. B. up to $150K/company Business Assessment / Medical Assessment (15) Prototype / Manufacture / Animal & Clinical Trials / IP / FDA (5) Aura Medsystems Boston, MA Photochemical Tissue Bonding Oz Technologies Springfield, MA User Friendly Pessary Smart Surfaces Worcester, MA Ulcer Prevention Mattress MedicaMetrix Wayland, MA Prostate Measurement M2D2 Worcester Matching “FastLane” Loan Fund $500,000 JAII Project Award A. B. up to $150K/company Business Assessment / Medical Assessment (15) Prototype / Manufacture / Animal & Clinical Trials / IP / FDA (5) Aura Medsystems Lowell, MA Photochemical Tissue Bonding Oz Technologies Springfield, MA User Friendly Pessary Smart Surfaces Worcester, MA Ulcer Prevention Mattress MedicaMetrix Wayland, MA Prostate Measurement MoMelan Cambridge, MA Expanded Skin Grafting M2D2 Worcester M2D2 Has Worked With >100 Product Concepts to Date In less than 2 years $2.4M of Federal and private funding leveraging ~$500K of M2D2 direct commitments to date Graduation M2D2 Lead Sources for M2D2 VCs VCs 15/ 15/ month month •• Brook Brook Ventures, Ventures, Ned Ned Williams Williams •• Prism Prism Venture, Venture, John John Brooks Brooks •• Ironwood Ironwood Equity, Equity, Josh Josh Tolkoff Tolkoff •Others •Others UMass UMass System System 3/month 3/month •UMass •UMass Medical, Medical, Sheila Sheila Noone, Noone, John John Sullivan, Sullivan, •OTM, •OTM, James James McNamara McNamara •CVIP, •CVIP, Bill Bill Rosenberg, Rosenberg, 25/ 25/ Month Month Other Other Universities Universities 2/month 2/month 2/ 2/ month month •MTTC/MATTO, •MTTC/MATTO, Abi Abi Barrow Barrow •CIMIT •CIMIT ,, Janice Janice Crosby Crosby •WPI, •WPI, Grant Grant McGimpsey McGimpsey Mass Mass Hospitals Hospitals •Partners •Partners (CIMIT), (CIMIT), Janice Janice Crosby Crosby •Children’s •Children’s Hospital, Hospital, Jacqueline Jacqueline Armstrong Armstrong •• Baystate Medical Center Baystate Medical Center ,, David David Glass Glass 300/ 300/ Year Year Industry Industry Groups Groups 3/month 3/month •MassMEDIC, •MassMEDIC, Tom Tom Sommer Sommer •IGNITE, •IGNITE, •• MDG, Marty Sclar MDG, Marty Sclar •• MBI, MBI, Kevin Kevin O’Sullivan O’Sullivan M2D2 Worcester 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 Worcester M2D2 Application Process Business Scan (All Apps.) Application Received Management Team Review Medical Assmt. (If Needed) M2D2 Process Outcomes •Inventor raises matching funds •Inventor enters M2D2 Incubator • Inventor contracts for Support Management Team Review •Identify FastLane Candidates •Identify STTR/SBIR Candidates •Filter Out Inappropriate Steering Committee Review STTR/SBIR 3X YR FastLane Contract Developed •Review All approved Apps. •Select FastLane Apps. M2D2 Worcester UMW 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 post manufacturing? Lessons Learned: • Link inventor with medical expert early for consultation and development of realistic clinical pathway M2D2 Massachusetts Life Sciences Center Worcester M2D2 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) M2D2 Massachusetts Life Sciences Center Worcester UMMS and UMass Memorial Access to top-notch Clinical Experts Large patient population pool for clinical trials Centralized 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 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 Physicians and Researchers to provide rapid design feedback Network of Private Sector Design, Fabrication and Testing Firms M2D2 Worcester M2D2 Steering Committee Industry Focused & Engaged M2D2 Worcester M2D2 Reaches Beyond Boston/Cambridge Steering Committee Companies M2D2 Companies Past & Current Prospective M2D2 Companies Partnerships with Incubators Statewide Lowell Beverly Boston Worcester Springfield Fall River M2D2 Worcester M2D2 Facilities / Incubator Regional Innovation Center $4 Million Capital Commitment •Gov. Deval Patrick and Sen. Steven Panagiotakos Help Establish Innovation Center at UMass Lowell M2D2 Worcester M2D2 Facilities / Incubator Regional Innovation Center 1. 333 Aiken St. - Incubator Space with Wet Labs VasoTech and Vista Scientific currently Aura (Jan 2010) 2. Wannalancit Mill – M2D2 Build Out – 15,000 sq ft - UMass Building Authority 3. Emerging Technologies Building – M2D2 Labs M2D2 Worcester