This presentation describes the role of the medical device industry in the economy of Massachusetts and how the Massachusetts Medical Device Development (M2D2) Center can assist entrepreneurs and new companies working in this space

Hafer, Nathaniel

McCarthy, Stephen P.

Tello, Steven

English

eScholarship@UMMS

University of Massachusetts Medical School eScholarship@UMMS UMass Center for Clinical and Translational Science Seminar Series 2013 UMCCTS Seminar Series Oct 17th, 12:00 PM Medical Device Innovation in Massachusetts -- M2D2: Massachusetts Medical Device Development Center Stephen P. McCarthy University of Massachusetts - Lowell Et al. Let us know how access to this document benefits you. Follow this and additional works at: https://escholarship.umassmed.edu/umccts_seminars  Part of the Analytical, Diagnostic and Therapeutic Techniques and Equipment Commons, and the Translational Medical Research Commons McCarthy SP, Tello S, Hafer N. (2013). Medical Device Innovation in Massachusetts -- M2D2: Massachusetts Medical Device Development Center. UMass Center for Clinical and Translational Science Seminar Series. Retrieved from https://escholarship.umassmed.edu/umccts_seminars/2013/seminars/4 Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 License. This material is brought to you by eScholarship@UMMS. It has been accepted for inclusion in UMass Center for Clinical and Translational Science Seminar Series by an authorized administrator of eScholarship@UMMS. For more information, please contact Lisa.Palmer@umassmed.edu. M2D2: Fueling the Life Sciences Economy Medical Device Innovation in Massachusetts  M2D2: Massachusetts Medical Device Development Center  Directors: Stephen McCarthy  Steven Tello Nate Hafer    M2D2: Fueling the Life Sciences Economy   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 M2D2 Massachusetts Medical Device Development Center  UMass Lowell & Worcester   M2D2 Medical Realization Process Product Realization Process Incubators/ Facilities Business Realization Process M2D2: Fueling the Life Sciences Economy Investors Products Jobs Inventors Ideas Patents Product Development Business Development Medical Development With M2D2 They Reach Across M2D2 M2D2: Fueling the Life Sciences Economy M2D2: An Economic Engine for the Medical Device Industry •  M2D2 Gets New Medical Device Ideas from  Patent to Production  •  Partnership with UMass  Medical School  •  Industry focused,  industry engaged  •  Statewide Reach  •  Model for Regional Innovation Center M2D2: Fueling the Life Sciences Economy UMass Partnership •  Materials Characterization, Analysis, Selection •  Design and Prototyping •  Testing and Verification •  Surgeons with Ideas •  Partnership with Pre-Clinical Investigators •  Large animal testing/clinical trial facilities Lowell: Engineering Expertise Worcester: Clinical Expertise Lowell: Business Expertise •  Opportunity Assessment, Business Planning •  Market Identification, Analysis •  Integrated into Graduate Courses M2D2: Fueling the Life Sciences Economy 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   S. McCarthy – M2D2 Worcester M2D2: Fueling the Life Sciences Economy   Worcester   M2D2  Massachusetts Life Sciences Center M2D2 Business Assessment  • Phase I - Initial Business Assessment Process • 3-6 page summary of Business Opportunity    -40+ Reviews to Date  • Integrated into UG/G Coursework • Initial Review by Management Team, Prioritize • Factor into FastTrack, Inventor-Funding Decs.  • Phase II - Business Plan Consultation • Longer term engagement with Inventor-Founder • Consult w/Expert Business Faculty & Grads/ • Assist in Business Plan Development  M2D2: Fueling the Life Sciences Economy M2D2 Clinical Trial Capability n  UMass Worcester and UMass Memorial Medical Center n  Facilitate partnership with clinical investigators  n  Provide access to patient population for clinical trials n  Provide regulatory support for FDA submissions n  Medical expertise across broad therapeutic areas: Ø surgery (plastic, wound healing, vascular, urology) Ø medicine (cardiology, digestive diseases, diabetes) Ø radiology (interventional, imaging); pediatrics, geriatrics  Ø women’ health (urogynecology, endocrinology) n  Dedicated central service for support through life cycle of clinical study (feasibility to close-out)     M2D2  Massachusetts Life Sciences Center M2D2: Fueling the Life Sciences Economy Ø  Highest priority of NIH Director, Dr. Francis Collins  Ø  Focused on advancing the science of translational medicine and enhancing the efficiency of developing novel approaches to prevent or treat diseases Ø  New Director (Sept, 2012): Christopher P. Austin, M.D. Ø  Success measured by novel products in clinical use and advances in clinical practice   National Center for Advancing  Translational Sciences   M2D2: Fueling the Life Sciences Economy M2D2 Economic Development •  UMass President      (2005)    $135,000 •  Mass. Economic Dev.  (2007)    $650,000  •  Mass. Capital Funds   (2007)     $4,000,000  Direct Funding to Start-Ups •  Federal SBIR/STTR       $4,700,000 •  Company Investment        $ 22,000,000 •  40 Companies  152 Employees   37 Interns    Worcester M2D2: Fueling the Life Sciences Economy    Flow Forward Medical  Wearable Blood Pump System to  Enhance Arteriovenous Fistulae Eligibility Raised $6 million M2D2: Fueling the Life Sciences Economy Proprietary wireless remote patient monitoring platform for superior heart arrhythmia monitoring and diagnosis  Raised   $ 3.2 million 12 Employees M2D2: Fueling the Life Sciences Economy Vista Topical Ophthalmic Drug Delivery Device  $1.6 million NIH SBIR Grant M2D2: Fueling the Life Sciences Economy VasoTech Biodegradable Drug Eluting Stent $1.2 million NIH STTR M2D2: Fueling the Life Sciences Economy Lucifics Photodynamic Theraphy for Non-melanoma Skin Cancer M2D2: Fueling the Life Sciences Economy SafePath  Safety Suture Needle  Eliminates accidental needle stick injuries in hospitals. M2D2: Fueling the Life Sciences Economy TheraTorr Medical  Reactive Mattress to Prevent Pressure Ulcers M2D2 FastLane Award Raised $1.4 million M2D2: Fueling the Life Sciences Economy MedicaMetrix ProstaGlove – Prostate Measurement M2D2 FastLane Award Raised $3.5 million M2D2: Fueling the Life Sciences Economy M2D2 Advisory Board Industry Focused & Engaged  M2D2: Fueling the Life Sciences Economy   Tsongas visits M2D2 Updated:   07/17/2012 12:32:54 PM EDT   U.S. Rep. Niki Tsongas, left, watches a demonstration from Howard Loree, vice president of Research & Development at Flow Forward, a tenant firm of the Massachusetts Medical Device Development Center in Lowell. Tsongas visited the center Friday to learn about developmental-stage companies. Flow Forward is developing a product that opens veins in such a way as to make them more accessible for medical procedures. COURTESY PHOTO    M2D2: Fueling the Life Sciences Economy M2D2 “liked” by U.S. Senator Elizabeth Warren  M2D2: Fueling the Life Sciences Economy Thank You Director Stephen P. McCarthy, Ph.D. Engineering, UMass Lowell    Director Steven Tello, Ed.D. Business, UMass Lowell •  Director Nate Hafer, Ph.D. Medical, UMass Worcester Learning with Purpose Massachusetts  Medical Device Ecosystem Steven Tello, Ed. D. Assoc. Vice Chancellor, UMass Lowell Director, M2D2 Learning with Purpose "   6.65 million residents "   $365 B annual economic output (GDP) 13th largest US economy (7.2% unemployment) "   Key Industry Sectors include: •  Biopharma & Medical Devices •  Business, Financial & Legal •  Computer & Hardware  •  Defense Manufacturing •  Diversified Industrial Manufacturing •  Health Care Delivery •  Post Secondary Education •  Software & Communications Massachusetts Learning with Purpose Mass.	  Life	  Science	  Cluster	  	  •  Biotechnology •  Medical Devices •  Pharmaceuticals •  Wholesale Trade •  Medical Testing Laboratories •  Teaching Hospitals  •  $1 B State commitment through Mass. Life Science Center   Learning with Purpose Impact of Med Device Companies in Mass.  •  400 Med. Device Companies  24,300 employees •  Mix of companies     •  Eastern/Central Mass. Focus 41% in Middlesex County 	  	  	  Small	  	  <30	  Emp.	  	  	  	  	  Medium	  30-­‐300	  Emp.	  	  	  	  	  	  Large	  >	  300	  Emp.	  304	   86	   13	  Learning with Purpose Impact of Med Device Companies in Mass.  •  Broader economic impact •  3.4 X multiplier in related industries 82,500 employees  •  13% of  Mass. Exported Goods -  $3.4 B Fastest growing export category   •  Captured 12% of US Med Device venture funding   $   329 M Med Device  $1,084 M Biotech Invesment Learning with Purpose Range of Good Jobs Created BASIC	  RESEARCH	  APPLIED	  RESEARCH	  PROTOTYPE	  &	  DEVELOPMENT	   COMMERCIALIZATION	  SCIENCE	  	  	  Ph.D	  Biology,	  Chemistry,	  	  	  BS,	  MS	  Research	  Assts.	  	  Lab	  Technicians	  SCIENCE & ENGINEERING  PhD Researchers  MD, Clinical Researchers  Research Assts.  Statisticians  Clinical Lab Tech  ENGINEERING,	  REGULATORY	  &	  BUSINESS	  	  Engineers	  NPD/	  OperaRons	  Finance	  Manufacturing	  Market	  AnalyRcs	  QA/QC	  Regulatory	  	  Technicians	  BUSINESS LAUNCH & OPERATIONS  Acounting & Finance Customer Serv. Marketing Medical Affairs Brand Managers Manufacturing Operations Sales & Distribution   Learning with Purpose Why	  MassachuseWs?	  •  World-Premiere Medical & Research Institutions •  Highly educated workforce – 50% + college •  Engaged High Ed Community, Angel/VC, Industry/Trade Councils •  Government commitment •  Established and Startup Life Science Companies •  Business Services to support Company Growth •  Willingness to Partner  Learning with Purpose Networks in Massachusetts •  M2D2 –  Concept to Prototype, Resource Network –  Business, Clinical, Engineering Assistance –  Incubator •  Massachusetts Life Sciences Center –  Research Funding, Accelerator Funding –  Infrastructure Support, Summer Intern Program   •  MassMEDIC  –  MedTech Ignite Mentoring by Experienced Med Tech Execs,  Education programs Learning with Purpose Other Networks •  MATCH Team – University of Ulster –  Explore technical and business development –  Reserch and education partnerships •  Mass. Technology Transfer Center –  Platform Presentation –  Entrepreneur/Inventor Training –  Revolving Grants Program  •  Massachusetts Technology Collaborative Innovation Institute Innovation activities across industry sectors in Mass.  –  IT/Wireless, Life Sciences, Medical Devices  Learning with Purpose Closing	  Thoughts	  •  Medical	  Devices	  are	  a	  subset	  of	  the	  larger	  Life	  Science	  Cluster	  	  •  Development	  of	  this	  subset	  has	  signiﬁcant	  mulRplier	  implicaRons	  	  – Creates	  range	  of	  research,	  development	  and	  employment	  opportuniRes	  – Research	  to	  Market	  more	  quickly	  than	  Big	  Pharma	  	  •  You	  may	  already	  have	  the	  ecosystem	  in	  place	  Learning with Purpose Resources •  www.uml.edu/m2d2   •  The Medical Device Industry in Massachusetts – Deloitte & Touche, LLP, MassMEDIC Annual Meeting, May 3, 2011   •  Annual Index of the Massachusetts Innovation Economy 2012, Innovation Institute, Mass. Technology Collaborative  

Medical Device Innovation in Massachusetts -- M2D2: Massachusetts Medical Device Development Center

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Medical Device Innovation in Massachusetts -- M2D2: Massachusetts Medical Device Development Center

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