Medical Technology Enterprise Consortium (MTEC) James B. (JB) Phillips, Ph.D., PMP Office of the Principal Assistant for Acquisition U.S. Army Medical Research and Materiel Command (USAMRMC) November 2015 The views expressed in this presentation are those of the authors and may not necessarily be endorsed by the Department of Defense UNCLASSIFIED

Current Challenges  Need for better collaboration with industry, small business and academic partners  Acquisition strategies rely on the use of Contracts, Assistance Agreements governed by the Federal Acquisition Regulation (FAR), the Department of Defense Grant and Agreement Regulations (DoDGAR), and Cooperative Research and Development Agreements (CRADA), which have certain limitations & cost impacts  Future public-sector funding for research and development (R&D) addressing military medical needs is expected to decrease  Private sector funding is available but largely unreachable UNCLASSIFIED2

Better Buying Power 3.0*  Affordability – Facilitates Government/industry dialogue for better aligning Government requirements and industry efforts  Cost control – Allows rapid transition of successful prototypes to FAR-based production contracts  Elimination of unproductive processes and bureaucracy – Allows “pre- positioning” a long term agreement between the Government and industry/academia in a key technology domain where terms and conditions are negotiated and added by phase  Promotion of competition – Preserves competition in all funded research initiatives  Incentivize productivity – Government retains “Inherently Governmental Functions,” including source selection authority and final price reasonability determination, while outsourcing laborious, time-consuming “Closely Associated Functions” to the Consortium Manager  Incentivize innovation –Enables participation of “non-traditional” government contractors, allowing them to compete equally with traditional government contractors  Improve acquisition tradecraft – Accommodates both annual R&D funding strategies and rapid response to urgent / out-of-cycle requirements * USD(ATL), April 2015UNCLASSIFIED3

 An “enterprise partnership” between the Government and a consortium of technology developers/providers in a specific domain where…  The “Government” partner can be a single sponsor (program executive officer) or multiple sponsors coordinated through a lead agency  The “Consortium” partner is a group of for-profit, not-for-profit and/or non-profit companies, universities, and other academic research organizations having competence in the technical domain of interest  The parties are connected through a binding instrument called an “Other Transaction” that is not subject to the FAR The OT-Consortium Business Model 4

MTEC as a Public-Private Collaboration A Consortium of industry, academic, and other organizations organized and operated through a 501(c)(3) non-profit corporation and an Other Transaction Agreement (OTA)  Provides a flexible method to combine public and private resources to focus research, prototype development, and commercialization on specific shared military and civilian medical technology needs  Facilitates negotiable and flexible operations, collaborations, and competitive research project awards that are not subject to the FAR and DoDGAR acquisition policies and procedures  Permits streamlined contracting such as lifecycle acquisitions UNCLASSIFIED5

MTEC as a Public-Private Collaboration  Attracts Small Business and non-traditional contractors  Limits antitrust liability of Consortium members, promoting collaboration within MTEC  National Cooperative Research and Production Act  Federal Register posted June 2014  Expedited transition from development into follow-on production through more typical direct contracting mechanisms via Section 822 of the FY2002 National Defense Authorization Act (NDAA) UNCLASSIFIED6

DoD Consortia Operating Within OTA UNCLASSIFIED7

MTSC # USAMRMC Executive Governance Board MTEC with USAMRMC Users* UNCLASSIFIED8 USAMRMC AO * Example Diagram Only # Medical Technology Support Center ^ prototype OTA Operational phase USAMRMC Users: Science & Technology, Advanced Development Communities USAMRMC Directors Consortium Member Agreement Management Team MTEC 501(c)(3) Corporation Horus Vision Restoration Horus Vision Restoration Examples Only Regenerative Medicine Prosthetics

MTSC # USAMRMC Executive Governance Board MTEC with Users Outside USAMRMC* UNCLASSIFIED9 USAMRMC AO * Example Diagram Only # Medical Technology Support Center ^ prototype OTA Operational phase Other Government: Departments of Veterans Affairs and Health & Human Services, DoD USAMRMC MOA IAA ISA Directors Consortium Member Agreement Management Team MTEC 501(c)(3) Corporation Horus Vision Restoration Horus Vision Restoration Examples Only Regenerative Medicine Prosthetics

USAMRMC MTEC Public-Private Collaboration* UNCLASSIFIED10 * Example Diagram Only ^ prototype OTA Project funding Directors Consortium Member Agreement Management Team MTEC 501(c)(3) Corporation Horus Vision Restoration Horus Vision Restoration Examples Only Regenerative Medicine Prosthetics Shared funding & resources $ Projects Other Government: Departments of Veterans Affairs and Health & Human Services, DoD Funding & resources $ Projects Philanthropy Venture Capital Foundations Funding & resources

Investment Community (Angels & Institutional Venture Capital) MTEC Public-Private Collaboration* UNCLASSIFIED11 Private Capital Funding Directors Consortium Membership Agreement Management Team MTEC 501(c)(3) Corporation De-risking investments including: Cost-sharing of projects with mutual interest Market analysis Assessing commercial viability Establishing dual-use business case for both federal and commercial markets (multiple markets) Expedited transition from development into follow-on production Fast-track timeline to the commercial market De-risk Investment $ Projects Intellectual Property: Patents License to Use (Exclusive or Non-Exclusive) Technology Production & Distribution Return on Investment Outcomes / Products

MTEC USAMRMC Team  Dr. J.B. Phillips  Office of the Principal Assistant for Acquisition  Dr. Jonathan Miller  Office of the Principal Assistant for Research & Technology  Mr. Ron Marchessault  Telemedicine & Advanced Technology Research Center  Henry M. Jackson Foundation  Mr. Don Wheatley  U.S. Army Medical Research Acquisition Activity UNCLASSIFIED12

Additional Information  For additional information contact: Stacey Lindbergh (843)  Visit Name, Title, UNCLASSIFIED13