The TATRC Technology Transfer Imperative

2. The TATRC Technology Transfer Imperative Federal Technology Transfer Act passed in 1986 (PL 99-502) Encourages transfer of technologies to the private sector. Authorizes laboratories to assign or license inventions License inventions or intellectual property that may be voluntarily assigned to the Government. TATRC granted laboratory authority in 4th Quarter, FY 03 to facilitate: License Agreements CRADAs Materiel Transfer Agreements Etc. As a consequence, TATRC must appoint a Research Technology Applications Officer or (ORTA).

3. FY 2004TATRC Technology TransferInitiative

4. Technology Transfer Strategic “Snap” Study Conduct 90 day Strategic “Snap”study to document : “As-Is” Organizational Capabilities “To-Be” Requirements “Gaps” Between “As-Is” and “To-Be” States Action Plans to fill “Gaps” “RoadMap” of ORTA FY 04 Priorities and Timelines

5. Preliminary Impressions… …“As-Is” Status 250 (+) Candidate Technology Projects Established Life Cycle Management Framework (I C M E O) Significant Number of Existing Public–Private Partnerships with impressive Technology Transfer Capabilities Sufficient Projected Funding to Support FY 2004 Initiatives

6. Types and QuantityofTATRC Candidate Technology

7. Telemedicine and Advanced  Medical Technology Program Mission Apply physiological and medical knowledge, advanced diagnostics, simulations, and effector systems integrated with information and telecommunications for the purposes of enhancing operational and medical decision-making, improving medical training, and delivering medical treatment across all barriers. The program scope is to identify, explore, and demonstrate key technologies and biomedical principles required to overcome technology barriers that are both medically and militarily unique.

8. As documented in the Joint Warfighting Science and Technology Plan, this will be achieved by developing and integrating technology in 3 Operational Capability Areas: Joint Medical Readiness Battlespace Medical Awareness Effective Employment of Medical Forces Each of these areas is further supported by subordinate Operational Capability Elements, and operationalized by investments in specific functional capability R&D programs. For example……(Cite specific linkages)As documented in the Joint Warfighting Science and Technology Plan, this will be achieved by developing and integrating technology in 3 Operational Capability Areas: Joint Medical Readiness Battlespace Medical Awareness Effective Employment of Medical Forces Each of these areas is further supported by subordinate Operational Capability Elements, and operationalized by investments in specific functional capability R&D programs. For example……(Cite specific linkages)

9. 5 P’s of Precision HealthcareScope of TATRC Functional Objectives

10. The U.S. Army Medical Research and Materiel Command (USAMRMC), Telemedicine and Advanced Technology Research Center (TATRC) focuses on: - Accelerated R&D Life Cycle Management - Rapid Prototyping of High Potential Candidate Technologies - End State Demonstration, Validation & Technology Exploitation Today, I am going to tell you a story. Actually a story of 9 technologies that have recently passed through this process. Each is different. They range from handheld, wireless devices to medical simulators to telepresence systems that transmit images, vital signs and video in the theater of battle, in ambulances or in a disaster. These are not only stories of cutting edge medical technology. But, also cutting edge strategies for: - public/private partnering - academic, industry and government collaboration - and end users embedding in the R&D process In the end, I want to share with you a system of integrated approaches, that we think, allow for more rapid adaptation to changing medical conditions, while reducing the “flash to bang” between concept exploration and definitive problem solving.. The U.S. Army Medical Research and Materiel Command (USAMRMC), Telemedicine and Advanced Technology Research Center (TATRC) focuses on: - Accelerated R&D Life Cycle Management - Rapid Prototyping of High Potential Candidate Technologies - End State Demonstration, Validation & Technology Exploitation Today, I am going to tell you a story. Actually a story of 9 technologies that have recently passed through this process. Each is different. They range from handheld, wireless devices to medical simulators to telepresence systems that transmit images, vital signs and video in the theater of battle, in ambulances or in a disaster. These are not only stories of cutting edge medical technology. But, also cutting edge strategies for: - public/private partnering - academic, industry and government collaboration - and end users embedding in the R&D process In the end, I want to share with you a system of integrated approaches, that we think, allow for more rapid adaptation to changing medical conditions, while reducing the “flash to bang” between concept exploration and definitive problem solving..

11. Core Research Leads to  ….Transformational Technologies

12. 5Ps Transition to Bio Intelligence!

14. Preliminary Impressions… …“As-Is” Status Candidate Technology Projects TATRC has sufficient quantity and types of technologies to sustain a credible Technology Transfer effort. The pipeline of 5P technologies is full and promising BioIntelligence technology basic/applied research investment increases dramatically in FY 04 Our direction is consistent with international driving forces of techno-economic development

15. Life Cycle Management Framework I C M E O

16. Core Business Processes I C M E O The implementation Strategies for the objectives are as follows...The implementation Strategies for the objectives are as follows...

18. Conventional Prototyping for projects of this type in the military could take up to 20 years to Get into the hands of the users. The Rapid Prototyping model we use enables us to Research, Develop Prototypes, and get them into the hands of the users in sometimes under 30 days Discuss requirements, benefits, and issues of using new proceduresConventional Prototyping for projects of this type in the military could take up to 20 years to Get into the hands of the users. The Rapid Prototyping model we use enables us to Research, Develop Prototypes, and get them into the hands of the users in sometimes under 30 days Discuss requirements, benefits, and issues of using new procedures

19. Leverages Academic Partnerships …For Basic and Applied Research Georgetown University (CA-Medical Vangaurd) Howard University (CRDA-Urban Telemed) Harvard University (CA-CIMIT) Mass Institute of Technology (CA-CIMIT) University of Maryland (IPA/CA – ORF) University of Utah (Contract-Teleopth) Saint Francis University (CRDA-CERMUSA) Loma Linda University (CA-NMTB/Proton Beam) University of Tex - Houston HSC (CA-DREAMS) University South Florida (CA-Telerad/Adv Cancer Detect) University of Hawaii (CA-Telemed Curric’lm) University of Pittsburgh (Contract-GGTS) Stanford University (Contract-Affiliates Prog) Yale University (IPA-Adv Tech Watch) Texas A & M (CA-DREAMS) Johns Hopkins University (CA-Periscopic MIS) University of Southern Calfornia (CA-NGI) We will also continue our strategy of actively pursuing and more fully leveraging academic partnerships through a variety of relationships ...We will also continue our strategy of actively pursuing and more fully leveraging academic partnerships through a variety of relationships ...

20. USAMRMC has made clear distinctions between what is medically unique and what is not in its core competency In non-medical arenas we plan to reach out and develop partnerships in areas for which medical researchers lack core competency. This is one reason why ATACCC is so important. USAMRMC has made clear distinctions between what is medically unique and what is not in its core competency In non-medical arenas we plan to reach out and develop partnerships in areas for which medical researchers lack core competency. This is one reason why ATACCC is so important.

21. Leverages… International Partnerships to Accelerate Development US/Norway Telemedicine (Wireless, Handheld) European Union Collaboration NATO – Telemedicine Standardization Committee South African Military Health Service (Peacekeeping) International Global Satellite System: Poland (CME) Landmine Victim Assistance: Central America > Afghanistan Partnership for Peace – Romanian Needs Assessment Pakistani Exchange Program Yuma Proving Ground - Panama Telemedicine South Korean Exchange Program ATA Symposiums: EU (2001) – Africa (2002) - Latin America (2003) We also maintain a robust set of International Partnerships. These allow us not only to transfer useful technology and knowledge to our international partners, but to learn from them in areas in which their competency exceeds ours. Examples of partnerships include Congressionally directed efforts working with Norway in the development of high speed, handheld wireless medical digital assistants and landmine victim assistance distance learning programs in Central America and extending this year into Afghanistan managed by the Center for International Rehabilitation. We also host foreign officers for training in telemedicine and advanced medical technology, at this conference I am joined by two of guests – both physicians from Pakistan. In addition we sponsor, in conjunction with the ATA, an international telemedicine forum each year, this year focusing on Latin America and the Caribbean, and next year on Eastern Europe.We also maintain a robust set of International Partnerships. These allow us not only to transfer useful technology and knowledge to our international partners, but to learn from them in areas in which their competency exceeds ours. Examples of partnerships include Congressionally directed efforts working with Norway in the development of high speed, handheld wireless medical digital assistants and landmine victim assistance distance learning programs in Central America and extending this year into Afghanistan managed by the Center for International Rehabilitation. We also host foreign officers for training in telemedicine and advanced medical technology, at this conference I am joined by two of guests – both physicians from Pakistan. In addition we sponsor, in conjunction with the ATA, an international telemedicine forum each year, this year focusing on Latin America and the Caribbean, and next year on Eastern Europe.

22. Preliminary Impressions… I C M E O Improvements Needed to Support Technology Transfer Inputs Modify TATRC Pre-Proposals to include projected market healthcare market data > Leverage templates developed by National Medical Technology TestBed (NMTB) Quality Controls Ensure Proposal Review Board (PRB) fully evaluates projected impact on healthcare market > Leverage iPIP Matrix developed by Center for Integration of Medicine and Innovative Technology, (CIMIT) Funding Mechanisms Leverage full range of funding mechanisms to support of life cycle management/advanced development: CSI, P6, P8, SBIR, STTR, DEPSCOR, ATD, ACTD, etc. Develop capabilities to locate/secure private sector 2d round funding for advanced development/commercialization. Execution Streamline/Enhance Regulatory Compliance strategy to optimally address FDA/CMS requirements Enhance PLR system to assess: Potential market size Expected market share Potential profit margins Expected useful life of the technology Anticipated production time to marketability Projected cost of marketing Potential technology development hurdles Potential regulatory hurdles Intellectual property protection issues Leverage In Progress Review Process and Business consulting capabilities developed by NMTB Establish Technology Transfer Committee Outputs Develop management controls and performance metrics for tracking, forecasting and reporting of: Prototypes Intellectual Property: Patents, Royalties, Peer Reviewed Scientific Articles and Findings Dual Use Commercialized Products Proof of Concept Demonstration and Validations

23. Examples of TATRC Partnerships with Significant Technology Transfer Capabilities

24. As mentioned earlier USAMRMC generate these rapid prototypes by aggressively partnering with academia, industry and other government agencies in agreements managed by my Telemedicine and Advanced Technology Research Center (TATRC). Many of these relationships develop out of Congressionally directed programs, but an increasing number also involve Small Business Innovative Research (SBIR) and Small Business tech transfer research (STTR) programs. As mentioned earlier USAMRMC generate these rapid prototypes by aggressively partnering with academia, industry and other government agencies in agreements managed by my Telemedicine and Advanced Technology Research Center (TATRC). Many of these relationships develop out of Congressionally directed programs, but an increasing number also involve Small Business Innovative Research (SBIR) and Small Business tech transfer research (STTR) programs.

27. CIMIT Assumptions re: Health Care Major advances in next 10-15 years - Devices, Minimally Invasive Procedures, Imaging, Drug Delivery Systems Good News – - Enabling technology already exists Bad News – - Major barriers to “capturing” technology: Clinical Insertion Economic /Regulatory Industrial Involvement These barriers can be rapidly overcome by: - Systematic Culture Blending - Committed Experts - Individualized Facilitation

29. CIMITIndustry Liaison Group General Electric Medical Systems Johnson & Johnson Cordis Ethicon Endosurgery COSAT Karl Storz Endoscopy Omnicell, Inc Pentax Precision Instrument Corp Radianse, Inc 10 Blade, Inc Ascension Technology, Corp AstraZeneca Baxter Healthcare, Corp B-K Medical Systems, Inc. Boston Scientific, Corp Olympus America, Inc. OmniGuide Communications, Inc. Pharmacia, Inc. Physical Sciences, Inc. Welch Allyn, Inc. Medtronic, Inc. Bristol Myers Squibb Co. Terumo Medical Corp Draeger Medical, Inc. Foster-Miller, Inc. Foxfire Interactive Corp Getinge-Castle, Inc. Harvard Clinical Technologies, Inc HydroCision, Inc. IDEO Instrumentarium, Corp Granite Peak Technology Hewlett Packard Company Guidant Corporation Mobile Aspects, Inc. Motorola, Inc. Percadia, Inc. Pfizer, Inc. TYCO TissueLink Medical, Inc.

30. CIMITCharles Stark Draper Research LaboratoryNavigator Technology Ventures (NTV) The NTV is the Venture Capital subsidiary of The Charles Stark Draper Laboratory, Inc. of Cambridge, Mass. Founded in 2000, Focuses on early stage investments. Identifies technologies with attractive commercial potential Helps set up start up companies Provides seed financing Arranges later-stage funding partners. NTV concentrates on intense engineered technologies: Electronics Software MEMS Optics RF Material Across industries such as energy, biotech, telecom, IT, wireless and Internet. NTV currently has investments in Polychromix Inc. and Sionex Corp.

32. Initial Technical Focus Areas

33. CEMBR Industrial Members 2003A Diverse Group of Synergistic Companies

34. Cleveland Clinic FoundationComputer Assisted Minimally Invasive Surgery (CAMIS)

37. DREAMS/T5 Technology Transfer Strategy

38. NASA Commercial Space Centers (CSCs) TATRC has funded relationships with two CSCs that focus on medical technology: Medical Informatics and Technology Applications Consortium (MEDITAC), Virginia Commonwealth University Microsoft Virginia Biotechnology Research Park USSC TeleVital Olympus Compaq QRS Immersion Spacelab Stanford/NASA Ames Commercial Space Center Medical Technology Information Technology Materials Sciences

39. GE Medical Systems Intel Corp Medweb Nortel Networks AT&T Johnson & Johnson Trestle Corp Eastman Kodak SBC Communications, Inc Verizon Communications ScottCare Corp Computerized Screening AMD Telemedicine Polycom iMetrikus IBM Life Sciences Siemens Tandberg, LLC American Telecare, Inc. Vitelnet, Inc. Samsung Electronics Co. SMS Health Hero Network HomMed PhoneDoctorx Healthcare Vision & Healthcare Computer Corp. Biosign Viterion Teleheathcare

40. RTI Tech Transfer provides a range of services: Develop marketing materials Identify and target relevant companies outside your core business to solicit licensing interest Project the value of technology Evaluates offers Assists in negotiating sales, licensing, or donation agreements.

41. Other PotentialTATRC Technology Transfer Partnerships

42. Potential Partnerships… Requiring Further Exploration and Development Government Affiliated Federal Laboratory Consortia Rossetex (Sarnoff – SRI Joint Venture) In-Q-Tel (CIA Affiliate) Mohawk, Inc. (DOE Affiliate) Pacific Telehealth HUI (DOD/VA) Academic Columbia University (CIE) Drexel University (CIMERC) Uniformed Services University of Health Sciences (USUHS) Henry Jackson Foundation University of Maryland (OR of Future) University of South Florida (National Functional Genomics Center) University of Pittsburgh (Various Congressionals) University of California, Los Angeles (CASIT) Indiana University (Emerging Technologies Center – Business Incubator) Commercial or Non-Profit Vesalius Venture Capital The Global Telemedicine Group Battelle Memorial Institute

43. Preliminary Impressions… …“As-Is” Status Technology Transfer Partnerships TATRC has numerous potential partners TATRC should form partners into a nationwide, distributed network of Technology Transfer Centers of Excellence Facilitate the commercialization of government funded advanced medical technology Intellectual Property

44. Sufficient Funds are ProjectedtoSupport Technology TransferInitiative in FY 2004

45. “To-Be”Technology TransferProjection 

46. Evolution of an IdeaDistributed Network for Advanced Medical Technology Transfer (DISNET – AMTT) Indignant rejection Reasoned objection Qualified opposition Tentative acceptance Qualified endorsement Judicious modification Cautious adoption Impassioned espousal Proud parenthood Dogmatic propagation HK Silver, 1965

47. DISNET – AMTTFunctions

48. TATRC – “To Be” Requirements Implement internal I C M E O changes Create a distributed network of Best of Breed partners, for example: CEMBR = Biomateriels CIMIT = Biosensors, Simulation, Etc. NMTB = Market Analysis, Individualized Facilitation, Review ATA = Telemedicine DREAMS = Cardiology, Trauma Care Cleveland Clinic = Ultrasound, Robotics, Etc.. Objective: Streamline COTS development and raise the percentage of government IP commercialized. Convene > Organize > Execute > Evaluate

49. TATRC manages projects through integrated business processes that are designed to bring end users into the development process at the earliest opportunity. These processes include: Integrated Research Teams (IRT) 3 day Programmatic Reviews End Users and Developers meet That meet periodically, (3-5 years) Develop 5 year technology roadmap for the future in that area Broad strategic planning and oversight Integrated Product Team (IPT) Project level More frequent, scheduled semi annual End user involvement Project-specific guidance Product Line Review (PLR) Assessments of research by outside experts One research category per month; annual cycle Moving rapidly from basic research to applied research and ending in prototyping, TATRC works TATRC manages projects through integrated business processes that are designed to bring end users into the development process at the earliest opportunity. These processes include: Integrated Research Teams (IRT) 3 day Programmatic Reviews End Users and Developers meet That meet periodically, (3-5 years) Develop 5 year technology roadmap for the future in that area Broad strategic planning and oversight Integrated Product Team (IPT) Project level More frequent, scheduled semi annual End user involvement Project-specific guidance Product Line Review (PLR) Assessments of research by outside experts One research category per month; annual cycle Moving rapidly from basic research to applied research and ending in prototyping, TATRC works