Telemedicine and Advanced Technology Research Center TATRC Cutting Edge Medical Technology

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TELEMEDICINE ADVANCED TECHNOLOGY RESEARCH
CENTER (TATRC) U.S. Army Medical Research and
Materiel Command Rapid Prototyping
Technology Transfer Strategy for Fiscal Year
2004 31 March 2004
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The TATRC Technology Transfer Imperative

• Patent and Trademark Law Amendment Act (Bayh-Dole
  Act) of 1980
• Option to retain rights to inventions
• Must disclose invention to government (within 2
  months)
• Must file patent
• Must pursue commercialization
• Must give preference to small business for
  licensing
• Must ensure products manufactured in US
• Must provide government a non-exclusive,
  non-transferrable, irrevocable paid-up license
  to use federally funded inventions.

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The TATRC Technology Transfer Imperative

• Federal Technology Transfer Act passed in 1986
  (PL 99-502)
• Requires Federal Labs to transfer tech
• Chartered Federal Laboratory Consortium (FLC) to
  promote tech transfer
• Specifies following tech transfer activities
• Tech Assistance Request from company,
  university, or government to a Federal Lab.
• Authorizes laboratories to assign or license
  inventions
• Cooperative Research and Development Agreements
  (CRADAs) Agreement between Federal Lab and
  industry, non-profit or government to collaborate
  on project of mutual interest.
• Educational Partnerships May loan equipment,
  donate surplus, provide lab personnel
• Cooperative Agreements Provides funding to
  support research of interest to Fed Lab.
• Grants Same as CA, but does not involve govt
  involvement.
• TATRC granted laboratory authority in 4th
  Quarter, FY 03

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Telemedicine and Advanced
Medical Technology Program
Telemedicine Advanced Technology Research
Center Cutting Edge Medical Technology

• 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.

Department of Defense, Joint Warfighting Science
and Technology Plan, Chapter IX, Joint Readiness
and Logistics, 1999
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5 Ps of Precision HealthcareScope of
TATRC Functional Objectives
Predictive - Leverage Emerging Developments
in Genetics, Bio-Informatics
Multi-Modality Imaging Preventive - Act
Proactively to Prevent Disease Point of Care -
Utilize Mobile Communications, Ubiquitous
Computing and Local intelligence Pinpoint
therpeutics Parametric - Analyze
Multi-Parametric Information Referenced to
Patient Baseline and Standard Model Personalized
- Individualize Therapeutics to Each Patient
SATAVA 7 July, 1999 DARPA
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5Ps Transition to Bio Intelligence!
Biosensors Biomaterials Biomimetic
BIOLOGICAL DOMAIN (science)
PHYSICAL DOMAIN (engineering)
FUTURE
Robotics MEMS/ Nanotech Microarray Molecular
Imaging
Genomics Proteomics Bioinformatics Biocomputation
INFORMATION DOMAIN (computers)
Richard M. Satava, MD U of Washington/ TATRC/DARPA
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Core Research Leads to .Transformational
Technologies
Decade of the 1950s
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TATRC TECHNICAL AREAS SYSTEMS
Informatics MAJ RAPP
IM/IT CARL HENDRICKS
Bio-Surveillance MARY PARKER
Bio-Informatics JAQUES REIFMAN
Mobile Med Tech TOMMY MORRIS
HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT M.
PARKER
FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT G.
GILBERT
BATTLEFIELD SYSTEMS INT T. MORRIS
OPERATING ROOM OF THE FUTURE SYS INT G. MOSES
CLINICAL SYSTEMS INTEGRATOR R. POROPATICH
TRAINING SYSTEMS INTEGRATOR C. PUGH
OPERATIONAL TMED SYS INTEGRATOR T. MORRIS
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TATRC TECHNICAL AREAS SYSTEMS
Bio-Sensors KEN CURLEY
Med Mod Sim GERRY MOSES
Robotics GARY GILBERT
Adv. Imaging GREG MOGEL
Adv Surg Tech GERRY MOSES
HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT M.
PARKER
FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT G.
GILBERT
BATTLEFIELD SYSTEMS INT T. MORRIS
OPERATING ROOM OF THE FUTURE SYS INT G. MOSES
CLINICAL SYSTEMS INTEGRATOR R. POROPATICH
TRAINING SYSTEMS INTEGRATOR C. PUGH
OPERATIONAL TMED SYS INTEGRATOR T. MORRIS
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TATRC TECHNICAL AREAS SYSTEMS
Cell/Molecular Bio KEN CURLEY
Nano-Medicine GARY GILBERT
Comp Alt Med KEN CURLEY
Chronic Disease R. POROPATICH
Ther Clincal Tech DEAN CALCAGNI
HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT M.
PARKER
FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT G.
GILBERT
BATTLEFIELD SYSTEMS INT T. MORRIS
OPERATING ROOM OF THE FUTURE SYS INT G. MOSES
CLINICAL SYSTEMS INTEGRATOR R. POROPATICH
TRAINING SYSTEMS INTEGRATOR C. PUGH
OPERATIONAL TMED SYS INTEGRATOR T. MORRIS
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TATRC TECHNICAL AREAS SYSTEMS
Digital Mission Plan DOUG FLETCHER
Bio-Materials CONRAD CLYBURN
Opthalmology BILL FLYNN
Adv Dist Learning CARLA PUGH
HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT M.
PARKER
FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT G.
GILBERT
BATTLEFIELD SYSTEMS INT T. MORRIS
OPERATING ROOM OF THE FUTURE SYS INT G. MOSES
CLINICAL SYSTEMS INTEGRATOR R. POROPATICH
TRAINING SYSTEMS INTEGRATOR C. PUGH
OPERATIONAL TMED SYS INTEGRATOR T. MORRIS
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Examples of Commercialized Products over the Last
12 Months
BMIS-T Chest
Tube Simulator Digital
X-ray
Dreams Digital Ambulance Smallpox
Inoculation Retinal Imaging Training Unit
STAT-CARE
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Life Cycle Management Framework
TATRC

• I C M E O

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Core Business Processes I C M E O
Advanced Technology Watch
Mechanisms
Execution
Outputs
Inputs
Controls
Project Management Regulatory Compliance Technol
ogy Review
Functional Scientific Review Prioritization
Prototypes Patents Royalties Articles Products Dem
os
RDTE, Congressional Defense Health DUST -
SBIR STTR- ACT II CEP - ACTD WRAP -
AWE Interagency Partnerships
Proposals Taskers
TATRC
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T A T R C
S U P P O R T I N G B U S I N E S S P R ACTICES

• TATRC manages projects through professional
  business processes
• Integrated Research Team (IRT)
• Program level
• Periodic, as required
• Broad strategic planning and oversight
• Milestone Reviews
• Project Level
• Pre-Award
• Establish performance metrics, deliverables and
  milestones
• Integrated Product Team (IPT)
• Project level
• More frequent, scheduled
• Project-specific guidance
• Product Line Review (PLR)
• Assessments of research by outside experts
• One research category per month annual cycle

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I C M E O Improvements Needed to Support
Technology Transfer

• Inputs
• Modify TATRC Pre-Proposals to include projected
  market healthcare market data
• gt Leverage templates developed by National
  Medical Technology TestBed (NMTB)
• Quality Controls
• Ensure Proposal Review Board (PRB) fully
  evaluates projected impact on healthcare market
• gt 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

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Total Funding
Telemedicine Advanced Technology Research
Center Cutting Edge Medical Technology
Projected FY04 TOTAL 200m
FY04 TOTAL 200m
FY03 TOTAL 114m
FY02 TOTAL 114m
FY01 TOTAL 116 .6m
FY00 TOTAL 85 m
FY99 TOTAL 67m
FY98 TOTAL 61m
Dollars are in Millions
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TATRC Funding Analysis
FY03 TOTAL 112,825 (000)

• 782K Army Core provided by RAD 1,2,3,4 for
  Bioinformatics Cell/Etc.. 
• 98,099K CSI based on congressionals less the
  DA withholds. 
• 33 FY03 Congressional Special Interest Budgets
• 6,975 DHP is PT III and 5,000 RFS
• Overhead 10 of portfolio managed

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TATRC can draw from a network of existing
advanced medical technology RD public private
partnerships.
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Leverages Academic Partnerships For Basic
and Applied Research
Telemedicine Advanced Technology Research
Center Cutting Edge Medical Technology

• 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 Curriclm)
• 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)

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Telemedicine Advanced Technology Research
Center Cutting Edge Medical Technology
Uses DoD Federal Partnerships for Non-Medical
and Supporting Technologies

• RD Panels and Commands Partnerships
• U.S. Army Research Laboratory
• Los Alamos National Laboratory
• Sandia National Laboratory
• U.S. Army, Signal Battle Laboratory
• Commo Electronic Command
• Oak Ridge National Laboratory
• Veterans Administration
• NASA
• DARPA
• National Library of Medicine (NIH)
• Agency for Health Research Quality (HHS)

Distributed, Synchronized Databases Advanced,
Adaptive Multilevel Security Data Mining of
Disparate Databases Secure Global Positioning
System Network Management Tools Info Warfare
Surveillance Defense Tools Artificial
Intelligence - Expert Systems Fault Avoidance
and Recovery Systems Hands Free, Wireless
Telecom Wireless Networking Data
Compression High Bandwidth Datalinks Low
Power Electronics Multi-platform, Interoperable
Software Complex Modeling and Simulation

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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 gt
  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)

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Examples of TATRC Partnerships with Significant
Technology Transfer Capabilities
TATRC
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National Medical Technology Testbed
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Center for Integration of Medicine and Innovative
Technology
SOLUTION RICH ENVIRONMENT
PROBLEM RICH ENVIRONMENT
CIMIT
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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

Dr John Parrish Institute of Medicine Director,
CIMIT
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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.

• 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

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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.

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CeMBR The Center for Military Biomaterials
Research Biomaterials Solutions to Acute
Trauma Bringing the Full Power of Materials
Science to Combat Casualty Care
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Initial Technical Focus Areas
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CEMBR Industrial Members 2003A Diverse Group of
Synergistic Companies

• Major Corporations
• Avon Products
• Boston Scientific
• Cordis, a JJ Company
• Dupont
• Medtronic
• Unilever
• Associated Research Centers
• Center for Biomaterials Advanced Technologies,
  Medical Products Group (Ethicon, Inc.)

• Production and Fabrication
• The MedTech Group
• Corium
• Supporting Law Firm
• Norris, McLaughlin and Marcus
• Participating Venture Capital Groups
• The Vertical Group

• Medical Device
• Start-ups
• Advanced Materials Design
• BioCure
• REVA Medical
• Vectramed
• Vyteris
• Midsize Medical Device Companies
• Enzon
• Integra Lifesciences
• Hydro Med Sciences
• LifeCell
• Osteotech
• Stratec

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Cleveland Clinic FoundationComputer Assisted
Minimally Invasive Surgery (CAMIS)
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Cleveland Clinic Foundation (CCF)
Innovations gtNew Technology Transfer
Centerlt 2003 Medical Innovation Summit
Participants

 
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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

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Industry Advisory Group
TATRC has long-standing relationship with
ATA Funds Annual Advanced Briefing for Industry
Academia (ABFIA), partially funds ATA Annual
Conference

• 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

• GE Medical Systems
• Intel Corp
• Medweb
• Nortel Networks
• ATT
• Johnson Johnson
• Trestle Corp
• Eastman Kodak
• SBC Communications, Inc
• Verizon Communications
• ScottCare Corp
• Computerized Screening
• AMD Telemedicine
• Polycom
• iMetrikus

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TATRC has long standing relationship with RTI -
funds various dual use simulators

• 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.

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Other PotentialTATRC Technology Transfer
Partnerships
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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

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TATRC Tech Transfer

• 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

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TATRC Changes in FY 04

• 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 gt Organize gt Execute gt Evaluate

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Designed to Accelerate the Flash to Bang
from Basic Research to Tech
Transfer
Nanomedicine BioTechnology Molecular
Genetics Biomateriels BioSensors Basic Research
Forward Deployed Digital Systems Medical Modeling
Simulation Operating Room of the
Future Wireless Medical Enterprises IM/IT
Systems Homeland Security Systems Disease
Surveillance Systems Telemedicine
Assured Connectivity Medical Informatics Med
Training Technologies Robotics Therapeutics Appli
ed Research Advanced Technology Development Early
Prototyping
Demonstration Validation
Engineering Manufacturing Development,
Procurement, Operations Maintenance
Technology Transfer
Program Managers for Army (PM, MC4), Navy, Air
Force, DOD, Industry