Download - Medical Development Program
Medical Development Program
W. K. PrusaczykProgram Manager, Medical Development Program
Director, Congressional Programs Office
VANGUARD 2009Jacksonville, FL
10 FEB 2009
This Brief is Unclassified2
Process decomposes from Policy Guidance to Warfighting Concepts to Capability Areas to Potential Solutions (material & non-material) to Products
• Top-down guidance• Joint Concepts enables the warfighter to
shape and influence the trade space debate• Provides the “trade space” discussion at
the right level
Capabilities-based Process
Strategic Planning
Guidance/National Military
Strategy
1
Battlespace Awareness
Command & Control
Force Application
Protection
Focused Logistics
Homeland Security
Major Combat
Operations
Stability Operations
Strategic Deterrence
USAUSN
USAFUSMC
Servic
e Con
cepts
Join
t Fun
ctio
nal C
once
pts
Joint Operating Concepts
Capability Disconnect
Policy
Concepts
CapabilityAssessment
Functional Area * Functional Needs* Functional Solution
1
I
SOF
Context
Engagement
Kinetic Non-Kinetic
Lethal Non-Lethal
2
I
SOF
EngageMovingSmallBoats
EngageMovingSoft
Targets
EngageMoving Semi-
Hardened Targets
EngageMovingArmoredTargets
Moving Target Attributes/Metrics
Networked Agile Survivable
SSPK Networked Environment Range
Employment
Carriage
Capabilities
Attributes
Metrics
Operational Flex
Discriminating
CollateralDamage
GuidanceProfile
Countermeasures
Responsiveness
Lethal
Loadout
040325 J7/JTD/040325 Concepts to Capabilities Brief to NWC v319
M o v in g A rm o red T arg e ts
M o v in g sem i-h ard en ed T arg e ts
M o v in g S o ft T arg e ts
M o v in g S m all B o ats
30M M ( g u n am m o ) 44 46 55 4820M M (g u n am m o ) 19 25 55 48
2 .75 H yd ra 17 22 29 12 5 .0" Z u n i 20 25 30 15
C B U 99 /100 20 22 26 18C B U 99 /100 w F M U -140 20 22 26 18
C B U -87 C B U -103 C E M 21 24 25 19C B U -103 C E M 23 26 28 21C B U -105 S F W 36 40 45 47
A T A C M S II 49 50 54 33T O W II 44 50 56 32
A P K W S 31 37 52 28A G M 114 H e llfire (lo n g b o w ) 68 68 68 49
H e llfire 71 71 71 43P en g u in 37 42 53 34G B U -12 36 48 59 67G B U -16 36 52 58 68G B U -10 65 61 57 69G B U -15 67 63 59 71
A G M 65 A /B /H T V S H (M averick (A F ) 62 60 58 63A G M 65 K T V S H /B F (M averick (A F ) 63 61 59 65
A G M 65 D /G 2 IR S H S H /B F (M averick (A F ) 59 59 58 62A G M 65 F IR S H /B F M averick (D o N ) 55 59 59 65
A G M 65 E L S R S H /B F M averick (D o N ) 55 59 59 65A G M -130 51 65 63 75S L A M E R 50 65 63 71
JC M 88 88 88 89S D B II 89 88 87 93
Systems to Capability Assessment
Provide Operational Capability with fielded Systems to meet a Capability Gap
Assesses potential programmed capabilities in an warfighting operational context
Capability Road Map
Operational Availability
Assess end of program Forces in warfighting scenarios
Assess Program
Deliver
This Brief is Unclassified3
Joint Warfighting ConceptsJoint does not mean the solution has to be SAME
Despite heroic efforts, some
Joint Warfighting Concepts have
met with limited success
during experimentation.
This Brief is Unclassified4
Joint Capability Integration and Development System (JCIDS)
Goal: Provide the Joint Force with the capabilities needed to perform across the range of military operations and challenges.
Through: • Integrated, collaborative review process• Leveraged expertise of all government agencies• Application of Joint Operating Concepts and
integrated architectures.
JCIDS along with the Defense Acquisition System and the Planning, Programming, Budgeting and Execution process form the
principal DOD decision support tools for transforming the military forces to support the national military strategy and the defense strategy
JCIDS is necessary, but not sufficient!
This Brief is Unclassified5
Defense Acquisition Management Framework
IOCBA
Single Step or Evolution to Full
Capability
Concept &Tech Development
System Development& Demonstration
Production & Deployment
Pre-Systems Acquisition
Systems Acquisition(Demonstration, Engineering
Development, LRIP & Production)
Operations & Support
Sustainment
Enter process at Milestones A, B, or C (or within phases)
Program outyear funding when it makes sense, but no later than Milestone B
Technology Opportunities & User
Needs
Concept Exploration
Component Advanced
Development
System Integration
System Demonstration
LRIP Full-Rate Prod & Deployment
DecisionReview
InterimProgressReview
FRPDecisionReview
A B
Sustainment
Disposal
BLOCK IIBLOCK III
Validated & approved by operational validation authority
C FOC
This Brief is Unclassified6
Medical R&D Process
AORCurrent Ops
BA1[6.1]
BA5→OP,N[6.5/Procurement]
BA2→BA3[6.2/6.3]
BA3→BA4[6.3/6.4]
BA4→BA5[6.4/6.5]
$
DEMVAL EMD
Basic Research
Applied Research Adv Tech Dev
Adv Tech Dev DEMVAL
Procurement / O&S
Production & Deployment
Scientific Steering Committee
Integrated Product Team
BCAD
IPRDISCOVERY
Concept & Technology Development
C
System Development
& DemonstrationConcept
Exploration
Component Advanced
Development
A
Deployment Tech Base Development
Same Objective - Different Nomenclature
ONR FHPFNC → SYSCOM / Naval Med ADONR D&I, E&D SYSCOM / Naval Med AD End User
This Brief is Unclassified7
DoD Financial Management Regulation Volume 2B, Chapter 5 July 20080502 UNIFORM BUDGET AND FISCAL ACCOUNTING CLASSIFICATION 050201. RDT&E Budget Activities
A. The RDT&E budget activities are broad categories reflecting different types of RDT&E efforts. The definitions are provided below. B. Budget Activity 1, Basic Research. Basic research is systematic study directed toward greater knowledge or understanding of the fundamental aspects of
phenomena and of observable facts without specific applications towards processes or products in mind. It includes all scientific study and experimentation directed toward increasing fundamental knowledge and understanding in those fields of the physical, engineering, environmental, and life sciences related to long-term national security needs. It is farsighted high payoff research that provides the basis for technological progress. Basic research may lead to: (a) subsequent applied research and advanced technology developments in Defense-related technologies, and (b) new and improved military functional capabilities in areas such as communications, detection, tracking, surveillance, propulsion, mobility, guidance and control, navigation, energy conversion, materials and structures, and personnel support. Program elements in this category involve pre-Milestone A efforts.
C. Budget Activity 2, Applied Research. Applied research is systematic study to understand the means to meet a recognized and specific need. It is a systematic expansion and application of knowledge to develop useful materials, devices, and systems or methods. It may be oriented, ultimately, toward the design, development, and improvement of prototypes and new processes to meet general mission area requirements. Applied research may translate promising basic research into solutions for broadly defined military needs, short of system development. This type of effort may vary from systematic mission-directed research beyond that in Budget Activity 1 to sophisticated breadboard hardware, study, programming and planning efforts that establish the initial feasibility and practicality of proposed solutions to technological challenges. It includes studies, investigations, and non-system specific technology efforts. The dominant characteristic is that applied research is directed toward general military needs with a view toward developing and evaluating the feasibility and practicality of proposed solutions and determining their parameters. Applied Research precedes system specific technology investigations or development. Program control of the Applied Research program element is normally exercised by general level of effort. Program elements in this category involve pre-Milestone B efforts, also known as Concept and Technology Development phase tasks, such as concept exploration efforts and paper studies of alternative concepts for meeting a mission need.
D. Budget Activity 3, Advanced Technology Development (ATD). This budget activity includes development of subsystems and components and efforts to integrate subsystems and components into system prototypes for field experiments and/or tests in a simulated environment. ATD includes concept and technology demonstrations of components and subsystems or system models. The models may be form, fit and function prototypes or scaled models that serve the same demonstration purpose. The results of this type of effort are proof of technological feasibility and assessment of subsystem and component operability and producibility rather than the development of hardware for service use. Projects in this category have a direct relevance to identified military needs. Advanced Technology Development demonstrates the general military utility or cost reduction potential of technology when applied to different types of military equipment or techniques. Program elements in this category involve pre-Milestone B efforts, such as system concept demonstration, joint and Service-specific experiments or Technology Demonstrations and generally have Technology Readiness Levels of 4, 5, or 6. Projects in this category do not necessarily lead to subsequent development or procurement phases, but should have the goal of moving out of Science and Technology (S&T) and into the acquisition process within the future years defense program (FYDP). Upon successful completion of projects that have military utility, the technology should be available for transition.
E. Budget Activity 4, Advanced Component Development and Prototypes (ACD&P). Efforts necessary to evaluate integrated technologies, representative modes or prototype systems in a high fidelity and realistic operating environment are funded in this budget activity. The ACD&P phase includes system specific efforts that help expedite technology transition from the laboratory to operational use. Emphasis is on proving component and subsystem maturity prior to integration in major and complex systems and may involve risk reduction initiatives. Program elements in this category involve efforts prior to Milestone B and are referred to as advanced component development activities and include technology demonstrations. Completion of Technology Readiness Levels 6 and 7 should be achieved for major programs. Program control is exercised at the program and project level. A logical progression of program phases and development and/or production funding must be evident in the FYDP.
F. Budget Activity 5, System Development and Demonstration (SDD). SDD programs have passed Milestone B approval and are conducting engineering and manufacturing development tasks aimed at meeting validated requirements prior to full-rate production. This budget activity is characterized by major line item projects and program control is exercised by review of individual programs and projects. Prototype performance is near or at planned operational system levels. Characteristics of this budget activity involve mature system development, integration and demonstration to support Milestone C decisions, and conducting live fire test and evaluation and initial operational test and evaluation of production representative articles. A logical progression of program phases and development and production funding must be evident in the FYDP consistent with the Department’s full funding policy.
G. Budget Activity 6, RDT&E Management Support. This budget activity includes research, development, test and evaluation efforts and funds to sustain and/or modernize the installations or operations required for general research, development, test and evaluation. Test ranges, military construction, maintenance support of laboratories, operation and maintenance of test aircraft and ships, and studies and analyses in support of the RDT&E program are funded in this budget activity. Costs of laboratory personnel, either in-house or contractor operated, would be assigned to appropriate projects or as a line item in the Basic Research, Applied Research, or ATD program areas, as appropriate. Military construction costs directly related to major development programs are included.
H. Budget Activity 7, Operational System Development. This budget activity includes development efforts to upgrade systems that have been fielded or have received approval for full rate production and anticipate production funding in the current or subsequent fiscal year. All items are major line item projects that appear as RDT&E Costs of Weapon System Elements in other programs. Program control is exercised by review of individual projects. Programs in this category involve systems that have received Milestone C approval. A logical progression of program phases and development and production funding must be evident in the FYDP, consistent with the Department’s full funding policy.
Budget Activity 5, System Development and Demonstration (SDD). SDD programs have passed Milestone B approval and are conducting engineering and manufacturing development tasks aimed at meeting validated requirements prior to full-rate production. This budget activity is characterized by major line item projects and program control is exercised by review of individual programs and projects. Prototype performance is near or at planned operational system levels. Characteristics of this budget activity involve mature system development, integration and demonstration to support Milestone C decisions and conducting live fire test and evaluation (LFT&E) and initial operational test and evaluation (IOT&E) of production representative articles. A logical progression of program phases and development and production funding must be evident in the FYDP consistent with the Department’s full funding policy.
Budget Activity 5, System Development and Demonstration (SDD). SDD programs have passed Milestone B approval and are conducting engineering and manufacturing development tasks aimed at meeting validated requirements prior to full-rate production. This budget activity is characterized by major line item projects and program control is exercised by review of individual programs and projects. Prototype performance is near or at planned operational system levels. Characteristics of this budget activity involve mature system development, integration and demonstration to support Milestone C decisions and conducting live fire test and evaluation (LFT&E) and initial operational test and evaluation (IOT&E) of production representative articles. A logical progression of program phases and development and production funding must be evident in the FYDP consistent with the Department’s full funding policy.
This means that a Technology Readiness Level (TRL)
of 6 or 7 has been achieved.
This Brief is Unclassified8
(e) Budget Activity 5, System Development and Demonstration (SDD). SDD programs have passed Milestone B approval and are conducting engineering and manufacturing development tasks aimed at meeting validated requirements prior to full-rate production. This budget activity is characterized by major line item projects and planned operational system levels. Characteristics of this budget activity involve mature system development, integration, and demonstration to support Milestone C decisions, and conducting live fire test and evaluation (LFT&E) and initial operational test and evaluation (IOT&E) of production representative articles. A logical progression of program phases and development and production funding must be evident in the FYDP consistent with the Department’s full funding policy.
The Navy Medical Development Program is funded in PE 0604771Nand is classified as BA-5 consistent with
DoD Financial Management Regulation, Volume 2B, Chapter 5, Section 050201, July 2008
This Brief is Unclassified9
Technology Readiness Level (TRL)B
A1
BA
2
B
A3
BA
4
B
A5
This Brief is Unclassified10
TRLs for Medical RDT&EDoD Technology Readiness Assessment (TRA) Deskbook
What Constitutes a Product?
This Brief is Unclassified11
This Brief is Unclassified12
DOT LPFMateriel/Devices Pharmaceuticals
Product Development Pathway& Risk Management
Development Level (TRL)
Rel
ativ
e R
isk
This Brief is Unclassified13
Getting to the Solution
Fleet/ForceNeeds
TechnologyOpportunities
“Due Diligence”
Transition to
the User
MOA/MOUTTA
CRADA
DevelopEducateIntegrate
Stakeholder Confidence
Technical Risk
“Success”
“Programming & Execution”
“Planning”
Technical
Business
Business CaseAnalysis
NeedsFleet/Force
BUMED, MCCDC,OPNAV
TechnologyOpportunities
DoN, DoD, National Labs,Industry, Academia
ResourcesDoN, USMC,
Other DoD, DARPAOSD (TTI, DACP, ACTD)
Industry (CRADA)
DEALS
This Brief is Unclassified14
Medical Development ProgramPartnering Opportunities
Capability/Requirement Identification
Review/Downselect
LOI Call/Review/Screening
TEMP Development
Document Dissemination
TEMP Review IPT Process Initiation
Finalize Program
Capabilities Document
Program Approval Brief
RDT&E Capability Assessment
Distribution Plan
Program Planning and Execution Cycle
Execution
This Brief is Unclassified16
Medical Development ProgramDelivery On the Horizon
Infusible HemostaticFY12
CyberCricFY09
Limb SalvageFY15+
MOVES FY09
MOVES AnesthesiaFY12
Test for Wound ClosureFY11
This Brief is Unclassified17
Medical Development Program
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