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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