Tongariro National Park, NZ

1903 Wright brothers

first flight

Land on Asteroid2025

Crewed Mission to Mars ~2035

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Thanks… Questions?

1

TRL

2

TRL

3

TRL

4

TRL

5

TRL

6

TRL

7

TRL

8

TRL

9

TRL

Research

• Core research / technology options

• War fighter needs

Concept

• Product options

• Product requirements

File

• Complete PMA

• Obtain FDA clearance

• IOT&E

Lifecycle Mgmt

• Maintenance

• Track/report adverse events

• Database for next generation improvements

• Post-marketing studies

Planning and Definition

• Development strategy

• Detailed product definition

• Hardware design

• Software design

• Product development plan/functional group schedules

• Proof of concept system

Commercial

Launch

• Market release

• Ramp to volume

Design and Implementation

• Detailed design and layout

• Software implementation

• Hardware/software integration

• Verification/Validation and Test design and generation

• Pre-clinical testing

• Product/process validation and verification

• Transfer to manufacturing

• Build – evaluation/clinical units

• System prototype – I

• Initiate Intellectual Property

Clinical / User Tests

• System integration / design readiness review

• User acceptance tests

• 510K Clearance

• Clinical strategy and trial design and conduct

• Recruitment

• Data collection and analysis

• PMA/Regulatory submission compilation

• Logistics planning

• Environmental testing

• System prototype – II

De

vice

s

PostLaunch Review

Milestone B Product Design

Materiel Developme

ntDecision

Milestone AProduct

Specification

PMAClearance,

Launch

File(PMO Only)

IOC FOCProgram InitiationB C

Do

D

LaunchLifecycleManage-ment

Production & Deployment

Operations & Support

A

Clinical / User Tests

Design and Implementation

Planning andDefinitionConceptResearch

Engrg & Mfg Development & Demo

Technology DevelopmentMateriel Solution Analysis

Evaluation and Verification

Product Requirement

6.1 6.2 6.3 6.4 6.5 Procurement OMA

Milestone CPMA Filing

Full Production Rate IPR

MRL; SRL

DOD Acquisition and NASA

1903 Wright brothers

first flight