Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text

 
Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
Technology Readiness Levels - TRL
  Text
   Text
NASA’s contribution to Horizon 2020

    EIT Health is supported by the EIT,
    a body of the European Union                                              Gustav Notander
                                          Interim Business Creation Coordinator CLC Scandinavia
Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
The purpose of the TRL

Communication tool                 Development roadmap

                                   •   Minimize risk in the
                                       development

                                   •   Develop products that are
                                       fit for purpose

                                   •   Encourage real-world
                                       testing and iteration

                                   •   Introduce “reality checks” in
More objective assessment of the       the development process
development level between
stakeholders

                                                                       2
Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
Important considerations (explanations on next slide)

                    Start here

More
important                                   TRL             Risk
                                            application     Complexity

Less
important
                                             There is no one way of
                                             doing it and there are no
                                             accepted best practices
                                             (at the moment)

                                                                   3
Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
Important considerations
• Start from the top - the “distance” left to TRL 8-9 (product on the market) is
more important than the distance travelled from the idea stage

• Important to strike a balance between the application of the TRL and the risk
and complexity of the project (not necessary to include all steps in lower
risk/complexity projects)

• The higher the TRL, the more it costs to achieve it

• The closer to the market, the more expensive it is if the technology/product
fails

• There is no one way of doing it and there are no accepted best practices (at
the moment)

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Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
Generic TRL  Specific TRL
The TRL is generic  the stages and definitions have to be
adapted to the specific project

       “Technology validated in relevant environment”

Technology development stage        Definition of the
                                    environment in which the
         Proof-of-Concept?          technology has been tested
         Validation?
         Demonstration?
         System?
         Technology?
         Component?
Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
Overview of the TRLs
A comparison of the EC version of TRL and the
“original” NASA/DoD version – focus on the
most relevant levels in EIT Health
   Text
    Text

      EIT Health is supported by the EIT,
      a body of the European Union
TRL 3 - EC vs NASA

              Experimental proof of concept

              Analytical and experimental proof of concept of critical functions
              and/or characteristics

              Analytical studies to predict the performance of separate elements of
              the technology in appropriate context
              Laboratory-based studies to physically validate that the analytical
Description   predictions are correct

              Biocide applied to a patch of non-woven filter media is shown to kill
 Example      gram negative bacteria in lab tests (Anti-legionella filter)

                                                                                      7
TRL 4 - EC vs NASA

              Technology validated in lab

              Component and/or breadboard validation in a laboratory
              environment

              Basic technological components are integrated to establish that they
              will work together. This is relatively “low fidelity” compared with the
              eventual system
Description
              Separate components – Radio Frequency (RF) communication,
              sensors, microcontroller, connectors and related components –
 Example      connected and output signals processed by fall algorithm in computer.
              Simulated stimuli generates the alarm to be transmitted via wireless
              communication. (fall alarm system)
                  “Low-fidelity”
                  A representative of the component or system that has limited ability to provide
                  anything but initial information about the end product.                           8
TRL 5 - EC vs NASA

              Technology validated in relevant environment

              Component and/or breadboard validation in a relevant environment

              Basic technological components are integrated with reasonably
              realistic supporting elements (high-fidelity) so they can be tested in a
Description   controlled relevant environment

              A 2 meter steel test beam (I-profile) spray coated with the new
              intumescent coating in fire certification test laboratory and “burnt” in
 Example      an industrial oven at ISO standard fire temperature. (new intumescent
              coating)

               “High-fidelity”
               Addresses form, fit, and function. A high-fidelity laboratory environment would
               involve testing with equipment that can simulate and validate all system
               specifications within a laboratory setting.
                                                                                                 9
TRL 6 - EC vs NASA

              Technology demonstrated in a relevant environment

              System/subsystem model or prototype demonstration in a relevant
              environment

              Representative model or prototype system, which is well beyond that
              of TRL 5, is tested in a relevant environment. Represents a major step
Description   up in a technology’s demonstrated readiness

              Prototype door built by a door manufacturer according to the new
 Example      construction and installed in a room in one of the project participants
              facilities. (New door construction)

                                                                                        10
TRL 7 - EC vs NASA

              System prototype demonstration in an operational environment

              System prototype demonstration in an operational environment

              Prototype near or at planned operational system. Represents a major
              step up from TRL 6 by requiring demonstration of an actual system
              prototype in an operational environment (e.g., in an aircraft, in a
Description   vehicle, or in space). Normally only performed when the technology
              and/or subsystem is mission critical and relatively high risk.

              A fully functional miniaturized device prototype (the “patch” in its
              final form factor) worn by a real person in an elderly home apartment
 Example      fitted with motion sensors and a functional system in-home control
              box. Connected to the alarm system of the elderly home. (fall alarm
              system)

                                                                                      11
TRL 8 - EC vs NASA

              System complete and qualified

              Actual system completed and qualified through test and
              demonstration

              Technology has been proven to work in its final form and under
              expected conditions
Description
              A complete DryToilet Kit is produced, packaged, shipped, assembled,
 Example      installed, and used at a target end-user’s facility for 6 months. (dry
              toilet kit)

                                                                                       12
Development stage summary
      TRL 9   Technology system in its final form and in full commercial deployment

      TRL 8   Technology system in its final form

      TRL 7   Prototype near or at planned operational system. Represents a major step up from
              TRL 6
      TRL 6   Representative model or prototype system, which is well beyond that of TRL 5.
              Represents a major step up in a technology’s demonstrated readiness
      TRL 5   Basic technological components are integrated with reasonably realistic
              supporting elements so they can be tested in a controlled relevant environment

      TRL 4   Basic technological components are integrated to establish that they will work
              together. This is relatively “low fidelity” compared with the eventual system

      TRL 3   Analytical studies to predict the performance of separate elements of the
              technology in appropriate context - Laboratory-based studies to physically validate
              that the analytical predictions are correct
      TRL 2   Practical concepts or applications are formulated

      TRL 1   Scientific research begins to be translated into applied research and development

                                                                                                  13
Complex systems
      TRL 8-9 - System       All technical elements that comprise the project operating as
                             a single system to deliver a defined capacity.

      TRL 6-7 - Prototype    A physical or virtual model used to evaluate the technical or
                             manufacturing feasibility or utility of a particular technology
                             or process, concept, end item, or system.

                             A functional form of a system, generally reduced in scale,
      TRL 6 – Model          near or at operational specification. Models will be
                             sufficiently hardened to allow demonstration of the technical
                             and operational capabilities required of the final system.
      TRL 4-5 - Breadboard   Integrated components that provide a representation of a
                             system/subsystem and that can be used to determine
                             concept feasibility and to develop technical data. Typically
                             configured for laboratory use to demonstrate the technical
                             principles of immediate interest. May resemble final
                             system/subsystem in function only.

      TRL 3-4 - Component    A single element of technology. The lowest sub-system that
                             provides sufficient granularity to identify technical risks and
                             opportunities.

                                                                                               14
Environment descriptions
       TRL 8-9 – Actual       Implementation of the final system by the end-user as
       operations             they seem fit in their day-to-day operations

       TRL 7 – Operational    Environment that addresses all the operational
       environment            requirements and specifications required of the final
                              system
       TRL 6 – Simulated      Either (1) a real environment that can simulate all the
       operational            operational requirements and specifications required of
       environment            the final system or (2) a simulated environment that
                              allows for testing of a virtual prototype
       TRL 5-6 – Relevant     Testing environment in a lab or other controlled
       environment            environment that simulates both the most important
                              and most stressing aspects of the operational
                              environment.
       TRL 3-4 – Laboratory   The normal environment where the technology or
                              product is developed, usually not related to the
                              environment where it will be used
       TRL 1-2 – Desk/Lab

                                                                                        15
The difference between TRL 4, 5, 6, 7
The levels that are most difficult to define and separate

       EIT Health is supported by the EIT,
       a body of the European Union
Validation vs Demonstration
Validation (TRL 4, 5)

                                 Demonstration (TRL 6, 7)
Give evidence that the concept
will work
                                 Show that the concept actually works

• Quantifiable proof that the    • An act of showing or proving
new concept will perform to        something
the desired specifications       • An act of showing that something
                                   exists or is true by giving proof or
                                   evidence
                                 • An event that proves a fact
                                 • To show that the project/product
                                   complies with requirements by
                                   observation of results

                                                                          17
TRL 5 vs TRL 6 development definition
TRL 5: Basic technological components
are integrated with reasonably
realistic supporting elements                TRL 6: Representative model or prototype
                                             system
Integrated components that provide a
representation of a system/subsystem and     A functional form of a system, (full or reduced
that can be used to determine concept        scale), near or at operational specification used to
feasibility and to develop technical data.   evaluate the technical or manufacturing feasibility
Typically configured for laboratory use to   or utility of a particular technology or process,
validate the technical principles of         concept, end item, or system. Sufficient to allow
immediate interest. May resemble final       demonstration of the technical and operational
                                             capabilities required of the final system.
system/subsystem in function only.
                                             Engineering stage – the prototype is designed
“Artisanal” production of prototype          and engineered as a complete system and
                                             manufactured using methods similar to the final
                                             production

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Potential differentiating factors between
TRL 4, 5, 6, 7
• Size or form factor
• Level of integration of subcomponents
• “Finish” of the prototype – closeness to appearance of
final product
• Level of reality in the “relevant environment”
• Development phase of the technology and/or
components
• Etc.
Examples of TRL 4, 5, 6, 7

   EIT Health is supported by the EIT,
   a body of the European Union
Automatic hospital bed
TRL 7   System prototype   Could be the same prototype as
        demonstration in   TRL 6 below but tested in an
        an operational     actual hospital environment for
        environment        an extended period of time.

TRL 6   Technology         Prototype that resembles final
        demonstration in   product
        a relevant         in both function and form
        environment
TRL 5   Technology         Heavy, clumsy, full scale
        validation         prototype that proves that the
        in a relevant      concept will work technically.
        environment        Not made to resemble a final
                           product in other aspects than
                           function.

                                                             22
X-ray scanner for moisture
content measurement

Application example: continuous measurement of moisture content in paper and pulp mill

             TRL 7 System            -   Full scale X-ray scanner, measuring moisture content of wood chips
                    prototype            from a paper mill on a conveyor belt in real-time but not connected to
                    demonstration        process control system. Installed on the premises of a paper mill and
                    in                   all flow rates and volumes of wood chips equal to that of the paper
                    an operational       mill.
                    environment
                                     -   Output data stored and evaluated in external computer
             TRL 6 Technology        -   Full scale X-ray scanner measuring moisture content of wood chips on
                    demonstration        a conveyor belt in real-time but not connected to process control
                    in a relevant        system.
                    environment      -   Test performed off-site
                                     -   Wood chips with prepared, varying moisture levels on a conveyor belt
                                         at similar speed as the paper mill and the data collected and analyzed
                                         to verify measurements
             TRL 5 Technology        -   Separate components: x-ray emission source + detector + integrated in
                    validation           a frame with a conveyor system tested with wood chips of known
                    in a relevant        moisture content. Not full scale.
                    environment      -   Algorithm developed for measurement signal processing run on
                                         separate computer.
Improvements of existing products

  EIT Health is supported by the EIT,
  a body of the European Union
Product improvements
• TRL is most clear cut when dealing with genuine New
Product Development with high inherent risk and
insecurity (that’s what it was designed for)

• Requires more thought when applied to product or
process improvements

                                                        25
Product improvements
Substantial improvement of a TRL 8-
9 system = starting again at TRL 2

But…                                                More
                                                    important
                                      Remember, the important
                                      thing when assessing how
                                      close you are to the market is
                                      not only what TRL you are at
                                      now, but the time, resources
                                      and steps required to get to
                                      TRL 8-9 (market introduction)

                                                    Less
                                                    important
       the road from a low TRL
       to a high TRL may be very
       short and fast…

                                                                       26
TRL vs other structured
development processes
There’s more than one way to skin a cat…

      EIT Health is supported by the EIT,
      a body of the European Union
Software development
       TRL 9      v1.x, v2.x, etc. – continuous development and improvement

       TRL 8      v1.0 - Final stable release to the end-users

       TRL 7      Open beta testing - open for anyone who signs up (“Black-box”)

       TRL 6      Beta testing for invited end-users (“Black-box”)

       TRL 5      “Black-box” alpha testing for selected external end-users or in-hose users/testeers
                  not associated with the development

       TRL 4      Alpha testing of the software by one or a few in-house developers or testers
                  (“White-box”)

       TRL        Concept/pre-alpha: script is more of an abstract idea than an actual working
                  program. Through this stage the coding starts and changes to functions are being
       1- 3       made until a working draft is created

       Alpha: working          Beta: program near      White-box: tests         Black-box: examining
       script, probably lots   completion, all         internal structures or   functionality without
       of bugs, might not      features working, may   workings of a            any knowledge of
       have all features,      be some bugs that       program, as opposed      internal
       but the core of the     may not have shown      to the functionality     implementation. The
       program is running      up in alpha testing     exposed to the end-      tester is only aware of
       and can be tested                               userby                   what the software is
       extensively                                                              supposed to do, not
                                                                                how it does it.
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Pharmaceutical development
       TRL 9     Post marketing studies and surveillance

       TRL 8     Phase 3 clinical trial is completed. FDA (CDER) approves New Drug
                 Application (NDA)
       TRL 7     Phase 2 clinical trial is completed. Phase 3 clinical trial plan is
                 approved by FDA (CDER)
       TRL 6     Phase 1 clinical trials support proceeding to phase 2 clinical trials.
                 Investigational New Drug (IND) application submitted to and reviewed
                 by FDA (CDER)
       TRL 5     Pre-clinical studies, including GLP animal safety & toxicity, sufficient to
                 support IND application

       TRL 4     PoC and safety of candidate drug formulation is demonstrated in a
                 defined laboratory or animal model

       TRL 3     Hypothesis testing and initial proof of concept (PoC) is demonstrated
                 in a limited number of in vitro & in vitro models
       TRL 2     Research ideas and protocols are developed

               Source: US Army Medical Department
                                                                                               29
Medical device development
       TRL 9     Post marketing studies and surveillance

       TRL 8     FDA (CDRH) approves the Premarket Approval (PMA) for medical
                 device or applicable 510(K) for devices
       TRL 7     Final product design is validated and final prototypes are produced
                 and tested.
       TRL 6     Class III device safety is demonstrated. 510(K) data demonstrates
                 substantial equivalency to predicate device.
       TRL 5     MD-CDRH review of Investigational Device Exemption (IDE) results is
                 sufficient to begin investigation

       TRL 4     PoC and safety of candidate device or system is demonstrated in a
                 defined laboratory or animal model

       TRL 3     Hypothesis testing and initial proof of concept (PoC) is demonstrated
                 in a limited number of in vitro & in vitro models
       TRL 2     Research ideas and protocols are developed

               Source: US Army Medical Department
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