Technology Readiness Levels - TRL - NASA's contribution to Horizon 2020 Text Text
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Technology Readiness Levels - TRL
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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
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
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
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)
4
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?
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 UnionTRL 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)
7TRL 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. 8TRL 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.
9TRL 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)
10TRL 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)
11TRL 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)
12Development 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
13Complex 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.
14Environment 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
15The 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 UnionValidation 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
17TRL 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
18Potential 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.
22X-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
25Product 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…
26TRL 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 UnionSoftware 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.
28Pharmaceutical 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
29Medical 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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