Text Text
EIT Health is supported by the EIT, a body of the European Union
Technology Readiness Levels - TRL NASA’s contribution to Horizon 2020
Gustav Notander Interim Business Creation Coordinator CLC Scandinavia
2
Communication tool
More objective assessment of the
development level between
stakeholders
The purpose of the TRL
Development roadmap
• Minimize risk in the
development
• Develop products that are
fit for purpose
• Encourage real-world
testing and iteration
• Introduce “reality checks” in
the development process
3
Important considerations (explanations on next slide)
Start here
More
important
Less
important
There is no one way of
doing it and there are no
accepted best practices
(at the moment)
Risk
Complexity
TRL
application
4
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)
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
Proof-of-Concept?
Validation?
Demonstration?
System?
Technology?
Component?
Definition of the
environment in which the
technology has been tested
Text Text
EIT Health is supported by the EIT, a body of the European Union
A comparison of the EC version of TRL and the “original” NASA/DoD version – focus on the most relevant levels in EIT Health
Overview of the TRLs
7
TRL 3 - EC vs NASA
Experimental proof of concept
Analytical and experimental proof of concept of critical functions and/or characteristics
Description
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
Example
Biocide applied to a patch of non-woven filter media is shown to kill gram negative bacteria in lab tests (Anti-legionella filter)
8
TRL 4 - EC vs NASA
Technology validated in lab
Component and/or breadboard validation in a laboratory environment
Description
Basic technological components are integrated to establish that they will work together. This is relatively “low fidelity” compared with the eventual system
Example
Separate components – Radio Frequency (RF) communication, sensors, microcontroller, connectors and related components – 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.
9
Technology validated in relevant environment
Component and/or breadboard validation in a relevant environment
Description
Basic technological components are integrated with reasonably realistic supporting elements (high-fidelity) so they can be tested in a controlled relevant environment
Example
A 2 meter steel test beam (I-profile) spray coated with the new intumescent coating in fire certification test laboratory and “burnt” in an industrial oven at ISO standard fire temperature. (new intumescent coating)
TRL 5 - EC vs NASA
“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.
10
Technology demonstrated in a relevant environment
System/subsystem model or prototype demonstration in a relevant environment
Description
Representative model or prototype system, which is well beyond that of TRL 5, is tested in a relevant environment. Represents a major step up in a technology’s demonstrated readiness
Example
Prototype door built by a door manufacturer according to the new construction and installed in a room in one of the project participants facilities. (New door construction)
TRL 6 - EC vs NASA
11
TRL 7 - EC vs NASA
System prototype demonstration in an operational environment
System prototype demonstration in an operational environment
Description
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 vehicle, or in space). Normally only performed when the technology and/or subsystem is mission critical and relatively high risk.
Example
A fully functional miniaturized device prototype (the “patch” in its final form factor) worn by a real person in an elderly home apartment fitted with motion sensors and a functional system in-home control box. Connected to the alarm system of the elderly home. (fall alarm system)
12
TRL 8 - EC vs NASA
System complete and qualified
Actual system completed and qualified through test and demonstration
Description
Technology has been proven to work in its final form and under expected conditions
Example
A complete DryToilet Kit is produced, packaged, shipped, assembled, installed, and used at a target end-user’s facility for 6 months. (dry toilet kit)
13
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
14
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 TRL 6 – Model
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, 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.
15
Environment descriptions
TRL 8-9 – Actual operations
Implementation of the final system by the end-user as they seem fit in their day-to-day operations
TRL 7 – Operational environment
Environment that addresses all the operational requirements and specifications required of the final system
TRL 6 – Simulated operational environment
Either (1) a real environment that can simulate all the operational requirements and specifications required of the final system or (2) a simulated environment that allows for testing of a virtual prototype
TRL 5-6 – Relevant environment
Testing environment in a lab or other controlled 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
EIT Health is supported by the EIT, a body of the European Union
The levels that are most difficult to define and separate
The difference between TRL 4, 5, 6, 7
17
Validation vs Demonstration
Validation (TRL 4, 5)
Give evidence that the concept
will work
• Quantifiable proof that the
new concept will perform to
the desired specifications
Demonstration (TRL 6, 7) Show that the concept actually works • An act of showing or proving
something • 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
18
TRL 5 vs TRL 6 development definition
TRL 5: Basic technological components
are integrated with reasonably
realistic supporting elements
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
validate the technical principles of
immediate interest. May resemble final
system/subsystem in function only.
“Artisanal” production of prototype
TRL 6: Representative model or prototype system A functional form of a system, (full or reduced scale), near or at operational specification used to evaluate the technical or manufacturing feasibility or utility of a particular technology or process, concept, end item, or system. Sufficient to allow demonstration of the technical and operational capabilities required of the final system. Engineering stage – the prototype is designed and engineered as a complete system and manufactured using methods similar to the final production
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.
EIT Health is supported by the EIT, a body of the European Union
Examples of TRL 4, 5, 6, 7
22
Automatic hospital bed
TRL 7 System prototype
demonstration in
an operational
environment
Could be the same prototype as
TRL 6 below but tested in an
actual hospital environment for
an extended period of time.
TRL 6 Technology
demonstration in
a relevant
environment
Prototype that resembles final
product
in both function and form
TRL 5
Technology
validation
in a relevant
environment
Heavy, clumsy, full scale
prototype that proves that the
concept will work technically.
Not made to resemble a final
product in other aspects than
function.
X-ray scanner for moisture content measurement
TRL 7 System
prototype
demonstration
in
an operational
environment
- Full scale X-ray scanner, measuring moisture content of wood chips
from a paper mill on a conveyor belt in real-time but not connected to
process control system. Installed on the premises of a paper mill and
all flow rates and volumes of wood chips equal to that of the paper
mill.
- Output data stored and evaluated in external computer
TRL 6 Technology
demonstration
in a relevant
environment
- Full scale X-ray scanner measuring moisture content of wood chips on
a conveyor belt in real-time but not connected to process control
system.
- 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
validation
in a relevant
environment
- Separate components: x-ray emission source + detector + integrated in
a frame with a conveyor system tested with wood chips of known
moisture content. Not full scale.
- Algorithm developed for measurement signal processing run on
separate computer.
Application example: continuous measurement of moisture content in paper and pulp mill
EIT Health is supported by the EIT, a body of the European Union
Improvements of existing products
25
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
26
Product improvements
Substantial improvement of a TRL 8-9 system = starting again at TRL 2
But…
the road from a low TRL to a high TRL may be very short and fast…
More
important
Less
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)
EIT Health is supported by the EIT, a body of the European Union
There’s more than one way to skin a cat…
TRL vs other structured development processes
28
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 1- 3
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 made until a working draft is created
Alpha: working
script, probably lots
of bugs, might not
have all features,
but the core of the
program is running
and can be tested
extensively
Beta: program near
completion, all
features working, may
be some bugs that
may not have shown
up in alpha testing
White-box: tests
internal structures or
workings of a
program, as opposed
to the functionality
exposed to the end-
userby
Black-box: examining
functionality without
any knowledge of
internal
implementation. The
tester is only aware of
what the software is
supposed to do, not
how it does it.
29
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
30
Medical device development
Source: US Army Medical Department
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
