Critically evaluating the commercial readiness or maturity of technology for a life sciences product can be challenging. Conversation to reach alignment on these topics can be inefficient. It’s often somewhat arbitrary or ambiguous.
So how can teams accurately determine how far along they really are in the development of a new technology? And how can they build a common understanding that allows for clarity and alignment on next steps? These are questions that become especially important when it comes to life science instrument development, where products are highly complex and time-to-market pressure means very little room for missteps or delays.
This is where the Technology Readiness Levels (TRL) framework is quite useful and valuable. At Plexus, we’ve found great value in using the TRL framework to help scope life science instrument development projects, build alignment, identify risks and bring clarity to life sciences project management.
What are Technology Readiness Levels?
"The TRL rating tells you how far a technology or product is from being commercially available to the public, or allows you to estimate the amount of time and resources still required to make it available as a viable product or technology."
The Technology Readiness Levels are a framework of nomenclature, standards and methods used to assess and communicate the maturity of a technology. TRLs are assessed on a scale from 1 to 9, with 1 being the earliest readiness level and 9 being the most mature technology level.
Most importantly, TRLs provide a consistent reference and method for engineers, investors and other stakeholders to understand the current maturity of a technology, regardless of their background. Essentially, the TRL rating tells you how far a technology or product is from being commercially available to the public, or allows you to estimate the amount of time and resources still required to make it available as a viable product or technology. In addition, TRLs provide value by informing risk assessment and management, decision making for financial or resource investment, schedule and resource planning, and more.
A brief history of the Technology Readiness Levels framework.
The TRL framework was first developed by NASA in 1974. At that time, the framework consisted of 7 technology maturity levels. It has since evolved within NASA to include 9 levels, which can be simplified into three main stages: research, development and deployment.
When NASA first developed the TRL framework, it was to help support the Jupiter Orbiter design team from Jet Propulsion Laboratory (JPL) Propulsion Division. Specifically, the JPL team first used TRLs as a risk assessment tool. The assumption was that lower maturity level technologies introduce more risk into the overall program. The 7-level approach was formally defined in 1989, with levels that were very specific to aerospace.
Original NASA TRL Levels and Definitions (1989)
- Level 1 – Basic principles observed and reported
Level 2 – Potential application validated
Level 3 – Proof-of-concept demonstrated, analytically and/or experimentally
Level 4 – Component and/or breadboard laboratory validated
Level 5 – Component and/or breadboard validated in simulated or real-space environment
Level 6 – System adequacy validated in simulated environment
Level 7 – System adequacy validated in space
However, as NASA teams continued to use the framework, it evolved into the 9-level scale we know today, as defined in a 1995 publication from NASA physicist John Mankins.
Current NASA TRL Levels and Definitions
- Level 1 - Basic principles observed and reported
Level 2 - Technology concept and/or application formulated
Level 3 - Analytical and experimental critical function and/or characteristic proof-of-concept
Level 4 - Component and/or breadboard validation in laboratory environment
Level 5 - Component and/or breadboard validation in relevant environment
Level 6 - System/subsystem model or prototype demonstration in a relevant environment (ground or space)
Level 7 - System prototype demonstration in a space environment
Level 8 - Actual system completed and “flight qualified” through test and demonstration (ground or space)
Level 9 - Actual system “flight proven” through successful mission operations
Subsequently, TRLs have evolved over time to be adapted and adopted by an increasingly broad number of fields, sectors and agencies. What began as a very specific, aerospace-focused tool to help space missions literally get off the ground, has proved valuable across multiple industries and types of technology.
Sectors using the Technology Readiness Levels framework include:
NASA and other U.S. government agencies.
NASA is still very much an active user of TRLs, and use has expanded to several other government agencies, including the Department of Defense (DoD), Department of Energy (DOE) and the U.S. Air Force (USAF). These types of organizations use the truest and most original form of TRLs.
International governments and agencies.
TRL adoption has also been global in nature. For example, the European Space Agency (ESA) adopted TRLs for use in the mid-2000s. Furthermore, the European Union (EU) adopted TRLs in 2010 as an innovation policy tool. They have extended the use of TRLs beyond space, to include weapons programs, communications and nanotechnology.
Private sector aerospace, defense, manufacturing and technology companies.
There has also been increasing adoption in the private sector. Many private sector aerospace and defense organizations have become active users of the TRL scale and practice — after all, this all started in aerospace. But it has expanded well beyond the aerospace industry. Companies like John Deere, Alstom and Google all use variations of TRL, maintaining the core principles and the core 9-level scale. Examples of applications in less-traditional technology sectors include use in oil and gas (e.g., use for assessment of oil spill response technologies and equipment or subsea drilling technology), renewable energy, and software development for everything from military systems to medical informatics software.
Increasingly, TRLs are an accepted approach and standard used to assess and communicate the readiness of a technology or product for commercialization or investment.
Venture capitalists and entrepreneurs.
Speaking of investment, another set of users that is increasingly adopting TRLs is venture capitalists (VC) and entrepreneurs. These groups use TRL assessments to align on the maturity of technology (which is fundamentally related to its value), investment requirement and time to market and return on investment. For example, an entrepreneur with a higher-level TRL can negotiate a higher valuation of their technology and of their company compared to a startup with a competing technology or product at a lower TRL.
These groups have even adopted the parallel use of a complementary framework for Investment Readiness Level (IRL). This IRL is very similar to TRL in that is has a scale from 1 to 9, but it’s very broad so that it can apply to a range of products and technologies, including software and services. VCs use TRLs and IRLs to eliminate bias and intelligently assess investments. The evaluations also help investors balance portfolios to cover earlier technology investments (low TRL and IRLs) with more mature, shorter time-to-market technology investments.
Technology Readiness Level Examples
||Basic principles observed
||Scientific observations made and reported. Examples could include paper-based studies of a technology’s basic properties.
||Technology concept formulated
||Envisioned applications are speculative at this stage. Examples are often limited to analytical studies.
||Experimental proof of concept
||Effective research and development initiated. Examples include studies and laboratory measurements to validate analytical predictions.
||Technology validated in lab
||Technology validated through designed investigation. Examples might include analysis of the technology parameter operating range. The results provide evidence that envisioned application performance requirements might be attainable.
||Technology validated in relevant environment
||Reliability of technology significantly increases. Examples could involve validation of a semi-integrated system/model of technological and supporting elements in a simulated environment.
||Technology demonstrated in relevant environment
||Prototype system verified. Examples might include a prototype system/model being produced and demonstrated in a simulated environment.
||System model or prototype demonstration in operational environment
||A major step increase in technological maturity. Examples could include a prototype model/system being verified in an operational environment.
||System complete and qualified
||System/model produced and qualified. An example might include the knowledge generated from TRL 7 being used to manufacture an actual system/model, which is subsequently qualified in an operational environment. In most cases, this TRL represents the end of development.
||Actual system proven in operational environment
||System/model proven and ready for full commercial deployment. An example includes the actual system/model being successfully deployed for multiple missions by end users.
Common descriptions and examples of TRLs used across industries and technology sectors. (Source: TWI Global)
Using Technology Readiness Levels to accelerate life sciences product development.
One additional area where the TRL technology evaluation framework has found a foothold is in the design, development and manufacturing of life sciences technologies. The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have adopted use of TRLs specifically for life sciences technologies. Private life sciences companies have followed suit.
The NIH have adapted the TRL framework to aid in evaluating drug and biological development, therapeutic devices and diagnostic assays and testing technology. The agency has defined life science-specific TRLs that include criteria such as:
- Chemical compound screening
- In vitro demonstration
- Regulatory and clinical study benchmarks
Notable here is that the use of TRLs for life science technologies is increasingly incentivized by grants and funding agencies, including the NIH and Biomedical Advanced Research and Development Authority (BARDA). These organizations use TRL assessments of life science technologies as an input for decisions on grant funding.
How Technology Readiness Levels benefit the life sciences instrument development process.
The fact that TRLs are being adopted by, and adapted to, so many technologies and industries worldwide is a testament to the value that TRLs provide. As we drill down to consider TRLs in the context of life science technology development, it’s worthwhile to take a closer look at exactly what some of those benefits are.
TRL Benefit #1: Common nomenclature and standards.
One of the most fundamental benefits of using TRLs is that the TRL framework provides a common set of nomenclature and standards. This is valuable in itself, in that teams have an existing technology evaluation framework with which to assess their technology, rather than creating a framework in parallel to evaluating the technology. This drives efficiency, removes a significant amount of ambiguity and helps reduce the emotion and bias that many individuals bring to technology readiness assessments.
TRL Benefit #2: Common understanding of technical maturity level.
Furthermore, this common framework is quite valuable in that it provides a general, common understanding of a technology’s maturity across a wide range of stakeholders. This is to say that TRL assessments can help provide an aligned understanding of the maturity of technology across roles with quite different backgrounds, education levels and experience levels. For example, a TRL assessment can help align roles as varied as project managers, CEOs, R&D team leads, systems engineers, finance partners, product managers, production staff and more. By using TRL, not every stakeholder needs to understand the technology to be able to grasp and understand its maturity — or what the technology’s maturity level means relative to their role in the project or company.
TRL Benefit #3: Identifying and managing risks.
Going back to why TRLs were first used (risk assessment), we find another core benefit and use of TRLs. The TRL assessment process and results are quite useful for identifying and helping to manage risks. Essentially, earlier TRL maturities are associated with greater risks. Furthermore, the application of TRLs at a component or subsystem level helps to identify system-level risks at the subsystem and component level.
TRL Benefit #4: A planning tool for life sciences project management.
Bootstrapping on the above points, TRLs are quite valuable as a planning tool for project management and system engineering teams. Specifically, TRL assessments help inform areas like project timelines, resourcing requirements and subsystem prioritization. Not only does knowing the current TRL state help inform how much work remains to move the technology to a fully commercialized (TRL 9) product, but it also informs the relative certainty with which to estimate timelines and costs. Data show that earlier TRL projects have a greater slippage in schedule than those at more mature TRLs.
Schedule Slippage as a Function of TRL. (Source: Semantic Scholar; Dubos, Gregory F., Joseph Homer Saleh and Robert D. Braun. “Technology Readiness Level, Schedule Risk and Slippage in Spacecraft Design: Data Analysis and Modeling.” (2007).)
TRLs are also useful to life sciences project management teams in that they help identify and define the milestone criteria for a project/product/technology to advance to the next Technology Readiness Level.
"TRL assessments can inform projects while they are internal, as well as indicate when to involve or transfer projects to outside partners."
Similarly, making regular TRL assessments during a project can help inform decisions concerning transitions to the next stage of development, whether that be to internal teams or to outside partners. For example, some companies and agencies focus on either early-stage technology development or later-stage technology commercialization. NASA, in fact, commonly transfers projects to outside commercial partners once they reach TRL 6. In this way, TRL assessments can inform projects while they are internal, as well as indicate when to involve or transfer projects to outside partners.
TRL Benefit #5: Informing decision makers on funding and resourcing.
TRL assessments also play a key role in decision making for funding and resourcing. This can be decisions about internal investment and resource allocation, or decisions about which projects and companies a funding agency supports. For example, the NIH website states that the NCAI/REACH programs expect that the majority of technology supports will be between TRL 3 and TRL 5.
For investors, understanding the current TRL status, combined with the funds invested to date, helps them assess the business case for a potential investment and the startup’s trajectory status and potential. Likewise, some investors use TRLs to help identify status toward key milestones that represent inflection points that could be tied to return on investment or decisions to seek additional funding rounds.
For companies, assessing TRLs regularly during a project helps identify the development status of key components and the overall project to know if everything is on track with the project plan. If progress on one component is lagging, the company can recognize it early and address the issue via resource allocation changes. Or they can use the information to shift resources to a more promising project.