Technology Readiness Levels: A framework to help accelerate life science instrument development.

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

TRL	Description	Example
1	Basic principles observed	Scientific observations made and reported. Examples could include paper-based studies of a technology’s basic properties.
2	Technology concept formulated	Envisioned applications are speculative at this stage. Examples are often limited to analytical studies.
3	Experimental proof of concept	Effective research and development initiated. Examples include studies and laboratory measurements to validate analytical predictions.
4	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.
5	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.
6	Technology demonstrated in relevant environment	Prototype system verified. Examples might include a prototype system/model being produced and demonstrated in a simulated environment.
7	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.
8	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.
9	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.

A helpful technology evaluation framework … not a silver bullet.

As valuable as the TRL framework is, it is not a silver bullet. Technology Readiness Levels do not replace the need for qualified talent or relevant knowledge and experience. Specifically, the full-fledged TRL assessment and rating is not a quick or simple task if done according to the strict and full TRL definitions and process. A proper TRL assessment requires a full systems team and stakeholders from across functions and the technology’s or product’s full life cycle. The TRL framework can, however, guide and make a qualified team’s technology assessment far more efficient and less ambiguous.

"The TRL framework is not a silver bullet. But in the hands of a qualified team, it can make technology assessment far more efficient and less ambiguous."

Likewise, higher-level TRL assessments that use a much lighter process have also found use across funding and development agencies. These lighter processes allow relatively quick estimations of TRL status without substantial time and resource investment. But these are estimates and still require a skilled and experienced team for the TRL estimation to be as accurate as possible.

As a developer and manufacturer of life science technology products, Plexus has the role of helping customers move their products from various TRL stages through to TRL 9 (that is, a fully commercially viable product that is in the market and used by customers to address life science applications). In our role of serving partners to move their technologies and products to TRL 9, we have found great utility in adopting and using TRLs.

Given the complexity of life science product solutions, which increasingly include custom consumables, miniaturized components and a greater number of subsystems, we apply a systems-level approach and make TRL assessments at various levels of depth. These might be quick and relatively superficial TRL assessments that take place early as part of intake and quoting of a new project. Or they could be more in-depth system and sub-system TRL assessments to inform project planning and resourcing.

The value of TRLs in creating alignment within our team and with our customers can’t be overstated. But it’s also part of an overall approach that brings deep expertise in life sciences technology, product development, engineering and manufacturing to the table. The key to unlocking the value of the TRL framework is to put it in the hands of the right team.

How to conduct a Technology Readiness Assessment (TRA).

Making technology readiness assessments requires a skilled and experienced team using the TRL framework. This is true whether conducting full-fledged TRL assessments or in making relatively quick and superficial assessments for funding, investment or other purposes.

To help teams make a TRL assessment there are several guides and tools that have been developed by various agencies and companies. These include the Technology Readiness Assessment Guide published by the U.S. Government Accountability Office and the Technology Readiness Assessment (TRA) Deskbook from the Department of Defense. Both provide detailed recommendations and best practices for evaluating TRLs. Other agencies, including the government of Canada, have also published TRL assessment tools and guidance documents.

Further, agencies such as the U.S. Air Force have published Excel-based Technology Readiness Level (TRL) calculator files that help to determine a TRL based on user responses to a series of questions posed in the tool. The Defense Acquisition University has also published the Decision Point tool to help technologists, project managers and teams develop the roadmap to successfully shepherd a technology to completion (i.e., TRL 9). While these tools and guides are quite extensive, there are similar, very simplified versions of decision-making flow charts published by NASA and other agencies. All of these resources provide a useful guide to understanding and assessing the maturity of technology.

Challenges and limitations of Technology Readiness Levels.

While the value of using the TRLs is clear, there have been some criticisms of the TRL process and its application to technology sectors outside of its original intent.

Some say that that use of the TRL framework, process and tools outside of their original setting is diminishing the value and rigor of TRL. These critics note that the expanding use of TRLs by other fields has introduced ambiguity around standards, which can undermine their value. Adoption of the TRL scale by the European Union was published in The Innovation Journal making these very points.

Other criticisms that have been leveled against TRLs include the following:

• The TRL scale is imprecise and TRL assessments are somewhat subjective and leave room for bias from those conducting the TRA.
• TRL assessments must be done by a skilled and experienced team to be valid and accurate, which is often not the case.
• Simplification — especially over-simplification — of TRL definitions and evaluation criteria can lose nuance and important details that result in inaccurate TRL assessments.
• The TRL framework tends to overlook or disregard several factors important to a product or technology’s initial and long-term success. These include human factors and operational environment, obsolescence factors, regulatory requirements, business case and business development activities and more.
• Technology readiness doesn’t always map to the technology’s appropriateness. Just because a technology can be ready doesn’t mean the research was done to know if it’s a fit to appropriately address a demonstrated market need. Put more simply, just because you can do it, doesn’t mean you should.

While acknowledging these caveats of the TRL framework, the value is still clear and outweighs these criticisms. Being aware of these caveats and limitations helps to mitigate their impact. Customizing the TRL standards for specific use cases and applications, like software or life science technologies, further helps to mitigate and reduce some of these limitations.

Build understanding. Create alignment. Get to market faster.

The Technology Readiness Levels framework has consistently proved its value in helping teams assess and track the maturity of technology or products. The use and growing adoption of TRLs over the past 40 years are clear proof of the framework’s value.

As an engineering and manufacturing partner tasked with helping companies get their products and technologies to market, Plexus has found great value in adopting and adapting the TRL framework. Specifically, it has been quite useful as a tool for both early evaluation of new life science projects and for ongoing life science project management and systems engineering teams. Use of the TRL framework has provided efficiency in aligning internal teams, including business development, project management, engineering and manufacturing. The TRL methodology has also played a role in creating alignment with customers around expectations for the time and budget required to get a life sciences product to market.

Alignment and understanding are critical for any team project — that’s especially true the more complex and involved a project becomes. The TRL technology evaluation framework can help create that alignment and common understanding. It’s one tool that life science product development teams do well to keep in their toolbox.

If you’d like help evaluating the maturity of your life science technology, or need support to bring a new instrument to market, reach out to our Life Sciences team. We’ll bring you the tools, knowledge and expertise to get your life science instrument to TRL 9 — and into the hands of your customers.

 

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