Realistic Time to Market (1)

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Technology Readiness Level

Episode 1/2

One of the main challenges to developing a new product is estimating the time and money to get it to the market. In many cases, professionals focus on the two major areas: Marketing (such as, market research, user experiences), and Development (building prototypes, manufacturing, etc.)

Others may pay attention to the business side as well and make sure they are indeed building a profitable business as they go.

Let's put the question in a different way:

How mature is your product now,
and how mature should it become,
to be market-ready?

NASA has developed and has been using a highly efficient scale called Technology Readiness Level or TRL, to describe and assess the evolution stages of a new technology.

In this article I attempt to show how practical use of the TRL can help accelerate your product development journey, while adding confidence to your planning and processes.

In particular I will address how to review Assumptions and Risks from a TRL perspective.

What is a TRL

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Often when R&D starts planning a product, the common questions are about the size and cost of effort. Then management updates could be summarised in answering the question “How far are we”? and soon they turn into “Are we there yet”?

However, before attempting to answer how much progress you’ve made and how far or near is your journey’s end, obviously the main question is “Where are you now?”; which is especially important before the first planning sessions.

One of the tools to consider in answering where you are now, is the TRL or Technology Readiness Level, which was developed by NASA in the 1970s for measuring the maturity level of technologies before using them. It is a scale to assess the maturity of a technology from the idea level to market acceptance.

There are nine TRLs: TRL 1 is the first, starting from the scientific idea, and TRL 9 is the last with a product that has proven market presence.

TRL IS about using validated technology
in the relevant environment

In this respect the lower levels are about the technology per-se, and the higher TRLs are about the product. Usually levels between 1 to 5-6 are about developing concepts and technology to support a product, whereas the levels between 6-7 to 9 are about developing the product and using it in the market.

The TRL method got more attention over the years, and was adopted by other organisations including ARENA (Australian Renewable Energy Agency), and MRMC (Medical Research and Material Command) in the US Army.

The idea of TRL is to assess the maturity or risk of using a technology; also, to assess how more development you should expect to invest in a technology before it is usable to your needs.

A technology with TRL 9 (say a USB cable) is obviously something reliable you can add to your product without hesitation. An emerging technology could be less reliable, or needs more integration effort (for example, Immersive Virtual Reality).

Below is a brief description of NASA's TRL's and you can find links to get more information at the end of the article.

Although this looks like a heavy tool for complex projects, I find it very helpful in planning sessions of any product, from complex medical devices to simpler pure software projects. Especially in providing focused attention to assumptions and risks in particular; such as: should you integrate with this free database? how reliable is this sensor? etc.

TRL of ASSUMPTIONS

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Often I encounter teams that don't have a concrete idea about the risks they may be facing, or even the assumptions they have that allows them to continue with their current plan.

Having a TRL mindset, or a TRL ladder in mind, helps teams focus their attention each level at a time, and clarify the assumptions they intuitively had, and come up with relevant new questions as well. This could be as simple as "tick the box" exercise because you have it all good, or find out things you missed, in which case the sooner you find out, the better!

Especially, if you are developing a device with sensors, or special new functionality, or integrating with third party components (software or hardware), here are some helpful questions, both to estimate the maturity of the technology you want to use, and to make sure your product is beyond these levels or TRL.

The below are questions for TRL 1 to 5 on the Component / Technology level:

TRL 1 (scientific idea)

  • In theory, is the idea feasible? Is there scientific /academic research that proves the idea is feasible?

  • Is the research fully applicable to the idea, or further fine-tuning is required?

  • In practice, is the concept feasible?

TRL 2 (Technological Concept)

  • Is there a technology or a component that provides the functionality needed?

  • Is the technology patented? especially: do you need to protect the IP? Or are you breaching others’ IP?

TRL 3 (Critical Function)

  • Was the technology applied to this application or to support this idea before?

  • Is there a simulation to showcase the functionality?

  • What are the required and/or sufficient conditions of operation?

TRL 4 (Lab Environment)

  • Is there a bench or lab experiment to showcase the use of technology or prototype component?

  • What are the requirements and conditions of successful operation?

TRL 5 (Relevant Environment)

  • Did you complete your Marketing research?

  • Do you finalise your Business plan?

  • Do you have requirements and do they need fine-tuning?

From TRL 6 and above, you would be focusing on the final stages of the full product development, rather than early stage prototypes. I also added special points of focus for teams developing medical devices in particular.

TRL 6 - Subsystems

  • Component level design, implementation and testing.

  • For a medical device you need to complete the product realization plan: Intended Use, Regulatory strategy, Risk Plan, Development Plan, etc.

TRL 7 - System Development  

  • Complete Design, Integration and Implementation.

  • Possible Market test or limited pre-launch.

  • For a medical device: clinical trials and readiness to regulatory submissions. 

8 System Validation        

  • Product certification before sales.

  • Focus on production efficiency and yield.

  • Focus on Marketing and sales preparations (at least in the immediate countries of sale).

  • For a medical device, regulatory approval.

9 System Operations      

  • Focus on failures in the field, product maintenance.

  • Next generation improvements.

  • For a medical device you need to focus on, medical events reporting, and regulatory submissions in further countries of sale.

In the next article I will continue and discuss how to estimate risks in your development plan based on TRL approach and provide some useful tips and links for you to develop this further with your team.

To Be Continued...

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Medical Device Development

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Realistic Time to Market (2)