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TRL
Technology Readiness Level
Research Phase
TRL 1
Translational research begins with the identification of a problem that could potentially be solved by new research. These problems usually related to a medical need or a way to improve global public health problems.
Research Phase
TRL 2
The next step is the development of an idea to address the issue identified in the first level. The process of developing an idea can be difficult. It often begins with an extensive literature review, its important to understand the current state of the field. From here hypothesis can be drawn with an idea towards the experimental design.
Technology Development Phase
TRL 3
TRL3 is where things start to look different based on the type of project, and the underlying problem trying to be addressed. As things get more technical, different projects will start to look very different. But the common factor to all TRL3 projects is making an initial development through to validation of the concept. For example, if the project is in therapeutics this would be the development of an initial prototype all the way through testing the efficacy in vivo. For a diagnostic test, this would look something like an identification of a biomarker, and the establishment of specificity in clinical samples.
Technology Development Phase
TRL 5
Once at this stage an idea of the initial business are in mind. Things like the initial client base, the expected amount of product required among other things are necessities now. In TRL5 the project is being evaluated against regulatory standards. At this stage the manufacturing processes must be established to meet the required demand. Furthermore, these must meet good laboratory practices standards.
Product & Process Development Phase
TRL 7
The interaction with the end user continues and deepens here. For projects in therapeutics or medical devices, this means phase 2 clinical trials. These trails are now testing the efficacy and performance of newly developed product. For diagnostics this would be a small scale trail to determine if the implementation of the new diagnostic tool improves clinical outcomes.
Technology Development Phase
TRL 4
This stage of the TRL pipeline is focused on progressing the project beyond a proof of concept, into a pre-regulatory phase. This means establishing clear safety and toxicity formulations, demonstrating the efficacy and safety in animal models.
Product & Process Development Phase
TRL 6
This level is the projects first interaction with their intended target audience. For most projects there are the phases of a clinical trial, used to assess the safety in humans. Once the trails are completed and the safety of the product can be assured it is allowed to move forward. This will not be the same for projects in the diagnostics. At this stages projects in that field are looking to test their project with end user groups, be it hospitals or local community health centres. At this stage a diagnostic project will have established parameters based on clinical samples.
Product & Process Development Phase
TRL 8
These are the final stages of product development, For all types of projects this involves wider trials with greater numbers of participants. If these final trails are successful, the project can be authorized by the relevant government bodies and then released onto the market.