The TRL scale determines to what extent a technology is suitable for implementation in a real operational environment. It is often used as a measure of the risk associated with the introduction of new technologies into existing systems and standard operating procedures. In fact, a sufficient level of TRL is a prerequisite for the successful transition of research from an idea, to a laboratory experiment and finally to a real operational application. That is, there is a significant inverse relationship between the TRL and the risks of adopting technology: higher levels of TRL indicate lower perceived risks, and the low TRL indicates a higher level of risks (Scale from 1 to 9). See the previous post about TRL.
The manufacturing status and risk assessments are part of the procurement programs in a variety of ways. These evaluations, in spite of being very structured and well administered, do not use uniform ways to measure and communicate the risk and preparation of the manufacturing. The MRL criteria are designed to manage manufacturing risk in procurement while increasing the capacity of technology development projects for the transition of new technology (Scale 1 to 10). These criteria create a measurement scale and a vocabulary to evaluate and analyze the maturity and manufacturing risk. Key areas of consideration that are particularly relevant include Reproducibility, Materials, Processes, Workforce skills & training, the predictability of scheduling & cost, facility availability, and readiness.
MRL applied to biopharmaceuticals manufacturing.[i]
MRL-1 and MRL-2 correspond to the identification of basic manufacturing implications and concepts respectively. At this stage main activities focus on applying and translating basic research into specific solutions; understanding of feasibility and risk emerging; materials and process approaches are defined. Producibility assessments commenced and key design characteristics are identified. MRL correspond to research level of technology readiness scale (TRL 1-4)
As we are facing proof of concept manufacturing development (MRL-3) main activities are limited to validate manufacturing concepts through analytical or lab experiments; materials and processes characterized and defined. Although prototypes may have been developed, further demonstrations are required to set initial manufacturing cost projections and supply chain requirements (TRL-5).
MRL 4-7 occurs after proof of concept studies have been completed.
Capability to produce the technology in a laboratory environment (e.g. GLP) correspond to MRL-4. Manufacturing feasibility and producibility of key concepts are assessed, and key processes and prototype manufacturing risks are identified. Next manufacturing level (MRL-5) starts with the capability to produce technology components in a production-relevant environment (e.g. elements of GMP). Although technology level is relatively high (TRL-7), the manufacturing process still identifying critical component to build cost model.
At MRL-6 we are able to produce whole technology system in a production-relevant environment (e.g. elements of GMP). Initial manufacturing approach is developed after completed cost analysis. MRL-7 stat with technologies at TRL-9, full capability to produce technology in a production-representative environment (e.g. GMP) and supply chain management is set in place for producibility improvement ongoing (production personnel, materials, equipment, processes, work instructions, cleanliness, etc.)
At MRL-10, manufacturing is controlled to high-quality level.
MRL-8 is reached as pilot capability is demonstrated and ready to begin low rate production in a stable supply chain. The manufacturing process is mature and all materials are ready. After low rate production (MRL-9), where the manufacturing process is operating at target quality, cost & performance, lean production practices are in place for full-rate production (MRL-10). All materials, manufacturing processes and procedures, inspection and test equipment are in production and controlled to six-sigma or some other appropriate quality level.
The TRL:MRL pair is usually combined as a more accurate measure of the maturity of technological projects. For example, an evaluation with a result of “7:5” indicates that the project is currently facing phase 3 clinical trials (TRL 7) that is (or can be) in the first phase of GMP production (MRL 5).
Along with TRL and MRL, other innovation risk assessment markers can be used
There are other technology and innovation risk assessment markers such as the Investment Readiness Level (IRL 1-9), a scale similar to the TRL to define the suitability and inherent risks of the investment. Market Maturity Level (MML 1-4) to define the maturity of the target market. Other risk markers related to innovation can be expressed at the component integration level. Integration Readiness Level (IRL 1-7), or at the level of the entire System Readiness Assessment Level (SRA 1-5), however, these scales are not standardized, nor as international as the TRL or MRL, and generally, it depends on the vision of each department/company to define the scope of each of these scales.
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[i] Adapted from NIIMBL (http://www.niimbl.us)