Frequently Asked Questions

Do l need to have an existing business to apply?

Yes, you must have a UK registered business (you will need to provide a company registration number). The company should be fully committed to driving the venture forward and to making the most of the accelerator support package or have a product/service which is at TRL 3 and above. You will be required to explain how you meet the TRL level. TRL guidance below

TRL1	Technology’s Basic Principles Report	1. Lowest level of technology readiness; 2. Theoretical explanation on technology’s basic principles; 3. Initial survey on the benefits of the technology; 4.Basic concept review of scientific theories underlying the related medical device technology; 5. Formulation of basic concept and theoretical substantiation; and 6. Scientific literature review in relation to the technology’s basic principles.
TRL2	Technology Concept Formulation	1. Formulation of research topics, preparing hypotheses, and planning of experimental design to find the solution to problems on the basis of the technology concerned; 2. Preparation of scientific hypotheses. Research and protocol planning have been reviewed and approved; and 3. Through literature review and scientific discussions, a research and study plan is prepared to identify the potential and opportunity for therapeutic targets. Documented in the form of protocol or research plan to be reviewed and approved.
TRL3	Research to substantiate the technology concept (Research of Technology Concept).	1. Basic research, experimental data collection and analysis, to test the prepared hypotheses. Checking for alternative concepts, and identify and evaluate the technology’s components; 2. Initial testing on the design concept and evaluation of various alternatives; 3. Design verification, component specification determination; 4. Initial proof of concept of limited medical device’s technology and laboratory models; and 5. Documentation of results of laboratory-scale experiments providing initial proof of concept of the medical device’s technology.
TRL4	Laboratory-scale validation of components and/or sets of system (validation component in laboratory).	1. Laboratory-scale experiment and testing to evaluate and review the level of safety, side effects, and efficacy; 2. Preparation of procedures and methods to be used in a non-clinical and clinical studies; 3. Proof of concept of the technology and safety level; and 4. Publication (peer-reviewed) of data about proof of concept of the technology and safety level.
TRL5	Laboratory-Scale Prototype.	1. Designation of classification (class 1, 2, or 3) of the medical device prototype based on its equivalence with existing medical devices; 2. Lab-scale testing of prototype’s safety level against the applicable standard (for example: iec60601); 3. Lab-scale validation testing on prototype’s efficacy and side effects, and its disruption to/by other devices. (for medical device classes 1-2); and 4. Lab-scale substantiation of prototype’s safety level and efficacy.
TRL6	Industrial Scale Prototype.	1. Industrial-scale limited validation testing of the prototype on its efficacy and side effects, and its disruption to/by other devices. (for medical device classes 1-2); 2. Industrial-scale limited phase 1 clinical testing of the prototype to find out its safety level and efficacy (for medical device class 3); and 3. Industrial-scale limited substantiation of the prototype’s safety level and efficacy.

Source- annex_2_technology_readiness_level_trl_033020_final.pdf (britishcouncil.id)