Table 4 Technology readiness assessment of the BCI-hand robot systems

TRL 1

Lowest level of technological readiness

Literature reviews and initial market surveys

Scientific application to defined problems

TRL 2

Generation of hypotheses

Development of research plans and/or protocols

TRL 3

Testing of hypotheses – basic research, data collection and analysis

Testing of design/prototype – verification and critical component specifications

Initial proof-of-concept in limited amount of laboratory/animal models

Most studies from the prototype group (N = 18) [86,87,88,89,90,91,92,93,94,95,96,97,98,99,100, 102,103,104]

TRL 4

Proof-of-concept of device/system in defined laboratory/animal models

Safety testing – problems, adverse events and potential side effects

Witkowski et al., 2014 [101]

TRL 5

Comparison of device/system to other existing modalities or equivalent devices/systems

Further development – testing through simulation (tissue or organ models), animal testing

Drafting of Product Development Plan

Barsotti et al., 2015 [76], Ono et al., 2016 [81], Chowdhury et al., 2018-b [78], Tsuchimoto et al., 2019 [84]

TRL 6

Small scale clinical trials (Phase 1) – under carefully controlled and intensely monitored clinical conditions

Carino-Escobar et al., 2019 [85], Chowdhury et al., 2018-c [79], Norman et al., 2018 [82], Wang et al., 2018 [83]

TRL 7

Clinical trials (Phase 2) – safety and effectiveness integration in operational environment

Ang et al., 2014 [75], Frolov et al., 2017 [80]

TRL 8

Clinical trials (Phase 3) – evaluation of overall risk–benefit of device/system use

Confirmation of QSR compliance

Awarding of PMA for device/system by CDRH or equivalent agency

TRL 9

The device/system may be distributed/marketed