iQbD: A Technological Readiness Level-Indexed Quality-by-Design Paradigm for Medical Device Engineering

Abstract

Risk assessment is a critical step in the roadmap of medical device development. Failure modes, effects and criticality analysis is a common approach based on declarative prior information that proved beneficial in the risk assessment of well established processes. But at early steps of development when innovative materials or technologies are embedded, the lack of experience on those innovations introduces too much subjectivity in FMECA for a robust risk assessment. Since mid-2000, the Quality-by-Design guideline has been proposed within the pharmaceutical industry as a proactive engineering approach of drug development. This paradigm enables a data-driven risk assessment throughout the development workflow, which completes risk assessment provided by FMECA. Nevertheless, its implementation guide is unclear and not flexible enough to be efficiently applied to the development of medical devices. To address this issue, a new QbD paradigm indexed on the technological readiness level of the innovative product is proposed. It covers the development of medical devices throughout the whole preclinical phase and is composed of at least nine learning cycles. The first part of this medical device QbD layout, composed of three consecutive risk assessment cycles, is evaluated through a real study case with the objective to demonstrate the proof of concept of a photobleaching controller in photodynamic therapy. Beyond this experimental result, this application has confirmed practical ability of the iQbD approach to complete FMECA and to provide an alternative solution to risk assessment when prior knowledge on the technological innovation is not available.

Adaptation of the technology readiness levels for impact assessment in implementation sciences: The TRL-IS checklist

“…2 ). Of these, four are review articles [ [40] , [41] , [42] , [43] ], four are research articles [ 19 , [44] , [45] , [46] ], one is a science-policy brief [ 47 ], one is a conference paper [ 48 ], and one is a research report [ 18 ]. Excluding the reviews, two studies were located in Spain, two in France, and one each in USA, Ecuador, and Guatemala.…”

“…Selected studies most frequently referenced or used the US Department of Energy version of the TRL [ 40 , 42 , 43 ], and the HORIZON 2020 version [ 19 , 45 , 48 ]. Other versions referenced or used are US Department of Health and Human Services [ 18 ], US Department of Defense [ 47 ], TRL scale for development of innovative medical devices and drugs [ 44 ], and TRL for medical machine learning [ 41 ]. One study did not reference a TRL [ 46 ].…”

“…In the study by Bastogne [ 44 ], the Quality by Design (QbD) approach is applied to the risk assessment in medical device development, offering a proactive engineering approach to the development process. This approach aims to address the lack of experience with innovative materials and technologies, introducing a new Quality by Design (QbD) paradigm indexed on the technological readiness level (TRL) of the innovative product.…”

Development of Smart Clothing to Prevent Pressure Injuries in Bedridden Persons and/or with Severely Impaired Mobility: 4NoPressure Research Protocol

“…The TRL will be used to evaluate the readiness of the structural fibre system and the textile technology developed in the second phase. In the third phase, the TRL will be used to assess the readiness of clothing design and modelling [41][42][43][44].…”

Translation of Medical AR Research into Clinical Practice

“…TRL is a measurement system that was originally developed the National Aeronautics and Space Administration (NASA, Washington, DC, USA) to assess the maturity level of space technology 1 . This scale has already been proven to be suitable for application in the medical device development realm [ 7 ] and for the maturity assessment of medical AR systems in a literature review conducted by Eckert et al [ 1 ]. The completion of each TRL stage requires validation of increasing complexity to ensure that the requirements and specifications are met before moving to the next stage.…”