Our goal was to develop both a new Quality-by-Design paradigm and a web-based platform devoted to the safe development of class-III medical devices containing nanomaterials. This objective is pursued in the context of the European H2020 project TBMED (An Open Innovation test bed for the development of high-risk medical devices).

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A six-step QbD approach is proposed. The first four stages are devoted to the preclinical development while the next two steps concern the industrial implementation. Three categories of risk-assessment methods are used at different development steps: failure mode and effects analysis based on prior knowledge, statistical designs of experiments and Bayesian inference. To assess its applicability, we applied the integrated QbD approach to the development of a new medical device devoted to the realtime control of light during photodynamic therapy using nanoparticle-based photosensitizers.

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Four key categories of documents have been established during the preclinical study: the target product profile, the list of critical quality attributes (quality/safety descriptors), the list of critical material attributes and process parameters (risk factors associated with the design and production phases) and the design space: a key concept of risk assessment in QbD leading to the optimization of the MD settings.

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Reference: 

[1] J. Deleforterie, Y. Kolasa, L. Batista, J. Hutin, and T. Bastogne, “Quality-by-design for the safe devel- opment of medical devices containing nanomaterials. a study case in photodynamic therapy,” in Proc. of the Nanomed Europe Conference., (Braga, Portugal), June 17-19 2019.

[2] J.-B. Tylcz. T. Bastogne, “Process to control the realtime activation of a photosensitizing agent in biological tissues and device implementing with process. EP2737926A1, European Patent Office, 2012.

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