Nerve guidance conduit development for primary treatment of peripheral nerve transection injuries: A commercial perspective,Acta Biomaterialia

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Nerve guidance conduit development for primary treatment of peripheral nerve transection injuries: A commercial perspective
Acta Biomaterialia ( IF 9.4 ) Pub Date : 2021-09-04 , DOI: 10.1016/j.actbio.2021.08.052
Bradyn J Parker ₁ , David I Rhodes ₂ , Carmel M O'Brien ₃ , Andrew E Rodda ₄ , Neil R Cameron ₅

Affiliation

Commercial nerve guidance conduits (NGCs) for repair of peripheral nerve discontinuities are of little use in gaps larger than 30 mm, and for smaller gaps they often fail to compete with the autografts that they are designed to replace. While recent research to develop new technologies for use in NGCs has produced many advanced designs with seemingly positive functional outcomes in animal models, these advances have not been translated into viable clinical products. While there have been many detailed reviews of the technologies available for creating NGCs, none of these have focussed on the requirements of the commercialisation process which are vital to ensure the translation of a technology from bench to clinic. Consideration of the factors essential for commercial viability, including regulatory clearance, reimbursement processes, manufacturability and scale up, and quality management early in the design process is vital in giving new technologies the best chance at achieving real-world impact. Here we have attempted to summarise the major components to consider during the development of emerging NGC technologies as a guide for those looking to develop new technology in this domain. We also examine a selection of the latest academic developments from the viewpoint of clinical translation, and discuss areas where we believe further work would be most likely to bring new NGC technologies to the clinic.

Statement of significance

NGCs for peripheral nerve repairs represent an adaptable foundation with potential to incorporate modifications to improve nerve regeneration outcomes. In this review we outline the regulatory processes that functionally distinct NGCs may need to address and explore new modifications and the complications that may need to be addressed during the translation process from bench to clinic.

中文翻译：

用于外周神经横断损伤初级治疗的神经引导导管开发：商业视角

用于修复周围神经不连续性的商用神经引导导管 (NGC) 在大于 30 毫米的间隙中几乎没有用处，对于较小的间隙，它们通常无法与它们旨在替代的自体移植物竞争。虽然最近开发用于 NGC 的新技术的研究已经产生了许多先进的设计，在动物模型中似乎具有积极的功能结果，但这些进展尚未转化为可行的临床产品。尽管已经对可用于创建 NGC 的技术进行了许多详细的审查，但这些审查都没有关注商业化过程的要求，这对于确保将技术从实验室转化为临床至关重要。考虑对商业可行性至关重要的因素，包括监管审批、报销流程、在设计过程的早期，可制造性和规模化以及质量管理对于为新技术提供实现现实世界影响的最佳机会至关重要。在这里，我们试图总结在新兴 NGC 技术开发过程中要考虑的主要组成部分，作为那些希望在该领域开发新技术的指南。我们还从临床转化的角度研究了一些最新的学术发展，并讨论了我们认为进一步工作最有可能将新的 NGC 技术引入临床的领域。在这里，我们试图总结在新兴 NGC 技术开发过程中要考虑的主要组成部分，作为那些希望在该领域开发新技术的指南。我们还从临床转化的角度研究了一些最新的学术发展，并讨论了我们认为进一步工作最有可能将新的 NGC 技术引入临床的领域。在这里，我们试图总结在新兴 NGC 技术开发过程中要考虑的主要组成部分，作为那些希望在该领域开发新技术的指南。我们还从临床转化的角度研究了一些最新的学术发展，并讨论了我们认为进一步工作最有可能将新的 NGC 技术引入临床的领域。