Key considerations on the development of biodegradable biomaterials for clinical translation of medical devices: With cartilage repair products as an example
| Autor: | Yuandong Dou, Boon Chin Heng, Yanan Du, Li Wang, Jiaqing Chen, Daisong Li, Qing Jiang, Jia-Kuo Yu, Feng Xu, Haobo Pan, Zhen Zhen, Jianmei Wang, Qianqian Han, Wan Wenqian, Bin Cao, Zigang Ge, Xiaolei Guo, Zepu Zhang, Quanyi Guo |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Financial costs
Translation QH301-705.5 Biomedical Engineering Biomaterial Pipeline (software) Commercialization Article Biomaterials Clinical needs Market analysis Key (cryptography) TA401-492 Medical devices Engineering ethics Biology (General) Cartilage repair Polymer Materials of engineering and construction. Mechanics of materials Biotechnology Pace Regulation |
| Zdroj: | Bioactive Materials Bioactive Materials, Vol 9, Iss, Pp 332-342 (2022) |
| ISSN: | 2452-199X |
| Popis: | With the interdisciplinary convergence of biology, medicine and materials science, both research and clinical translation of biomaterials are progressing at a rapid pace. However, there is still a huge gap between applied basic research on biomaterials and their translational products - medical devices, where two significantly different perspectives and mindsets often work independently and non-synergistically, which in turn significantly increases financial costs and research effort. Although this gap is well-known and often criticized in the biopharmaceutical industry, it is gradually widening. In this article, we critically examine the developmental pipeline of biodegradable biomaterials and biomaterial-based medical device products. Then based on clinical needs, market analysis, and relevant regulations, some ideas are proposed to integrate the two different mindsets to guide applied basic research and translation of biomaterial-based products, from the material and technical perspectives. Cartilage repair substitutes are discussed here as an example. Hopefully, this will lay a strong foundation for biomaterial research and clinical translation, while reducing the amount of extra research effort and funding required due to the dissonance between innovative basic research and commercialization pipeline. Graphical abstract Image 1 Highlights • To elucidate the chain of medical devices development and basic research process. • To propose rationales of biomaterial research with mindset of clinical translation. • To elaborate with established medical devices for cartilage repairs as examples. |
| Databáze: | OpenAIRE |
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