A regulatory perspective on recombinant collagen-based medical devices

Advancing medical device regulatory reforms for innovation, translation and industry development in China

“…All medical devices must fulfill clinical needs and solve practical problems [ [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] ]. The academic value of research findings is not always aligned with their clinical values.…”

“…The academic value of research findings is not always aligned with their clinical values. However, if an innovation is expected to bring new technologies and products to the market, then research on market and clinical demands should be conducted as early as possible [ [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] ]. The urgent clinical needs and unsolved problems should be pinpointed to refine the research program accordingly.…”

Preparation of Recombinant Human Collagen III Protein Hydrogels with Sustained Release of Extracellular Vesicles for Skin Wound Healing

“…Currently, commercial collagen is mainly derived from animal tissue, and suffers from poor solubility, batch-to-batch purity variation and pathogenic contamination [ 24 ]. Recombinant collagen is a novel biomaterial manufactured by synthetic biology techniques and is a candidate material for various medical applications [ 25 ]. Type III collagen is a major component of the extracellular matrix in internal organs and skin in adults [ 26 ].…”

Translation of biomaterials from bench to clinic

“…A total of 24 articles [ [4] , [5] , [6] , [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] ] are included in this special issue. These articles can be categorized in terms of authors, biomaterials and targeted clinical areas, and article types.…”

“…As an emerging field, regulatory science has been gradually developed to play an important role during the translation of innovative biomaterial-based medical products. Several articles in this special issue are on regulatory science and discuss the new standards, tools, and approaches to evaluate the safety, efficacy, quality, and performance of medical products [ 10 , 13 , 17 , 19 ]. This special issue also covers a wide range of article types including research article [ [1] , [2] , [3] , [4] , [5] , [6] , [7] , [8] , [9] , 11 , 12 , 15 , 16 , [18] , [19] , [20] , [23] , [24] , [25] , [26] ], reviews [ 14 , 17 , 21 , 22 , 27 ], perspectives [ 10 , 13 ] and opinion paper [ 18 ].…”