Key considerations on the development of biodegradable biomaterials for clinical translation of medical devices: With cartilage repair products as an example

Abstract

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.

Structural Strength Analyses for Low Brass Filler Biomaterial with Anti-Trauma Effects in Articular Cartilage Scaffold Design

“…Over the last few decades, researchers and scientists have attempted to fulfil the demands [1] of osteoarthritic patients [2,3] with an articular cartilage scaffold [4,5] equipped with requisite strength [6,7], cell growth factors [8][9][10], and anti-inflammatory properties [11,12]. Unfortunately, they invented biomaterials, such as hydrogels and their derivatives, that were equipped with the carriers of cell growth factors [13] and anti-inflammatory properties [14] but without the requisite strengths [15].…”

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.…”

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.…”

“…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 ].…”