Division of Plastic Surgery, Ruby Memorial Hospital, West Virginia University, Morgantown, WV, United States of America.
Tissue Engineering and Wound Healing Laboratory, Division of Plastic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States of America.
PLoS One. 2020 Mar 4;15(3):e0229455. doi: 10.1371/journal.pone.0229455. eCollection 2020.
Skin Replacement Technologies (SRTs) emerged as skin alternatives for burns, large excisions or trauma. The original publications represent the available knowledge on a subject and can be modeled as a logistic S-curve which depicts the technology's evolution life-cycle. The Technology Innovation Maturation Evaluation (TIME) model was previously introduced to study the life-cycles of biotechnologies.
PubMed database was searched 1900-2015 to review relevant publications. All skin replacement or regeneration products on the US market were included. The TIME model was applied to assess evolutionary patterns for each technology.
Three SRT clusters were identified: processed biologics technologies (PBT), extracellular matrix technologies (EMT), and cell-based technologies (CBT). Publications on EMTs and CBTs start decades after PBTs, however, are greater in number and follow an ascending trend. PBTs reached a plateau, suggesting near-senescence. The CBT curve was non-logarithmic and the TIME model could not be applied. The technology initiation point (Ti) for PBTs was 1939 and the establishment point (Te) 1992. For EMT, Ti was 1966 and Te 2010. Sixty-one products were identified (49 EMTs, 7 CBTs, 5 PBTs). PBTs appeared 11 years after Te and EMTs four years prior Te. Thirty-seven products in the EMT category, and one in the PBT category, were developed before Te. The most common FDA regulatory mechanism for SRT was found to be 510(k) followed by HCT/P 361.
Innovation is an indicator of the evolution of technology. The number of publications can be used as a metric of this evolution and the fact that the SRT field falls under such pattern demonstrates that SRT is an innovation-based industry. EMT is the most efficient cluster. Few products from SRT registered a commercial success, and from those that did, those technologies were generally found to be part of the most productive cluster, 1st in concept, conceptually simple, easily regulated and produced, cost and clinically efficient, reimbursable, able to solve a specific problem efficiently, had a platform technology design that allowed for further innovation and adaptation for other uses and, as found by application of the TIME model, appear prior to technology establishment.
皮肤替代技术（SRT）作为烧伤、大面积切除或创伤的皮肤替代品出现。原始出版物代表了一个主题的现有知识，并可以建模为逻辑 S 曲线，描绘了技术的进化生命周期。之前介绍了技术创新成熟度评估（TIME）模型来研究生物技术的生命周期。
在 1900 年至 2015 年期间，对 PubMed 数据库进行了搜索，以回顾相关出版物。纳入了所有在美国市场上的皮肤替代或再生产品。应用 TIME 模型评估每个技术的进化模式。
确定了三个 SRT 集群：处理生物制品技术（PBT）、细胞外基质技术（EMT）和基于细胞的技术（CBT）。关于 EMT 和 CBT 的出版物在 PBT 之后几十年开始，但数量更多且呈上升趋势。PBT 达到了一个高原，表明接近衰老。CBT 曲线是非对数的，无法应用 TIME 模型。PBT 的技术起始点（Ti）为 1939 年，建立点（Te）为 1992 年。对于 EMT，Ti 为 1966 年，Te 为 2010 年。确定了 61 种产品（49 种 EMT、7 种 CBT、5 种 PBT）。PBT 在 Te 之后 11 年出现，而 EMT 在 Te 之前 4 年出现。EMT 类别中有 37 种产品，PBT 类别中有 1 种产品在 Te 之前开发。SRT 最常见的 FDA 监管机制是 510(k)，其次是 HCT/P 361。
创新是技术发展的一个指标。出版物的数量可用作这种发展的衡量标准，而 SRT 领域符合这种模式这一事实表明，SRT 是一个基于创新的行业。EMT 是最有效的集群。SRT 的少数产品取得了商业成功，而在这些产品中，那些技术通常被发现属于最具生产力的集群，第一个概念，概念简单，易于监管和生产，成本和临床效率高，可报销，能够有效地解决特定问题，具有允许进一步创新和适应其他用途的平台技术设计，并且如通过应用 TIME 模型所发现的，它们出现在技术建立之前。
