The life-cycles of skin replacement technologies.

Abstract

INTRODUCTION: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. METHODS: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. RESULTS AND DISCUSSION: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. CONCLUSION: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.