The commercialization of tissue engineered medical products: Challenges and recommendations

Abstract

Tissue engineering merges engineering and life sciences to create biological constructs that restore or enhance tissue function. Since its inception in 1993, it has drawn significant interest for its potential to address donor tissue shortages and overcome limitations of mechanical replacements. Tissue engineering utilizes two main approaches: in situ regeneration with cell-free matrices and in vitro growth with cell-seeded matrices. Despite progress, the commercialization of tissue-engineered medical products (TEMPs) lags behind other biomedical innovations like cell and gene therapies. A literature review was conducted to analyze challenges in FDA regulations, funding, manufacturing, and storage for TEMPs. Key issues identified include regulatory hurdles, manufacturing limitations, and preservation challenges. The FDA's unclear classification of tissue-engineered products creates legal barriers, while high costs and specialized processes hinder manufacturing scalability. Additionally, current storage technologies and the need for rapid sterility testing complicate tissue preservation and distribution. To overcome these challenges, the paper recommends companies collaborate with the FDA, clearly define product benefits, and reference similar approved products. For funding and manufacturing, securing investments, early automation collaboration, and planning for large-scale production are essential. Early selection of hypothermic or cryogenic preservation methods is also crucial for maintaining tissue viability. In conclusion, the paper consolidates current strategies, challenges, and recommendations for advancing tissue engineering.