The interdisciplinary field of regenerative medicine – comprised of tissue engineering (TE), cell therapy (CT), and gene therapy (GT) – is growing rapidly, characterized by groundbreaking therapeutic advances that have the potential to change how healthcare providers deliver care. The fields of CT and GT have been the primary contributors to this growth in the past decade, demonstrated by the increase in available funding and marketed products, while in comparison, the field of TE has lagged behind. We believe this delayed maturation of TE is mainly due to the greater relative complexity of tissue engineered medical products (TEMPs) compared to cell and gene therapies.
As Lev Gerlovin, Andrew Thomson, and Jack Vailas discuss in 3Dprint.com, this elevated complexity, which refers to both the structural composition of the end-product as well as the associated manufacturing process, has manifested itself in three key hurdles currently holding back TE:
- Complex manufacturing requirements
- Undefined regulatory pathways
- Insufficient reimbursement streams
