A Tissue Engineering product development pathway

Tissue engineering is a field of inquiry and research that uses engineering techniques and principles of biological sciences to develop functional substitutes for reconstruction of damaged organs. Commercial translation of tissue engineering products is currently in progress all over the world. Many companies are moving their interest towards this market segment that grows by 6% per year. Aim of this thesis is to probe the possibility of developing tissue engineering products in the most cost-effective way, minimizing the industrial risk and developing a specific fund raising model. Tissue engineering is based on three main features: cells, scaffolds and bioreactors. Cells are seeded on a scaffold and cultured in a bioreactor in order to obtain a tissue engineering product. Nevertheless, developing cell carrying products is hampered by certification claims (“advanced therapies” certification rules) that unbearably increase R&D and certification costs and can be faced by either big companies or start-ups of big companies and spin-offs of complex aggregates of research centers involved in advanced cell research. On the other hand, scaffolds (certification class IIb) and bioreactors for tissue engineering (certification class I) can be developed with a lower economic effort, being the competition based on innovation, since their market is in the “growth phase” for scaffolds and in the “introduction phase” for bioreactors in the Levitt’s product life cycle theory. Purpose of this thesis is to basically study scaffold and bioreactor features, then to preliminarily design some models of bioreactors and, eventually, to set a business model, based on private and public fund raising, aimed to the development of scaffolds for dental implantology and of bioreactors for cardiovascular and bone tissue engineering. Finally, a business plan of a company being spin-off of Politecnico di Torino and industrial start-up has been elaborated.