**Author details**

development of a product through to approval, manufacture, and marketing is complex, and most companies (within and outside health care) use a staged process to ensure efficient and effective product development. The general scheme that applies for health care products (devices, biologics, or drugs) is outlined in the figure. These stages encompass all the activities that are required to develop a product through to the market. This integrated product development process can be customized to be appropriate for the development of products

**Figure 9.** The general product development pathway used to develop tissue-engineered products

Patient protection for an individual product is a critical feature of product development. Developing new patents is costly, the outcome is uncertain, and it must occur near the beginning of product development. The limited time for patent protection (usually 10 years from initial submission) requires that the product development pathway be followed in an efficient manner; otherwise, patent protection will be lost by the time profitability arrives.

Laboratory of Bioengineering and Tissue Regeneration-University of Málaga (LABRET-UMA) is supported by grants from the Spanish (PI10/02529, and Red de Terapia Celular, RD06/00100014), and the Andalusian Governments (PI-0729-2010, and PAID BIO217). CIBER-BBN is an initiative funded by the VI National R&D&I Plan 2008-2011, *Iniciativa Ingenio 2010, Consolider Program, CIBER Actions* and financed by the Instituto de Salud Carlos III (Ministry of Economy and Competitiveness) with assistance from the *European Regional Development*

addressing repair and regeneration.

172 Regenerative Medicine and Tissue Engineering

**Acknowledgements**

*Fund.*

José M. López-Puerta1,2, Plácido Zamora-Navas2,3, Silvia Claros2,4, Gustavo A. Rico-Llanos2,4, Inés Avedillo5 , José A. Andrades2,4 and José Becerra2,4

1 Department of Orthopaedic Surgery and Traumatology, Universitary Hospital Virgen del Rocío, Sevilla, Spain

2 Networking Biomedical Research Center in Bioengineering, Biomaterials and Nanomedi‐ cine (CIBER-BBN), University of Málaga, Málaga, Spain

3 Department of Orthopaedic Surgery and Traumatology, Universitary Hospital Virgen de la Victoria, Málaga, Spain

4 Laboratory of Bioengineering and Tissue Regeneration (LABRET-UMA), Department of Cell Biology, Genetics and Physiology. Faculty of Sciences, University of Málaga, Málaga, Spain

5 Innovaxis Biopharmaceuticals Ltd., Technological Park of Jerez, Jerez de la Frontera, Spain
