**5. Commercial and industrial translations in tissue engineering**

Applications for TE and biomaterials were originally limited to prosthetic devices and surgical manipulation of tissues but now include development of biomaterial scaffolds, bone/cartilage engineering, tissue-engineered blood vessels and wound healing, among other fields.

As an industry, it could significantly contribute to economic growth if products are success‐ fully commercialized. However, to date, relatively few products have reached the market owing to a variety of barriers, including a lack of funding and regulatory hurdles. Policy interventions, including increased translational government funding, adaptation of policies, and regulatory clarity, would likely improve the general outcomes for the regenerative medicine industry.

The technical challenges of TE are, of course, intellectually and scientifically interesting and can add substantial and previously unattainable knowledge to our understanding of biological systems (Mansbridge et al., 2006). TE models of biological systems can even provide insight into pathologic processes. However, perhaps the major attraction of academic researchers and industrial organizations to this field is the potential of the technology to be readily converted to clinical applications. For this to happen, the technology almost always will be transferred from an academic environment to an industrial organization that will lead the comprehensive translational studies and convert scientific observations into a manufactured product.

As s technology, TE has been shown to be feasible *in vitro* and *in vivo,* but the true demonstra‐ tion of the potential value of the technology is in its clinical applications. Although the field is still in its infancy, there are already tissue-engineered products on the market, addressing previously unmet clinical needs in wound care and in orthopedics and demonstrating that the attractiveness and motivation of the field is justified. Perhaps one of the next major challenges is demonstration that the technology can lead to commercially feasible products, with manageable investment, product development costs, and time to market and, finally, a revenue generation that justifies the expense. The close connection between new technology, clinically effective treatment, and commercially feasible product is obvious and is no better demon‐ strated than in TE. All three of these areas, each complex in itself, must be aligned and achieved before TE can be regarded as successful.

#### **5.1. Product development pathway**

**Figure 8.** Schematic diagram of SOX9 gene transfection using a modified and non-modified biodegradable nanopar‐ ticles, an example of Non-viral transfection. During hMSCs transfection, nanoparticles interact with the negatively charged lipid bilayers and are influxed into endosomes and destabilized, resulting in the release of the transfected

**Figure 7.** Upstream and downstream regulation of Sox9. From the same authors, published by Tissue engineering.

Part B, Reviews 15(1): 29–41. Copyright 2009

170 Regenerative Medicine and Tissue Engineering

genes into the cytosol. *From the same authors, published by Biomaterials 32(1): 268–278. Copyright 2011*

To appreciate the challenge of developing a tissue-engineered product, it is useful to first understand in general terms the various processes that must be completed (Fig. 9). The 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 addressing repair and regeneration.

**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.
