Tissue Engineering/Regenerative Medicine Ventures Should Invest Early in Market Research to Understand the Future Market's Needs

“Strategy without tactics is the slowest route to victory; tactics without strategy is the noise before defeat.”

—Sun Tzu

In this issue of Tissue Engineering, Part B, you will find the review article, Meeting the Need for Regenerative Medicine Therapies: Translation-Focused Analysis of U.S. Regenerative Medicine Opportunities in Cardiovascular and Peripheral Vascular Medicine Using Detailed Incidence Data, by Tillman et al. I would like to highlight this article, not necessarily for the therapeutic-specific conclusions drawn by the analysis, but for the need for this type of analysis as a critical element in the development of any new venture. Without a firm grasp of the business proposition, the venture is likely to follow a noisy, if not flawed, path. While the need for this clear vision is important to any new business venture, it is especially vital to tissue-engineered products, which have been shown in many cases to be more complex to develop and manufacture. Market research is the tool needed to clarify this vision.

Market research is a broad term that encompasses many different techniques (e.g., surveys and focus groups), levels of sophistication, expense, and range from qualitative to quantitative. There is a common goal to all of these: know your customer and the market landscape (competition, trends, etc). Only through a solid understanding of these elements, can one truly appreciate the product's opportunity, value proposition, and benefit to the end user. Without this clarity, a product may find itself approved and commercialized, but floundering in the market with no truly differentiable benefit from other products or procedures, or simply an insufficient market to sustain the venture.

The need for a clear vision/strategy is not new; however, it is arguably more important in the field of tissue engineering/regenerative medicine than other more traditional therapies because of unique complexities. While the clinical stakes are just as high with other technologies (i.e., addressing unmet needs in cardiovascular, neurological, etc), the tissue-engineered products have, for the most part, shown themselves to be more complex to develop (cost and time) and manufacture. This is especially true for cell-based therapies. Unfortunately, the field's business model still has few blockbuster commercial successes to tout and is still enduring several struggling public companies. In short, the room for error is small.

Besides the importance of simply conducting the research, doing so at the earliest possible point of development is wise. For example, a product should be designed with specific clinically relevant endpoints in mind, not simply what is achievable for the product. In this case, the product may prove to be efficacious in the clinical trials, but the clinical suite of data will ring hollow with the community and languish in the market. Further, early research allows for constantly rechallenging the conclusions drawn and assumptions made, which are key to refining the strategy and staying current with the evolving landscape. Admittedly, the market research can be expensive and is therefore often under-resourced or superficially assessed in early development. This is a difficult balance to strike, especially when resources are scant. Nonetheless, even inexpensive research initiatives such as homemade online surveys or off-the-shelf reports can help avoid potential misguided design features (clinical or product-related) or avoid blind spots (price point or payor complexities).

That said, market research is not a panacea and must be approached with an air of caution. As with any model, it is only as good as the assumptions upon which it is built. Consequently, flawed assumptions can lead to similarly flawed conclusions. How questions are posed in the surveys or focus groups may predispose respondents to a certain answer. As such, it is of critical importance that any manuscript, presentation, white paper, proposal, etc. explicitly define the assumptions and methodology used in the analysis, so that the readers can challenge and make their own assertions.

Each of us in this field should be encouraged and empowered to incorporate this type of analysis into our development efforts. While this is obviously important to businesses defining design requirements and clinical endpoints, the need also applies to the graduate student performing basic research in writing the introduction of a poster for an upcoming conference. Incorporating market analyses into the DNA of our translational scientists may aid in the efficiency of bringing impactful therapies to market.

I appreciate and applaud the authors' submission of this manuscript to the journal. Moreover, I encourage others to submit their nonproprietary analyses—be it disease state-focused or methodology-focused. Sharing these with the tissue-engineering community will help us collectively make smarter decisions about the design of products early on, making more viable ventures for the future.