The editorial of the first 2011 issue Tissue Engineering Part A is dedicated to the challenges in tissue engineering and regenerative medicine products commercialization. The results of a survey of The Tissue Engineering and Regenerative Medicine International Society-North America (TERMIS-NA) Industry Committee is published and available in open access.
A semi-quantitative online opinion survey was developed and applied over a 5-week period from October to November 2009 to identify potential obstacles or hurdles in the product development process for each of the different constituent groups within TERMIS-NA that participate in technology commercialization, namely, (1) Academia, (2) Start-up Companies, (3) Development Stage Companies, and (4) Established Companies.
The most common hurdles in RegenMed products commercialization, identified among all groups were the following:
- Intellectual property, patenting and technology transfer;
- Understanding the market needs and expectations.
There was some specific difference between groups of responders. Iâ€™ll highlight the following as some self-assessed hurdles:
most difficult: obtaining and seed research funds
most easy: concept development
most difficult: obtaining and seed funding, recruiting experienced managment, technology transfer
most easy: obtaining space for operations
For development stage companies:
most difficult: generation of initial revenues
most easy: retaining experienced management
For established companies:
most difficult: growing to meet market expectations, securing IP, scaling up manufacturing, working with the FDA
most easy: obtaining enlarged space for operations
Very interesting conclusions were made about the perception of hurdles and difficulties between groups:
The results indicate that groups perceive the difficulties of their own hurdles to be greater than other groups perceive them to be. Of all groups, startup companies considered their hurdle difficulties to be the greatest and established companies considered theirs to be the least difficult. Other groups were the most likely to understand the hurdle difficulty level of academics and least likely to understand the hurdle difficulty of development-stage companies. In contrast, development-stage companies were best able to appreciate the hurdle difficulties of other groups, whereas academics and established companies appreciated these the least. Established companies were especially weak in their perception of the hurdle difficulties of startup companies and development-stage companies.
I highly recommend this very interesting, comprehensive analysis to everyone who is developing cell products for commercialization.