Synthasome, Inc., San Diego, California 92109, USA.
Tissue Eng Part B Rev. 2011 Dec;17(6):443-7. doi: 10.1089/ten.TEB.2011.0236. Epub 2011 Sep 23.
The fields of tissue engineering and regenerative medicine have the capacity to substantially impact clinical care through the introduction of new products that can address unmet clinical needs, or significantly improve on present therapies. These products will be developed through the demonstration of therapeutic effectiveness, adequate safety, and meeting regulatory requirements. The technology used in the product will dictate the product development and manufacturing costs; the regulatory pathway; and the time taken to complete clinical trials, gain regulatory approval, and become commercialized. A comparison of the required investment of time and funds, with the potential revenue generated, allows for a determination of the likely commercialization opportunity. Ultimately, the long-term success of a product will be dependent on its clinical effectiveness and commercial viability.
组织工程和再生医学领域有能力通过引入新产品来显著影响临床护理，这些产品可以满足未满足的临床需求，或显著改善现有疗法。这些产品将通过展示治疗效果、充分的安全性和符合监管要求来开发。产品中使用的技术将决定产品开发和制造成本；监管途径；以及完成临床试验、获得监管批准和商业化所需的时间。通过比较所需的时间和资金投入与潜在的收入，可以确定可能的商业化机会。最终，产品的长期成功将取决于其临床效果和商业可行性。
