Extensive research of biomaterials at nanoscale has led to development of novel medical technologies including prosthetic devices and new surgical material and methods. In many cases, however, biomechanical properties and health impacts of nanomaterials are poorly understood. The FDA has even established a separate group within the Agency to develop better knowledge of interactions of nanomaterials with biological systems, and to assess the adequacy of testing approaches for evaluating safety, effectiveness, and quality of products containing nanomaterials.
Here we present three key innovations used in treatment of severe bone injuries among veterans and athletes: (i) Prof. Ilizarov’s apparatus, (ii) ‘Perftorun’, known as ‘blue blood’ therapy discovered by Prof. Beloyartsev in Russia, (iii) ‘Litar’, an artificial bone technology invented by Prof. Krasnov that is used to replace bones defects. Prof. Petrov, a coauthor of this paper, has extensive experience in implementation of novel technologies for health protection and safety including the use of the above mentioned technologies .
Further we present our analysis of key challenges that hinder commercialization of new biomedical technologies and limit the use of such technologies in human patients. By way of example, we will illustrate how suboptimal regulatory approval process for new biomedical devices can substantially increase the time and cost of technology translation from bench to bedside and will discuss the importance of technology’s patent protection in attracting private investment required for commercialization of biomedical technologies. Lastly, using the three above-mentioned innovations as our case studies, we will suggest approaches for improving the outcomes of biomedical technology translation.