Oxana Semyachkina-Glushkovskaya

Abstract: Fundamental science is the foundation for applied technologies. However, it always remains unknown which ideas will be able to transform into technologies and enter the market. Is it possible to make the process of transferring fundamental ideas to the market fast and reliable? How long will it take? What rules should be developed for this?
Based on our RSF mega grant No. 23-75-30001, I will give an example of the life cycle of a medical technology from TRL 0 to TRL 8 in just 2 years. For the rapid transfer of a scientific idea to the market, two factors must be a prerequisite: 1) an industrial partner who is ready to produce a new technology; 2) practicing doctors who will conduct clinical trials, i.e. the medical organization in which doctors work must be accredited to conduct clinical trials. These two conditions will allow the most effective adaptation of the design and composition of the technology to the capabilities of the industrial partner and the medical conditions of its application. This will also help to take into account the necessary requirements for the materials from which the technology will be made, because all medical devices must be made from certified materials, i.e. approved in a particular country for use on humans.
After manufacturing the technology, an important stage is the preparation of documents for its technological and toxicological testing. In this case, it is important to use the services of certified companies, preferably operating on the basis of medical institutions, which will help in the correct preparation of documents. After receiving certificates for technical and toxicological tests, these companies can also help in submitting documents to the Ministry of Health, which issues permission to conduct clinical trials. Approval of the clinical trial plan is approved by the ethics committee of the medical organization appointed for this by the Ministry of Health. Upon completion of clinical trials and receipt of positive results, the Ministry of Health issues a registration certificate for the technology, assigning it the status of medical equipment. After this, the industrial partner launches production of the technology on its site and brings it to the medical equipment market when it becomes commercially available. Thus, for efficient and fast (in 2-3 years) implementation of the life cycle of the developed technology from TRL 0 to TRL 8, already at the initial stages, the presence of an interested industrial partner ready to produce the technology and qualified doctors ready to apply this technology in their clinical practice is required. With these two factors, the translation of the technology from the idea to its launch on the market becomes reliable with minimal risks.

Keywords: neurotechnology, medicine, photobiomodulation, Alzheimer's disease, brain injury.

Acknowledgments: The research was supported by the Russian Science Foundation grant No. 23-75-30001.