The project conducted under 5 WPs.Under WP2 (Micro-architecture and Design improvement) we found a specialized company on medical designing to improve the architecture of the device.This collaboration helped us to identify different bottlenecks and obstacles with the device and to improve them all.We also collaborated with different companies which help us to select the best materials to improve the quality of the product and to produce the device more economically. However, due to COVID situation companies couldn't provide samples and revised products due to factory closes because of Covid positive cases among their staff.The situation caused delay in our initial plan.In
order to further improve the device we created a Scientific Community with participants of 12 gynecologists and urologists from different hospitals/universities in Turkey. We organized many workshops to collect feedbacks and all are used for further improvements of the device.Current version of the device provides the highest level of user comfort through advanced industrial design, the best material selection and necessary safeties for doctor and patient. As a result of those joint work,final version of the device composed of 20 different pieces works efficiently. Also,none of the available needles were compatible with our device therefore, together with solution providers, our engineers developed a new needle. To load the needle efficiently and easily into the mouth of device, a special “needle box” designed,developed and produced.In
addition, a safety mechanism added on device to control the needle transfer from one side to other successfully.Those additional specifications also added to our patent application.While working on the improvements of the device, a contract signed with a Clinical Research Organization (CRO) to conduct cadaver and clinical studies (WP3).After these permissions, the research team carried out cadaver studies with the very final product and results were 100% satisfactory. In collaboration with CRO, it's planned to prepare all ethical paperwork and to apply for necessary permissions for clinical studies (WP6) but we couldn’t start the clinical trials due to Covid.After successful and very positive feedbacks from very first two cadaver studies with earlier version of the device,we accelerated the process to obtain the CE Mark, Class II a (WP4) We received professional services to prepare technical files for CE Mark application and conduct all necessary tests (biocompatibility, irritation etc.) to apply for CE Mark.The CE Mark successfully obtained in the third week of May 2021. Currently FDA approval process and product registration to Ministry of Health System (WP4) have started. We are preparing necessary files for Clinical studies. It is expected to start recruiting participants in clinical trials at the beginning of October 2021.Main results achieved in Period 1;
a)Improved design and usability of the device,
b)Enhanced durability with strong safety mechanism,
c)Successful production of final version of the device,
d)Successful caver studies with the latest version of the device with good results,
e)Obtained CE Mark.
f)Patent,design and trademark protection in EPO,Canada and US.