From the laboratory concept to clinical trials: the journey of Otoimplant so far.

INTRODUCTION: Nowadays, the role of alloplastic prostheses has become more important in ossicular chain reconstruction. Especially, bioactive medical devices may be an alternative for those currently used on the market. Areas covered: Medical devices which are implanted for over 30 days in the body are required to fulfil strict requirements. It is crucial to ensure the proper level of biocompatibility, biological stability and lack of cytotoxicity of the implanted material. If a medical device is expected to play an additional role, e.g. act as a bioactive or bactericidal agent, supplementary tests should be conducted to assess the relevant qualities. The aim of this article is to present the sequence of procedures leading to the success of a middle ear prosthesis called Otoimplant - from a theoretical concept to the clinical trial. Expert commentary: However, to introduce a new prosthesis into the market, research such as, in vitro, in vivo and clinical trials are required to keep medical devices approved. This article describes a research path that medical device ought to negotiate before the clinical trials may start.