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

ABSTRACT

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 fulfill 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.

KEYWORDS:

• Medical device
• middle ear prosthesis
• ossicular reconstruction
• bactericidal efficacy

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was financially supported by the National Centre for Research and Development (NCBR) grant no: LIDER/154/L6/14/NCBR/2015.