Abstract

In May 2006, the Institut Superieur d'Ingenieurs de Franche-Comté (ISIFC) launched its own virtual firm, which was named Biotika® by students. Virtual means that this company has no real legal status. It is a pedagogic model; however, the situation scenario for the ISIFC student engineers is real. They are currently working in real conditions on the development of new medical devices and on the modernization of medical products. The need for these innovative medical devices was identified by the students during their second-year (6 weeks) internship in hospitals. Biotika® is open between March and December every year. The students are "recruited" following an imitation job interview and each is then entrusted with a mission (engineer, project manager etc.) in one of the company's four departments: Research & Design, Quality-regulatory affairs, Clinical investigations, and Public relations-marketing. The personnel of Biotika® work on the development of innovative medical devices and/or the preparation of CE or FDA certification for 2 days per week. Since its launch, Biotika® has developed eight products and obtained many grants and prizes from French research and governmental organizations. It is also certified ISO 13485.

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