AT THE SERVICE OF HEALTH AN ORIGINAL ENGINEERING OFFICE CLINICAL AFFAIRS R&D DEPARTMENT & DESIGN TECHNICAL ASSISTANCE

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1 REGULATORY ASSISTANCE QUALITY ASSISTANCE R&D DEPARTMENT & DESIGN TECHNICAL ASSISTANCE CLINICAL AFFAIRS AN ORIGINAL ENGINEERING OFFICE AT THE SERVICE OF HEALTH

2 MESSAGE FROM THE CHIEF EXECUTIVE OFFICER The technology of medical devices is ubiquitous in medicine. It increases the life expectancy and quality of the patients life. By gathering on the same place, ISIFC s young engineer students and experts in studies/quality/regulatory and clinical affairs, Biotika does more than catalyzing innovation for health from the upstream phases of projects, it federates teams and creates the leaders of tomorrow and business owners, who are transdisciplinary and can provide a valuable interface between nurses, scientists and industrial s requirements (regulatory restrictions and ethical code). Nadia Butterlin, Biotika CEO - Besançon A COMPANY INTEGRATED INTO AN ENGINEERING SCHOOL Founded in 2006, Biotika is a public company of ISIFC (a biomedical engineering French school), it is a non-profit organization eligible for the French Research Tax Credit. Integrated into the educational mock-up of ISIFC, Biotika is also an intrapreneurship and entrepreneurship module of 200 hours hold during the last two years of engineering degree courses (Master level). The unit is built in continuum of the students internships. For ISIFC s engineering students, Biotika is a real springboard to professional life. The aim is also to give them the desire to create their own companies.

3 A SPECIFIC POOL OF EXPERTISE Recognized for its expertise in medical devices, Biotika describes itself as an engineering office specialized in technical and medical concepts. The projects teams carry out the upstream work of projects with conceiving and designing experimental or digital prototypes in order to conduct feasibility, scientific, and pre-clinical studies. Biotika also offers services in regulatory affairs, clinical affairs, quality, pre-market studies and intellectual property. The aim is to help companies preparing, during the upstream phase, the technical fi les needed to introduce new medical devices and getting marketing authorization. Biotika provides its services for clinical evaluations and clinical investigations plans writing. Biotika ensures confi dentiality and data ownership respect. Biotika helps to catalyze the collaboration between industrials and hospitals in order to speed up the launching of medical products that are best suited to the needs of clinicians and patients. A QUALITY MANAGEMENT SYSTEM ESTABLISHED ACCORDING TO THE ISO INTERNATIONAL STANDARDS To prove and approve its quality management system, Biotika received the ISO : 2012 certification by LNE/G-MED from September 2012 to This certifi cation is a guarantee of compliance, quality and confi dence towards carried projects, processes and procedures in Biotika. It shows above all that even based on an original concept a company - within an engineering school - Biotika succeeds to meet the same requirements as its industrials partners.

4 BIOTIKA S TEMPORAL ORGANIZATION Biotika operates on a part time basis, over fragmented periods of the year and alternating with ISIFC s students internships. There is an annual 100% turnover of its students teams : The quality management system must be well-established to ease cooperative work with the direction management team in place since BIOTIKA S EQUIPMENT A dedicated 200 m² space within ISIFC, 6 months / year : Offi ces reserved for project managers and their teams A test bench platform A rapid prototyping and 3D modeling room A computers room optimized for design Dedicated and controlled equipment according to the QMS : Data Acquisition Cards (Software-Controlled) Simulation and modeling software : Labview, Simpleware, Comsol, Matlab, Créo, Solidworks, Ansys, Altium... 3D printers (FDM / SLA) and 3D scanner Monitoring and measuring devices High precision sensors Drip devices Electronic documents management, thanks to a collaborative digital work sharing system (Agora-Project) In 2019, Biotika will move to the BIO INNOVATION platform, which will be dedicated to Medical Devices and BioEngineering. The place is intended to bring together the major players on Temis Santé, closer to the CHRU in Besançon and the Blood Center (EFS). Thus, meetings between doctors, start-ups and industrialists will be facilitated.

5 EXEMPLES OF DELIVERED SERVICES DIGIT TECH Design / Conception according to clients specifications Development of an electromechanics demonstrator to diagnose carpal tunnel syndrome Collaboration contract over 3 years Scientific publication in the CETSIS congress Implementation of experimental and technical validation tests S-ALIVE Prototype development for a continuous delivery of artificial saliva ( patients irradiated of the jaw) Collaboration between the CHU and laboratory of pharmacochemistry in the Faculty of Health of Besançon Pre-clinical tests to Lyon s vetenary school and R&D internships ISIFC Project transfer to the startup Cisteo Medical and the hiring of two ISIFC s graduates Funding of Oséo and ANR Emergence

6 WE PROVIDE YOU WITH EXPERT KNOW-HOW TO SUPPORT YOU IN YOUR PROJECTS 23 rue Alain Savary Besançon - FRANCE Phone : contact.biotika@univ-fcomte.fr THEY TRUSTED US BYPA Research, Cevres Sante, Circle BPS, FCI SAS, Holiste / PHYSIO FRANCE, HUGO GYNECO, INNORALIS, LHS Lambda Health System, MICRO-MEGA, Ormex Confort, ProviSkin, Rhéofast, SATT GRAND EST. OUR PARTNERS Vers Conception : Steeven Flores Prod - Photo Credits : L. Godard / Archimède / N. Roux Dit Buisson