-

Transcription

1 CLINICAL INVESTIGATION CENTRE NETWORK FOR INNOVATIVE TECHNOLOGY

2 Dedicated to research and innovation on Health Technologies, the CIC-IT network mission is to coordinate the CIC-ITs efforts, mutualize their skills; promote all the initiatives that can best respond to the expectations of the research community, the industrial sector and healthcare organizations. What is a CIC-IT? Located in hospitals (CHU Centres Hospitaliers Universitaires), the Clinical Investigation Centres for Innovative Technology (CIC-IT) are open spaces for research laboratories, industrial companies and clinicians. CIC-ITs provide methodological support and technical platforms dedicated to innovation and Health Technology evaluation. The CIC-IT bring innovation up to the patient s bed. The CIC-ITs strength comes from their dual affiliation to Inserm (Ministry of Research) and the Hospital and Health care administration (Direction des Hôpitaux et de l Organisation des Soins Ministry of Health). Clinician Testimony I want to thank everyone who participated to the project s writing in a record time. The good will and enthusiasm have been remarkable all along the project. Many thanks for coordinating these actions. Pr Jean-Charles LE HUEC (PU-PH, CHU de Bordeaux) Researcher Testimony In less than five years, the CIC-IT Network has built a true synergy between research, innovation and clinical studies. This year they manage to obtain a National Call project. Jean-Louis COATRIEUX (DRE Inserm, PhD.) The Network A reference in the Health Technology field Recent European directives (from 2007, applied in the French legislation in 2010) focus on respecting standards and norms for the development, evaluation and valorization of medical devices. Building on its expertise in the evaluation of innovative medical devices, the CIC-IT network is at the forefront to help face the multiple methodological stakes in the necessary steps towards Health Technology valorization. Three-party collaboration The CIC-IT network facilitates exchanges and partnerships between fundamental research, clinicians and industrials. A complementary network The CIC-ITs work on complementary topics. Besançon focuses on microtechniques, Bordeaux on biomaterials, Garches on motor disability compensation devices, Grenoble on computer-assisted surgery, Lille on biosensors and e-health, Nancy on magnetic resonance imaging, Rennes on implantable cardiac prosthesis and monitoring systems and Tours on ultra sound and radiopharmaceuticals. Industrial Testimony Well done for your tenacity that enabled to collect the maximum amount of data. Thanks for all your efforts. Maurice Bagot d Arc (Sr Medical Affairs Director Asia Pacific R & D Global Bio surgery BAXTER BioSciences)

3 MIssIons Foster translational research and the emergence of technological innovation. Carry out demonstrative studies and studies proving clinical concepts. Perform technical, ergonomic, pre-clinical and clinical evaluation of Health Technologies. Research/Upstream advice 1 st prototype Principle of the innovation Regulatory study Translational research research Accompany the biomedical innovation from the bench to the bed. Technical evaluation Ergonomic evaluation In vivo evaluation In vitro evaluation PrecLInIcaL evaluation ProoF of concept Promote access to a high-tech university hospital environment for the private-sector industry. Take part in training in Health Technologies. KeepInG In MInd THe objective of THe patient-benefits PatIent Evaluation of basic need Evaluation of medical benefi t MaturatIon Process of a MeDIcaL DeVIce: CIC-IT S INTERVENTIONS VaLorIZatIon Industrialization Recommendations Publications clinical evaluation FeasIBILItY Drafting protocols Seeking funding and call for tender s submission Cost evaluation Submission helps for regulatory authorities Setting up the study and data collection Supporting scientifi c paper s writing key Facts the network added VaLue: common VaLues 8 centres; 8 excellence platforms, 8 fi elds of expertise; 114 industrials (clients/partners); 116 associates; 265 clinical studies in progress; Numerous partnerships with public or private organizations. A quality approach The quality approach developed in each centre is coordinated by the network through: CE Marking The Ce marking is the witness of the conformity to the essential health and safety requirements written into european directives. Clinical data have been required since march 2010, in, irrespective of the medical device class, in order to obtain the CE marking of all medical devices (according to the 2007/47/ CE directive, which amends the 93/42/CEE directive for medical devices and the 90/385/CEE for active implantable medical devices). In this new situation, the CIC-ITs thanks to their methodological, regulatory and supply-chain expertise on clinical investigation in medical devices are the privileged interlocutors for industrial manufacturers who want to establish a proof of concept and clinical evidence of their innovative medical device. - Setting up valorization conventions and agreements; - sharing practices, technical resources and supply chain approaches; - sharing databases and methodologies for evaluation. An investment in e-learning Since 2009, the network has been offering a remote training program on Health Technology innovations. each centre accommodates interns and phd students: physicians, clinicians, engineers, Human Factor experts who have the opportunity to work on very innovative projects. CONTACT: Régis Beuscart, National CIC-IT Network Coordinator - 150/154 rue du Dr Yersin - Institut Hippocrate - Pôle Eurasanté LOOS - Phone: Copyright photo : Inserm / Patrice Latron A National and International visibility The network is a privileged partner of national and european research networks.

4 BesanÇon cic-it MICROTECHNIQUES FOR HEALTH BESANÇON CHU UNIVERSITY OF FRANCHE-COMTÉ The CIC-IT steps in the design and evaluation of new medical devices requiring precision techniques or miniaturization. Lionel pazart and emmanuel Haffen BorDeauX cic-it BIOMATERIALS AND IMPLANTABLE MEDICAL DEVICES BORDEAUX CHU UNIVERSITY OF BORDEAUX SEGALEN BERGONIÉ INSTITUTE The CIC-IT integrates in its approach, the validation and assessment of biomaterials and implantable innovative medical devices in terms of biocompatibility and clinical applicability. Laurence Bordenave and Marlène durand CHU de Besançon Besançon plateforme Technologique d Innovation Biomédicale (ptib) Hôpital Xavier arnozan avenue du Haut Lévêque PESSAC [email protected] Garches cic-it (ParIs) MOTOR DISABILITY COMPENSATION DEVICES AP-HP UNIVERSITY OF VERSAILLES The CIC-IT focuses on three main specifi c orientations in neurological handicap and motor disability: mobility, communication and respiratory defi ciency. djillali annane, david orlikowski and Frédéric Barbot GrenoBLe cic-it MAXIMIZATION OF THE EFFECT OF TARGETED EXPERT THERAPIES CHU DE GRENOBLE UNIVERSITÉ JOSEPH FOURIER The CIC-IT supports the whole process of maturing medical devices, mainly in the fi eld of Computer aided Medical Interventions (CaMI). philippe Cinquin and alexandre Moreau-Gaudry 104 Bd Raymond Poincaré GARCHES [email protected] pôle de santé publique DMIS CHU de Grenoble GRENOBLE Cedex 9 [email protected]

5 LILLe cic-it BIOSENSORS AND E-HEALTH: INNOVATION AND USABILITY LILLE CHRU UNIVERSITY OF LILLE 2 DROIT ET SANTÉ The CIC-IT is dedicated to technological innovation in biosensors and ehealth, as well as to usability evaluation of health technologies thanks to its Usability Lab. régis Logier and sylvia pelayo nancy cic-it MRI EQUIPMENT, METHODOLOGY AND TECHNIQUES NANCY CHU UNIVERSITY OF LORRAINE The CIC-IT s main role is to support innovative medical devices, new sequences or MrI acquisition techniques. It also develops and validates new techniques for the acquisition and processing of MrI images. jacques Felblinger and Cédric pasquier 150/154 rue du Dr Yersin Institut Hippocrate - pôle eurasanté LOOS [email protected] CHU de nancy Brabois 4 e étage Tour Drouet rue du Morvan VANDOEUVRE-LES-NANCY [email protected] rennes cic-it CARDIAC PROSTHESES AND MONITORING SYSTEMS RENNES CHU UNIVERSITY RENNES 1 The CIC-IT focuses on intelligent communicating implantable cardiac prostheses, as well as monitoring systems dedicated to pediatrics. philippe Mabo and Guy Carrault tours cic-it ULTRASOUNDS AND RADIOPHARMACEUTICALS TOURS CHRU FRANÇOIS RABELAIS UNIVERSITY The CIC-IT is dedicated to two major sectors of medical imaging: ultrasounds and radiopharmaceuticals. Frédéric patat and Catherine roussel CHU de Rennes / Centre cardio penumologique rue Henri Le Guilloux RENNES Cedex [email protected] [email protected] Hôpital Bretonneau 2 Bd Tonnellé / Bâtiment B1A, 1 er étage TOURS Cedex 9 [email protected]