Benoit Hallier Email & Phone Number

Provides consulting services and support of clinical affairs, product training, and commercial activities in the medical device industry.

Région De Paris, France

Paris Area, France

Lausanne Area, Switzerland

Responsibilities• International (Europe, Brazil, Japan, Singapore) project management of pre-market clinical studies for ACURATE TA (2011-2012) and ACURATE neo (2011 to now, transfemoral, transapical and transaortic access)• Preparation and submission of clinical dossier for CE certification• Field support for TAVI cases (including CT/ECHO screening, case and logistics planning, device preparation)• TAVI Physician Training & Proctoring• Training & certification of employees (co-trainers and field product specialists)• Team (3 persons) and CRO management• Development of new process and SOPs for clinical and training activities• Development of implantation technique / training materialKey Accomplishments• ACURATE TA™ Transapical access - First-in-man study to CE certification in less than 2 years - Full management of 3 clinical trials with KOLs in Europe - Field support for 100+ TA-AVI implantations - Preparation and submission of Clinical Evaluation Report• ACURATE neo™ – Transfemoral access - First-in-man study to CE certification in less than 2 years - Full management of 4 clinical trials with KOLs in Europe, Brazil, Japan and Singapore - Field support for 100+ TF-AVI implantations - Preparation and submission of Clinical Evaluation Report• ACURATE neo™ – Low-Profile Transapical access - Successful completion of primary endpoints of first-in-man study in Germany in less than 6 months from initial submission

Brussels Area, Belgium

Positions:• Clinical Project Manager, Research and New Product Evaluation (2009-2010)• Clinical Project Manager, Research (2008 – 2009)• Clinical Project Leader, Research (2005– 2008)Responsibilities• Project management of Research clinical activities for the Cardiac Rhythm Management Division (Sylmar and Sunnyvale, CA, USA and Sweden)• Project management of New Technology Assessments for the Cardiac Rhythm Management Division (Sylmar, CA, USA)• Team management (2 persons)• Coordination and execution of clinical studies with European clinical and field teams in Germany, France, UK, The Netherlands, Italy, Denmark and Sweden• Scientific publications• Liaison with European KOLs Key Accomplishments• Successful execution of 20+ Research clinical studies• Successful execution of 10+ New Technology Assessments• Member of the EMEAC Clinical Advisory Board• Co-author of multiple abstracts / manuscripts

Paris Area, France

Responsibilities• Definition of device specifications with physicians and firmware engineers• Definition of device User’s interfaces with physicians and software engineers• Pre-clinical validation• Field technical support (implantation and follow-up) in France• Management of pre-market and post-market clinical trials• Scientific publicationsKey Accomplishments• User’s interface and specifications for Ovatio ICD platform• Pre-clinical validation and clinical evaluation of Ovatio ICD and Alto II MSP CRT-D (from bench testing to first-in-man implantation)• Patent US 20070135849 “Improved detection of ventricular tachycardia in an active implantable medical device having an AAI operating mode”• Major contributor to the analysis and publications of the PIPAF studies• Co-author of multiple abstracts

Master Of Science (Msc), Biomedical/Medical Engineering

Biomedical Engineering

Dut, Physical Measurements

Physical measurements