Ben Wolf has 20+ years of industry experience, working across a broad range of functional areas including R&D, manufacturing engineering, program management, product development and business leadership.

Ben began his career as a Manufacturing Engineer with Hewlett-Packard/Agilent Technologies in the telecommunications industry. He then moved to the medical device industry where he worked in R&D for a start-up organization developing stent grafts for the treatment of aortic aneurysms. Ben later joined Medtronic where he spent 15 years in R&D with the cardiovascular business, primarily focused on developing stent grafts for abdominal and thoracic aortic diseases. Ben’s time with Medtronic spanned many areas within R&D, including fatigue and durability testing, in vivo boundary conditions development, computational modelling, nitinol stent design, bench test methods, failure and root cause analysis, standards development and due diligence efforts.

CORE COMPETENCIES

• Management of cardiovascular implants and ancillary devices used in the treatment of vascular disease
• Development of in vivo boundary conditions for use in device development, computational analysis and non-clinical testing
• Advisement on test method development for cardiovascular devices, including aortic, peripheral vascular and heart valve devices
• Management of cardiovascular implant durability testing and computational modelling methods and strategies
• Development of design controls and manufacturing technologies
• Administration of root cause analysis for bench and clinical device failures
• Regulatory strategy development, including device evaluation strategy approaches
• Presentations to the FDA for submissions, including pre-submissions, breakthrough designations, IDE and PMA submissions

RECENT PROJECTS 

• Developed in vivo boundary conditions summary and associated bench test/computational modelling strategy for a Class III cardiovascular device; reached agreement with FDA on the proposed strategy through Spring Submission and presentation
• Led a comprehensive root cause analysis effort to investigate the cause of observed clinical device fractures; determined the cause of the failures and worked with Client to develop a strategy forward
• Completed a Breakthrough Device Designation Submission for an early-stage company with a novel software diagnostic technology and worked with the Client on the overall development program strategy