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.
- 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
- 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