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Ben Wolf, MS

Ben Wolf, BS, MS

Regulatory Strategy Associate

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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