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 has a bachelor’s degree in mechanical engineering from UC Davis and a master’s degree in mechanical engineering from Stanford University. He began his career as a manufacturing engineer with Hewlett-Packard/Agilent Technologies in the telecommunications industry, before moving into the medical device industry, working in R&D for a startup company 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 disease. 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. Ben led the R&D development teams and the program management office (PMO) team and was part of the senior leadership team for Medtronic’s aortic business unit.

Ben continued his involvement in the medical device industry with NAMSA’s product development strategy consulting team for two years before founding Abel and Wolf Consulting with Dorothy Abel. Ben’s focus areas include fatigue and durability testing, in vivo boundary conditions development, computational modeling, nitinol stent design, bench test methods, failure and root cause analysis, standards development, and due diligence assessments. Ben has also been invited to present on root cause analysis and bench testing topics at multiple conferences.

Core competencies:

• 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.

• Test method development expertise for cardiovascular devices, including aortic, peripheral vascular, and heart valve devices.

• Cardiovascular implant durability testing and computational modelling methods and strategies.

• Medical device product development process, design control, and manufacturing technologies.

• Root cause analysis for bench and clinical device failures.

• Regulatory strategy development, including Device Evaluation Strategy approaches.

• FDA presentations and submissions, including Pre-Submissions, Breakthrough Designations, IDE and PMA submissions.