About Us
Dorothy Abel
Dorothy Abel, BSBME, retired from the FDA after over 30 years of regulating vascular and endovascular devices. While at the FDA, she was the primary liaison to medical professional societies to develop appropriate clinical evaluations of vascular and endovascular grafts. She was the convener or project leader for the ISO Vascular Prostheses Committee for over 25 years and is an AIMBE Fellow. She co-founded the Early Feasibility Study Program and worked on other Center initiatives to promote innovation. She has been a member of the steering committee for the Greenberg Stent Summit for over 10 years. Dorothy’s focus areas include device evaluation strategy development, clinical evaluation strategic planning, FDA submission planning, drafting or review of FDA submissions, and FDA meeting support.
Ben Wolf
Ben Wolf has over 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 master’s degree in mechanical engineering. He began his career developing electronic test equipment, before moving into the medical device industry. Ben has worked in startups and large companies, most recently spending 15 years with Medtronic, focused on developing stent-grafts. 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.
Aditi Upadhye
Aditi Upadhye has over 17 years of regulatory experience within the medical device industry. Over those 17 years, she has held positions of increasing responsibility at Medtronic leading the Regulatory function for various Business Units. Aditi’s regulatory experience spans over the entire product lifecycle, inclusive of pre-market and post market areas. Aditi has a master’s degree in biomedical engineering and holds a RAC. Her focus areas include creation of regulatory strategies for Class III medical devices, drafting or review of FDA submissions and FDA meeting support. Aditi also has experience with recall management and audit preparation.
Darren Hopkins
Darren Hopkins has over 25 years of experience within the medical device industry. His career has included overseeing medical device design and development, risk management, design test planning and evaluation, manufacturing quality, overall quality systems management, and, most recently, preparing regulatory submissions in both the US and countries outside the US (non-EU), and clinical study management. Darren led teams at both small and large medical device companies in roles ranging from department manager to VP. He specializes in biocompatibility, sterilization, packaging, risk management, test planning, and quality systems deployment.
Scott Westerman
Scott Westerman brings nearly 20 years of management and business intelligence experience across multiple industries and functions, including operations, marketing, education and training, and clinical sales. His expertise lies in overseeing complex projects while fostering collaboration among diverse teams to bridge the gap between technical experts and business leaders. Most recently, Scott spent 11 years with Medtronic in the Peripheral and Aortic Vascular business, focused on data-driven marketing planning, tracking, and decision-making. He has a particular passion for continued physician education, which helped him achieve success in both training device sales teams and as a physician education program manager.