Brandon joined NAMSA as a Principal Regulatory and Product Development Strategy Consultant in February 2022. He previously worked for Medtronic in their cardiovascular business for 15 years, most recently as a product development senior program manager. His other roles at Medtronic included R&D engineer, quality engineer, systems engineer, lab manager, CAPA owner, and program manager.

Brandon has experience in stent graft, heart valve, endostaple, vascular closure, balloon, guidewire, and delivery system design and testing. He spent 3 years managing the durability lab supporting IDE and PMA submissions. He has successfully supported projects in all phases of development from early ideation to design verification, all the way through post-market maintenance. He also spent 3 years improving product development processes and defending those systems in external audits. Prior to his medical device career, Brandon served as a military intelligence officer in the U.S. Army.

Mr. Woll earned his Bachelor of Science in Physics and Nuclear Engineering at the United States Military Academy at West Point. He received his MBA from Sonoma State University.

CORE COMPETENCIES

• Leading large global cross-functional teams in support of medical device development, including coordinating efforts within NAMSA (e.g., strategy consulting, biological safety, preclinical studies, medical writing, biostatistics)
• Developing regulatory strategies for medical devices to support various stages of medical device product development (e.g., early feasibility study, pivotal study, marketing submission)
• Preparing FDA submissions, including writing and reviewing of regulatory documents (e.g., pre-submissions, IDEs, PMAs)
• Primary regulatory correspondent for Sponsors’ communications with the FDA
• Developing strategies and communications in response to FDA feedback and decision letters, including hosting meetings with the FDA
• Developing device evaluation strategies (e.g., bench testing, preclinical testing, biocompatibility evaluations)
• Supporting medical device design and test method development strategy and decision-making
• Leading root cause analysis and CAPA planning & execution
• Development experience in implantable, non-implantable, and combination products
• Deep understanding of medical device regulations, standards, quality systems, and design controls

RECENT PROJECTS

• Assisted a small company in responding to a long IDE deficiency letter through the FDA Q-Submission process, re-writing their IDE submission, which resulted in IDE approval
• Program Director for a large FDA regulatory submission for a novel heart valve
  • Reviewed and edited bench testing reports and then incorporated these documents into their staged pivotal IDE submission
  • Led the cross-functional team in writing the IDE submission, resulting in IDE approval
• Coached a small startup company through the development of their overall device evaluation strategy and bench testing plan
  • Led the team as we wrote and submitted two FDA pre-submissions including hosting the FDA meetings
• Program director for a modular PMA submission for a company developing a surgical valve, with four modules accepted by FDA