Event Details

Regulatory affairs professionals must have both a solid foundation surrounding regulatory strategy and an in-depth understanding of how this plan links to the overall product development strategy to achieve efficient, cost-effective development outcomes and commercialization success.

Whether navigating a new regulatory pathway, understanding how to secure clinical data to achieve successful commercial outcomes, or ensuring reimbursement strategies are coordinated with regulatory strategy throughout the planning process, it is essential all stakeholders to take steps to secure broader market success for newly developed medical technologies.

This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and how early integration of regulatory, reimbursement and clinical research planning are the keys to commercial success.

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

Learning Objectives

• Understand how looking beyond current regulatory approaches can lead to commercial success
• Review common challenges related to the regulatory approach of “least resistance”
• Reason why regulatory approval does not always equal reimbursement
• Apply best practices to achieve effective clinical study design through early planning and integration of regulatory affairs and reimbursement requirements
• Explain how leveraging best practices and tactics linking regulatory, reimbursement and clinical strategies is key to saving time and costs throughout the development process and accelerating commercialization

Who Should Attend

• Medical device industry executives
• Quality professionals
• Regulatory affairs professionals
• Clinical affairs professionals
• R&D engineers
• Global strategy business managers
• Regulatory affairs and operations leaders
• Product managers and business analysts
• Medical writing professionals
• Compliance managers
• Risk management professionals

Speakers

• Edward Black, director of global reimbursement strategy, NAMSA

Edward Black serves as NAMSA’s Director of Global Reimbursement Strategy where he oversees reimbursement strategy, payer relations and health economics for medtech and biotech companies in the U.S. and abroad. Prior to joining NAMSA, he founded Reimbursement Strategies, LLC in 2008, a medtech consultancy focused on reimbursement services. In total, Mr. Black possesses 25 years of experience in health and provider network management within U.S. healthcare systems. He has served on two national advisory boards where he was responsible for leading efforts for consistency in medical benefit and payment policies. Mr. Black is active in several global medical technology initiatives and is a frequent international lecturer. He serves as an adjunct faculty member of the University of Minnesota—Minneapolis in the Masters of Science in Medical Device Innovation Program, and is a Reimbursement Advisor at the U of MN Office for Technology and at the National University of Ireland Galway (BioExel Program). Mr. Black earned his MBA at Minnesota State University—Mankato.

• Vincent Legay, director of global product development strategy, NAMSA

Vincent Legay possesses over 15 years of experience in the medical device industry and currently serves as NAMSA’s Global Director of Product Development Strategy. In his role, he leads a team of senior consultants specialized in product development consulting, regulatory, clinical and preclinical strategies that provide solutions across the entire medical device lifecycle continuum. His expertise also includes management of sterilization, biocompatibility, clinical evaluation, risk management and quality management systems for medical device Sponsors throughout the globe. Mr. Legay holds a PhD in Biology from Lyon University (France) and an executive MBA from EMLyon (France).

• Carla Wiese, sr. product development strategist, NAMSA

Carla Wiese currently serves as NAMSA’s Sr. Product Development Strategist where she provides strategic consultation to clients in the medical device industry to help them meet commercialization goals. Carla also acts as a Program Director leading client projects from early stage device development through commercialization; ensuring that the client has key resources, managing project tasks/timeline and contributing to budget development. Prior to NAMSA, she gained regulatory expertise while serving at the U.S. Food and Drug Administration (FDA) as a Lead Reviewer and Engineering Consultant in the Division of Cardiovascular Devices. Carla also led the Early Feasibility Studies Program at FDA working across CDRH divisions and in collaboration with the National Institute of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS) to pave a clearer pathways for clinical evaluation of novel technology in the US. Additionally, Ms. Wiese’s experience includes research and development, serving as an engineer in the medical device industry for over a decade for both large and small organizations. Ms. Wiese holds a BS in Mechanical Engineering from The Ohio State University.