A significant degree of overlap exists between reimbursement and regulatory approval of medical devices with sometimes a lack of integration of the processes. An early-stage company may have competing priorities and areas of focus, preventing it from achieving the major milestones of commercialisation. Making decisions and pursuing regulatory pathways without considering the company’s reimbursement goals can ultimately interfere with the reimbursement process, delay product launch and result in substantial losses for the company. How to ensure the reimbursement strategies are coordinated with regulatory strategy throughout the planning process? When best to research reimbursement and financial return options? How should clinical research planning fit into this? This session will focus on best practices in the early integration of regulatory, reimbursement and clinical research planning to secure commercial success.
Moderator: Artur Olesch, Founder & Editor-in-Chief, about Digital Health