Financing and Reimbursement in Biomedical Product Development

Catalog description

Introduces the complex discipline of market access and pricing strategy for medical device, drug, and biologic products. As cost and relative efficacy drivers become increasingly important to market biomedical products successfully, life-sciences regulatory professionals must evaluate regulatory compliance criteria in relation to reimbursement and product pricing concerns. Regulatory professionals must also be involved in demonstrating that utilization of new biomedical products is comparatively cost-effective when measured against standards of clinical care. Using specific case studies from the United States and abroad, offers students an opportunity to analyze these market developments, as well as their resulting implications for biomedical product development, manufacturing, and commercialization, with an overall objective to develop comparatively and financially informed regulatory systems.