Biomedical Technology Law
This course will focus on the commercial aspects of biomedical technology. Initially, students will explore the evolution of biotechnology companies. Topics in this section will include: product development, regulatory approvals, testing and market distribution and exclusivity programs. The course will then turn its attention to the integration of medical technologies in healthcare delivery systems and the responsibility of providers with respect to medical technology. Next, students will examine the development and commercialization of evolving medical technologies with a focus on human tissue products and the genome project. Finally, students will be provided with an overview of the role of governmental oversight in the field of medical technology and the emerging law relating to product advertising and liability. Significant time will not be spent on the following topics that are covered in other courses: intellectual property protections (including, patent, copyright and trademark law), antitrust concerns, bioethics and medical technology in the academic setting.