Technology Assessment and Regulation of Medical Devices
Pietzsch Jan Benjamin
The healthcare industry is an increasingly challenging environment for medical technology innovation. Health systems struggling to find the right formula for balancing and aligning risks and rewards for medical providers and suppliers. The gap is widening between health care that can be provided and health care that can be afforded. Growing cost-pressures lead to the increasing importance of economic factors for medical treatment decisions. To meet these challenges, engineers must adopt a new motto: It is not simply invention; it is inventiveness put to use.
This course gives engineers an introduction to technology assessment methods and the regulation of medical devices. The first half of the course focuses on regulation, the second half on health-economics and reimbursement. Students build a solid understanding of regulatory and reimbursement requirements, and of how to establish, demonstrate, and strategically influence the value of new technologies.
Two guest lectures will be given by senior personnel from the FDA's Office of Device Evaluation and from a global medical device company. Several other guest speakers will present their companies' technologies and related regulatory and reimbursement challenges during the quarter. These will be 15-minute presentations and discussions at the end of each class.