The objective of this course is to provide students with regulatory body and ethics considerations by which they engineer safe medical device products intended for use as implantable devices or in contact with body tissue and fluids. A top down approach will be taken where the regulatory path for product approval and associated costs with product development and validation are reviewed for different biomaterials and devices. This path is then assessed in the context of product specific reimbursement, ethics, safety, competitive positioning, and regulatory concerns. Students will be required to use their existing knowledge of biomaterials and devices, and their biocompatibility to frame the questions, challenges and opportunities with a mind to re-engineering products in order to capitalize on niche regulatory pathways. The resulting regulatory path gives a good idea of the kind of trial design the product must prevail in and ultimately the design characteristics of the device itself. Decision making will be made with ethical considerations. The discussion model will focus mostly on the United States regulatory office with some comments on Canada and Europe. Lastly, quantitative product development risks estimates are considered in choosing a product path strategy for proof of concept and approval of safe products. Ethical issues can also impact design since in biomedical engineering they are currently studied in the fields of bioethics, medical ethics, and engineering ethics. Yet, professional ethical issues in biomedical engineering are often different from the ones traditionally discussed in these fields as they need to align with the engineering profession. Biomedical engineers differ from medical practitioners, and are similar to other engineers, in that they are involved in research for and development of new technology, and do not engage in the study, diagnosis, and treatment of patients. Biomedical engineers differ from other engineers, and are similar to medical practitioners, in that they aim to contribute to good patient care and healthcare. The ethical responsibilities of biomedical engineers thus combine those of engineers and medical professionals, including a responsibility to adhere to general ethical standards in research and development of technology and to do R&D that adheres to the specific standards set forth by medical ethics and bioethics. This course focuses on products currently for sale as case studies, or may be approved for sale within the next two years consistent with its practical commercial focus.