The objective of this course is to provide students with strategies by which they can "reverse engineer" 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, safety, competitive positioning and regulatory concerns. Students will be required to use their existing knowledge of biomaterials and 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. The United States and Europe will be contrasted with respect to both their regulatory environment and reimbursement. Lastly, quantitative product development risks estimates are considered in choosing a product path strategy for proof of concept and approval.
35.4 (Fall), 38.4 (Winter), 73.8 (Full Year)