Laboratory of Orthopaedic Tissue Regeneration and Orthobiologics

BioE 4010 Biomedical Design Theory

Introduces principles of engineering design and applies them to the design of medical devices. Covers materials selection, fabrication processes, performance standards, cost analysis, and design optimization. Students defend a design project proposal in written and oral form before a faculty jury. Preq: BIOE 3020 or BIOE 3070 or BIOE 3200.
BioE 4030 Applied Biomedical Design

Creative application of bioengineering and design principles to solving clinically relevant design problems. Team-based development, construction and evaluation of design prototypes in accordance with design theory. Students present results to faculty jury and external collaborators through written reports and oral presentations. Preq: BIOE 4010. Coreq: BIOE 4031.
BioE 4510 Creative Inquiry "Engineering the IVD"

Disciplinary and multidisciplinary team research projects with the goal of developing the students' skills in literature research, engineering design, and data analysis. May be repeated for a maximum of six credits. Preq: Consent of instructor.
BioE 8600/8610 Master’s of Engineering Capstone Medical Device Design

The primary objective of this course series (BioE8600 and BioE8610) is to provide Bioengineering graduate students / engineers with an overview of key considerations, concepts and techniques which underlie the medical device design and product development process typically employed by the medical device industry. More specifically, this course aims to employ the student’s biomedical engineering knowledge towards solving real-world clinically relevant problems through the design, development and refinement of medical device prototypes by providing the student with relevant hands-on experiences in the medical device design and development process. Throughout this course series, students will be exposed to critical elements of this process through formal lectures, site visits and engineering design “gate” meetings in which the students must defend their design prototypes by providing engineering, scientific and business justification in the presence of experienced design advisory board mentors. Additionally, the student will be required to complete various key elements / documentation required of an FDA premarket notification (510(k) and which will include voice of customer feedback on their designs. Furthermore, they will be required to develop verification testing protocols and define engineering acceptance criteria with which they will use to verify their prototype designs.
8620 Preclinical assessment and Regulatory Affairs for Medical Devices

This course addresses the common pre-clinical requirements and regulatory processes required for medical device commercialization. Lectures focus on the regulatory pathways, quality system regulations, risk assessment, pre-clinical study design, protocol development and testing as it applies to medical devices.