Course Detail

This course covers technical and managerial aspects involved in the development and manufacturing of instruments used in the medical devices and diagnostics industry, through a combination of lectures and case studies, delivered by the course instructors and invited industry experts. Through the case studies and a small number of labs, students will solve specific tasks from the perspective of a project manager, product manager, development engineer, industrial / product designer, manufacturing engineer, or operations manager. Related aspects of market research, quality control, and the FDA approval process are emphasized in other complementary courses within the medical devices focus track. This course will lead students through (a) product definition and requirements specification, (b) feasibility demonstration for mechanical, electrical, and optical subsystems, user interface, and firmware/ software components, (c) integration of subsystems, (d) prototype development for preclinical or beta trials, (e) pilot production, and (f) commercial cGMP manufacturing. Students will receive an overview of general industry standards and certification processes. Device connectivity standards related to cross-platform compatibility as well as data transfer for patient identification and electronic patient records will be addressed. We will discuss how to achieve reliability, manufacturability, and cost targets through component qualification for both custom and commercial-off-the-shelf (COTS) products, and how to decide which components to manufacture in house and which to outsource. We will include aspects of enterprise resource planning / supply chain management, and discuss how cost of goods and manufacturing influence pricing and profit margin.

Class Participation     10%
Case Studies     60%
Prelabs and Lab Reports     30%