ALS 425: Diagnostic and Device Product Development
Course Number: ALS 425
Course Name: Diagnostic and Device Product Development
No. Units: 3.0
Faculty/Instructor(s): Anna Iwaniec Hickerson
This course covers technical and managerial aspects involved in the development and manufacturing of instruments used in the 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 GMP manufacturing. Students will receive an overview of general industry standards and certification processes.. 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.
408, 435, or permission of instructors
· Students will be able to compare and contrast options from the instrument-design toolbox items listed above and provide a cost-benefit analysis for specific applications.
· Students will be able to specify appropriate regulatory, commercial, and manufacturing standards for specific instrumentation types.
· Students will be able to analyze business information to determine viability for the move to commercial manufacturing of particular instruments.
· Students will be familiar with several application-specific technologies and will be able to specify COTS options.
Class Participation 10%
Case Studies 10%
Prelabs and Lab reports 40%