Description
MEDICAL PRODUCT DEVELOPMENT
A didactic course that uses principles of system engineering, the stage-gate process for medical product development and engineering and business analysis principles to evaluate the commercial potential proposed medical devices to further develop feasible solutions to a clinical problem identified in BIOENG 2150. Students will demonstrate use of systems engineering techniques to prioritize a set of feasible device and/or system solutions and ability to use intellectual property (IP) tools to determine suitability for further development. Students will demonstrate use of course principles in development of a commercialization plan for a proposed medical product. Design controls required by fad and international bodies; systems engineering methodologies; intellectual property (IP) and IP search tools; brief market analysis; size by region, growth, competition, barriers to entry, sustainable advantage; reimbursement issues for proposed medical device/system; basic financial analysis ' students will construct spreadsheets typically presented to senior business management. This will include estimates of costs, margins, break-even analysis, NPV, hurdle rates, ROI, IRR; codes, standards, and regulatory processes (FDA, IEC & ISO, UL, ministry of health (Japan), NRC, BRH, notified bodies, obtaining broad indications for use); safety, reliability, product liability considerations, manufacturability considerations (DFM ' design for manufacture, workflows)
Details
Grading Basis
Grad Letter Grade
Units
3
Component
Lecture - Required
Offering
Course
BIOENG 2151
Academic Group
Swanson School of Engineering
Academic Organization
Bioengineering Program
Campus
Pittsburgh Campus
Enrollment Requirements
PREQ: BIOENG 2150; PROG: Swanson School of Engineering
Typically Offered
Spring