Pitt | Swanson Engineering
BIOENG 2151 : Medical Product Development (Spring)

Medical Product Development

Instructor: Hirschman
Credits: 3

Term(s) Offered: Fall: No Spring: Yes Summer: No

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 (Medical Product Ideation).

BIOENG 2150 : Medical Product Ideation
Instructor permission.

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.

Topics Covered:
Design controls required by FDA 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
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