A Proposed Design for a Graduate Level Design Course Paul H. King, Ph.D., P.E. Vanderbilt University

Advanced Design of Medical Products, Processes, and Services – BME 373 MS & ME level BME + ME + ? + Management Fulfills ME design requirement Fulfills Entrepreneurship interests

Review of Design Web Sites 17 Universities identified graduate design courses 5+ unique courses 3 duplicated courses 5 design – similar to proposed

Unique Courses Artificial Organ – U T Austin Medical Device Dev. (Polymeric – Rutgers) Biomedical Device Manufacturing – Purdue Prosthetics - Clemson

Duplicated Courses Rehabilitation emphasis: Carnegie Mellon, Catholic U. Entrepreneurship: U. Penn, U. Miami Technology Transfer: GA Tech, U FL

Similar to Proposed Course UCSD – bioengineering design project U IL/Chicago – medical product development U Michigan – biomedical engineering design U Minnesota – new product design and business development Stanford – medical device design and evaluation

UCSD the purpose of the new M.Eng. degree is to prepare design and project engineers for careers in the biomedical and biotechnology industries. … intended for students who are primarily interested in engineering design, development, manufacturing and management within an industrial or professional setting.

UCSD Bioengineering Bioengineering Design Project (2-quarters, 4 units each) - independent work by graduate students focused on design, applied research and professional experience

University of Illinois/Chicago BME494 – Medical Product Development … apply (BS/MS) in a corporate setting - business plan, structure of corporations, FDA, ISO, presentation of product concepts, planning, R&D No end product

University of Michigan Biomedical Engineering Design (450) One semester, senior or MS (BME only) “ instrumentation design products “ Problem definition through prototype Local industry, hospital, engineering sponsor project(s) Introductory design lectures only

Stanford University ME 282 Medical Device Design and Evaluation 2 quarter 2 hour corporate sponsored project course Team formation, testing, standards, FDA, physiology as necessary, IP, marketing Mechanical Engineering home

University of Minnesota New Product Design and Business Development Management + Institute of Technology + Biomedical Engineering 2 semester Teams: ½ engineering + ½ management Corporate sponsored projects (Medtronic, Scimed, SpineTech, others)

U MN continued Definition through prototype IP agreements up front Mixed engineering and management lectures on relevant material through the year Pricing, design for manufacturing, ethics, etc. from Ulrich/Eppinger Product Design & Development Emulate!

Vanderbilt – BME 373/MGT451 Design of Medical Products, Processes, and Services (Special Projects- Mgt.) This course is intended to involve graduate level engineering and management students in Medical Design from the initial phase of a design request as solicited from industry (or University) to the end product, prototype, plan, or feasibility analysis.

VU BME 373 Continued Instructors King (Engineering), Owens (GSM). Engineering prerequisite BME 272 (First semester senior BME design) GSM prerequisite masters level, special topics credit, entrepreneurship 3 credit hours, ME credit, MS Mgt. Credit Engineering: BME, ME, EE, Mgt. Tech.

Need: A need exists in the Biomedical Engineering Department for a non- thesis Masters of Engineering Design Project option. This course will allow a student to imitate and perhaps complete this requirement. It will in addition expose students to collaborative work with students and faculty in Management.

Expanded definition … lectures and demonstrations as necessary to ensure that all are familiar with the basics of team building, brainstorming, intellectual property rights and research, forecasting, market surveys, and design strategies. … form teams comprised of both Management and Engineering students. Each team will, under the guidance as necessary of the course principals (and other advisors), perform:

Performance: 1. task clarification and market analysis 2. concept elaboration and refinement 3. preliminary design, testing and prototyping 4. final design, testing and documentation 5. Intellectual property analysis and documentation 6. solution communication Of a product, process, or service.

First offering: Spring BME ME students, 2 OGSM now Choice of 4 projects … commercial? Yearly thereafter.

Thank You! Questions? Sponsored in part by the NSF under award number EEC