Univ. of Virginia William F. Walker

Forum on Innovation and Entrepreneurship in Biomedical Engineering Education

BIOM 200

Intro. to BME Design and Discovery

• What is BME?

– Medical Imaging – Tissue Engineering – Biomaterials – Medical Instrumentation – Biomechanics – Computation in BME • Conservation Principles • System Design • Experimental Design • Data Analysis (in MATLAB) – Basic Statistics – Curve Fitting – Data Presentation • Product Development – Intellectual Property – Team Selection and Development – Developing a Business Plan / Acquiring Capital – Medical Device Regulation University of Virginia

BIOM 450 / BIOM 460

BME Capstone I / BME Capstone II

• Project Planning • BME Roles in Industry • Medical Device Development – Quality Control – Standards – Design and Process Control • Proposal / Progress Report Writing • Intellectual Property • Regulatory Issues – FDA Regulation – Clinical Trial Design – Human Trials Policy and Enforcement • Marketing and Market Analysis • Product Development Process in Industry • Abstract Writing and Scientific Ethics • Entrepreneurship in BME • Professional Presentation of Self University of Virginia

BIOM 495 / BIOM 695

Biomedical Engineering Entrepreneurship

• Intellectual Property • SBIR Grant Application • FDA 510k Application • Elements of a Business Plan – The Medical Problem and the BME Product – Management – Development Plan and Marketing Strategy – Marketing Analysis – Financial Analysis • Launching a Business – Understanding Entrepreneurship – Getting Started – Managing Time and People – Financing the New Enterprise – Marketing and Selling the Product – Negotiating Deals – Protecting Intellectual Property University of Virginia

Novel Methods in BIOM 200

• Team Selection Memo – Teams must justify membership – Opens the door for a discussion of gender bias • Women - Organized, Creative, Good Communicators, Good Teamwork • Men - Good at Science/Math, Good Technical Skills (Programming), Hard Working – Both genders identify prejudices – Prejudice about self is often strongest – Both genders recognize how these biases can affect career development • Students Identify Projects – Only constraint is that it must be in BME – Work with medical and engineering consultants – Teams usually identify their own consultants – Students sometimes identify a problem after talking to a consultant • Intellectual Property is discussed early and emphasized – Students perform patent searches on their ideas – Classroom discussions consider how the IP status of an idea may impact development.

University of Virginia

Outcome Measurement in BIOM 200

• Weekly Progress Memos – Check performance on specific tasks • Brainstorming • Design Comparison • Prior Art Search • Etc.

• Project Proposal Memos – Detailed summary of work to date – Detailed plan for remaining effort – Time and financial budgets • Final Project Presentations – Discuss high level goals – Describe the problem addressed – Present and demonstrate design – Reviewed by a panel of TAs and faculty • Course Evaluation – Written student evaluations – Instructor and Chair review University of Virginia

Representative Project from BIOM 200

• Improved Obstetric Forceps Strain Gauge Conforming Putty Antibacterial Gel University of Virginia