Biomedical Engineering
Senior Design:
Entrepreneurship in Design of
Medical Devices and Biomedical
Research Instruments
Amy L. Lerner
Biomedical Engineering - University of Rochester
1
Senior Design Course Format
Fall Semester - 2 cr.
Medical Device Benchmarking
Proposal for design project
Spring Semester - 4 cr.
System Level Design
Design Reviews
Prototype Development
Realistic Constraints
Testing and Evaluation
Biomedical Engineering - University of Rochester
Senior Design Course Format
Medical Device Benchmarking
Introduction to design process with a familiar device
Concept of “customer”
Teamwork, group dynamics
Business Memos
Quic kT i me™ and a T IFF (Unc ompres s ed) dec ompres s or are needed t o s ee thi s pi c ture.
Brainstorming
Benchmarking
“House of Quality”
QuickT i me™ and a T IFF (Uncompressed) decompressor are needed t o see thi s pi cture.
Patent Searches
Biomedical Engineering - University of Rochester
Capstone Design Project
• “Customers”
– Local community
– Medical Center
– BME Faculty
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Students apply to work on teams
Assigned BME faculty supervisor
Instruction on formal design methodology
Analysis of customers’ needs and wants
Submit and orally present proposal for work in
spring semester
Biomedical Engineering - University of Rochester
Course Structure
Rick Waugh
BME Department Chair
Amy Lerner
Director of BME Design
Dottie Welch
Director of Administration &
Purchasing
Art Salo
Facilities and Assembly Director
Laboratory Safety Monitor
Steve Proulx
Assistant Design Director
Jim McGrath
Project Supervisor
Greg Gdowski
Project Supervisor
Mike King
Project Supervisor
Amy Lerner
Project Supervisor
Red Blood Cell
Bioreactor
Clinical Vestibular
Chair
Continuous
CO2 Monitor
Murine Activity
Monitoring System
Target Repositioning
Error Correction Filter
Catheter-based
Air Emboli Detector
Pulmonary Surfactant
Assay Development
Pathology Screening
Technology
Technology for
Pediatric Obesity
Capstone Design Project
• Spring Semester - 4 cr.
– Project development
• Weekly meetings with rotating
meeting leaders
• Systems Level Design
• Detailed Design Reviews
• Prototype construction
• Testing and Evaluation
• Realistic Constraints
Biomedical Engineering - University of Rochester
Realistic Constraints
• Lectures, discussions, seminars
– Ethics (Jane Greenlaw, Director of Clinical Ethics)
– Marketing (Peter Waasdorp, Simon School of Business)
– Regulatory (Mike Ackerman, Center for Clinical Trials and
Medical Device Evaluation, School of Nursing)
– Intellectual Property (Mark Coburn, Office for Technology
Transfer)
– Health Care Economics (Kevin Hart, Community and
Preventive Medicine)
– Manufacturing
– Environmental
• Individual reports on applications to capstone
design projects
Biomedical Engineering - University of Rochester
Examples of Past Projects
• Research Instruments
– may include design of both
instruments and protocols
Murine Bone
Mechanical Testing System
(Department of Orthopaedics)
Cell Adhesion Assay
(Department of Biomedical Engineering)
Examples of Past Projects
• Clinical Devices
– require development of
prototype and assessment of
market
Nursing Home Alert System
(Blossom Nursing Home)
Antiseptic Airway Suction Catheter
(School of Nursing)
Examples of Past Projects
• Assistive Technology
– require development of
prototype and assessment of
market
Sip and Puff Controlled
Manipulation Arm
(Department of Pediatrics and local
community)
Accessible Ergometer for
Diverse Abilities
(RERC Design Competition)
Project Selection
• Challenging but realistic
• Require integration of biological and engineering
knowledge and skills
• Diversity
– Concentration areas
– Customer types
– Research and Clinical
Biomedical Engineering - University of Rochester
Final Reports / Presentations
• Formal Presentations to an audience of BME
faculty, students, staff, customers
• Formal Reports
– Documentation of detailed design
– Results of Testing
– Suggestions for further implementation, with
consideration of realistic constraints
• Poster Presentation
– Public presentations, demonstrations, posters,
Celebration!!!
Biomedical Engineering - University of Rochester