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1 Biomedical Engineering - University of Rochester Biomedical Engineering - University of Rochester Biomedical Biomedical Engineering Senior Engineering Senior Design: Design: Entrepreneurship in Entrepreneurship in Design of Medical Design of Medical Devices and Biomedical Devices and Biomedical Research Instruments Research Instruments Amy L. Lerner Amy L. Lerner

1 Biomedical Engineering - University of Rochester Biomedical Engineering Senior Design: Entrepreneurship in Design of Medical Devices and Biomedical Research

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1Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Biomedical Engineering Biomedical Engineering Senior Design: Senior Design:

Entrepreneurship in Design of Entrepreneurship in Design of Medical Devices and Biomedical Medical Devices and Biomedical

Research InstrumentsResearch Instruments

Amy L. LernerAmy L. Lerner

Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Senior Design Course Format Senior Design Course Format

Fall Semester - 2 cr. Fall Semester - 2 cr.

Medical Device Benchmarking Medical Device Benchmarking

Proposal for design projectProposal for design project

Spring Semester - 4 cr.Spring Semester - 4 cr.

System Level DesignSystem Level Design

Design ReviewsDesign Reviews

Prototype DevelopmentPrototype Development

Realistic ConstraintsRealistic Constraints

Testing and EvaluationTesting and Evaluation

Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Senior Design Course Format Senior Design Course Format

Medical Device BenchmarkingMedical Device BenchmarkingIntroduction to design process with a familiar device

Concept of “customer”

Teamwork, group dynamics

Business Memos

Brainstorming

Benchmarking

“House of Quality”

Patent Searches

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QuickTime™ and aTIFF (Uncompressed) decompressorare needed to see this picture.

Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Capstone Design Project Capstone Design Project

• ““Customers”Customers”– Local community

– Medical Center

– BME Faculty

• Students apply to work on teams Students apply to work on teams

• Assigned BME faculty supervisorAssigned BME faculty supervisor

• Instruction on formal design methodologyInstruction on formal design methodology

• Analysis of customers’ needs and wantsAnalysis of customers’ needs and wants

• Submit and orally present proposal for work in Submit and orally present proposal for work in spring semesterspring semester

Course StructureCourse Structure

Dottie WelchDirector of Administration &

Purchasing

Art SaloFacilities and Assembly Director

Laboratory Safety Monitor

Steve ProulxAssistant Design Director

Red Blood CellBioreactor

Target RepositioningError Correction Filter

Jim McGrathProject Supervisor

Clinical VestibularChair

Catheter-basedAir Emboli Detector

Greg GdowskiProject Supervisor

ContinuousCO2 Monitor

Pulmonary SurfactantAssay Development

Mike KingProject Supervisor

Murine ActivityMonitoring System

Pathology ScreeningTechnology

Technology forPediatric Obesity

Amy LernerProject Supervisor

Amy LernerDirector of BME Design

Rick WaughBME Department Chair

Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Capstone Design Project Capstone Design Project

• Spring Semester - 4 cr.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 RochesterBiomedical Engineering - University of Rochester

Realistic Constraints Realistic Constraints • Lectures, discussions, seminarsLectures, 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

• Individual reports on applications to capstone design Individual reports on applications to capstone design projectsprojects –Environmental

• Research InstrumentsResearch Instruments– may include design of both

instruments and protocols

Murine BoneMurine BoneMechanical Testing SystemMechanical Testing System(Department of Orthopaedics)(Department of Orthopaedics)

Examples of Past ProjectsExamples of Past Projects

Cell Adhesion AssayCell Adhesion Assay(Department of Biomedical Engineering)(Department of Biomedical Engineering)

• Clinical DevicesClinical Devices– require development of

prototype and assessment of market

Examples of Past ProjectsExamples of Past Projects

Nursing Home Alert SystemNursing Home Alert System(Blossom Nursing Home)(Blossom Nursing Home)

Antiseptic Airway Suction CatheterAntiseptic Airway Suction Catheter(School of Nursing)(School of Nursing)

• Assistive TechnologyAssistive Technology– require development of

prototype and assessment of market

Examples of Past ProjectsExamples of Past Projects

Accessible Ergometer for Accessible Ergometer for Diverse AbilitiesDiverse Abilities

(RERC Design Competition)(RERC Design Competition)

Sip and Puff Controlled Sip and Puff Controlled Manipulation ArmManipulation Arm

(Department of Pediatrics and local (Department of Pediatrics and local community)community)

Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Project SelectionProject Selection

• Challenging but realisticChallenging but realistic

• Require Require integrationintegration of biological and engineering of biological and engineering knowledge and skillsknowledge and skills

• DiversityDiversity– Concentration areas

– Customer types

– Research and Clinical

Biomedical Engineering - University of RochesterBiomedical Engineering - University of Rochester

Final Reports / PresentationsFinal Reports / Presentations

• Formal Presentations to an audience of BME Formal Presentations to an audience of BME faculty, students, staff, customersfaculty, students, staff, customers

• Formal ReportsFormal Reports– Documentation of detailed design– Results of Testing– Suggestions for further implementation, with

consideration of realistic constraints

• Poster Presentation Poster Presentation – Public presentations, demonstrations, posters,

Celebration!!!