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

Biomedical Engineering - University of Rochester 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 Brainstorming Benchmarking “House of Quality” Patent Searches

Biomedical Engineering - University of Rochester Capstone Design Project “Customers”“Customers” –Local community –Medical Center –BME Faculty Students apply to work on teamsStudents 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 spring semesterSubmit and orally present proposal for work in spring semester

Course Structure

Biomedical Engineering - University of Rochester 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 Rochester 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 projectsIndividual reports on applications to capstone design projects –Environmental

Research InstrumentsResearch Instruments –may include design of both instruments and protocols Murine Bone Mechanical Testing System (Department of Orthopaedics) Examples of Past Projects Cell Adhesion Assay (Department of Biomedical Engineering)

Clinical DevicesClinical Devices –require development of prototype and assessment of market Examples of Past Projects Nursing Home Alert System (Blossom Nursing Home) Antiseptic Airway Suction Catheter (School of Nursing)

Assistive TechnologyAssistive Technology –require development of prototype and assessment of market Examples of Past Projects Accessible Ergometer for Diverse Abilities (RERC Design Competition) Sip and Puff Controlled Manipulation Arm (Department of Pediatrics and local community)

Biomedical Engineering - University of Rochester Project Selection Challenging but realisticChallenging but realistic Require integration of biological and engineering knowledge and skillsRequire integration of biological and engineering knowledge and skills DiversityDiversity –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, customersFormal Presentations to an audience of BME faculty, students, staff, customers Formal ReportsFormal Reports –Documentation of detailed design –Results of Testing –Suggestions for further implementation, with consideration of realistic constraints Poster PresentationPoster Presentation –Public presentations, demonstrations, posters, Celebration!!!