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NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Industry Gate Reviews as a Method to Facilitate Senior Capstone Design
John DesJardins
Director, Bioengineering Design ProgramsAssistant ProfessorDepartment of Bioengineering,Clemson University, Clemson, SC
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Education 2006, Ph.D., Bioengineering, Clemson University 1994, M.S., Mechanical Engineering, Univ. of Pittsburgh 1992, B.S., Mechanical Engineering, Carnegie Mellon Univ.
Work History 1998-Present, Clemson University 1997-1998, University College London 1995-1997, Johns Hopkins University 1994-1995, University of Pennsylvania
Research Experience Orthopaedic Biomechanics,
Total Joint Replacement Mechanics, Biomaterials Tribology, Implant Retrieval and Design, EWH
http://www.eng.clemson.edu/bio/people/desjardins.html
Dr. John DesJardins
Clemson University: A Brief OverviewA land-grant university founded in
1889Focus on agriculture and engineeringTradition of economic transformation in
agriculture, textiles, ceramics, chemicals
Technically oriented public research university17,000 graduate and undergraduate
students$170 million in research expendituresStrength in engineering, architecture,
agriculture, entrepreneurship, and communication
Clemson University
U.S.News & World Report, Best Graduate Schools, 2010#22 Bioengineering
U.S.News & World Report, Best Public Universities, 2011#23 Clemson UniversityScientist magazine, 2007
#1 Place to Work in Academia
Leadership and Entrepreneurship
Family and Community Living
General Education
AdvancedMaterials
Automotiveand
TransportationTechnology
Biotechnology and
BiomedicalSciences
SustainableEnvironment
Informationand
CommunicationTechnology
Clemson UniversityAcademic Emphasis Areas
Clemson University Academic Plan, 2002-2010
Bioengineering Cardiovascular Biomaterials/ Neuroscience/Tissue Engineering Biomechanics Bioelectronics
Psychology Human Factors Industrial/Organizational Human Performance Psychology Appraisal Enhancement
Clemson University: A Brief OverviewPhD 1963
Department 1968
New undergraduate program in 2006296 current sophomore-seniors65 in current senior class
ABET accredited 2011
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
1963
2003
Clemson University
Bioengineering
45 years of tradition and excellence in bioengineering education and research
2009
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
MD/PhDDMD/PhD
Clinical ResearchResearch Training
SUMMERS
Translational ResearchFrom Bench to Bedside
EducationIncubation
ACADEMIC SEMESTERS
Basic Research
Technology Development
Undergraduate & Graduate Education
1963
2003
2003
2010
Clemson/USCEducational-Clinical
Partnerships
SC BioengineeringAlliance1985
Bioengineering, Statewide Collaboration
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Senior Design
Brief HistoryBefore our Undergraduate
Program (pre-2006)
Biomedical DesignCore undergraduate
course in Bioengineering Minor
One of three courses needed for BioE minor
3 credit, one semester course
Lectures + Design at the same time
Non-BioE majors (mostly BioSc)
Small Class Size (< 10 students)
~ Everything is designed. Few things are designed well.
-Brain Reed
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Senior Design
Brief HistoryNew Undergraduate Program
(2006)
First Group of BioE Seniors in 2009
29 students
BioE401 Biomedical Design3 credit, one semester courseLectures + Design at the
same timeInternally FundedStudent Selected Designs
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Senior Design
A Growing Problem OpportunityFinding, Managing and Financing Clinically
Relevant Senior Design Projects for:6 Students, 200829 Students, 2009
Major Curriculum RevisionBioE 401, Bioengineering Design Theory (Fall)BioE 403, Applied Bioengineering Design
(Spring)38 Students, 201054 Students, 2011 65 Students, 201285+ Students, 2013
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering, Biomaterials Curriculum
Manufacturing Skills
Assessment
SolidWorks/Matlab
Freshman Mentoring
and Design
Experiences in CI
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering, Biomaterials Curriculum
Bioinstrumentation Design
Design Theory
Applied Design
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering
Design CurriculumBioE 451, Freshmen Design Experiences
(Creative Inquiry) 2010-Present (Fall and Spring) To introduce interested freshmen to exciting design
experiences that are intended to educate them about what the field of bioengineering encompasses and to give freshmen immediate and tangible access to bioengineering educators, facilities and administrators who can assist them with decisions and choices about their future academic path.
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering
Design CurriculumBioE 401, Bioengineering Design Theory
2007-Present (Fall Course) Principles of engineering design are introduced and
applied to the design of medical devices. Materials selection, fabrication processes, performance standards, cost analysis, and design optimization are covered. Students defend a design project proposal in written and oral form before a faculty jury.
BioE 403, Applied Bioengineering Design 2010-Present (Spring Course) Creative application of bioengineering and design
principles to solving clinically relevant design problems. Team-based development, construction and evaluation of design prototypes in accordance with design theory. Students present results to faculty jury and external collaborators through written reports and oral presentations.
~ People ignore design that ignores people.
-Frank Chimero
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
The AIDS/HIV Pandemic◦2007 Statistics
42 Million Infected World Wide 3.1 Million deaths, 5 Million New
InfectionsDesign Objective
To design an inexpensive alternativeto more costly cutting tools to:Increase procedure safetyIncrease the number of safe procedures performed Metal handle w/ blade ~ $4.00-$10.00
www.qcsupply.com, www.surgicalonline.com, www.zefon.com
Surgical scissors ~ $20.00-
$50.00
Plastic handle w/ blade (disposable) ~ $1.00-$2.00 $0.07
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Enhancing Athletic Performance of Amputees
◦2005 Statistics An estimated 185,000 people undergo
amputation each year 500 amputees from the Iraq war participated
in the ParalympicsDesign ObjectiveTo design elite performance prosthesis
for competitive eventsImprove quality of life for active amputees
picasaweb.google.com, www.thisisbrian.com
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Biomedical Device Design
Solutions to Venous Disease
◦ 2007-8 Statistics 600,000 cases of DVT 100,000 deaths per year related to PE Aging population to heighten need
Design ObjectiveTo design a Class III novel
vascular device to improve venous function
Design integration of novel materials and catheter deployment methodologies
http://www.surgeongeneral.gov/topics/deepvein/calltoaction/call-to-action-on-dvt-2008.pdfSathe, R. et. al, “Flexible Prosthetic Vein Valve”, June 2007, Journal of Medical DevicesPavcnik, "Percutaneous management of chronic deep venous reflux: review of experimental work and early clinical experience with bioprosthetic valve", Vascular Medicine.
Bi-leaflet
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Enhancing Treatment of Sleep Apnea Through Device Design
◦2009 Statistics Apnea affects over 12 million Americans, 1 in
15 Americans are actually diagnosed Significantly affects quality of life (Fatigue,
Hypertension, Spouse)
Design ObjectiveTo design enhanced Bi-PAP
system to more affectively treat sleep apnea
Use novel monitoring system, patient feedback, bio-instrumentation
http://theauburner.com
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering
Senior Design Curriculum, 1st Semester
BioE 401, Bioengineering Design Theory (Fall) Mental Reset, Re-Design the MindNeeds Finding, AssumptionsMarket AnalysisDesign DocumentationQFD, Constraints, DrawingPatents, IPBrainstorming, IdeationProblem DefinitionTargets, InputsManufacturingProduct DevelopmentRegulationDesign Theory Models
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
BioE 403, Applied Bioengineering Design (Spring) ProposalsClinical/Industry MeetingsBudgets, TimelinesAgendas, MinutesDesign History FilesPrototypingVerification/ValidationDesign ReviewsPatent DisclosuresRegulatory PaperworkDesign Competitions
Bioengineering Senior Design Curriculum, 2nd Semester
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Design “Method(s)”
~ Design is the conscious effort to impose a meaningful order. - Victor Papanek
Design Review
Design Verification
Design Validation
Design ReviewsDesign
Transfer
Design Inputs
Design Outputs
Product Requirements
Design/Development Planning
System Requirements Specification
Requirements Design Review
The Product Development Process
Before this??????
Product Requirement
s
Product Idea Generation
Product Design Team Formation
Product Definition
Customer and QFD
Product Documentation,
Business Proposal, Markets, Risks
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Needs Product DefinitionRequirements
(Units)
Requirement Specifications
DesignSpecifications
INPUTS
Verification andValidation
OUTPUTS
Targets
The Design “Method(s)”
Review
ReviewReview
Review
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Design “Gate” Model Examples
www.devicix.com
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
www.devicix.com
Design “Gate” Model Examples
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Industry Gate Reviews as a Method to Facilitate Senior Capstone Design
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design
Clinically Relevant Designs and Experiences Through Industry Partnerships
Design Proposals solicited from Biomedical companies Intellectual property agreements with company
Companies “hire” student teams to design solutionsStudents work on clinical/industry relevant projectsFaculty mentors assist students and collaborate with industry
Industry funding supports the design program Industry has access to students for potential hiresStudents learn industry relevant design processes
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design
Industry Partnership in Design Education
Electrode CompaniesDesigning, manufacturing and distributing
neurodiagnostic electrodes and accessories
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Design “Gate” Model Examples
www.devicix.com
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
www.devicix.com
Design “Gate” Model Examples
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 1: Design Proposal (review)Gate 2: Design Technical CompetencyGate 3: Prototype Production PlanGate 4: Verification/Validation PlanGate 5: Prototype
Presentation/SpecificationGate 6: V/V Results/Analysis
Final Showcase (poster show)
Week
3-45-6
7-8
9-10
13-14
15-16
17~ Good design goes to heaven. Bad design goes everywhere.
- Mieke Gerritzen
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Bioengineering Design Gates
Gate 1: Proposal (review)Gate 2: TechnicalGate 3: Production PlanGate 4: V/V PlanGate 5: PrototypeGate 6: V/V Results
Final Showcase (poster show)
GateDocument
DHFDocs.
Week
3-45-6
7-8
9-10
13-14
15-16
17
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Typical Gate Format Team of 4-5 students 2-3 faculty, 1 TA45 minutes, once every 2 weeks
Agenda and Minutes produced by students15 min presentation, 30 min discussion
Gate Topic Presentation, Review of Progress, Assessment of:Professional Meeting Flow, Team Health,
Technical Competency, Design Goals on Track, Use of Design Principles
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 1: Design Proposal (review)15 minute presentation
Topic background, clinical need, scope, objectives, design inputs, materials/equipment/lab resources, proposed budget, timeline, milestones
1st rough prototypeGate Document
Design Proposal (10 pages) DHF Documents
1) Timeline, 2) Stakeholder, 3) Core Team, 4) QFD
Week
3-4
~ Designers are meant to be loved, not understood.
- Fabien Barral
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 2: Design Technical Competency20 minute presentation
Topic theoretical background, technical literacy, bioengineering knowledge base review.
NOT practical knowledge
2nd rough prototypeGate Document
5 Journal Article Reviews DHF Documents
5) Competitor Assessment, 6) Market Analysis
Week
5-6
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 3: Prototype Production Plan20 minute presentation (and document)
Concise engineering description of the prototypeProposed production methods
Parts ListMaterials and Materials SpecificationsManufacturing Methods and Suppliers# of parts to be producedEngineering level drawings of the parts and complete
design (with dimensions).
3rd rough prototypeDHF Documents
7) Budget, 8) DFMEA
Week
7-8
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 4: Verification and Validation Plan20 minute presentation, 25 min discussion
Balance of Quality System Assurances, Verification and Validation Plans (mock clinical trials)
10-20 hours of V/V work per team memberSummaries of Design Inputs, Targets and Outputs
Equipment, Materials and Supplies for Testing Standards and Tests Methods Expected Results, Analysis of Data
V/V Document (Contract)DHF Documents
9) Regulatory Pathway, 10) Industry/Customer Interviews, 11) Standards
Week
3-45-6
7-8
9-10
13-14
15-16
17
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 5: Prototype PresentationPhysical Device and Use Presentation
Demonstration of Device Function and ParametersVerification of User-Met Needs
Device Specification SheetTechnical summary, market niche (specification key
features), clear listing of the engineering specifications with operational values, photos or drawings of device and preferably with the device in use.
DHF Documents12) Patent Review, 13) Drawings
Week
3-45-6
7-8
9-10
13-14
15-16
17
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design Gates
Gate 6: Verif./Valid. PresentationPresentation of Outputs = Inputs
Statistical Discussion of Device Performance Assessment, Tests Performed, Data Collected, Surveys Received.
All data summarized in Conference-Style AbstractsV/V Reports, 1 page per input
Input Abstracts (1 page per Input)Need, Input, Materials and Methods, Standards, Data
analysis, Discussion, Risk
DHF Documents13) Patent Disclosure,
14) Video,15) NCIIA Document
Week
3-45-6
7-8
9-10
13-14
15-16
17 ~ Good design is a lot like clear thinking made visual.
- Edward Tufte
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
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© 2010 Institute for Health Technology Studies
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Senior Design Paradox
Design Theory
vs.
Build and Test a Prototypevs.
Refine/Market/Produce a Final Product
~ Good design is obvious, Great design is transparent.
-Joe Sparano
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering Design
Clinically Relevant Designs Through Industry Partnerships
201038 Students7 Teams, 1 Sponsor2 Patent Disclosures
201154 Students11 Teams, 3 Sponsors2 Patent Disclosures (more pending)1 License of Rights
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”Bioengineering
Design CurriculumBioE 850, Graduate Design
2008-Present Graduate level design experiences that
address industry and clinical level challenges in product development
BioE MS/MBA Design Innovation Partnership 2006-2008, 2012-Present Multi-disciplinary Faculty and Teams Biotech Entrepreneurship and Start-up
BioE MS Medical Device Reprocessing and Re-sterilization Certificate 2012-Present Focus on Analysis and Design of Systems and
Devices for Recyclability and Reuse Partnerships with Device Industry
NHTSA Contract No. DTNH22-07-D-00049, Task Order 6“Pedal Application Errors”
Industry Gate Reviews as a Method to Facilitate Senior Capstone Design
John DesJardins
Director, Bioengineering Design ProgramsAssistant ProfessorDepartment of Bioengineering,Clemson University, Clemson, SC