open2012 industry-gate-reviews

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

[email protected]


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


1963

2003

Clemson University

Bioengineering

45 years of tradition and excellence in bioengineering education and research

2009

http://www.clemson.edu/agforestryresearch/gh/images/biosys_jpg.jpg


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

http://www.clemson.edu/agforestryresearch/gh/images/biosys_jpg.jpg

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


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


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.


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


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


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


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


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

http://upload.wikimedia.org/wikipedia/commons/d/d6/Waterfall_vs_iterative.JPG

http://upload.wikimedia.org/wikipedia/commons/d/d6/Waterfall_vs_iterative.JPG

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


Needs Product DefinitionRequirements

(Units)

Requirement Specifications

DesignSpecifications

INPUTS

Verification andValidation

OUTPUTS

Targets

The Design “Method(s)”

Review

ReviewReview

Review


Design “Gate” Model Examples

www.devicix.com


www.devicix.com


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


Industry Partnership in Design Education

Electrode CompaniesDesigning, manufacturing and distributing

neurodiagnostic electrodes and accessories



www.devicix.com

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


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


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


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


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


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


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


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


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


~ P

ractice

safe

desig

n: U

se a

con

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etru

la V

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© 2010 Institute for Health Technology Studies

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


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


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



John DesJardins

Director, Bioengineering Design ProgramsAssistant ProfessorDepartment of Bioengineering,Clemson University, Clemson, SC

[email protected]

open2012 industry-gate-reviews

Education

bioengineering design

bioengineering minor

bioengineering education

bioengineering educators

field of bioengineering

clemson university u

pedal application errorsdr

undergraduate students