Open2012 industry-gate-reviews

Industry GateApplication Errors” Task Order 6
NHTSA Contract No. DTNH22-07-D-00049, as a
“Pedal
Reviews
Method to Facilitate Senior
Capstone Design

John DesJardins

Director, Bioengineering Design Programs
Assistant Professor
Department of Bioengineering,
Clemson University, Clemson, SC

jdesjar@clemson.edu

NHTSA Contract No. DTNH22-07-D-00049, Task Order 6
“Pedal Application Errors”
Dr. John DesJardins
 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

Clemson University: A Brief Overview
 A land-grant university founded in 1889
 Focus on agriculture and engineering
 Tradition of economic transformation in
agriculture, textiles, ceramics, chemicals
 Technically oriented public research
university
 17,000 graduate and undergraduate students
 $170 million in research expenditures
 Strength in
engineering, architecture, agriculture, entrepreneu
rship, and communication

Clemson University

U.S.News & World Report,
Best Public Universities, 2011
#23 Clemson University

Scientist magazine, 2007
#1 Place to Work in Academia

U.S.News & World Report,
Best Graduate Schools, 2010
#22 Bioengineering

Clemson University
Academic Emphasis Areas

Leadership and Entrepreneurship

Automotive Biotechnology Information
Advanced and and and Sustainable
Materials Transportation Biomedical Communication Environment
Technology Sciences Technology

Family and Community Living
General Education

Bioengineering Cardiovascular Biomaterials/ Neuroscience/
Tissue Engineering Biomechanics Bioelectronics

Psychology Human Factors Industrial/Organizational Human Performance
Psychology Appraisal Enhancement
Clemson University Academic Plan, 2002-2010

Clemson University: A Brief Overview
 PhD 1963

 Department 1968

 New undergraduate program in 2006
 296 current sophomore-seniors
 65 in current senior class

 ABET accredited 2011

Clemson University
1963
Bioengineering

2003

2009

45 years of tradition and
excellence in bioengineering
education and research

Bioengineering, Statewide Collaboration
Translational Research
From Bench to Bedside
Education
Incubation
ACADEMIC SEMESTERS
2010

Basic Research

Technology
Development Clemson/USC
Educational-Clinical
Undergraduate & Partnerships
Graduate
Education SC Bioengineering
1985 Alliance

MD/PhD
DMD/PhD
1963
Clinical Research
Research Training
SUMMERS
2003

2003

Bioengineering Senior Design
Brief History
 Before our Undergraduate Program
(pre-2006)
 Biomedical Design
 Core 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.

Brief History
 New Undergraduate Program (2006)

 First Group of BioE Seniors in 2009
 29 students

 BioE401 Biomedical Design
 3 credit, one semester course
 Lectures + Design at the same time
 Internally Funded
 Student Selected Designs



A Growing Problem Opportunity
 Finding, Managing and Financing Clinically Relevant Senior
Design Projects for:
 6 Students, 2008
Major Curriculum Revision
 BioE 401, Bioengineering Design Theory (Fall)
 BioE 403, Applied Bioengineering Design (Spring)
 85+ Students, 2013

Bioengineering, Biomaterials Curriculum

Manufacturin
Freshman
g Skills
Mentoring
Assessment
and Design
Experience
s in CI

SolidWorks
/Matlab

Bioengineering, Biomaterials Curriculum

Bioinstrumentatio
n Design

Design
Theory

Applied
Design

Bioengineering “Pedal Application Errors”

Design Curriculum
 BioE 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.

~ People ignore design that ignores
Bioengineering people.
-Frank
Design Curriculum Chimero

 BioE 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.

The AIDS/HIV Pandemic
◦ 2007 Statistics
 42 Million Infected World Wide
 3.1 Million deaths, 5 Million New Infections

Design Objective
 To design an inexpensive alternative
to more costly cutting tools to:
 Increase procedure safety
 Increase the number of safe procedures performed
 Metal handle w/ blade  Surgical scissors  Plastic handle w/ blade
 ~ $4.00-$10.00  ~ $20.00-$50.00 (disposable)
 ~ $1.00-$2.00

$0.07
www.qcsupply.com, www.surgicalonline.com, www.zefon.com

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
Paralympics
Design Objective
 To design elite performance prosthesis
for competitive events
 Improve quality of life for active amputees

picasaweb.google.com, www.thisisbrian.com

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
Bi-leaflet
Design Objective
 To 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.pdf
Sathe, R. et. al, “Flexible Prosthetic Vein Valve”, June 2007, Journal of Medical Devices
Pavcnik, "Percutaneous management of chronic deep venous reflux: review of experimental work
and early clinical experience with bioprosthetic valve", Vascular Medicine.


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 Objective
 To 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 Mind
 Needs Finding, Assumptions
 Market Analysis
 Design Documentation
 QFD, Constraints, Drawing
 Patents, IP
 Brainstorming, Ideation
 Problem Definition
 Targets, Inputs
 Manufacturing
 Product Development
 Regulation
 Design Theory Models


Senior Design Curriculum, 2nd Semester
 BioE 403, Applied Bioengineering Design (Spring)
 Proposals
 Clinical/Industry Meetings
 Budgets, Timelines
 Agendas, Minutes
 Design History Files
 Prototyping
 Verification/Validation
 Design Reviews
 Patent Disclosures
 Regulatory Paperwork
 Design Competitions

Design “Method(s)”

~ Design is the
conscious effort to
impose a meaningful
order.

Before this??????
Product Requirements
The Product
Development
Design/Development Planning
Process
System Requirements
Specification

Requirements
Design Review

Design Inputs

Design
Outputs

Design Review

Design Verification

Design Validation

Design Transfer Design Reviews

Product Idea
Generation

Product Design Team
Formation

Product Definition

Customer and
QFD

Product
Documentation, Business
Proposal, Markets, Risks

Product
Requirements

The Design “Method(s)”

Needs Requirements (Units) Product Definition

Requirement Design
Specifications Specifications

Targets
Review
Review
OUTPUTS
INPUTS

Review Verification and Review
Validation

Design “Gate” Model Examples

www.devicix.com


Industry Gate Reviews as a
Method to Facilitate Senior
Capstone Design

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 solutions
 Students work on clinical/industry relevant projects
 Faculty mentors assist students and collaborate with industry

 Industry funding supports the design program
 Industry has access to students for potential hires
 Students learn industry relevant design processes


Industry Partnership in Design Education
 Electrode Companies
 Designing, manufacturing and distributing
neurodiagnostic electrodes and accessories

Bioengineering Design Gates

Week
3-4  Gate 1: Design Proposal (review)
5-6  Gate 2: Design Technical Competency
7-8  Gate 3: Prototype Production Plan
9-10  Gate 4: Verification/Validation Plan
13-14  Gate 5: Prototype Presentation/Specification
15-16  Gate 6: V/V Results/Analysis
~ Good design goes
17 Final Showcase (poster show) to heaven. Bad
design goes
everywhere.

Gate DHF
Week Document Docs.
3-4  Gate 1: Proposal (review)  
5-6  Gate 2: Technical  
7-8  Gate 3: Production Plan  
9-10  Gate 4: V/V Plan  
13-14  Gate 5: Prototype  
15-16  Gate 6: V/V Results  

17 Final Showcase (poster show)


 Typical Gate Format
 Team of 4-5 students 2-3 faculty, 1 TA
 45 minutes, once every 2 weeks
 Agenda and Minutes produced by students
 15 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


Week  Gate 1: Design Proposal (review)
3-4  15 minute presentation
 Topic background, clinical need, scope, objectives,
design inputs, materials/equipment/lab resources,
proposed budget, timeline, milestones
 1st rough prototype
 Gate Document
 Design Proposal (10 pages)
 DHF Documents
 1) Timeline, 2) Stakeholder, ~ Designers are
3) Core Team, 4) QFD meant to be loved, not
understood.


Week  Gate 2: Design Technical Competency
 20 minute presentation
5-6  Topic theoretical background, technical literacy,
bioengineering knowledge base review.
 NOT practical knowledge
 2nd rough prototype
 Gate Document
 5 Journal Article Reviews
 DHF Documents
 5) Competitor Assessment, 6) Market Analysis


Week  Gate 3: Prototype Production Plan
 20 minute presentation (and document)
 Concise engineering description of the prototype
 Proposed production methods
7-8  Parts List
 Materials and Materials Specifications
 Manufacturing Methods and Suppliers
 # of parts to be produced
 Engineering level drawings of the parts and complete
design (with dimensions).

 3rd rough prototype
 DHF Documents
 7) Budget, 8) DFMEA


Week  Gate 4: Verification and Validation Plan
3-4  20 minute presentation, 25 min discussion
5-6  Balance of Quality System Assurances, Verification and
Validation Plans (mock clinical trials)
7-8  10-20 hours of V/V work per team member
 Summaries of Design Inputs, Targets and Outputs
9-10  Equipment, Materials and Supplies for Testing
13-14  Standards and Tests Methods
 Expected Results, Analysis of Data
15-16
 V/V Document (Contract)
 DHF Documents
17  9) Regulatory Pathway, 10) Industry/Customer
Interviews, 11) Standards


Week  Gate 5: Prototype Presentation
3-4  Physical Device and Use Presentation
5-6  Demonstration of Device Function and Parameters
 Verification of User-Met Needs
7-8
 Device Specification Sheet
9-10  Technical summary, market niche (specification key features),
clear listing of the engineering specifications with operational
13-14 values, photos or drawings of device and preferably with the
device in use.
15-16
 DHF Documents
 12) Patent Review, 13) Drawings
17


Week  Gate 6: Verif./Valid. Presentation
3-4  Presentation of Outputs = Inputs
5-6  Statistical Discussion of Device Performance Assessment,
Tests Performed, Data Collected, Surveys Received.
7-8  All data summarized in Conference-Style Abstracts
 V/V Reports, 1 page per input
9-10
 Input Abstracts (1 page per Input)
13-14  Need, Input, Materials and Methods, Standards, Data
analysis, Discussion, Risk
15-16
 DHF Documents
 13) Patent Disclosure,
17 14) Video,
~ Good design is a lot like
clear thinking made visual.
15) NCIIA Document - Edward

Senior Design Paradox

Design Theory
vs.
Build and Test a Prototype
vs.
Refine/Market/Produce a Final
Product

~ Good design is
obvious, Great design is
transparent.


Clinically Relevant Designs
Through Industry Partnerships

 2010
 38 Students
 7 Teams, 1 Sponsor
 2 Patent Disclosures

 2011
 54 Students
 11 Teams, 3 Sponsors
 2 Patent Disclosures (more pending)
 1 License of Rights


Design Curriculum
 BioE 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

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