Open2012 industry-gate-reviews

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Open2012 industry-gate-reviews

  1. 1. Industry GateApplication Errors” Task Order 6 NHTSA Contract No. DTNH22-07-D-00049, as a “Pedal ReviewsMethod to Facilitate SeniorCapstone Design John DesJardins Director, Bioengineering Design Programs Assistant Professor Department of Bioengineering, Clemson University, Clemson, SC jdesjar@clemson.edu
  2. 2. 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
  3. 3. 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
  4. 4. Clemson University U.S.News & World Report, Best Public Universities, 2011 #23 Clemson UniversityScientist magazine, 2007#1 Place to Work in Academia U.S.News & World Report, Best Graduate Schools, 2010 #22 Bioengineering
  5. 5. 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 EducationBioengineering Cardiovascular Biomaterials/ Neuroscience/ Tissue Engineering Biomechanics BioelectronicsPsychology Human Factors Industrial/Organizational Human Performance Psychology Appraisal Enhancement Clemson University Academic Plan, 2002-2010
  6. 6. 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
  7. 7. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Clemson University “Pedal Application Errors” 1963 Bioengineering 2003 2009 45 years of tradition and excellence in bioengineering education and research
  8. 8. Bioengineering, Statewide Collaboration NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Translational Research From Bench to Bedside Education Incubation ACADEMIC SEMESTERS 2010 Basic Research Technology Development Clemson/USC Educational-ClinicalUndergraduate & Partnerships Graduate Education SC Bioengineering 1985 Alliance MD/PhD DMD/PhD 1963 Clinical Research Research Training SUMMERS 2003 2003
  9. 9. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Bioengineering Senior DesignBrief 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.
  10. 10. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Bioengineering Senior DesignBrief 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
  11. 11. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Bioengineering Senior Design “Pedal Application Errors”A Growing Problem Opportunity Finding, Managing and Financing Clinically Relevant Senior Design Projects for:  6 Students, 2008  29 Students, 2009Major Curriculum Revision BioE 401, Bioengineering Design Theory (Fall) BioE 403, Applied Bioengineering Design (Spring)  38 Students, 2010  54 Students, 2011  65 Students, 2012  85+ Students, 2013
  12. 12. Bioengineering, Biomaterials Curriculum NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Manufacturin Freshman g Skills Mentoring Assessment and Design Experience s in CI SolidWorks /Matlab
  13. 13. Bioengineering, Biomaterials Curriculum NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Bioinstrumentatio n Design Design Theory Applied Design
  14. 14. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 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.
  15. 15. ~ People ignore design that ignores NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Bioengineering people. “Pedal Application Errors” -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.
  16. 16. 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 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 $0.07www.qcsupply.com, www.surgicalonline.com, www.zefon.com
  17. 17. Enhancing Athletic Performance of NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” 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 amputeespicasaweb.google.com, www.thisisbrian.com
  18. 18. Biomedical Device Design NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” 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 methodologieshttp://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 workand early clinical experience with bioprosthetic valve", Vascular Medicine.
  19. 19. 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 Objective  To design enhanced Bi-PAP system to more affectively treat sleep apnea  Use novel monitoring system, patient feedback, bio-instrumentationhttp://theauburner.com
  20. 20. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Bioengineering “Pedal Application Errors” 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
  21. 21. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Bioengineering “Pedal Application Errors” 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
  22. 22. Design “Method(s)” NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”~ Design is theconscious effort toimpose a meaningfulorder.
  23. 23. 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
  24. 24. Product Idea Generation Product Design Team Formation Product Definition Customer and QFD Product Documentation, Business Proposal, Markets, Risks Product Requirements
  25. 25. The Design “Method(s)” NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Needs Requirements (Units) Product Definition Requirement Design Specifications Specifications Targets Review Review OUTPUTS INPUTSReview Verification and Review Validation
  26. 26. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Design “Gate” Model Examples www.devicix.com
  27. 27. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Design “Gate” Model Examples www.devicix.com
  28. 28. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Industry Gate Reviews as aMethod to Facilitate SeniorCapstone Design
  29. 29. Bioengineering Design NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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
  30. 30. Bioengineering Design NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Industry Partnership in Design Education Electrode Companies  Designing, manufacturing and distributing neurodiagnostic electrodes and accessories
  31. 31. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Design “Gate” Model Examples www.devicix.com
  32. 32. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Design “Gate” Model Examples www.devicix.com
  33. 33. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”Week 3-4  Gate 1: Design Proposal (review) 5-6  Gate 2: Design Technical Competency 7-8  Gate 3: Prototype Production Plan9-10  Gate 4: Verification/Validation Plan13-14  Gate 5: Prototype Presentation/Specification15-16  Gate 6: V/V Results/Analysis ~ Good design goes 17 Final Showcase (poster show) to heaven. Bad design goes everywhere.
  34. 34. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” Gate DHFWeek 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)
  35. 35. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors” 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
  36. 36. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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.
  37. 37. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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
  38. 38. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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
  39. 39. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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 Outputs9-10  Equipment, Materials and Supplies for Testing13-14  Standards and Tests Methods  Expected Results, Analysis of Data15-16  V/V Document (Contract)  DHF Documents 17  9) Regulatory Pathway, 10) Industry/Customer Interviews, 11) Standards
  40. 40. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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 Sheet9-10  Technical summary, market niche (specification key features), clear listing of the engineering specifications with operational13-14 values, photos or drawings of device and preferably with the device in use.15-16  DHF Documents  12) Patent Review, 13) Drawings 17
  41. 41. Bioengineering Design Gates NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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 input9-10  Input Abstracts (1 page per Input)13-14  Need, Input, Materials and Methods, Standards, Data analysis, Discussion, Risk15-16  DHF Documents  13) Patent Disclosure, 17 14) Video, ~ Good design is a lot like clear thinking made visual. 15) NCIIA Document - Edward
  42. 42. ~ Practice safe design: Use a concept. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”- © 2010 Institute for Health Technology Studies
  43. 43. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”
  44. 44. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Senior Design Paradox “Pedal Application Errors” Design Theory vs. Build and Test a Prototype vs. Refine/Market/Produce a Final Product~ Good design isobvious, Great design istransparent.
  45. 45. Bioengineering Design NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 “Pedal Application Errors”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
  46. 46. NHTSA Contract No. DTNH22-07-D-00049, Task Order 6 Bioengineering “Pedal Application Errors” 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
  47. 47. Industry GateApplication Errors” Task Order 6 NHTSA Contract No. DTNH22-07-D-00049, as a “Pedal ReviewsMethod to Facilitate SeniorCapstone Design John DesJardins Director, Bioengineering Design Programs Assistant Professor Department of Bioengineering, Clemson University, Clemson, SC jdesjar@clemson.edu

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