Biomedical Engineering Design Course Content: Industrial v Academic Viewpoints

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Biomedical Engineering Design Course Content
Industrial v Academic Viewpoints

• Paul King, Vanderbilt University
• Richard Fries, Datex-Ohmeda Corp.

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Why?

• ABET requires a capstone design course.
• No BME Design Textbook exists.
• No BME Specific Design Taxonomy Exists.
• Are Industrial Academia Viewpoints different?
• Are there any suggestions regarding additions?

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ABET Statement Criterion 4

• Students must be prepared for engineering
  practice through the curriculum culminating in a
  major design experience based upon the knowledge
  and skills acquired in earlier coursework and
  incorporating engineering standards and realistic
  constraints that include most of the following
  considerations economic environmental
  sustainability manufacturability ethical
  health and safety social and political.

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ABET Criteria for BME Design

• One course, primarily design, preferably senior
  (Jr acceptable)
• More than ½ engineering design
• Must require prerequisite(s)
• Reference 2000-2001 Criteria for Engineering
  Programs ABET p14,15

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No BME Design Textbook exists

• Teaching notes Mixture of ME/EE/NSF
• Proposal to Whittaker (Outline)-gtReject
• Fries Reliable Design of Medical Devices
• KF -gt Whittaker (Outline) -gtAccept
• 4 Chapters -gt Whittaker -gt Reject

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No BME Specific Taxonomy Exists.

• NSF ERC in Bioengineering Education has a Design
  Thrust, part of the work to be done involves
  development of a Taxonomy of Design Education.
• Can we determine this taxonomy via scrutiny of
  the literature and a survey of industry and
  academia?

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Survey

• 42 Topics, H,M,L,X ask for additions
• Industry (Fries)
• Academia (US, King, see http//vubme.vuse.vanderb
  ilt.edu/King/design_education.htm )

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BME Specific Topics

• 7/42 Design Topic Survey Biomedical
• Definition Medical Device, History
• FDA Human Factors, Trials, Reporting,
  Documenting
• Materials environment(s)
• Animal Clinical Trials
• Safety, Reliability,

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Results

• 17 Academic Responses (47US)
• 9 Industrial (8 Industries)
• H3, M2, L1, X0, averages t-test
• to date

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Highest Rated (Academia)

• Product Definition Issues Initial Specification
  Issues 2.88 (out of 3)
• Progress Reports Expectations for Written
  Reports 2.76
• Product Specification Requirements, Design,
  Reliability, Tracking 2.65
• Design Examples 2.53

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Highest Rated - Industry

• Product Specification Requirements, Design,
  Reliability, Tracking AND Risk Analysis/Hazard
  Analysis 2.89
• Design Examples 2.78
• Product Definition Issues Initial Specification
  AND Design Documentation Requirements - 2.67

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Lowest - Academia

• Professional Societies and Licensure AND Business
  Plan Development 1.24 AND The Future of the
  Design Process
• Reverse Engineering Software and Hardware 1.17
• Poster Presentation Basics AND History of
  Biomedical Engineering Devices- 1.06
• Accident Reconstruction 1.00

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Lowest - Industry

• Industrial Design Group Construction and
  Management AND Accident Reconstruction 1.0
• Gannt and Pert Charts and Related Software - .89
• Professional Societies and Licensure AND Business
  Plan Development - 78

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Maximum Difference Industry-Academic

• Software and Process Design Considerations .76
  (p0.12)
• Risk Analysis/Hazard Analysis .71 (p0.01)
• Brainstorming/Idea Generation .75 (p.05)
• Gannt and Pert Charts Related Software AND
  Progress Reports Expectations -.87 (p0.03)

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Maximum Agreement IndustryAcademic

• Accident Reconstruction 1.0 p1.0
• QFD (1.89) Decision Matrix (2.1) p.99
• Future of the Design Process (1.21.2) p.97
• Estimating Life Cycle Costs (1.6) p.94
• Formal design (1.8) AND Reverse Engineering (2.2)
  AND DFMA (1.9) AND FDA/ISO (2.2) p.9
• Product Safety Liability (2.2) p.88

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Maximum Disagreement IndustryAcademic

• Animal/Clinical Trials, GLP (2.21.6) AND Medical
  Device Definition (2.61.9) AND IP Considerations
  (1.42) p.1
• Brainstorming (1.62.4) p.05
• Written Progress Reports (1.92.8) p.04
• CAD(2.11.4) AND Gannt/Pert (.91.8) p.03
• Risk/Hazard Analysis (2.92.1) p.01

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Comments Gathered

• . .. the course should prepare students to manage
  projects in the medical device industry. They
  should learn about project management and be
  given the opportunity to develop their
  interpersonal and communication skills. They
  should also learn something about business and
  how a company functions. At Marquette, we are
  presenting lectures to help prepare them for
  their careers by including topics such as
  professional development, career survival and
  management, and personal finance.

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Comments, Continued

• Nonetheless, I am a big believer in process, and
  think the students should leave a design course
  understanding that design is primarily a decision
  making process (i.e. Decision-based design) and
  that by following a process successful designs
  will be achieved. SUNY-SB

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Suggested Additions

• Ethics (7!)
• Economics/Cost/benefit analysis (2)
• Experimental design
• Clinical experiences
• Top-down design, Systems engineering
• OOPs, FOI, Large system errors

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To Be Done

• More Industrial Responses needed
• International Survey?
• Report at ASEE
• Report at BMES
• Report in journal form

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Summary

• Preliminary results indicate a fair amount of
  academic-industrial agreement.
• Academics emphasize training for reporting
  (oral/written) and overall project planning v
  Industry expects reporting ability and delegates
  planning elsewhere.