Stanford University

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					 Bringing Business Practical
Experience to BME Education


     L. Franklin Bost, MBA, IDSA
        Director of Design Instruction
What is a Biomedical Product?
             Early Observations
• Students like hands-on projects
• Students have good technical engineering skills
• Students have limited communication skills
• A project report is different from a lab report
• Most projects do not present well in scientific
  poster format
• Student careers
    – 50% want to design & build (be engineers)
    – 40% are using BME as route to med school
    – small % want to be on PhD/research route
            Product Development
    Needs and Wants                Who’s Needs and Wants

                                           Engineering Design
 Environment       Environmental             Specifications
 Social              Technology           Ideation         Innovation
    Political                                Creativity
                  Intellectual Property                   Human Factors
                                            Function      & Ergonomics
Regulatory Pathway                               Form        Build
                         GMPs, QSRs, ISO
 Costs    Price                                 Materials & Processes
                           Customer
                          Satisfaction                 Performance
Reimbursement
                                                      Engineering
                            Return                   Specifications
                    (Financial, Social, etc.)
                  Project Development in the
                    Corporate Environment
Problems, Opportunities                        Financial Plan
                                                                    Funding                Funding
                                                                    Sources              Commitments
   Wants and Needs
                                                                       Human
        Product                                                       Resources             Staffing
        Concept                                                        Strategy

                                                                                          Marketing &                  P&L
                                                                      Marketing            Sales and                  Results
                                                                      Strategy              Training
                                                                                           Materials
                                   Market        Business
                                   Analysis      Strategy
                                                                     Sales, Pricing
                                                                                           Field Sales
                                                                     & Distribution
                                                                                            Training
                                                                       Strategy


                                                IP Strategy                                                         Post Market
                                                                     Manufacturing
                                                                                                                    Surveillance
                                                                       Strategy
                                                                                                                   and Feedback


                    Concept                     Prototype &
                                   Concept                              Other              Production    Product
                  Refinement &                    Bench
                                 Development                           Strategy             Scale-up     Launch
                    Review                      Evaluation



                                 Regulatory                      Regulatory
                                                 Clinical                                                             User
                                  Pathway                       Submission &
                                                Evaluation                                                           Training
                                  Strategy                      Clearance(s)
                                                                                      Professional
                                                                                      Presentations
                                                                                          and
                                                                                       Publications
                 One Hour MBA
• Planning, Forecast, Budgets
    – Strategic, Annual Operational, Departmental, Project
    – Vision, Goals, Objectives, Action Plans, Assignments
•   Profit and Loss Statement
•   Balance Sheet, Cash Flow
•   Return on Investment
•   Project Evaluation - Financial Metrics
    – Breakeven analysis
    – Discounted cash flow
    – Cost of capital and hurdle rate
The Funnel          IDEAS




                  PROPOSALS

                 JUSTIFICATIONS

                    FUNDING

                 DESIGN & BUILD

              EVALUATION & TESTING

              REVIEW AND DECISION

             REGULATORY CLEARENCE

                    FUNDING

                   SCALE-UP

                MARKET LAUNCH


                   SUCCESS!
           Project Planning
• Balancing
  – Goals, tasks, timelines, milestones
  – Resources: people, funds, equipment,
    facilities
• Visual tracking and communication
  – MS Excel®, MS Project®, Project KickStart®
• Proficiency
  – project planning & management are route to
    advancement
     Design/Concept Generation
• Many concepts
    – Many approaches
    – Do not “lock-in” early
•   Being creative, innovative
•   Evaluating concepts
•   Iterative design and development process
•   Many solutions…
      Medical Device Regulations
• FDA Medical Device Classifications
• FDA Regulatory Pathways
  – 510(k), PMAs
• FDA GMPs and Quality Systems Regulations
  –   Design control documentation
  –   Verification & validation
  –   Software validation
  –   Human Factors & Ergonomics in medical devices
• ISO 13485 Medical Device Standards
                      Conclusion
       Communication Skills Development
• Visual Communications
  – Visual thinking – sketching, drawing
     • perspective, scale, iterations
  – Hands on modeling experience
  – Pin-ups; not scientific style posters
• Written Communications
  – Project Reports
  – Project Books – great in an interview
• Oral Communications
  – Personal presentation skills
Thank you