1. Bringing Business Practical Experience to BME Education L. Franklin Bost, MBA, IDSA Director of Design Instruction

2. What is a Biomedical Product?

3. 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

4. Product Development Needs and Wants Form Creativity Social Environment Innovation Return (Financial, Social, etc.) Performance Customer Satisfaction Price Who’s Needs and Wants Environmental Ideation Technology Political Engineering Design Specifications Regulatory Pathway Build Engineering Specifications Intellectual Property Reimbursement Function Costs Human Factors & Ergonomics Materials & Processes GMPs, QSRs, ISO

5. Project Development in the Corporate Environment Problems, Opportunities Wants and Needs

6. 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

7. The Funnel

8. 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

9. Design/Concept Generation Many concepts –Many approaches –Do not “lock-in” early Being creative, innovative Evaluating concepts Iterative design and development process Many solutions…

10. 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

11. 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

12. Thank you