Bringing Business Practical Experience to BME Education
L. Franklin Bost, MBA, IDSADirector 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
Form
Creativity
Social
Environment
Innovation
Return
(Financial, Social, etc.)
PerformanceCustomer
Satisfaction
Price
Who’s Needs and Wants
Environmental
IdeationTechnology
Political
Engineering Design
Specifications
Regulatory Pathway Build
Engineering
Specifications
Intellectual Property
Reimbursement
Function
Costs
Human Factors
& Ergonomics
Materials & Processes
GMPs, QSRs, ISO
Project Development in the Corporate Environment
Problems, OpportunitiesWants and Needs
Product Concept
Funding Sources
Production Scale -up
Sales , Pricing & Distribution
Strategy
Regulatory Submission & Clearance (s )
Prototype & Bench
Evaluation
Clinical Evaluation
Marketing Strategy
Financial Plan
Business Strategy
Regulatory Pathway Strategy
Market Analysis
Concept Development
Concept Refinement &
Review
Marketing & Sales and Training
Materials
IP Strategy
Product Launch
Field Sales Training
Post Market Surveillance
and Feedback
Manufacturing Strategy
Funding Commitments
User Training
Professional Presentations
and Publications
P& LResults
Human Resources Strategy
OtherStrategy
Staffing
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
PROPOSALS
JUSTIFICATIONS
FUNDING
DESIGN & BUILD
EVALUATION & TESTING
REVIEW AND DECISION
FUNDING
SCALE-UP
MARKET LAUNCH
SUCCESS!
REGULATORY CLEARENCE
The FunnelIDEAS
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
Top Related