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