Excerpt From

BioDesignThe Process of Innovating Medical Technologies

by Paul Yock, Josh Makower, and Stefanos Zenios

Cambridge University Press, 2010

IDENTIFY --> INVENT --> IMPLEMENT

THE 6 STAGES of MEDICAL DEVICE DEVELOPMENT1) Identify -- Needs Finding

strategic focus, need statement2) Identify -- Needs Screening

disease state, treatment options, stakeholder/market analysis, needs filtering3) Invent -- Concept Generation

ideation, brainstorming, concept screening4) Invent -- Concept Selection

intellectual property(IP), regulatory and reimbursement concerns, prototyping5) Implement -- Development Strategy and Planning

strategy for research/development, clinical use, IP, regulatory, quality, marketing6) Implement -- Integration

business plan, operating plan, financial model, funding sources, licensing

see website www.ebiodesign.org

Quotes to inspire Needs Finding -->

If you want to have good ideas, you must have many ideas-- Linus Pauling, Nobel Prize, BioChemistry

If I had asked my customers what they wanted, they would have said a faster horse.

-- Henry Ford