Biodesign: The Process of Innovating Medical Technologies

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  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2009-09-25
  • Publisher: Cambridge University Press
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Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovoation process identify, invent, implement provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at ebiodesign.org.

Table of Contents

Needs Finding
Strategic focus
Observation and problem identification
Need statement development
Case study
Needs Screening
Disease state fundamentals
Treatment options
Stakeholder analysis
Market analysis
Needs filtering
Case study
Concept Generation
Ideation and brainstorming
Concept screening
Case study
Concept Selection
Intellectual property basics
Regulatory basics
Reimbursement basics
Business models
Final concept selection
Case study
Development Strategy and Planning
IP strategy
R&D strategy
Clinical strategy
Regulatory strategy
Quality and process management
Reimbursement strategy
Marketing and stakeholder strategy
Sales and distribution strategy
Competitive advantage and business strategy
Case study
Operating plan and financial model
Business plan development
Funding sources
Licensing and alternate pathways
Case study
Table of Contents provided by Publisher. All Rights Reserved.

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