Biodesign : The Process of Innovating Medical Technologies
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 innovation 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.
- Electronic book text
- CAMBRIDGE UNIVERSITY PRESS
- Cambridge University Press (Virtual Publishing)
- Cambridge, United Kingdom
- 106 b/w illus. 79 tables
'Everything you ever wanted to know about medical device entrepreneurship and more. Paul, Josh and Stefanos have led an A class team of experienced device company builders to produce a reference document to guide an aspiring device entrepreneur through all the challenges of getting an idea to market. These are tough times. Whether you're a physician with an idea, an engineer or a businessman, this is a unique and powerful resource.' John Abele, Founder Chairman, Boston Scientific '... fascinating ... I would recommend this book strongly to SMEs ... in Europe who wish to penetrate the American market with medical device related products.' Scope
Table of contents
Preface; Community; Biographies; Glossary; Part I. Identify; Section 1. Needs Finding: 1. Strategic focus; 2. Observation and problem identification; 3. Need statement development; Case study; Section 2. Needs Screening: 4. Disease state fundamentals; 5. Treatment options; 6. Stakeholder analysis; 7. Market analysis; 8. Needs filtering; Case study; Part II. Invent; Section 3. Concept Generation: 9. Ideation and brainstorming; 10. Concept screening; Case study; Section 4. Concept Selection: 11. Intellectual property basics; 12. Regulatory basics; 13. Reimbursement basics; 14. Business models; 15. Prototyping; 16. Final concept selection; Case study; Part III. Implement; Section 5. Development Strategy and Planning: 17. IP strategy; 18. R&D strategy; 19. Clinical strategy; 20. Regulatory strategy; 21. Quality and process management; 22. Reimbursement strategy; 23. Marketing and stakeholder strategy; 24. Sales and distribution strategy; 25. Competitive advantage and business strategy; Case study; Section 6. Integration: 26. Operating plan and financial model; 27. Business plan development; 28. Funding sources; 29. Licensing and alternate pathways; Case study; Index.