Shreefal S. Mehta

Commercializing Successful Biomedical Technologies (eBook, PDF)

Basic Principles for the Development of Drugs, Diagnostics and Devices

• Format: PDF

Produktbeschreibung

Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.

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Produktdetails

• Verlag: Cambridge University Press
• Erscheinungstermin: 24. April 2008
• Englisch
• ISBN-13: 9780511401305
• Artikelnr.: 38202295

Autorenporträt

Shreefal S. Mehta is Clinical Associate Professor of Biotechnology Management and Biomedical Engineering, Rensselaer Polytechnic Institute and Vice President, Business and Corporate Development, Cytopia Inc. He received his PhD in Biomedical Engineering from University of Texas Southwestern Medical Center in 1995. He was CEO and co-founder of Myomatrix Therapeutics, a cardiovascular pharmaceutical startup and recipient of the '40 under 40' award for rising business leaders in New York. He has been a reviewer for the NSF Biotechnology Commercialization SBIR Review panel.

Inhaltsangabe

Foreword
Glossary
1. Biomedical device and drug design industry and markets
2. Markets of interest and market research steps
3. Intellectual property and licensing
4. Product development
5. Regulatory pathway
6. Manufacturing
7. Reimbursement and distribution
Appendices: A. General sources of information (websites, associations)
B. Alphabet soup of regulatory bodies, regulations and standards
Index.