Commercializing Successful Biomedical Technologies
Commercializing Successful
Biomedical Technologies
Basic Principles for the Development of Drugs,
Diagnostics, and Devices
SHREEFAL MEHTA
Preface
This book will help readers get an overview of the process of taking a biomedical
invention and creating a product that can pass regulatory approval to be successfully
commercialized. The regulated products included in this context are drugs
(both small molecules and biologics), medical devices, diagnostics, and their combination
products, as defined by the Food and Drug Administration (FDA) – the
regulatory agency that is responsible for overseeing the world’s single largest
healthcare market, the United States. The term ‘‘biomedical technologies’’ refers
to the collective technologies underlying these FDA-regulated products: biotechnology,
various engineering technologies, chemistry and materials science, etc.
The book aims to highlight key issues that might help improve chances of success
through the complete commercialization process for biomedical technologies and
products. This text started as an expansion of a series of lectures given to students at
the Lally School of Management and Technology, Rensselaer Polytechnic Institute
in Troy, NY as part of a class called ‘‘Commercializing biomedical technology.’’
However, going beyond the classroom in writing this book, information has been
taken from many sources and experienced people from industry have contributed
to add current and practical information to various segments of the book.
This book could be used to bring science and engineering students together with
business and law students, and show them the benefits of approaching this complex
process as a team. Many of these students have found the information useful in job
interviews and in planning careers in the biotech industry and its service sectors.
This book has focused on keeping a practical perspective throughout, so that
current scientists, engineers and managers in the industry can apply these concepts,
issues, and exercises within the context of their job functions in the industry. What’s
more, aspiring entrepreneurs may seek to apply these concepts to their invention or
idea; walking through all the steps and exercises to create a sound commercialization
plan that can form the basis for a business plan for a new venture (see figure).
Business models and financial plans vary with the economic or personal context
and the goals of the founders. However, any business model, to be successful, must
come from an understanding of the complete commercialization path for the
regulated product. The linear roadmap shows the components that must be
assessed to build a sound commercialization plan, but the processes are all carried
out in parallel, with shifting emphasis on each component as one proceeds down the
plan. The sequence of components is mirrored in the sequence of chapters
Download
http://s18.alxa.net/s18/srvs2/02/003...chnologies.rar
Commercializing Successful
Biomedical Technologies
Basic Principles for the Development of Drugs,
Diagnostics, and Devices
SHREEFAL MEHTA
Preface
This book will help readers get an overview of the process of taking a biomedical
invention and creating a product that can pass regulatory approval to be successfully
commercialized. The regulated products included in this context are drugs
(both small molecules and biologics), medical devices, diagnostics, and their combination
products, as defined by the Food and Drug Administration (FDA) – the
regulatory agency that is responsible for overseeing the world’s single largest
healthcare market, the United States. The term ‘‘biomedical technologies’’ refers
to the collective technologies underlying these FDA-regulated products: biotechnology,
various engineering technologies, chemistry and materials science, etc.
The book aims to highlight key issues that might help improve chances of success
through the complete commercialization process for biomedical technologies and
products. This text started as an expansion of a series of lectures given to students at
the Lally School of Management and Technology, Rensselaer Polytechnic Institute
in Troy, NY as part of a class called ‘‘Commercializing biomedical technology.’’
However, going beyond the classroom in writing this book, information has been
taken from many sources and experienced people from industry have contributed
to add current and practical information to various segments of the book.
This book could be used to bring science and engineering students together with
business and law students, and show them the benefits of approaching this complex
process as a team. Many of these students have found the information useful in job
interviews and in planning careers in the biotech industry and its service sectors.
This book has focused on keeping a practical perspective throughout, so that
current scientists, engineers and managers in the industry can apply these concepts,
issues, and exercises within the context of their job functions in the industry. What’s
more, aspiring entrepreneurs may seek to apply these concepts to their invention or
idea; walking through all the steps and exercises to create a sound commercialization
plan that can form the basis for a business plan for a new venture (see figure).
Business models and financial plans vary with the economic or personal context
and the goals of the founders. However, any business model, to be successful, must
come from an understanding of the complete commercialization path for the
regulated product. The linear roadmap shows the components that must be
assessed to build a sound commercialization plan, but the processes are all carried
out in parallel, with shifting emphasis on each component as one proceeds down the
plan. The sequence of components is mirrored in the sequence of chapters
Download
http://s18.alxa.net/s18/srvs2/02/003...chnologies.rar