In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
"This book comprehensively captures the essence of inventing medical devices through anecdotes, case studies and real life examples. A recommended must read for any aspiring entrepreneur who wishes to invent new medical devices in India." - Dr. Balram Bhargava,Padmashri, Professor of Cardiology, Cardiothoracic Sciences Centre, Executive Director, Stanford India Biodesign Centre, School of International Biodesign (SIB), All India Institute of Medical Sciences, New Delhi. "A timely resource- This is a remarkably readable and useful primer on medical device innovation in India, written by one of the emerging leaders in the field. The realistic perspective and practical suggestions in this book have arrived just in time for a health technology ecosystem that is in a substantial stage of growth." - Dr. Paul Yock, Founder and Director, Stanford Biodesign "Despite the stated focus as a book for doctors looking to engage with the MedTech ecosystem in India, this book has several teachings for engineers, product designers, business strategists, marketing folks and investors as well." - The Hans India In this book, the author shares his experiences, anecdotes, insights and failures while inventing medical devices in India over the last six years. The idea is to give entrepreneurs (clinicians, engineers, designers, business professionals) a realistic expectation of the time, money, co-ordination and teamwork required to develop a medical device in India. This book includes case studies, anecdotes, caricatures and a special “how I do it” section at the end of the book that gives step-by-step guidelines on how to identify a need, make clinical observations, create need statements, perform needs filtering, develop criteria, conceptualize a solution and take it to a proof of concept. This book is recommended for all Indian healthcare professionals, engineers and product designers who seek to solve unmet clinical challenges with new medical devices, but are unsure of how to go about taking their idea from the concept stage to an actual product. This book illustrates ways for engineers and designers to formally engage with doctors, and gives a comprehensive perspective of the path from ideation to commercialization.
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.
Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha
"The Inventor's Guide for Medical Technology: From Your Napkin to the Market--What Innovators Need to Know" offers a series of clearly defined steps, guiding inventors in the process of taking their idea "from concept to market." In chapters such as "The Invention," "Research and Development," "Manufacturing," “Finance and Accounting,” “Launching in the U.S.” and “The Exit,” Paul Kullmann discusses trademarks and patents, clinical trial designs, funding, choosing the right team, and so much more. Each chapter ends with a tidbit of personal advice, based on Kullmann's insight and indisputably expert knowledge. With Kullmann's guidance, inventors and entrepreneurs alike can sidestep the pitfalls and increase their probability of success. See the free tool library information available inside the book. With his over twenty-eight years in the medical technology field and a long history as an entrepreneur, speaker, educator, and angel investor, Patrick Kullmann is the voice of experience.
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
The MedTech ecosystem in India is emerging and the Indian medical devices industry is on the growth curve, estimated to be a 14 Billion USD industry by 2020. However, the ecosystem is poorly understood with its diverse healthcare systems, complex stakeholders and limited available data. It is important to understand the MedTech ecosystem in India well before developing new medical technologies that suit this environment. In this book, the author shares his experiences, anecdotes, insights and failures while inventing medical devices in India over the last five years. The idea is to give entrepreneurs (clinicians, engineers, designers, business professionals) a realistic expectation of the time, money, co-ordination and teamwork required to develop a new medical device in India. This book is specially recommended for Indian healthcare professionals who are passionate about solving unmet clinical challenges by inventing new medical devices, but are not sure of how to go about taking their idea from a concept stage to an actual product. Entrepreneurs from engineering, design and business backgrounds, will also find this book useful, as it illustrates ways to engage with doctors, and gives a comprehensive perspective of the path from ideation to commercialization. This book attempts to address all common queries a budding entrepreneur in India can have such as "Where to find clinical challenges worth solving?" "How to find them?" " How do I form a cross-disciplinary team?" "Where do I find these people?" "If I have a great idea, when and how can I sell it?" "How long does it take to make a new medical device in India?" " How can I raise money for this development?" "How can full time practicing doctors work with engineers to develop a new device?" "How can engineers engage doctors for clinical inputs and validation?" " How can an invention that is developed at an academic institute be successfully translated to market through a start up company?" "How and when can I start making money?." The list is endless and understandably so because the MedTech ecosystem in India is still evolving and growing from infancy to adulthood. This book also provides in great detail, real life examples of financial expenditures necessary for various stages of the device development process and some financial terms for licensing and investment deals.
