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.
"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.
Ever year, new technologies advance and improve societies. Some of the most influential inventions have occurred in the health and medical field. This book explores important inventors and the inventions that have influenced the medical industry, such as the smallpox vaccine, CT scanners, and DNA cloning.
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.
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.
Did you know that a scientist discovered X-rays by accident? Or that people have been taking pain medicine for more than 5,000 years? Get ready to learn the strange stories behind inventions you use every day. From the Roman warrior with a famous false hand to the Boy Scouts who made Band-Aids a big deal, you'll find out how we got the medical wonders that help us heal faster and feel better.
"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 Physician Inventor is a practical roadmap for doctors, nurses, engineers, startups and others looking to protect their medical devices and methods. The purpose of this book is to equip you to make decisions. Caselaw and footnotes are intentionally kept to a minimum, focusing instead on functional knowledge, sensible advice, and useful anecdotes and examples. The nuances of medical devices are explored based on patent attorney Peter D. Sleman's years of experience with device manufacturers. This book will teach you how to: * Understand the various forms of intellectual property * Conduct a patent search to ensure that your invention is viable * Save thousands of dollars by hiring the right patent attorney * Utilize advanced prosecution techniques to minimize waste * Build an international strategy * Approach business partners with confidence and prudence
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 recent momentum and urgency around translating science and technology into health innovation is inspiring. It is transforming academia, too, as the rapidly-evolving world of health innovation has given rise to a new breed of academic - the academic entrepreneur - who works to move ideas from initial research to practical implementation. The work of these individuals is crucial to realizing the potential of investments in better care, and yet there existed no central repository for information and wisdom relevant to their mission; no place to house and explore the evolving knowledge base around translating evidence into impact.We aim to build one. In the spirit of collaboration, the Children's Hospital of Philadelphia (CHOP) Research Institute collaborated with the University of Pennsylvania's (Penn) Institute for Translational Medicine and Therapeutics (ITMAT) to seed fund a grassroots effort of editors, subject matter experts, and translational research students to create a free open education resource stored on ScholarlyCommons (University of Pennsylvania, Philadelphia, PA).Academic Entrepreneurship seeks to build a diverse community of empowered professionals who know how to bridge the worlds of academic research and commercialization to turn ideas and discoveries into innovations that provide value to patients, providers, and healthcare systems, thereby realizing full market potential and societal impact. This book is a repository of tools, advice, and best practices that establishes a foundation for academic researchers and innovators wherever they may reside.Recognizing that academic entrepreneurs are busy and bright, and have limited time to learn entrepreneurship, the chapters in this book were designed as an efficient and state-of-the-art source of guidance. With carefully curated content as a strong foundation, the reader will have quick introductions to key topics in academic entrepreneurship and innovations with a list of resources for those who wish to go further.This book was created as a limited print run of the first edition of the living content stored in the University of Pennsylvania's open access repository, ScholarlyCommons, as of 1/1/2020. As a living e-textbook, the content of Academic Entrepreneurship for Medical and Health Scientists is continuously enhanced and revised.
